This document is an excerpt from the EUR-Lex website
Document C:2017:408:FULL
Official Journal of the European Union, C 408, 30 November 2017
Official Journal of the European Union, C 408, 30 November 2017
Official Journal of the European Union, C 408, 30 November 2017
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ISSN 1977-091X |
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Official Journal of the European Union |
C 408 |
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English edition |
Information and Notices |
Volume 60 |
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Notice No |
Contents |
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I Resolutions, recommendations and opinions |
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RESOLUTIONS |
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European Parliament |
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Wednesday 2 April 2014 |
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2017/C 408/01 |
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2017/C 408/02 |
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Thursday 3 April 2014 |
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2017/C 408/03 |
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2017/C 408/04 |
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2017/C 408/05 |
European Parliament resolution of 3 April 2014 on the EU strategy towards Iran (2014/2625(RSP)) |
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RECOMMENDATIONS |
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European Parliament |
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Wednesday 2 April 2014 |
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2017/C 408/06 |
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2017/C 408/07 |
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2017/C 408/08 |
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II Information |
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INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Parliament |
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Wednesday 2 April 2014 |
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2017/C 408/09 |
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Key to symbols used
(The type of procedure depends on the legal basis proposed by the draft act.) Amendments by Parliament: New text is highlighted in bold italics . Deletions are indicated using either the ▌symbol or strikeout. Replacements are indicated by highlighting the new text in bold italics and by deleting or striking out the text that has been replaced. |
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(1) Text with EEA relevance. |
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EN |
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30.11.2017 |
EN |
Official Journal of the European Union |
C 408/1 |
EUROPEAN PARLIAMENT
2014-2015 SESSION
Sittings of 2 and 3 April 2014
The Minutes of this session have been published in OJ C 100, 26.3.2015 .
The texts adopted of 3 April 2014 concerning the discharge for the financial year 2012 have been published in OJ L 266, 5.9.2014 .
TEXTS ADOPTED
I Resolutions, recommendations and opinions
RESOLUTIONS
European Parliament
Wednesday 2 April 2014
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30.11.2017 |
EN |
Official Journal of the European Union |
C 408/2 |
P7_TA(2014)0256
Effectiveness of European Social Fund spending on older workers (Court of Auditors Special Report 25/2012)
European Parliament resolution of 2 April 2014 on: Are tools in place to monitor the effectiveness of European Social Fund spending on older workers? (Court of Auditors Special Report 25/2012) (2013/2173(INI))
(2017/C 408/01)
The European Parliament,
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having regard to the European Court of Auditors Special Report 25/2012 ‘Are tools in place to monitor the effectiveness of European Social Fund spending on older workers?’, |
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having regard to the European Foundation for the Improvement of Living and Working Conditions, and, more particularly, its 2012 analysis of employment trends and policies for older workers in the recession, |
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having regard to the contribution of the European Agency for Health and Safety at Work on priority groups, in particular older workers, |
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having regard to the 2013 Eurofound study on the role of governments and social partners in keeping older workers in the labour market, |
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having regard to the first international survey on adult skills carried out by the Commission and the OECD in 2013 as part of the Programme for the International Assessment of Adult Competencies (PIAAC), |
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having regard to the guiding principles of the new European Social Fund regulations for the 2014-2020 programming period adopted by Parliament on 20 November 2013, |
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having regard to Rules 48 and 119(2) of its Rules of Procedure, |
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having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on Employment and Social Affairs (A7-0151/2014), |
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A. |
whereas population ageing, changing working conditions, the incentives for early retirement that still exist, the financial crisis and changes in production patterns, as well as demand for increasing competitiveness, call for strong responses to enable older workers to remain active in the labour market, including when they wish to do so beyond retirement age; |
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B. |
whereas the Lisbon Agenda defined an ‘older worker’ as any person of working age between 55 and 64 years old; |
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C. |
whereas in 2012 the employment rate for people aged 55 to 64 was less than 50 % in the European Union (54,4 % for men and 41,8 % for women) and whereas in certain Member States it dropped to as low as around 30 %; whereas this trend could be caused by a number of factors such as outdated skills and qualifications, employers’ attitudes towards older workers, difficulties with reconciling professional and family life, and declining health; |
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D. |
whereas an older labour force and longer working lives can make a positive contribution to recovery and future growth; |
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E. |
whereas older people are indispensable in terms of passing on knowledge and experience to future generations; |
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F. |
whereas the Lisbon Agenda (1) and the Europe 2020 strategy (2) adopted in 2010, which establishes the European Union’s economic and social strategies, include action plans for greater growth and more jobs, and set goals, in particular regarding employment; |
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G. |
whereas maintaining the employability of older workers, as well as keeping a high proportion of the population in work until later in life, is crucial to addressing demographic challenges and reaching the EU target of 75 % of the 20- to 64-year-old population in employment by 2020; |
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H. |
whereas it is necessary, in order to support recent changes in pension systems resulting from the raising of the retirement age, to introduce measures in the labour market and in the workplace to encourage longer careers and enable people to continue working until the retirement age; |
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I. |
whereas, as a result of the current demographic shift, with a rise in the average age of the population, those aged 55 to 64 will make up an ever increasing share of workers in Europe; |
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J. |
whereas several years of economic and financial crisis have meant that the European Social Fund’s (ESF) measures are more important than ever as one of the tools for tackling high unemployment, and lessons learned from implementing previous measures will be vital when the new programmes are put in place from 2014; |
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K. |
whereas the ESF, which during the programming period 2007-2013 accounted for 8 % of the total EU budget, is a key financial instrument intended to help Member States achieve EU employment policy and social inclusion objectives, and whereas reliable data are necessary in order to assess how effectively ESF resources are spent; |
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L. |
whereas regarding the period from 2007 to the end of 2013, neither the Member States nor the Commission can establish how many older workers have gained new qualifications, found or kept a job after participating in an action funded by the ESF; |
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M. |
whereas the lifelong learning measures promoted by the ESF are, on the whole, well suited to keeping people in employment (e.g. by employability training or retraining); |
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N. |
whereas older workers account for less than 5 % of participants in the lifelong learning activities of the ESF, which is evidence of lower levels of participation in training programmes but not of a lack of training or qualifications on the part of those workers; |
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O. |
whereas the Member States designate Managing Authorities (MAs) to implement the multiannual Operational Programmes (OPs), prepared by the Member States following consultations with stakeholders and bilateral meetings with the Commission and which were finally adopted in the form of Commission decisions, and which set up and maintain systems for financial management and control systems to carry out programming, checks, monitoring and reporting; |
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P. |
whereas OPs generally cover various groups of unemployed people (young people, older workers, the long-term unemployed and those not in employment, education or training (NEETs)); |
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Q. |
whereas the implementation of the ESF must comply with the EU’s Financial Regulations, in particular the fundamental principles of sound financial management, i.e. economy, efficiency and effectiveness; |
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Is concerned by the fact that in the OPs, for the period 2007-2013, the definition of ‘older workers’ is not used consistently; notes that many MAs do not use in their respective OPs the definition of ‘older workers’ as defined in the Lisbon Agenda, namely any person of working age between 55 and 64 years old, but instead use different age groups; is of the opinion that the definition of ‘older workers’ should be adapted to the maximum legal pension age in the respective Member States; |
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2. |
Regrets the fact that no complete and reliable data, including data disaggregated by gender, are available as a basis for assessing the effectiveness of ESF spending on older workers; takes the view that the use of ESF appropriations must be transparent; stresses that the information on funded programmes, achievement of their objectives and the amount budgeted should be available to citizens in an easily accessible manner on public websites; |
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3. |
Acknowledges that, depending on their own specific socioeconomic and demographic situations, Member States use different age groups to define older workers; considers it regrettable, however, that this definition is not always consistently applied throughout the whole programming process in a given Member State; encourages the Member States, therefore, to make sure, in the forthcoming programming period (2014-2020), that the age groups used for needs analysis are the same as the age groups used in the programmes and/or in the related actions and targets; |
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4. |
Stresses that the implementation of the ESF must comply with the EU Financial Regulation and, in particular, with the fundamental principles of sound financial management such as effectiveness, which should be understood as meaning the attainment of the specific objectives set and the achievement of the intended results; |
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5. |
Calls on the Member States to rely more on quantitative and qualitative data when analysing the socioeconomic situation of older workers and to provide for a measurable causal link between actions identified within operational programmes and the objectives pursued, which would facilitate the verification of consistency among identified needs, chosen strategy and the specific goals set, and make it possible to take sound decisions with regard to the future; |
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6. |
Regrets that the data necessary for evaluating the current employment situation for older workers, assessing future development and adopting measures to achieve the established objectives provided by the Member States are unreliable and of unsatisfactory quality; calls for measures to be adopted that will motivate the Member States to submit reliable and high-quality data; |
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Notes that the regulatory framework (2007-2013) provides for financial data at priority axis level only and that none of the OPs under review has a priority axis specifically for ‘older workers’; regrets the difficulty in assessing precisely how much funding has been allocated to the actions to which it was dedicated, in particular for ‘older workers’; |
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Notes that for the period 2007-2013, no priority theme dealing with initiatives for older workers, such as ‘encouraging active ageing and prolonging working lives’, is included in the OPs, mainly because of differing interpretations of the form a priority of this kind should take; |
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Is of the opinion that specific groups of workers, such as those working in shifts or in heavy industry, need specially adapted programmes and projects that differ from those in less physical jobs, such as workers in service industries and sectors; further points out that gender should be incorporated as a policy factor; |
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10. |
Strongly believes that the experience of older workers is an asset that should be used in the best possible way, not only so that individual workers are able to remain active in the labour market in their own job but also so that they can use this acquired experience when changing jobs; |
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11. |
Is concerned about the fact that, in the OPs, ‘older workers’, although identified as a target group, did not always have their own indicators or target values, leading to a situation where it is difficult or even impossible to assess the effectiveness of the measures addressing the needs of older workers; notes that, when indicators are in fact present in projects, they refer mostly to output, such as the number of participants and results, rather than to any specific impacts; |
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12. |
Calls on the Commission to put more emphasis on the fight against age discrimination of older workers and to use its prerogatives under existing legal instruments to tackle blatant forms of age discrimination in certain Member States and in certain sectors of the economy; |
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13. |
Calls for measures to assess not just employability but also progress in terms of skills (including ‘soft’ skills), higher self-esteem and greater motivation; notes that imparting life skills and providing informal training can make a major contribution in this respect; |
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14. |
Calls for all barriers that hamper active ageing to be monitored and removed and for lifelong learning to be supported, particularly with regard to the acquisition of new qualifications and technical skills, such as computer and foreign language skills; stresses that active ageing and life-long learning among older men and women should become regular features of working life and that these policies should be constantly monitored, evaluated and improved; |
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15. |
Calls, in the new OPs, for a more uniform approach to the choice of target groups and the use of labour market data at national level, in order to set ambitious but realistic targets; notes, given the future importance of the growing cohort of older workers, that preparations for the OPs should also include a dialogue on the prioritisation of target groups; |
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Is concerned about the fact that some of the goals and indicators used in the projects had no direct connection with the ESF interventions, making it difficult to assess their performance, for example determining their success or failure with regard to achieving the macro-economic targets set in the OPs, given that this is beyond the remit of the ESF’s actions, as they depend to a large extent on external factors such as the economic environment, social protection schemes and conditions for local public or private investment; |
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Finds it regrettable that none of the OPs included medium-term milestones, nor established an appropriate hierarchy among the different quantified goals to be reached, which would have allowed MAs to implement corrective action as soon as possible; |
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Deplores the fact that the Commission is therefore unable to report adequately on the overall results and impact of activities aimed at improving the situation for older workers in Member States funded by the ESF; |
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Strongly believes that the Commission should reinforce the way OP performance is assessed; strongly encourages the introduction of a clearly stated set of standardised performance data (which is reliable, verifiable and timely) for future programmes, which could be, when appropriate, aggregated at EU level for the programming period 2014-2020; |
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20. |
Welcomes the fact that the new focus of the Common Strategic Framework funds for the next programming period 2014-2020 is on results, under which any measure proposed must be designed to achieve a specific objective; |
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Stresses that setting clear priorities in the new OPs with a view to achieving results will enable synergies to be found between the various funds and other sources of financing, thereby helping to ensure that measures to achieve the proposed objectives are as effective as possible at both national and transnational level; |
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22. |
Believes it necessary for the indicators used under the new OPs to include alerts in respect of financial and physical factors, and welcomes the fact that these are subject to special monitoring so that the reasons for any deviation from a given threshold in respect of the programmed objectives is analysed by the evaluation unit in cooperation with the intermediary bodies for the programmes, with a view to determining whether the deviations are caused by temporary situations or structural problems requiring more in-depth analysis or, where necessary, modifications to the programme; |
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Believes it also necessary to monitor whether or not changes occur in the socio-economic context and in the national and/or Union priorities, and whether problems arise when the OPs are being implemented which require a programme to be evaluated and substantially modified; |
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Calls for the systematic use of relevant performance indicators such as operational goals, result targets and specific impact targets to be included from the project condition stage so that the 2014-2020 ESF programmes can improve not only the amount and quality of the data collected on ‘older workers’ in the labour market but also the decision-making process; |
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25. |
Calls on the Member States, in the next programming period, to apply and complement as appropriate the common indicators provided for in the ESF Regulation in order to establish how many older workers, disaggregated by gender, have participated in ESF-funded projects with a focus on workplace adaptation, acquisition of skills, an improved labour-market situation for individuals, or finding a job, and how many of them have gained new qualifications, improved their situation on the labour market or found a job after having benefited from projects financed by the ESF; |
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26. |
Recalls that, overall, it is necessary for the projects to properly reflect the OPs’ goals in order to reduce the risk of not meeting the initial objectives set; calls for MAs to systematically check the existence of this link in order to select the best projects; |
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27. |
Strongly encourages stakeholders to improve methodology where appropriate in order to move on from a simplistic approach concerning disbursement or actual costs to an integrated approach towards best performance in management projects; |
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28. |
Invites the Commission to verify the submission and quality of the data supplied by the OPs more thoroughly and to produce a guide containing operational advice which is made available to the Member States; |
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29. |
Takes the view that any monitoring system should rely on the effective documentation of checks carried out on the OPs in order to obtain a satisfactory level of insurance; |
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30. |
Welcomes the fact that MAs generally defined the monitoring data they required clearly; recalls, nevertheless, that monitoring and evaluation systems should allow for the timely and periodic verification of progress made towards the established objectives and for the possibility of reacting quickly to significant divergences from them; |
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31. |
Calls for more precise regulatory requirements regarding the evaluations requested from the MAs, and for OPs a minimum set of topics, to be covered in the evaluation process to be defined; calls for efforts to be made to ensure that lessons learned from programme management are duly taken into account in future decision making; |
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32. |
Calls on the Commission gradually to rebalance and enhance its management tools so as to move from simply monitoring compliance — on the basis of legality/regularity principles — towards measuring the progress in achieving the target values and the performance of the use of ESF in the forthcoming period 2014-2020; recalls that successfully establishing a robust performance framework, with clear and measurable aims and targets which provide accountability and results, is key to maximising the impact on growth and jobs and requires common and equivalent efforts from the Commission and the Member States; |
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33. |
Welcomes the Commission’s proposal to improve the performance assessment of OPs in the 2014-2020 programming period and the inclusion of a set of common output and result indicators, including long-term result indicators, in the ESF regulation; |
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Encourages the Commission, in this regard, to step up its collaboration with other international institutions, such as the OECD, on the basis of specific assessments for disadvantaged groups or vulnerable workers categories and by identifying concrete measures to help Member States better define key priorities, strategies and sustainable projects eligible for ESF funding in the forthcoming 2014-2020 period; |
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Instructs its President to forward this resolution to the Council and the Commission. |
(1) The aim of the Lisbon Agenda was to make the EU ‘the most competitive and dynamic knowledge-based economy in the world capable of sustainable economic growth with more and better jobs and greater social cohesion’ by 2010.
(2) Europe 2020, launched in 2010, replaces the Lisbon Agenda. It is about delivering smart, sustainable, and inclusive growth. The strategy focuses on five goals to be achieved by 2020 in the areas of employment, innovation, education, poverty reduction and climate/energy.
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30.11.2017 |
EN |
Official Journal of the European Union |
C 408/8 |
P7_TA(2014)0276
Mid-term review of the Stockholm Programme
European Parliament resolution of 2 April 2014 on the mid-term review of the Stockholm Programme (2013/2024(INI))
(2017/C 408/02)
The European Parliament,
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having regard to its resolution of 25 November 2009 on the Communication from the Commission to the European Parliament and the Council — An area of freedom, security and justice serving the citizen — Stockholm programme (1), |
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having regard to the European Council’s ‘Stockholm Programme — An open and secure Europe serving and protecting citizens’ (2), |
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having regard to Rule 48 of its Rules of Procedure, |
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having regard to the joint deliberations of the Committee on Legal Affairs, the Committee on Civil Liberties, Justice and Home Affairs and the Committee on Constitutional Affairs under Rule 51 of the Rules of Procedure, |
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having regard to the report of the Committee on Legal Affairs, the Committee on Civil Liberties, Justice and Home Affairs and the Committee on Constitutional Affairs and the opinions of the Committee on Foreign Affairs and the Committee on Women’s Rights and Gender Equality (A7-0153/2014), |
The Stockholm Programme and the Treaty of Lisbon
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Believes that the Treaty of Lisbon and the recognition of the legally binding force of the Charter of Fundamental Rights of the European Union have brought significant improvements and strengthened the constitutional basis for the EU institutions and the Member States to achieve the objective of establishing an area of freedom, security and justice, but observes that some areas require additional efforts, in particular as regards their implementation; considers that this objective requires the Treaties and secondary law to be applied evenly throughout the EU; agrees, therefore, that opt-outs or special regimes should be avoided, and where possible removed; requests that the Commission and the Council Presidency better fulfil their obligation to inform Parliament ‘immediately and fully at all stages of the procedure’ leading to the conclusion of international agreements; regrets the delays in bringing the acts of the former third pillar into line with the new hierarchy of norms — basic, delegated and implementing acts — in accordance with the Treaty of Lisbon and the new institutional structure; |
The Commission’s right to propose legislation and the ordinary legislative procedure
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Takes the view that the extension of the use of the ordinary legislative procedure has made law-making more legitimate and brought it closer to the people by giving Parliament, the only directly elected Union institution, a greater degree of influence; believes that in a future Treaty revision the remaining exceptions to the use of the ordinary legislative procedure should be removed; |
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Notes that, in its communication of 20 April 2010 entitled ‘Delivering an area of freedom, security and justice for Europe’s citizens — Action Plan Implementing the Stockholm Programme’ (COM(2010)0171), the Commission argued in favour of ‘greater ambition in responding to the day-to-day concerns and aspirations of people in Europe’ and emphasised that the ‘Union must be able to react to unexpected events, swift in seizing opportunities and in anticipating and adapting to future trends’; |
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Recalls the application of the EU ordinary legislative procedure as a principle encompassing the decision-making process in a wider range of policies relating to the area of freedom, security and justice, the Treaty requirement to take decisions ‘as openly and as closely as possible to the citizen’ and the increased need for flexibility; calls on the Commission to make use of its right to initiate legislation, with full respect for its competences as established by the Treaties and the principles laid down therein, including subsidiarity, and in close cooperation with the co-legislators; |
National parliaments
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5. |
Takes the view that the greater role played by national parliaments in the activities of the Union, as enshrined in Protocols Nos 1 (on the role of national parliaments in the European Union) and 2 (on the application of the principles of subsidiarity and proportionality) to the Treaty on European Union and the Treaty on the Functioning of the European Union, has had a positive impact on the development and functioning of the area of freedom, security and justice in particular, not only because the subsidiarity principle is now more likely to be complied with, but also because the broader and closer involvement of the peoples of Europe in the democratic process has made a significant contribution to law-making and to European policymaking; |
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Calls for strengthened cooperation and dialogue between national parliaments and the European Parliament, and between EU institutions and bodies in general and national parliaments, so to ensure that, as far as possible, information on EU initiatives is made available directly and promptly by EU institutions and bodies to national parliaments; |
Uniform electoral law for the European Parliament elections
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Notes that, even in the absence of an agreement on a uniform electoral procedure for the European Parliament elections, electoral systems are gradually becoming more similar, in particular as a result of the establishment of political parties and political foundations at EU level, the work done on drawing up a European statute based on the Commission proposal for a reform of the rules governing European political parties and the ban on holding a dual mandate, which has made the office of Member of the European Parliament incompatible with that of member of a national parliament; encourages more transparent procedures for the nomination of candidates, which guarantee their independence; |
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Takes the view that the public should be made more aware of Parliament’s democratic role and that European election campaigns should focus on genuinely European issues; |
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Takes the view, therefore, that a reform of the electoral procedure will be required in the future in order to enhance Parliament’s legitimacy and effectiveness in accordance with the principles laid down in the Treaties; considers that a reform of this kind will encourage EU citizens to take part in European elections in their Member State of residence if they are not nationals of that state; |
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Welcomes, nevertheless, as a first step, the adoption of Council Directive 2013/1/EU of 20 December 2012 amending Directive 93/109/EC as regards certain detailed arrangements for the exercise of the right to stand as a candidate in elections to the European Parliament for citizens of the Union residing in a Member State of which they are not nationals (3), in that it relaxes the requirements which EU citizens resident in a Member State of which they are not nationals must meet if they wish to stand as candidates in European elections; urges that the bureaucratic barriers which still hamper participation in the European elections by EU citizens residing in a Member State of which they are not nationals be eliminated, and encourages cooperation among the Member States with a view to stamping out this scourge that jeopardises the EU’s democratic standards; reiterates that further steps need to be taken in order to guarantee every EU citizen the right to vote regardless of their actual state of residence; |
European citizens’ initiative
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11. |
Welcomes the adoption of the regulation on the European citizens’ initiative (4), which grants EU citizens the same powers to make policy proposals as those already enjoyed by Parliament and the Council; |
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Takes the view that the citizens’ initiative can play a key role in identifying matters which should be dealt with at EU level and enhances the legitimacy of the policymaking procedure at EU level; |
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Deplores, however, the technical problems encountered by the organisers of citizens’ initiatives and calls on the Commission to resolve them; |
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Points out that the effective application of the citizens' initiative is being hampered not only by technical problems, but also by financial problems stemming from a lack of budgetary resources; |
Evaluation of the Stockholm Programme and its implementation
Fundamental rights
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15. |
Considers that the EU should promote the highest level of protection of human rights and fundamental freedoms for all; takes the view that the chapter of the Stockholm Programme on promoting citizens’ rights is in line with this ambition; notes, however, that despite the advances made, the implementation of this chapter needs to be stepped up; |
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16. |
Takes note of the Commission communication and recalls the positions adopted by Parliament on the establishment of a new EU rule of law framework to strengthen the Union’s capacity to to address the so-called ‘Copenhagen dilemma’ — a situation in which the Union sets high standards for candidate countries but lacks functional tools for the existing Member States whose aim must be to secure compliance by all Member States with the common values enshrined in Article 2 TEU with a view to continuity of the ‘Copenhagen criteria’, pending the amendment of the regulation establishing the Fundamental Rights Agency (5), as repeatedly requested by Parliament; |
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17. |
Welcomes, in this regard the Commission communication entitled ‘A new EU Framework to strengthen the Rule of Law’ (COM(2014)0158), and looks forward to cooperating with the Commission on the effective implementation of the framework; stresses, however, that a regular assessment of Member States’ compliance with the fundamental values of the EU as set out in Article 2 TEU remains necessary; acknowledges the special role given to the expertise and advice of the Venice Commission, and recalls that the FRA, judicial networks and other independent expertise bodies should also contribute to the assessment of threats to the rule of law; |
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18. |
Fears that the economic crisis may develop into a crisis of democracy and believes that strong political impetus and the transparent functioning of democratic institutions at national and European level are needed in order to defend democratic achievement, the rule of law and fundamental rights, to combat the rise of populism in Europe and to further strengthen EU citizenship; is concerned by the manifestation of open intolerance to the mobility of EU citizens, with the aim of undermining the rights of workers from some new Member States; |
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19. |
Considers that greater attention must be given to responding to the particular situation of vulnerable groups and strengthening the fight against racism, xenophobia, anti-Semitism, religious intolerance, Islamophobia, anti-Gypsyism, homophobia and transphobia; |
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20. |
Takes the view that the adoption and effective implementation of legislation tackling hate crime and hate speech, and those who promote, support and commit hate crime and hate speech, are paramount and calls for the further development of such legislation in full accordance with the principle of subsidiarity; |
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21. |
Regrets the lack of progress on the implementation of the national Roma integration strategies and the continuing acts of racism towards and discrimination against Roma across the EU, including the segregation of Roma children in education; calls on the Member States to step up their efforts to enforce the fundamental rights and social inclusion of Roma by implementing, as soon as possible, the recommendations set out in the Council Recommendation of 9 December 2013 on effective Roma integration measures in the Member States (6); calls on the Commission and the Member States to support Roma organisations financially and to involve them in all policies affecting Roma; |
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22. |
Underlines the fact that the principle of universality applies to fundamental rights and equal treatment; urges the Council, therefore, to adopt the proposal for an antidiscrimination directive; regrets the inadequacy of policies on integrating people with disabilities and of the extent to which their rights are taken into account; |
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23. |
Welcomes the adoption of Directive 2012/29/EU establishing minimum standards on the rights, support and protection of victims of crime (7), which pays special attention to the protection of disadvantaged groups such as women and children; underlines the frequent victimisation of these groups through all types of violence, including domestic violence; recommends the in-depth investigation, identification and prosecution of such severe violations of human rights; welcomes the adoption of Directive 2011/99/EU on the European protection order (8) and Directive 2011/36/EU on preventing and combating trafficking in human beings and protecting its victims (9) (the Anti-Trafficking Directive); calls on the Member States to transpose and implement those directives as soon as possible; |
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24. |
Refers to its inquiry into the electronic mass surveillance of EU citizens; reiterates the serious concern it expressed in its resolution of 4 July 2013 on the US National Security Agency surveillance programme, surveillance bodies in various Member States and their impact on EU citizens' privacy (10); considers mass surveillance to present a serious challenge to the Union principles of democracy, the rule of law and fundamental rights, and insists on the organisation of proper and effective parliamentary and judicial oversight and security at EU and national level; considers it essential that more checks and balances be put in place, in particular through the adoption of the EU legal framework on the protection of data, which should ensure full respect for fundamental rights; considers that action must be taken in relation to surveillance threatening the internal security of the EU; calls on the European Council to address the recommendations and calls made in its resolution of 12 March 2014 on the US NSA surveillance programme, surveillance bodies in various Member States and their impact on EU citizens’ fundamental rights and on transatlantic cooperation in Justice and Home Affairs; |
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25. |
Considers that a proper accountability process is crucial in order to protect and promote human rights effectively and to pursue legitimate and effective security policies based on the rule of law; calls on the Commission to propose an accountability mechanism aimed at strengthening the capacity of the EU and of its Member States to prevent, investigate and redress human rights violations at EU level, in particular those committed in the context of the alleged transportation and illegal detention of prisoners in European countries by the CIA; |
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26. |
Emphasises that the accession of the Union to the European Convention for the Protection of Human Rights and Fundamental Freedoms, as provided for by Article 6(2) of the Treaty on European Union, will strengthen even further the protection of fundamental rights in the Union, as guaranteed by the Charter of Fundamental Rights and the case law of the Court of Justice; |
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27. |
Notes that acceding to that convention will provide citizens, along with other people for whom the Union has a responsibility, with protection in the context of Union action, similar to that which they already enjoy in the context of action by individual Member States; points out that this is all the more relevant because the Member States have transferred significant competences to the Union, in particular in the policy spheres covered by the area of freedom, security and justice; |
|
28. |
Welcomes the draft agreement reached by the 47 Council of Europe member states and the EU on the latter’s accession to the European Convention on Human Rights, and awaits the positive opinion of the Court of Justice of the European Union (CJEU) on the agreed text; calls for Parliament and the Council to ratify the agreement rapidly upon the final ruling of the CJEU; |
|
29. |
Welcomes the fact that acceding to the convention will offer citizens, along with other people for whom the Union has a responsibility, vital extra protection, in particular in the context of the area of freedom, security and justice; underlines the excessively long deadline for concluding accession negotiations and deplores the fact that the EU has still not effectively acceded to the convention; recalls that the EU’s accession depends on ratification not only by its Member States, but also by the other States Parties to the convention; calls on all parties concerned to proceed with ratification as soon as possible; |
|
30. |
Strongly condemns the blockage and delays experienced by the EU in the negotiations for its accession to the ECHR and calls on the EU institutions and the Member States to accelerate the procedures for the EU’s accession to the ECHR and to reject any future further attempt to undermine the role, competences and powers of the ECHR in relation to citizens' and residents’ human rights and fundamental freedoms; |
|
31. |
Calls for the review of the Access to Documents Regulation (11) to be adopted on the basis of Parliament’s proposals; |
|
32. |
Calls on the Commission and the Member States to develop specific tools based on new information and communication technologies in order to share best practices in the fight against discrimination at European level; |
|
33. |
Stresses the importance of taking the gender dimension into account in all strategies to integrate people with disabilities, immigrants, the Roma population and other minorities, and excluded people; |
Judicial cooperation in civil and criminal matters
|
34. |
Notes that the Stockholm Programme aims to facilitate the free movement of EU citizens and residents by defending and respecting all the rights and obligations deriving from a European area of justice, and that judicial cooperation represents the main tool for achieving this objective; |
|
35. |
Recognises that initiatives in the field of the mutual recognition of legal situations, judgments and documents play a very important role in this respect, as mutual recognition leaves the legal systems of Member States unchanged, but reduces financial and bureaucratic burdens and legal obstacles for citizens, families and businesses exercising their Treaty freedoms, while also respecting the rule of law and fundamental rights; |
|
36. |
Recalls that the Stockholm Programme contains a number of major initiatives in the field of civil law, including easier recognition of judgments, Union-wide validity of wills, easier procedures for the acceptance of public documents, simpler cross-border debt enforcement and Union initiatives in the field of legal training; |
|
37. |
Notes that only three pieces of legislation in this field have been adopted so far, namely the Brussels I recast (12), the Successions Regulation (13) and the Rome III Regulation (14), of which only the third is applicable today, and that, whereas the Commission has made a significant number of the proposals called for in the Stockholm Programme, several major proposals are still outstanding, including those relating to the mutual recognition of the effects of civil status documents and the 14th company law directive; |
|
38. |
Considers that mutual recognition requires that citizens and legal professionals trust one another’s legal institutions; notes that the strengthening of a truly European legal culture that fully respects fundamental rights and the principles of subsidiarity and of judicial independence, the establishment of common standards and an understanding of other legal systems, in particular through training, play a very important role in underpinning mutual recognition and trust; points out that mutual recognition and trust can lead to gradual changes in national civil law traditions through an exchange of best practices between Member States; considers that this exchange should not detract from the value of national legal traditions; |
|
39. |
Notes that legislative initiatives in the field of civil law have so far been focused largely on substantive law; calls for a greater focus on procedural law in the future; |
|
40. |
Encourages the Commission to work effectively towards the establishment of an International Judgments Convention which would pursue similar aims to the Brussels I regulation; |
|
41. |
Welcomes the proposal for a directive on improving the gender balance among non-executive directors of companies listed on stock exchanges (15); stresses the need to combat the persisting ‘glass ceiling’, which remains one of the main obstacles to the development of women’s career paths; |
|
42. |
Welcomes the Commission’s proposal for a regulation on promoting the free movement of citizens and businesses by simplifying the recognition of certain public documents, thus eliminating bureaucracy and closing the existing gap between the EU institutions and citizens; |
|
43. |
Calls on the Commission, in line with previous commitments and following repeated requests from Parliament, to pursue existing plans to issue a proposal — adopting an all-encompassing approach — for a regulation on the mutual recognition of the effects of all civil status documents in the EU, in order to eliminate discriminatory legal and administrative barriers for both male and female citizens and their families who wish to exercise their right to free movement, and to allow EU citizens and residents and their families to retain throughout the Union existing rights attached to civil statuses already legally recognised in several European jurisdictions; |
|
44. |
Reiterates its call for the adoption of a European code of private international law; |
|
45. |
Calls on the Commission to develop the e-Justice programme further in order to allow citizens direct online access to legal information and justice; |
|
46. |
Recognises the progress made to date with the roadmap for strengthening the procedural rights of suspects and accused persons in criminal proceedings, including the adoption of directives on the right to interpretation and translation (16), on the right to information in criminal proceedings (17), and on the right of access to a lawyer in criminal proceedings (18); calls for their timely and correct transposition, and for training for government officials, judges, prosecutors and defence practitioners; reiterates that these measures are crucial to the proper functioning of EU judicial cooperation in criminal matters, in particular as regards the implementation of measures based on the mutual recognition principle, such as the European arrest warrant, and that continuing progress on the protection of the rights of suspects and defendants is essential; takes note of the proposals on legal aid, the presumption of innocence and safeguards for children; strongly believes that legal aid in particular must be effectively guaranteed in order to ensure effective implementation of the directive on the right to access a lawyer; calls for a discussion on the protection of witnesses and whistleblowers; calls for the strengthening of the procedural rights of suspects and accused persons in criminal proceedings to be a priority for the post-Stockholm programme and recalls that the roadmap is not exhaustive; |
|
47. |
Regrets the fact that further work remains outstanding in relation to pre-trial detention, administrative detention and the detention of minors, in respect of which standards in many Member States fall short of human rights and other international standards; recognises the need for an assessment of the effectiveness of non-legislative work on existing framework decisions, for widespread recognition of the problems with pre-trial detention law and practice across Europe identified as part of the Commission’s consultation, and for a commitment to revisiting the case for establishing minimum and enforceable standards in relation to pre-trial detention through legislative action; calls on the Commission to revisit the case for establishing such standards in relation to pre-trial detention, administrative detention and detention of minors through legislative action; |
|
48. |
Strongly believes that consistency in the principles applied in the development of an EU criminal justice area should be a priority and that the EU institutions should cooperate closely with one another in this respect, as outlined in Parliament’s resolution of 22 May 2012 on an EU approach to criminal law (19); |
|
49. |
Believes that mutual trust between the Member States must be strengthened by harmonising fundamental rights compliance in relation to criminal procedures and taking common measures to ensure the proper administration of justice and of prisons, which are often at the root of the lack of trust between Member States, and that mutual recognition and harmonisation of EU criminal law cannot progress without serious feedback on the implementation of these rules at Member State level; |
|
50. |
Welcomes the proposal for a Council regulation on the establishment of the European Public Prosecutor’s Office (COM(2013)0534); firmly believes that establishing the European Public Prosecutor’s Office would represent an important step in further developing an EU area of freedom, security and justice; welcomes, further, the proposal for a regulation on the European Union Agency for Criminal Justice Cooperation (Eurojust) (COM(2013)0535); |
|
51. |
Believes that greater efforts are needed in order to implement the principle of mutual recognition of judicial decisions concerning the enforcement of judgments in criminal cases; |
|
52. |
Believes that an effective, accessible, fair and fundamental-rights-compliant justice system is a powerful driver for democracy, the confidence and well-being of citizens and a prosperous economy; |
|
53. |
Welcomes the continued efforts of the EU institutions and the Member States to advance universal support and cooperation with the International Criminal Court (ICC), as an essential means of securing justice for victims of crimes under international law and promoting respect for international humanitarian and human rights law; encourages all the Member States to conclude framework agreements with the ICC, in particular on witness relocation, interim release, relocation of acquitted persons and sentence enforcement; calls on the EU Member States, as States Parties to the Rome Statute of the ICC, to ensure that the ICC has the necessary resources to fulfil its mandate and deliver justice in a robust, fair and transparent manner; |
|
54. |
Stresses the need to provide proper training for officials (police, healthcare personnel, court staff, etc.) likely to come into contact with cases in which a person’s physical, psychological and sexual integrity is considered to be at risk, especially cases involving women who are victims of gender-based violence; calls on the Member States to support the work of civil society — particularly NGOs, women’s associations and other voluntary organisations providing specialist support — and to collaborate with such organisations in providing support to women victims of gender-based violence; |
|
55. |
Calls on the Member States to ratify the Istanbul Convention on preventing and combating violence against women and domestic violence, and on the Commission to propose negotiating guidelines for the EU’s accession to that convention without any further delay; |
Internal security
|
56. |
Notes the progress made by the Member States and the Commission in the context of the Internal Security Strategy (ISS) and the EU policy cycle on organised and serious international crime, especially in the following fields; combating terrorism, transnational organised crime (including economic crime), cybercrime and cyber-facilitated crime such as child pornography; protection of critical infrastructure; and the fight against corruption, money laundering, terrorist funding, violent radicalisation and the trade in illegal firearms; points out, however, that further progress needs to be made in all these fields; |
|
57. |
Stresses that trafficking in human beings is a serious crime which particularly affects women and represents a violation of human rights and human dignity that the Union cannot tolerate; regrets the fact that the number of people being trafficked to and from the EU is rising, despite the entry into force of the Anti-Trafficking Directive in December 2011; calls on the Member States to increase their efforts to curb this worrying trend by ensuring that a common, coordinated and ambitious European strategy, along with legislation and measures to fight smuggling and trafficking in human beings and international organised criminal networks in this field, are developed and implemented in accordance with the directive, targeting women and minors in particular; stresses that action to combat trafficking in human beings, forced labour and irregular immigration and smuggling needs to focus on the root causes; |
|
58. |
Regrets the fact that the 2010-2013 EU action plan for strengthening chemical, biological, radiological and nuclear security (CBRN) (COM(2009)0273) was not fully implemented or incorporated into national policymaking by the Member States; calls, therefore, for the EU and its Member States to strengthen regional and European-level cooperation and coordination in the CBRN field and, in this connection, also calls on the Council to ensure coordination between national authorities and the Counter-terrorism Coordinator; |
|
59. |
Urges the Commission to intensify and reinforce its efforts to protect the Union’s financial interests and to complete the delayed reform of the European Anti-Fraud Office, fully integrating data protection and suspects’ rights on the basis of proper criminal definitions; |
|
60. |
Welcomes the agreement reached on the proposal for a directive on the freezing and confiscation of proceeds of crime in the European Union (COM(2012)0085); points out that confiscating criminal assets is one of the most effective ways to combat criminal organisations; |
|
61. |
Strongly believes that the EU’s counterterrorism policy needs to address the radicalisation of groups/individuals in European societies and the apparent trend towards the individualisation of terrorist activities in our societies; calls for better coordination of all EU services with responsibilities in the implementation of the EU’s counterterrorism policies, namely the EU Counter-terrorism Coordinator, Europol, the Council Standing Committee on Operational Cooperation on Internal Security (COSI), the Working Party on Terrorism (External Aspects) (COTER) and Eurojust; |
|
62. |
Finds it regrettable that the Commission communication of 10 April 2013 entitled ‘Second Report on the implementation of the EU Internal Security Strategy’ (COM(2013)0179) expresses scant criticism of activities carried out under the ISS, reasserting the same priorities as its initial communication of November 2010 and failing, in particular, to take account of the consequences of the incorporation of the Charter of Fundamental Rights, most of the provisions of which apply not only to EU citizens but to everyone on EU territory; |
|
63. |
Recalls that Parliament is now a fully fledged institutional actor in the field of security policies, and is therefore entitled to participate actively in determining the features and priorities of the ISS and in evaluating those instruments, including through monitoring of the implementation of the ISS, to be conducted jointly by the European Parliament, national parliaments and the Council under Articles 70 and 71 TFEU; believes that Parliament should play a crucial role in the evaluation and definition of internal security policies, as they have a profound impact on the fundamental rights of all those living in the EU; emphasises, therefore, the need to ensure that these policies fall within the remit of the only directly elected European institution, which is responsible for scrutiny and democratic oversight; |
|
64. |
Believes that a proper evaluation of the implementation, effects and concrete results of policies and legislation in the internal security field, an analysis of the security threats to be addressed, consideration of the principles of proportionality and necessity, and a democratic debate are essential conditions for an effective ISS; |
|
65. |
Points out that the current ISS will come to an end in 2014; calls on the Commission to start preparing a new ISS for the 2015 to 2019 period which takes account of the entry into force of the Treaty of Lisbon and the incorporation of the Charter of Fundamental Rights into Union law; calls on the Council to take proper account of Parliament’s input in respect of the new ISS before adopting the new strategy; takes note of Europol’s analyses, including its risk analysis, in this connection; |
|
66. |
Acknowledges that cross-border crime is on the increase in the EU and underlines, therefore, the importance of sufficient funding for agencies working in the area of law enforcement cooperation; believes that the current ‘landscape’ of the different instruments, channels and tools for European law enforcement information exchange is complicated and scattered, leading to inefficient use of the instruments available and to inadequate democratic oversight and accountability at EU level; calls for a future-oriented vision of how to shape and optimise law enforcement data-sharing in the EU while guaranteeing fundamental rights, including a robust level of data protection; notes the need to boost law enforcement authorities’ confidence in one another so as to step up the exchange of information; |
|
67. |
Rejects the concept of predictive policing without an initial suspicion, in particular the EU passenger name record proposal and the idea of an EU terrorist finance tracking system; calls on the Commission to repeal the Data Retention Directive (20); |
|
68. |
Calls on the Commission to encourage the Member States to set up aid centres in areas notorious for prostitution in order to provide victims with immediate psychological and physical assistance; |
|
69. |
Calls on the Commission to come forward quickly with proposals for bringing cross-border police cooperation instruments adopted under the former third pillar — such as the Prüm Decision and the Swedish Initiative — under the legal framework of the Lisbon Treaty; |
|
70. |
Welcomes the Commission’s proposal for the new Europol regulation, based on the new legal basis provided for in the Treaty of Lisbon, and hopes that this important legislative file will advance quickly, in full accordance with the principles of the Treaty, so that Europol can fulfil its role more effectively in fighting organised cross-border crime; |
|
71. |
Regrets the fact that the EU does not yet have the proper resources to prevent and respond to natural or man-made disasters; |
Borders and visas
|
72. |
Welcomes the conclusion of the negotiations on the Schengen Governance Package; calls on the Commission to play its role fully as coordinator of the Schengen evaluations and as guardian of the Treaties, in order to avoid any situation that could endanger the functioning of the Schengen area; recalls that the Schengen area depends on mutual trust and that each Member State fulfils its obligations, including the control of external borders, in accordance with the provisions of the Schengen Borders Code, comprising also the use of available technologies; highlights the importance of tackling trafficking and smuggling at borders, including the trafficking of migrants; reiterates its position that the Schengen area should, without further delay, be enlarged to include Romania and Bulgaria; |
|
73. |
Considers the absence of controls at internal borders as one of the major achievements of European integration; asks the Commission to pay particular attention to the absence of controls at internal borders, and firmly rejects all attempts to limit the free movement of people which are not in line with the acquis; |
|
74. |
Acknowledges that the Schengen area is unique and has so far been developed step by step; takes the view, however, that long-term reflection on its further development is necessary; believes that the Schengen external borders should in the future be guarded with the support of European border guards whose training includes human rights standards; |
|
75. |
Welcomes the reform of the mandate of Frontex and the agreement on Eurosur; welcomes the new rules on the surveillance of sea borders with which saving the lives of migrants as well as respect for the human rights of migrants and asylum-seekers, including the principle of non-refoulement, have also become priorities; recalls that international law, the acquis and, in particular, the case law of the European Court of Human Rights should be observed by the Union and its Member States in the context of interventions on the high seas or when carrying out the surveillance of the Union’s external borders; |
|
76. |
Expresses deep sadness and regret at the tragic loss of life at the borders of the EU, particularly in the Mediterranean Sea; reiterates its opinion that the events off Lampedusa should be a turning point for the EU, and that the only way to prevent another tragedy is to adopt a coordinated approach based on solidarity and responsibility, supported by common instruments; |
|
77. |
Calls on the Commission to provide information on the situation at detention centres, including as regards respect for human rights, and to bring forward initiatives concerning the operation of such centres in the future; |
|
78. |
Expresses alarm at the increasing number of deaths, particularly at sea, and of human rights abuses in the course of irregular migrants’ attempts to enter the EU; asks the Commission to inform Parliament prior to the conclusion of any agreement between Frontex and a third country; insists that such agreements must provide for stringent safeguards to ensure full respect for human rights standards, including with regard to return, joint patrolling, search and rescue, and interception operations; |
|
79. |
Recalls the key role of Frontex and the European Police College in training law enforcement personnel and border guards to execute European judicial and law enforcement which respects migrants’ human rights; |
|
80. |
Strongly endorses the European Council’s call for Frontex’s role to be reinforced in accordance with the Stockholm Programme in order to increase its capacity to respond more effectively to changing migration flows; |
|
81. |
Regrets the late migration to the Schengen Information System II and the increased costs incurred; welcomes the continued roll-out of the Visa Information System and the setting-up of the eu-LISA agency to handle their operational management; stresses that these new systems now need to stand the test of everyday use; reiterates its request that ‘new border management instruments or large-scale data storage systems should not be launched until the existing tools are necessary, fully operational, safe and reliable’; expresses deep concern at the reported hacks into the Schengen Information System and believes that the issue of outsourcing activities related to the management and operation of large-scale European IT systems should be discussed; calls on the Commission to present the evaluations of these systems provided for in the respective legal instruments in time; deplores the lack of progress regarding the use of secure breeder documents; |
|
82. |
Welcomes the progress made in the field of the visa acquis, but also calls for better implementation of existing rules; considers that common visa application centres have proven to be a useful tool which could become the standard in the future; believes that an interinstitutional discussion on the objectives of the common visa policy should define the steps to be taken towards further harmonisation of visa procedures, including common rules on the issuing of visas; calls for the conclusion of further visa facilitation agreements and the monitoring and improvement of existing ones; |
|
83. |
Calls on the Member States to make use of the current provisions of the Visa Code and the Schengen Borders Code allowing the issuing of humanitarian visas, and to facilitate the provision of temporary shelter for human rights defenders at risk in third countries; |
|
84. |
Calls on the EU institutions and the Member States to increase workers’ mobility by allowing temporary visas and facilitating the re-application process for those already in the system; considers that this would increase worker mobility effectively by guaranteeing legal certainty and increasing internal mobility within the EU; |
|
85. |
Calls on the Commission to further improve existing visa facilitation agreements between the Union and its eastern neighbours and to work towards a visa-free travel area enabling people-to-people contact; |
Asylum and migration
|
86. |
Recalls that in the Stockholm Programme the European Council stressed ‘that well-managed migration can be beneficial to all stakeholders’; expects further progress to be made in the adoption of legislation in the field of legal migration, and calls for greater efforts in the future, given the demographic challenges and the needs of the economy; believes, at the same time, that the integration of migrants requires greater attention; |
|
87. |
Calls on the European institutions and Member State governments to raise awareness among the wider public and employers of the EU Immigration Portal; calls on the Commission to monitor the transposition of the Blue Card Directive and to report on its application as provided for in the directive; |
|
88. |
Calls as a matter of urgency for greater transparency, requiring each Member State to report annually on the progress of each specific minority group in matters of labour market integration and equality policy impacts; encourages the European Commission to deliver an ‘annual trend report’ reflecting the comparable indicators on social cohesion that have been agreed upon and put forth as targets, including EU-wide monitoring of the situation of newcomers, long-term residents, naturalised migrants and the children of migrants, broken down by equality grounds (i.e. ethnic/racial, religion/belief, gender, age, sexual orientation and disability), so as to measure progress in social inclusion policies over time; considers that the Open Method of Coordination should be applied to this end; |
|
89. |
Acknowledges that the recent changes and turmoil in Northern Africa and the Middle East have intensified the pressure on the EU’s eastern and southern borders; |
|
90. |
Welcomes the adoption of the asylum package; calls on the Commission to monitor the correct implementation of the package by the Member States as from the date of application and to take the necessary steps to ensure that national legislation is in line with the case law; suggests that henceforth the European Asylum Support Office (EASO) include this new legislation in its training programmes; |
|
91. |
Calls for the establishment of a gender focal point in the EASO; |
|
92. |
Regrets the continuing and systematic practice of detaining migrants in detention centres as recently underlined by the UN Human Rights Council; calls for alternatives to detention to be further developed and implemented, including regularisation of undocumented migrants on the basis of clear criteria; |
|
93. |
Believes that, in the context of the Dublin system, the possibility of suspending transfers to Member States under significant pressure should be considered in the future; |
|
94. |
Deeply deplores the failure to make the principles of solidarity and fair sharing of responsibility, as laid down in Article 80 TFEU, a reality; believes that accentuated, more concrete measures will be necessary in the future, in particular for Member States receiving higher numbers of migrants and asylum applications; calls for the introduction of a coherent, voluntary permanent intra-EU relocation scheme for beneficiaries of international protection; |
|
95. |
Believes that the external dimension of asylum policy in relation to resettlement and protected entry procedures should be expanded; regrets the so far limited involvement of Member States in resettlement; |
|
96. |
Expresses deep concern about the fate of third-country nationals (TCNs) and stateless persons readmitted under EU readmission agreements (EURAs), including cases of indefinite detention, legal limbo or refoulement to their country of origin, and requests the exclusion of TCN clauses from these agreements; underlines the importance of implementing the recommendations made in the Commission’s evaluation of readmission agreements; |
External dimension of the area of freedom, security and justice
|
97. |
Notes the importance of a strengthened external dimension for European policies in the area of freedom, security and justice, and calls for cooperation with third countries to be strengthened at all levels in the areas of security, migration, fundamental rights and border management; |
|
98. |
Points out that the European Union and the Member States should continue to integrate immigration into development cooperation and strengthen their partnership agreements, with a view to promoting cooperation with third countries of origin and transit on tackling people-trafficking and irregular immigration, the restoration of family ties, return and readmission, in the context of the regular dialogue which the European Union conducts with these countries and the action carried out by the European External Action Service (EEAS); calls for solidarity with third countries located near countries experiencing civil conflict that take in refugees who are fleeing this conflict; |
|
99. |
Stresses the need to encourage voluntary return policies; |
|
100. |
Stresses that the Treaty on European Union (TEU) places human rights, democracy and the rule of law at the centre of both internal and external EU policies, as provided for in Articles 2, 3 and 21 TEU, and consequently believes that respect for, and the protection and promotion of, these values should be developed in a coherent manner, so that the EU is credible on the world stage; views as regrettable the Commission’s continued refusal to draft a Human Rights Action Plan to promote EU values in the external dimension of freedom, security and justice policies, as called for in the Stockholm Programme; |
|
101. |
Urges the Commission and the EEAS to take practical steps to ensure greater coherence and consistency between internal and external EU policies; |
|
102. |
Strongly believes that the EU and its Member States should not sign agreements with third countries in the field of freedom, security and justice (FSJ) where there is a serious risk of human rights violations and where the rule of law is not upheld; stresses that any agreements in this field should be concluded after a careful human rights impact assessment and should include a suspension clause relating to human rights; |
|
103. |
Expresses concern at the increasing demands being placed on neighbourhood countries in connection with the EU’s migration and border management policies; calls for a human-rights-based approach to EU migration and border management such that the rights of regular and irregular migrants and other vulnerable groups are always the first consideration; recalls the extraterritorial application of the European Convention on Human Rights in the implementation of EU migration policy, as ruled by the European Court of Human Rights; |
|
104. |
Calls for better coordination between the human rights dialogues and the subcommittees on ‘justice, freedom and security’ established under agreements with third countries, in particular the countries covered by in the European Neighbourhood Policy and, more generally, all those affected by readmission agreements; |
|
105. |
Calls on the Commission to propose actions to protect and provide assistance to women who are victims of trafficking in human beings and sexual exploitation through measures including the development of compensation schemes, safe return, reintegration aid in the host country in cases of voluntary return, assistance and aid during their stay in the EU, and cooperation with the authorities in the countries of origin in order to protect the families of victims of trafficking and sexual exploitation; |
Methods, tools and processes
|
106. |
Believes that the policy-making process needs to be of the highest standard possible; considers that the definition of problems, the discussion of possible solutions and the choice between possible options should follow a sequential order; notes that a greater research effort is required at European level and that closer cooperation and better information-sharing between the European institutions and agencies and the Member States would improve the creation and implementation of policy; |
|
107. |
Deplores the absence of an objective evaluation of progress towards an area of freedom, security and justice and of reliable information on the Member States’ implementation of the acquis; |
|
108. |
Proposes a systematic, objective and independent ex-post evaluation of legislation and its implementation, which should also assess the continuing need for legislation in this area; points out, in particular, the importance of conducting impact assessments at the Commission, Parliament and the Council for this purpose, while maintaining standards and avoiding excessive bureaucracy; |
|
109. |
Welcomes the initiative of the Commission in drawing up the EU Justice Scoreboard, which aims to ensure a high-quality justice system in the area of civil, commercial and administrative law, since at the end of the day the concrete application of laws is in the hands of the courts; |
|
110. |
Stresses that high-quality justice systems can play a key role in restoring confidence, bringing about a return to growth, and contributing to trust and stability; points out that predictable, timely and enforceable judicial decisions are important structural components of an attractive business environment, as outlined in the Commission communication entitled ‘The EU Justice scoreboard, a tool to promote effective justice and growth’ (COM(2013)0160); |
|
111. |
Asks the Commission to put more emphasis on overseeing and ensuring the concrete implementation of EU legislation by the Member States; considers that this must be a political priority in view of the wide gap which is often observed between policies adopted at European level and their implementation at national level; points out that any strategic planning must draw on the experience of past implementation and that such planning must therefore not consist merely of a list of objectives and priorities but must, rather, plan ahead with a view to assessing implementation; notes that, where the rights of citizens and residents are concerned, this needs to be done as of the first day an act enters into force; considers that more needs to be done to achieve proper implementation, including by means of coordination and cooperation between the Commission, the Member States and agencies, and of assisting Member States via guidelines, practical support and exchange of best practice; takes the view that the reasons for any failure to implement EU legislation should be identified and addressed, if necessary through infringement procedures; |
|
112. |
Is of the opinion that improving the quality of EU legislation in the area of freedom, security and justice requires a joint effort by the Member States and the European institutions in order to improve the exchange of information on each national system and to provide accurate legal information (on national/regional applicable legislation and standards), as well as information on implementation and practices; calls for better interinstitutional coordination; |
|
113. |
Regrets the fact that the Council does not involve Parliament more closely in the drawing up of strategy documents, such as the drugs strategy and the internal security strategy; |
|
114. |
Considers that the development of a European judicial culture is a key prerequisite for making the area of freedom, security and justice a reality for citizens and ensuring better application of EU law; calls, with this in mind, for much greater emphasis on, and funding for, EU judicial training for all legal professionals; notes the importance of using a ‘bottom-up’ approach for judicial training schemes, of ensuring greater accessibility of European law information resources via web technology (i.e. an e-justice portal), of improving knowledge of European law and language skills among the judiciary, of establishing and maintaining networks in this field, and of any other measures to facilitate judicial cooperation on a day-to-day basis in order to ensure mutual trust and consequent cooperation and mutual recognition; |
Next steps
|
115. |
Is of the opinion that guidance, coherence and benchmarks for the area of freedom, security and justice are necessary; considers that such objectives require a proper programming to be prepared in the spirit of the Treaty of Lisbon in a joint exercise between the Parliament, the Council and the Commission; |
o
o o
|
116. |
Instructs its President to forward this resolution to the Council and the Commission. |
(1) OJ C 285 E, 21.10.2010, p. 12.
(3) OJ L 26, 26.1.2013, p. 27.
(4) Regulation (EU) No 211/2011 of the European Parliament and of the Council of 16 February 2011 on the citizens’ initiative (OJ L 65, 11.3.2011, p. 1).
(5) Council Regulation (EC) No 168/2007 of 15 February 2007 establishing a European Union Agency for Fundamental Rights (OJ L 53, 22.2.2007, p. 1).
(6) OJ C 378, 24.12.2013, p. 1.
(7) OJ L 315, 14.11.2012, p. 57.
(8) OJ L 338, 21.12.2011, p. 2.
(9) OJ L 101, 15.4.2011, p. 1.
(10) Texts adopted, P7_TA(2013)0322.
(11) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
(12) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (recast) (OJ L 351, 20.12.2012, p. 1).
(13) Regulation (EU) No 650/2012 of the European Parliament and of the Council of 4 July 2012 on jurisdiction, applicable law, recognition and enforcement of decisions and acceptance and enforcement of authentic instruments in matters of succession and on the creation of a European Certificate of Succession (OJ L 201, 27.7.2012, p. 107).
(14) Council Regulation (EU) No 1259/2010 of 20 December 2010 implementing enhanced cooperation in the area of the law applicable to divorce and legal separation (OJ L 343, 29.12.2010, p. 10).
(15) COM(2012)0614.
(16) Directive 2010/64/EU of the European Parliament and of the Council of 20 October 2010 on the right to interpretation and translation in criminal proceedings (OJ L 280, 26.10.2010, p. 1).
(17) Directive 2012/13/EU of the European Parliament and of the Council of 22 May 2012 on the right to information in criminal proceedings (OJ L 142, 1.6.2012, p. 1).
(18) Directive 2013/48/EU of the European Parliament and of the Council of 22 October 2013 on the right of access to a lawyer in criminal proceedings and in European arrest warrant proceedings, and on the right to have a third party informed upon deprivation of liberty and to communicate with third persons and with consular authorities while deprived of liberty (OJ L 294, 6.11.2013, p. 1).
(19) OJ C 264 E, 13.9.2013, p. 7.
(20) Directive 2006/24/EC of the European Parliament and of the Council of 15 March 2006 on the retention of data generated or processed in connection with the provision of publicly available electronic communications services or of public communications networks and amending Directive 2002/58/EC (OJ L 105, 13.4.2006, p. 54).
Thursday 3 April 2014
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30.11.2017 |
EN |
Official Journal of the European Union |
C 408/21 |
P7_TA(2014)0286
EU comprehensive approach and coherence of EU external action
European Parliament resolution of 3 April 2014 on the EU comprehensive approach and its implications for the coherence of EU external action (2013/2146(INI))
(2017/C 408/03)
The European Parliament,
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having regard to the Annual Report from the Council to the European Parliament on the Common Foreign and Security Policy, |
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having regard to Articles 2, 3, 21, 24 and 36 of the Treaty on European Union (TEU), |
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having regard to Title V TEU and to the Treaty on the Functioning of the European Union (TFEU), |
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having regard to Article 21(3) TEU, which stipulates that the High Representative shall assist the Council and the Commission in ensuring consistency between the different areas of the Union’s external action, |
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having regard to Article 24(3) TEU, which states that the Member States shall support the Union’s external and security policy actively and unreservedly in a spirit of loyalty and mutual solidarity and shall comply with the Union’s action in this area, that they shall refrain from any action which is contrary to the interests of the Union or likely to impair its effectiveness as a cohesive force in international relations and that the Council and the High Representative shall ensure compliance with these principles, |
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having regard to the European Council conclusions of 14 December 2012, |
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having regard to the conclusions of the Inter-Parliamentary Conference for the Common Foreign and Security Policy and the Common Security Defence Policy of 6 September 2013, |
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having regard to the Joint Communication of the Commission and the HR/VP to the European Parliament and the Council of 11 December 2013 on the EU's comprehensive approach to external conflict and crises (JOIN(2013)0030), |
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having regard to its recommendation to the High Representative of the Union for Foreign Affairs and Security Policy/Vice-President of the Commission, to the Council and to the Commission of 13 June 2013 on the 2013 review of the organisation and functioning of the EEAS (1) and to the EEAS Review 2013 presented by the High Representative in July 2013 (2), |
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having regard to Parliament’s resolutions on the CFSP and the CSDP, in particular its resolution of 22 November 2012 on the Role of the Common Security and Defence Policy in cases of climate-driven crisis and natural disasters (3), |
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having regard to the European Consensus on Development, |
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having regard to the report of 15 October 2013 by the High Representative/Vice-President of the Commission on the Common Security and Defence Policy, |
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having regard to the EEAS report on the revision of CSDP crisis management procedures, adopted by the Political and Security Committee (PSC) on 18 June 2013, |
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having regard to the Charter of the United Nations, |
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having regard to Rule 48 of its Rules of Procedure, |
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having regard to the report of the Committee on Foreign Affairs and the opinions of the Committee on Development and the Committee on Women’s Rights and Gender Equality (A7-0138/2014), |
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A. |
whereas it is already a requirement of the Lisbon Treaty and the current decision-making processes to ‘ensure consistency between the different areas of the Union’s external action and between these and its other policies’; whereas this objective would benefit from Parliament playing a greater role in external relations; |
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B. |
whereas comprehensiveness refers not only to the joined-up deployment of EU instruments and resources, but also to the shared responsibility of EU-level actors and Member States, whose policies, actions and support should contribute to more coherent and more effective EU external action; |
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C. |
whereas with the Lisbon Treaty the EU has recently acquired new instruments of external action which enable it to develop a more active, unified and genuine EU foreign policy; |
The EU in a changing world
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1. |
Considers that significant geostrategic changes are taking place, owing in particular to the rise of a multipolar international scene with new actors pursuing competitive regional and global ambitions, growing interdependency, the rise of multidimensional asymmetric threats, the refocusing of US security policy towards the Asia-Pacific, the growing struggle over energy and resource security, the increasingly serious effects of climate change and a severe and long-lasting global financial and economic crisis affecting all EU Member States; |
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2. |
Stresses that in such a geopolitical climate, the EU must preserve and promote its values, interests and stability on the global stage, as well as protect the security and prosperity of its citizens; stresses that this demands a fresh approach to shaping, in cooperation with our strategic partners, a new multipolar world order that is inclusive, credible, just, cooperative, underpinned by respect for human rights, the rule of law and democracy and aims to achieve the resolution of differences without recourse to armed conflict; |
EU comprehensive approach: state of play in implementing the political framework
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3. |
Emphasises that the strength of the EU lies in its potential to mobilise resources across the full range of diplomatic, security, defence, economic, trade, development and humanitarian instruments — in full compliance with the provisions of the UN Charter — and that using these instruments in a comprehensive approach (CA) gives it a unique flexibility to effectively address the most challenging international issues and achieve its own policy goals; |
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4. |
Stresses the importance of effective coordination and coherence in the European Union’s external action; agrees with the view that the development, political and security spheres are interdependent and that the added value provided by the EU in responding to complex emergencies lies in its ability to create cross-sectoral and interinstitutional synergies in order to deliver sustainable results on the ground and achieve long-term strategic objectives; |
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5. |
Stresses that the CA is today considered by all relevant international actors (including multilateral organisations and states) to be the best way to frame an efficient response to multidimensional crises and to promote human security globally, directly coming from long-standing recognition that attempting to bring stability by means solely of a single approach is likely to fail; |
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6. |
Recalls notably that the United Nations has developed, since 2006, the concept of an ‘integrated approach’ to conflict and post-conflict situations and that NATO's members adopted, at the 2010 Lisbon Summit, a new Strategic Concept calling for a comprehensive approach to crisis management; |
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7. |
Underlines the fact that the Lisbon Treaty provides the framework for the Union to achieve a more coherent, joined-up and comprehensive approach for the effective pursuit of the Union’s external relations, including by creating the triple-hatted High Representative (HR) of the Union for Foreign Affairs and Security Policy, who is also Vice-President of the Commission and Chair of the Foreign Affairs Council, and by establishing a unifying and effective European External Action Service (EEAS); |
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8. |
Regrets that, despite the Lisbon Treaty innovations, lack of progress in the consistency of the Union’s external action persists in areas relating to security, humanitarian matters, development, trade, energy, environment, migration and other global issues; is concerned that the Commission often takes a restrictive approach, protecting its own competences in these areas and minimising coordination functions with the EEAS; |
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9. |
Urges the Member States to meet their Treaty-based commitments to support the Union’s external relations and security policy actively and in a spirit of mutual solidarity and to comply, in conducting their own policies, with the Union’s action in this area; calls on the Member States to play a constructive role by promoting strategic policy coordination at EU level; stresses that the EU foreign policy can only be effective if the Member States are willing and able to formulate common policy lines, particularly within multilateral organisations, such as the United Nations; |
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10. |
Welcomes the joint communication on the EU’s comprehensive approach to external conflicts and crises of 11 December 2013; regrets, however, that it relies more on existing processes rather than trying to explore new concrete ways to facilitate institutional and practical cooperation; |
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11. |
Insists that the CA is the common responsibility of all EU actors in EU institutions, in EU Member States and on the ground in third countries, and that, at the same time, it must fully respect the specific competencies of each institution and actor; |
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12. |
Calls for active engagement and dialogue with citizens and civil society to ensure legitimacy and a common understanding of the CA and the EU foreign policy in general; |
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13. |
Believes that as a basis for moving from concept to action in the pursuit of a CA, the following four areas must be addressed; |
1. Institutional coherence
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14. |
Believes that the concept of a CA should be understood as the coordinated work of all relevant institutions (the EEAS and the Commission’s relevant services, including ECHO, DEVCO, TRADE and ELARG, but also Parliament and the Council) pursuing common objectives within an agreed framework designed at EU level, and mobilising its most relevant instruments, including the CSDP when the security situation so requires; believes that, so far, institutional and procedural shortfalls have largely prevented such coherent EU external action in most crisis areas where the EU has acted damaging the EU’s credibility as a global actor and security provider; |
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15. |
Recalls that the Lisbon Treaty created the EEAS and the triple-hatted HR/VP to provide unity, consistency, visibility and effectiveness to the EU’s external action; underlines the fact that, so far, the potential of all three roles has not been fully exploited; calls for the vital coordinating role of the HR/VP as Vice-President of the Commission to be reinforced within the Commission itself, through institutionalised regular meetings of the RELEX college of Commissioners, chaired by the HR/VP and enlarged to include other relevant Commissioners; calls for an immediate reform of the EEAS based on the 2013 review and Parliament’s guidelines in order to make the best use of scarce financial resources; |
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16. |
Stresses that whilst cooperation is essential, the competencies and procedures of all institutions and Member States must be fully respected; calls, therefore, on all EU actors to act in good faith and to do their best to allow the pursuit of a CA; |
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17. |
Believes that a CA requires responsive, flexible and efficient structures in the EEAS; recalls its view that the EEAS institutional set-up should be streamlined to ensure effective decision-making and use of its instruments, including CSDP civilian and military instruments, as requested in Parliament’s 2013 report on the matter; |
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18. |
Underlines that the development of the CA should also ensure gender mainstreaming and balance in the formulation, development and implementation of all Union external actions; |
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19. |
Stresses the important role of mediation and dialogue in preventing and resolving conflicts peacefully; commends the progress the EEAS has made in strengthening its mediation capacities, reiterates its support for further enhancing Europe’s capacities in this field and calls for mediation to be made an important standard feature of any future CA for a specific crisis region; stresses Parliament’s role in formulating and monitoring common foreign policy and calls on the next Parliament to ensure its effectiveness and, above all, its coherence; draws attention to Parliament’s engagement to actively participate in election observation, mediation and democracy support; believes that Parliament’s involvement in mediation processes in Ukraine and the Former Yugoslav Republic of Macedonia (FYROM) has demonstrated the important role parliamentarians can play in this field; |
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20. |
Recalls that special attention must be paid to respecting the principles of humanitarian aid (independence, impartiality, neutrality); believes that safe access to affected populations and the security of humanitarian workers rely above all on how they are perceived by influential actors in the field, and that they should be seen as independent from any partisan political consideration; points out, however, that the Commission’s humanitarian aid and civil protection (ECHO) service is still part of the EU and, consequently, strongly believes that more should be done to enhance cooperation and coordination between ECHO and the EEAS; |
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21. |
Welcomes the Joint Communication of 11 December 2013, ‘The EU’s comprehensive approach to external conflict and crises’ (JOIN(2013)0030), which represents an opportunity to clarify and operationalise this approach in the new post-Lisbon institutional setting, as well as to consolidate the EU’s commitment to a comprehensive framework for its work in the field of external relations; acknowledges the considerable challenges inherent in promoting and implementing such an ambitious policy; welcomes, in particular, the emphasis it places on the link between security and development, which should be a key underlying principle in the application of a comprehensive EU approach; |
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22. |
Strongly supports the notion of a more coherent external action; stresses that the EU should not adopt a narrow definition of the comprehensive approach; welcomes the fact that the Joint Communication promotes an understanding of the comprehensive approach that covers all stages of the cycle of conflict or other external crisis through early warning and preparedness, conflict prevention, crisis response and management to early recovery, and stabilisation and peace-building to help countries get back on track towards sustainable and long-term development; recalls that foreign policy objectives should not be placed in opposition to development principles and principled humanitarian action, as all three policies are complementary; |
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23. |
Recalls that Article 208 of the Treaty on the Functioning of the European Union (TFEU) establishes the principle of Policy Coherence for Development (PCD), and emphasises the potential for tension between PCD on the one hand and the comprehensive approach to crisis management outside the EU on the other; stresses that the main goal of the EU’s development policy is the eradication of poverty and that it is therefore essential that anti-poverty objectives are not marginalised in EU foreign policy and that the comprehensive approach does not erode the civilian character of development cooperation; takes note of the fact that the Joint Communication entrusts the HR/VP and the President of the Commission with the responsibility to ensure strategic and operational coherence in external relations, including regarding the external impact of internal policies; calls on the HR/VP and the President of the Commission to commit to doing so; |
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24. |
Points out that both Article 214 TFEU and the European Consensus on Humanitarian Aid of 2008 protect principled humanitarian action; calls for the safeguarding of the humanitarian principles of humanity, neutrality, impartiality and independence which are crucial for both the effectiveness of humanitarian action and the safety of its actors; stresses firmly that counter-terrorism and security agendas must not undermine the ability of humanitarian actors to deliver assistance, and that humanitarian aid should under no circumstances serve political ends or be considered a crisis management tool; points out that to obtain access to populations in need humanitarian aid must not only be neutral but also be perceived as such; while acknowledging that a needs-based humanitarian delivery should be given some freedom of manoeuvre, calls for wider engagement with humanitarian actors in order to define better the parameters of their relationship with the comprehensive approach; |
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25. |
Is of the view that there is a strong link between development and conflict prevention, as poverty is often a prime source and outcome of conflict; stresses that prevention contributes to peace, security and sustainable development; welcomes the focus on prevention in the Joint Communication, and calls for the enhancement of the EU’s early warning systems; calls on the EU to continue to support countries in situations of fragility, in order to address the root causes and establish functioning and accountable institutions that can deliver basic services and support poverty reduction; underlines the need to draw up an EU strategy for fragile states, which would integrate into the EU system both the OECD-DAC fragile states principles and the objectives of the ‘New Deal for Engagement in Fragile States’ agreed in Busan in December 2011; |
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26. |
Welcomes the commitment to a long-term strategy expressed in the Joint Communication, since only a long-term engagement together with sustainable development can promote peace and security; calls for better coordination of the short-term and long-term objectives of EU policies, paying due regard to the views of the stakeholders at local level; |
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27. |
Stresses that, in order to be effective, the EU comprehensive approach should be based as fully as possible on joint analysis, assessment and planning across the EU system, with a clear division of responsibilities; points out, in this context, the importance of joint programming as a tool to achieve coherence in external action; |
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28. |
Believes that the CA must be rooted in a vision shared by all EU actors of the evolving strategic context in which EU action takes place; calls, therefore, for more regular and transparent information-sharing, policy co-ordination and teamwork between EU actors through all phases of EU action; calls, further, for the development of formal structures in which those exchanges could take place and where early warning, situation analysis and crisis and post-crisis monitoring could be conducted, potentially integrating existing structures (such as the EU SitRoom, the Emergency Response Coordination Centre and ARGUS); reiterates the need for a ‘Crisis Response Board’ within the EEAS, to be chaired by the HR/VP and bringing together all actors relevant to crisis management; |
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29. |
Believes that pursuing a CA also requires improving coordination, under the VP/HR’s leadership, with the EU’s internal policies that have a significant foreign policy dimension such as the internal market, migration, environment and energy; |
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30. |
Calls for better alignment between trade policy and common foreign policy, including human rights and development; |
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31. |
Stresses that poor coordination and policy planning amongst the relevant institutions is partly responsible for the weak implementation of the EU’s foreign policies on the ground; takes note that it is improving since the EU delegations took over the coordination function in the field, but more progress needs to be made to further enhance implementation of the EU’s foreign policies on the ground, particularly when it comes to crisis regions and when linked with CFSP activities; |
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32. |
Calls for the strengthening of the EU’s capacities for dealing with global challenges, notably climate diplomacy; calls on the EEAS to identify political trade-offs and strike political bargains by linking climate and other aspects of the EU’s relations with partner countries; hopes that in the run-up to the Paris UN climate conference in 2015, the EEAS will start using its extensive network of EU delegations around the world in order to deepen European understanding of the interests and domestic politics of climate action in partner countries; |
2. Financial coherence
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33. |
Underlines Parliament’s determination to ensure that the Union’s external financial instruments for the period 2014 to 2020 are designed so as to facilitate the pursuit of a CA to the Union’s external relations, in particular, by creating instruments that work across the nexus of conflict prevention, crisis management, peace-building, development cooperation and the strengthening of strategic partnerships; stresses that the new Partnership Instrument also provides the EU with a tool to accompany foreign policy activities with third countries financially; underlines its determination to exercise in full its democratic control of the implementation of these instruments to ensure that the Union’s important but finite resources are used in an efficient and cost-effective way to achieve results; underlines Parliament’s right, as part of the Mid-Term Review of the external financial instruments, to review the implementation of the instruments and make any necessary changes; |
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34. |
Regrets the lack of ambition in the EU budget for external action for the period 2014-2020; calls for better anticipation of the funding needed for the implementation of EU strategies; regrets that in some cases, the EU’s actions have been delayed because of financial matters; calls for such structural problems to be remedied in future, including by making use of the new provisions on strengthening capacities for participation and deployment in civilian stabilisation missions (Article 4c) provided by the Instrument for Stability and Peace (ISP); recalls also the need to review the financing mechanism for military CSDP operations (known as the ATHENA mechanism), so as to allow for a more adequate and fairer burden-sharing of the costs of EU military operations, thus enabling all Member States to contribute through force generation or financing the supporting costs; |
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35. |
Reminds the HR/VP that Parliament has revised the Union’s External Financial Instruments for the period 2014 to 2020 to provide scope for strengthening the capacity of like-minded international, regional, governmental and civil society actors who are willing to work with the Union in the pursuit of objectives, whilst upholding our fundamental values such as the promotion of democracy; |
3. Coherence in practice
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36. |
Welcomes the EU’s recent development of regional strategies to define political priorities, communicate policy objectives, coordinate policy responses, build partnerships and focus on the implementation of resources; calls for the systematic elaboration of EU strategies to frame and give coherence to the EU’s action on the ground, drafted jointly by the EEAS and the relevant services of the Commission (notably DEVCO and ECHO), and under the lead of the HR/VP; calls on the Commission to be actively involved in its areas of competence from the very beginning of this coordination; |
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37. |
Insists that such strategies should clearly set out the EU’s objectives and priorities and the specific timeframe for implementation and determine what instruments are best suited for action (ranging from inter alia humanitarian and development aid to diplomatic action and mediation, economic sanctions, and the CSDP); insists that the role and contribution from the CSDP should be part of the initial political analysis and definition of policy objectives, thereby facilitating early involvement of CSDP planners and the relevant parliamentary bodies at European and national level; welcomes in that context, the positive development of a Political Framework for Crisis Approach for CSDP missions and operations and calls for this to be extended for all crisis response initiatives; |
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38. |
Welcomes, in particular, the EU’s Strategic Framework for the Horn of Africa, which aims to bring stability to this strategic region by fighting piracy and its underlying causes, establishing legitimate authorities in Somalia and promoting regional cooperation through the simultaneous use of the EU’s external instruments, in cooperation with relevant partners in the field; recalls, however, that EU action in the region has been built up on the basis of pioneering CSDP initiatives (namely EUNAVFOR Atalanta and EUTM Somalia) that have then been followed by other EU instruments, making the CA in the Horn of Africa more of an ex-post empirical and pragmatic achievement rather than a well-designed and planned strategy; believes strongly that, in future, EU strategies must be drawn up before the EU engages in a region, not after; |
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39. |
Regrets that, even when strategies are defined, the EU often does not manage to implement them, and is instead forced to take contingency and emergency action; recalls that this has notably been the case in the Sahel region, for which a very comprehensive and well-prepared EU strategy document (the 2011 EU Strategy for Security and Development in the Sahel) had been unanimously approved but did not lead to satisfactory implementation until the situation in Mali deteriorated dramatically; calls for a lessons-learned analysis of this particular case, as well as — more broadly — for improved early warning analysis of key volatile regions, in order to establish concrete conflict-prevention and mediation initiatives and thereby improve upstream action by operating a policy shift from reactive-centric approaches to a more adequate and efficient prevention-focused approach; |
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40. |
Points out that many current national, regional and international conflicts are also climate-driven and that, as a consequence, the CA needs to incorporate the concept of human security; recalls the analysis published by UNEP in December 2011 on the situation in the Sahel region, where it is stated that rising temperatures have led to water shortages and have specifically put local populations, whose livelihoods are dependent on natural resources such as farming, fishing and herding, under strong pressure, resulting, in some cases, in violence and armed conflict; |
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41. |
Is convinced that, in cases where crises cannot be avoided, the EU must be able to plan and deploy the appropriate civilian and military assets, as well as mobilise complementary EU instruments, rapidly and effectively across the whole spectrum of crisis management operations, including in cases of humanitarian crises; calls for the implementation of the relevant Treaty articles in the field of rapid response, including Article 44 TEU; underlines, in that context, the need for political and security experts within the relevant EU delegations; |
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42. |
Insists that the EU should be able to consolidate peace and stability over the longer term; calls for clear transition strategies to be determined long in advance between short-term crisis-response instruments (notably diplomatic, CSDP, ECHO instruments, and the new ISP) and post-crisis instruments (notably ISP and development assistance) in order to sustain progress achieved in the field; welcomes — as a major first step — the effective cooperation between the EEAS and the Commission in support of the CSDP mission in Mali, and the consideration, at an early stage, of an exit strategy for EUTM Mali; |
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43. |
Calls on the EU to make further progress on acting as one at country level, with a clear division of responsibilities and under the leadership of a Head of Delegation, responsible for implementing the EU’s external policy in the country, while coordinating locally with Member States as well as the host government, civil society and other international partners; calls on the Member States to commit to unified EU action in third countries and to make sure that coordination and articulation of actions on the ground are duly concerted with the EU institutions, namely the Commission and the EEAS; regrets in this regard that autonomous action by Member States in third countries, especially post-conflict and democratising societies, without proper articulation between them and the EU local Delegation has proved damaging to the EU’s goals and interests, as well as to its credibility vis-à-vis the third state and other international partners; |
4. Partnerships
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44. |
Stresses that a successful CA also requires developing partnerships outside the Union’s institutions and Member States, to include other international and multilateral partners, strategic partners, host countries, regional organisations, civil society actors and the private sector, with due respect for the decision-making autonomy of the EU; |
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45. |
Urges the EU to ensure that the EU participates effectively in the work of the UN General Assembly, making use of all the powers conferred on it by its status as a regional integration organisation; |
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46. |
Reiterates the view, in keeping with the purposes of the Lisbon Treaty in enhancing EU foreign policy and the role of the EU in global peace, security and regulation, that an EU seat in an enlarged UNSC remains a central, long-term goal of the European Union; calls on the VP/HR to take the initiative to develop a common position of the Member States to that end; suggests, in order to achieve that goal in the future, working on prior coordination of positions in the Council of the EU on the introduction of new members of the UNSC and reform of the UNSC’s decision-making towards the possible use of a super-qualified majority; |
o
o o
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47. |
Instructs its President to forward this resolution to the Council and the Commission. |
(1) Texts adopted, P7_TA(2013)0278.
(2) http://eeas.europa.eu/library/publications/2013/3/2013_eeas_review_en.pdf
(3) Texts adopted, P7_TA(2012)0458.
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/28 |
P7_TA(2014)0338
Annual Report 2012 on the protection of the EU's financial interests — Fight against fraud
European Parliament resolution of 3 April 2014 on the Annual Report 2012 on the Protection of the EU’s Financial Interests — Fight against fraud (2013/2132(INI))
(2017/C 408/04)
The European Parliament,
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having regard to its resolutions on previous annual reports of the Commission and of the European Anti-Fraud Office (OLAF), |
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having regard to the report from the Commission to the European Parliament and the Council of 24 July 2013 entitled ‘Protection of the European Union’s financial interests — Fight against fraud — 2012 Annual Report’ (COM(2013)0548) and its accompanying documents (SWD(2013)0283, SWD(2013)0284, SWD(2013)0285, SWD(2013)0286 and SWD(2013)0287), |
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having regard to OLAF’s 2012 annual report, |
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having regard to the annual report of the Court of Auditors on the implementation of the budget concerning the financial year 2012, together with the institutions’ replies (1), |
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having regard to the proposal for a Council regulation on the establishment of the European Public Prosecutor’s Office (COM(2013)0534), |
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having regard to the Commission Communication of 17 July 2013 entitled ‘Improving OLAF’s governance and reinforcing procedural safeguards in investigations: a step-by-step approach to accompany the establishment of the European Public Prosecutor’s Office’ (COM(2013)0533), |
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having regard to the Commission Communication of 17 July 2013 entitled ‘Better protection of the Union’s financial interests: setting up the European Public Prosecutor’s Office and reforming Eurojust’ (COM(2013)0532), |
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having regard to the Commission Communication of 26 May 2011 on the protection of the financial interests of the European Union by criminal law and by administrative investigations — An integrated policy to safeguard taxpayers’ money (COM(2011)0293), |
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having regard to the Commission Communication of 24 June 2011 on the Commission Anti-Fraud Strategy (COM(2011)0376), |
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having regard to the Commission Communication of 6 December 2012 entitled ‘An Action Plan to strengthen the fight against tax fraud and tax evasion’ (COM(2012)0722), |
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having regard to the Commission Communication of 26 September 2013 entitled ‘Protection of the European Union budget to end 2012’ (COM(2013)0682), |
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having regard to the Commission Communication of 13 December 2013 entitled ‘Application of net financial corrections on Member States for Agriculture and Cohesion Policy’ (COM(2013)0934), |
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having regard to the report from the Commission to the Council and the European Parliament entitled ‘EU anti-corruption report’ (COM(2014)0038), |
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having regard to Council Directive 2013/43/EU of 22 July 2013 amending Directive 2006/112/EC on the common system of value added tax, as regards an optional and temporary application of the reverse charge mechanism in relation to supplies of certain goods and services susceptible to fraud (2), |
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having regard to Council Directive 2013/42/EU of 22 July 2013 amending Directive 2006/112/EC on the common system of value added tax as regards a quick reaction mechanism against VAT fraud (3), |
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having regard to the Commission proposal for a directive of the European Parliament and of the Council on the fight against fraud to the Union’s financial interests by means of criminal law (COM(2012)0363), |
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having regard to Regulation (EU) No 250/2014 of the European Parliament and of the Council of 26 February 2014 establishing a programme to promote activities in the field of the protection of the financial interests of the European Union (Hercule III programme) and repealing Decision No 804/2004/EC (4), |
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having regard to Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (5), |
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having regard to Article 325(5) of the Treaty on the Functioning of the European Union, |
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having regard to Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (6), |
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having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union (7), |
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having regard to Opinion No 1/2014 of the Supervisory Committee of the European Anti-Fraud Office (OLAF) on OLAF Investigation Policy Priorities, |
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having regard to Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities’ financial interests (8), |
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having regard to its resolution of 3 July 2013 on the Annual Report 2011 on the protection of the EU’s Financial Interests — Fight against fraud (9), |
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having regard to its resolution of 15 September 2011 on the EU’s efforts to combat corruption (10), |
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having regard to its declaration of 18 May 2010 on the EU’s efforts in combating corruption (11), and to the Commission Communication of 6 June 2011 entitled ‘Fighting corruption in the EU’ (COM(2011)0308), |
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having regard to its resolution of 23 October 2013 on organised crime, corruption and money laundering: recommendations on action and initiatives to be taken (12), |
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having regard to Rule 48 of its Rules of Procedure, |
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having regard to the report of the Committee on Budgetary Control (A7-0195/2014), |
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A. |
whereas, according to Commission estimates, EUR 1 000 000 000 000 of potential tax revenue is lost to tax fraud, tax evasion, tax avoidance and aggressive tax planning in the EU every year, representing an approximate annual cost of EUR 2 000 for every European citizen; |
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B. |
whereas protection of the financial interests of the EU is a key element of the EU policy agenda to strengthen and increase the confidence of citizens and ensure that their money is used properly; |
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C. |
whereas the Treaty of Lisbon has substantially strengthened the instruments available to protect the financial interests of the EU, requiring both the EU and its Member States to combat all forms of illegal activity affecting the financial interests of the EU; |
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D. |
whereas the wide diversity of legal systems and traditions within the EU means that protection of its financial interests against fraud and any other illegal activity is a particularly demanding and unavoidable challenge; |
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E. |
whereas, to protect the financial interests of the Union and combat fraud it is necessary to adopt an integrated approach, including strategies for fighting fraud and corruption by means of legal, effective, consistent and equivalent measures throughout the Union; whereas this is a responsibility shared by the EU and the Member States and close cooperation between the Commission and the Member States is even more essential at a time of budgetary constraint; |
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F. |
whereas the European Anti-Fraud Office (OLAF) has the responsibility to protect the Union’s financial interests by investigating fraud, corruption and any other illegal activities and whereas its supervisory committee was established in order to reinforce and guarantee OLAF’s independence by regularly monitoring the implementation of OLAF’s investigative function; |
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G. |
whereas the Member States have primary responsibility for implementing approximately 80 % of the Union budget; |
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H. |
whereas the Member States are responsible for calculating the harmonised basis of assessment for value added tax (VAT), amending the VAT rates applied and collecting the Union’s own resources, and whereas these three functions impact on its budget; |
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I. |
whereas, at Parliament’s request, the Commission has recently taken a number of important initiatives on strategic anti-fraud measures; |
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J. |
whereas the scale of fraud and tax avoidance in any form and of corruption in the EU undermines citizens’ trust and confidence in the Union; whereas greater guarantees of integrity and transparency with regard to public spending are necessary; |
Strengthening the European Union’s anti-fraud machinery
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1. |
Emphasises that it is incumbent on both the Commission and the Member States to do everything in their power to fight fraud, corruption and all other forms of illegal activity detrimental to the Union’s financial interests, in accordance with the provisions of the Treaty on the Functioning of the European Union; points out that close cooperation and coordination between the Commission and the Member States are essential in order to ensure that the Union’s financial interests are protected effectively, and hence such cooperation and coordination must, as a matter of priority, be strengthened and made as effective as possible; points out that protecting the Union’s financial interests demands an equally vigilant approach to both resources and expenditure; |
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2. |
Stresses that fraud is a deliberate unlawful act, which may constitute a criminal offence, while an irregularity is a failure to comply with a rule; finds it regrettable that the Commission’s report fails to consider fraud in detail and focuses largely on irregularities; points out that Article 325 of the Treaty on the Functioning of the European Union (TFEU) relates to fraud, not irregularities, and calls for a distinction to be made between fraud and errors or irregularities; |
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3. |
Takes note of the report from the Commission to the European Parliament and the Council on the Protection of the European Union’s financial interests — Fight against fraud — Annual Report 2012 (‘the Commission’s annual report’); notes that, in response to a request from the European Parliament, the report includes two new elements:
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notes that the aim of this approach is to afford insight into the extent and nature of the irregularities and how the Member States deal with them;
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4. |
Calls on the Commission, at the time of initiating the procedure for submission of the annual PIF report, to submit to Parliament a report on the monitoring and implementation of the recommendations adopted by Parliament following the PIF report of the previous year, and give a reasoned explanation regarding those which it has not considered or with which it has been unable to comply; calls on OLAF to do the same in respect of measures being sought by Parliament in this report; |
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5. |
Welcomes the main initiatives taken by the Commission, at Parliament’s request, to shape a new EU legislative landscape for anti-fraud policy, and in particular the proposal for a directive on the fight against fraud to the Union’s financial interests by means of criminal law, which aims to clarify and harmonise Member States’ provisions in criminal law on offences related to the EU budget (COM(2012)0363), the proposal for a Council regulation on the establishment of the European Public Prosecutor’s Office (COM(2013)0534), and the proposal for a regulation on the European Union Agency for Criminal Justice Cooperation (Eurojust) (COM(2013)0535), as well as the amendment to Regulation (EC) No 1073/1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and stronger legal rights for persons concerned by OLAF investigations; recognises the importance for these different pieces of legislation to be well calibrated and thoroughly evaluated; calls on the Council to take the necessary time and not to finalise negotiations in a rush, in order to develop a robust European legal framework and strengthen the existing institutional tools for protecting the Union’s financial interests; stresses that a premature transition to the enhanced cooperation procedure should be avoided; welcomes also the action plan to step up the fight against tax fraud and tax evasion, as well as VAT reform in the EU, both efforts having been initiated in 2011; |
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6. |
Notes that there was virtually no change in 2012, compared with 2011, in the number of fraudulent irregularities, with 1 231 cases of irregularity reported as fraudulent, while their financial impact decreased slightly to a total of EUR 392 million; notes that the incidence of fraud was highest in the areas of cohesion policy and agriculture — especially as regards rural development and fisheries — which remain the two sectors of greatest concern, suffering an estimated financial impact from fraud of EUR 279 million and EUR 143 million respectively; highlights, however, the general point that the number of fraudulent irregularities reported and the corresponding sums of money reflect the notion of fraud in its broadest sense and should not be seen as a reliable yardstick for levels of fraud; calls for clear distinctions to be made between cases of fraud, cases of error and cases of irregularity in the 2013 Annual Report on protection of the European Union’s financial interests — Fight against fraud; |
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7. |
Notes that the number of cases of non-fraudulent irregularity reported to the Commission in 2012 increased by approximately 6 % compared with 2011, with an associated financial impact of approximately EUR 2 900 000 000 (more than double the corresponding figure for 2011 and affecting in particular cohesion policy and direct expenditure); is concerned that while the increase is chiefly due to the impact of irregularities involving large sums of money, it also reflects systemic irregularities reported when programmes close; |
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8. |
Notes the considerable increase in 2012, to a value of EUR 3 700 000 000, in corrective measures adopted by the Commission vis-à-vis Member States, chiefly in the field of cohesion policy, and the fact that this reflects, inter alia, the close of the 2000-2006 programming period; |
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9. |
Observes that the recommendations made by the Commission to Member States in 2011 — in particular on reported fraudulent and non-fraudulent irregularities, the recovery of amounts improperly paid, the monitoring of the results of criminal investigations and the improvement of national fraud statistics — were generally appropriate, and regrets that a number of concerns were not fully addressed; calls on Member States to follow-up on the Commission’s recommendations made in 2011 and 2012 and to ensure that recommendations made to them in its 2012 report are followed in full, and that where action on recommendations cannot be taken they submit a reasoned explanation; |
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10. |
Proposes looking into the possibility of establishing a team of European customs officials specialised in combating fraud to work alongside national customs authorities; |
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11. |
Acknowledges that in the area of traditional own resources the amount to be recovered following fraud and other irregularity cases in 2012 reached EUR 444 million, of which EUR 208 million had already been recovered by the Member States; notes that a further EUR 83 million was recovered in 2012 relating to cases detected between 1989 and 2011; |
Revenue — own resources
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12. |
Regrets that own resources are no longer the main source of EU budget revenue, making up 20 % of it, with the result that the proper collection of VAT and customs duties has direct repercussions not only on Member States’ economies and the Union budget, but also on European taxpayers; recalls that, according to Commission estimates, tax evasion and tax fraud are costing the EU around EUR 1 trillion annually, that is to say around EUR 2 000 for every EU citizen; |
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13. |
Welcomes the Commission action plan to step up the fight against fraud and tax evasion; stresses that both the Commission and the Member States should continue to give absolute priority to combating fraud and tax evasion, for which it is necessary to develop a strategy for strengthened and multidimensional cooperation and coordination between Member States themselves and with the Commission to allow for better use of existing instruments, consolidation of existing legislation, adoption of pending proposals and administrative cooperation; notes that enhanced cooperation between the tax, police and legal authorities within a single country is likewise essential; calls for special attention to be paid to the development of mechanisms for prevention and early detection, evaluation of results, improved revenue collection and more effective customs transit monitoring, this being one of the areas still affected by the highest rates of systemic corruption in Europe; calls on the Commission and the Member States to be more active at international level so as to establish standards of cooperation based chiefly on the principles of transparency, good governance and exchange of information; |
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14. |
Calls on the Commission periodically to carry out a comparative analysis of differences in the effectiveness of national systems for the collection of traditional own resources, including the identification and dissemination of best practices regarding efficient recovery process in all Member States, and to propose suitable measures where necessary; |
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15. |
Expresses concern that although the number of non-fraudulent irregularities reported to be affecting income from traditional own resources in 2012 has remained stable, the total remains 20 % above the average for the period 2008-2012; |
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16. |
Calls for a closer analysis of the shortfalls between estimated levels of VAT revenue and the actual levels of revenue collected, and for this to be included in the Commission report in order to give a clearer picture of the loss to the Union envelope; reiterates that the Commission and the Member States must make combating tax evasion and the underground economy a constant objective; |
Excise Movement Control System (EMCS)
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17. |
Is satisfied that 98 % of total identified traditional own resources is collected in accordance with the rules, but asks the Commission to sustain its efforts in pursuing the 2 % affected by fraud and irregularities; |
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18. |
Notes that increased abuse of the Excise Movement Control System (EMCS) by criminal groups has been observed by enforcement agencies; believes that there is a lack of physical controls of goods being transported under the EMCS; stresses that additional investment in controls may result in an increase in collected taxes, and an increase in prevented tax evasion; notes, furthermore, that according to Articles 21(3) and 24(3) of Council Directive 2008/118/EC, the competent authorities of the dispatching and destination Member State will carry out an electronic verification of the data in the draft e-AD and in the report of receipt; strongly believes that criteria should be established according to which goods which are ready for dispatch and/or received must be inspected physically by the competent institution of the Member State; |
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19. |
Understands that increased inspections might also have the additional benefit of removing those businesses, or front companies, that were created by criminals only to facilitate their fraud; notes that up-to-date information on dispatch and receipt of excise goods is confirmed under the EMCS by business actors themselves; asks the Commission to take initiative in tightening the access rights of the EMCS to include a comprehensive history of compliance before trading so that it is possible to grant business actors the status of ‘empowered economic operator’ (‘trusted business actors’) so that only these actors could operate under EMCS directly by themselves; asks the Commission to present the results of current investigations concerning the need to amend Directive 2008/118/EC; |
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20. |
Demands that verification checks conducted by Member States on people and companies applying to the register be more robust and comprehensive; understands that goods can be easily mis-declared in order to evade excise duties; demands, in this connection, a higher degree of cooperation with tax authorities; |
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21. |
Considers that time limits allowed for the excise movements between authorised warehouses are unrealistically long; understands that such time limits allow for multiple movements on the same declaration and diversion before the delivery date is entered in the system; demands that the competent authority of the Member State declared as the destination and the new destination must be informed about changes immediately by the consignor; demands, furthermore, that the maximum allowed time for submission of the report on the receipt of the excise goods be one working day and, furthermore, that journey time be calculated and established for each delivery in accordance with the type of the means of transport used and distance between places of dispatch and destination; |
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22. |
Finds that the guarantees required to establish bonded warehouses are too low in comparison with the value of the excise goods; believes that a variable should be established depending on the type of goods and the level of trade that actually occurs; |
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23. |
Is concerned that Member States have implemented their own EMCS systems based on broadly defined requirements by the Commission; asks the Commission, in this connection, to take initiative for a more uniform system across the EU; |
VAT
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24. |
Takes note that, according to the new study on the VAT gap published in 2013 and financed by the Commission as part of its drive to reform the VAT system in the Union and put a stop to tax avoidance, EUR 193 000 000 000 in VAT revenue (1,5 % of GDP) was lost in 2011 through non-compliance or non-recovery; stresses, however, that the VAT gap is the product not only of fraud but also of other factors, including bankruptcy and insolvency, statistical errors, late payment and tax evasion; points out, in this connection, that effective action to close the VAT gap obviously requires a concerted, multidisciplinary approach; stresses the importance of implementing new strategies and making more efficient use of existing EU structures in order to combat VAT fraud more vigorously; |
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25. |
Welcomes the fact that the VAT reform process launched in December 2011 has already delivered important tools for ensuring better protection against VAT fraud; welcomes, in this regard, the fact that the directives on a quick reaction mechanism against VAT fraud and on an optional and temporary application of the reverse charge mechanism in relation to supplies of certain goods and services susceptible to fraud were finally adopted in July 2013, and calls on Member States to implement them without delay; |
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26. |
Believes also that there should be a focus on the need to simplify the VAT system for companies throughout Europe; welcomes, in this connection, the new measures designed to facilitate electronic invoicing and the special provisions for small companies, which came into force in 2013, and looks forward to the introduction of the standard VAT declaration form for the entire EU; hopes that the one-stop shop for e-services and telecoms businesses, which will become operational in 2015, will have a real effect in promoting compliance by simplifying VAT procedures for these businesses; |
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27. |
Calls on Member States to reform their national tax systems, making them simpler, fairer and more effective so as to facilitate compliance, prevent, deter and sanction tax fraud and evasion, and boost the efficiency of tax collection; also asks Member States to take heed of the country-specific recommendations made by the Commission in 2013; welcomes the Commission’s renewed call to Member States to extend their national tax bases and to restrict tax exemptions and deductions, thus enabling them not only to simplify their tax systems but also to avoid increasing their standard VAT rates; |
Irregularities reported as fraudulent and detrimental to the European Union budget
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28. |
Notes that, in terms of both numbers of cases and impact, the levels of fraudulent irregularity reported in 2012 were virtually the same as those of the previous year; |
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29. |
Notes that it takes on average two years and seven months from the start of a fraudulent practice until the moment it is detected; notes, furthermore, that another seven or eight months lapse before the irregularity is reported to the Commission; is concerned that guidelines on the times at which Member States report fraudulent irregularities and/or other irregularities to OLAF, if such guidelines exist in a Member State at all, differ not only across the individual Member States, but also across policy areas; expects the Commission to draw up Europe-wide guidelines for the reporting of fraudulent irregularities and/or other irregularities to OLAF; recalls that the staff of the European institutions are required, without delay and without any risk of their responsibility being called into question as a result, to notify OLAF of any fraud which has come to their attention in the fulfilment of their duties; |
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30. |
Notes that, on the revenue side, the number of cases of fraud reported in 2012 was 20 % below the average for the years 2008 to 2012; welcomes the fact that the Commission’s analyses show a clear downward trend in the numbers of fraud cases over that period; |
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31. |
Observes that, on the expenditure side, both the number of cases of irregularity reported as fraudulent and their value are low, that they involve already identified forms of irregularity and that over the period 2008 to 2012, fraud accounted for 5 % of the cases reported; notes that, as in previous years, cohesion policy was the field in which most of the fraudulent irregularity — 50 % of all cases and 63 % in terms of value — was detected; stresses that, out of the 1 194 cases of irregularity reported as fraudulent, 9 related to corruption and that all cases were detected in the cohesion policy area; is concerned that the incidence of such cases is rising; highlights with concern the trend towards simpler forms of fraud, probably reflecting the phenomenon of beneficiaries who would not normally break the law engaging in attempted fraud because of the economic crisis; believes that those trends should be monitored and studied in the years ahead; |
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32. |
Calls for corruption with an impact on the financial interests of the EU to be considered as fraud for the purposes of Article 325(5) TFEU and to be included in the Commission’s annual report on the protection of the European Union’s financial interests — fight against fraud; |
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33. |
Notes that, in the area of natural resources (agriculture, rural development and fisheries), there was an increase from 2011 to 2012 of almost 50 % in cases of irregularity reported as fraudulent, as the result of a single country reporting 56 cases, all involving the same modus operandi and linked to the same inquiry, and affecting the European Agricultural Guarantee Fund exclusively; notes that the rate of established fraud is slightly higher in agriculture — approximately 6 % of all cases reported in the 2008-2012 period — than it is overall; |
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34. |
Acknowledges that in the agriculture and rural development area, Member States recovered EUR 169,4 million from beneficiaries during the financial year 2012, while EUR 1 216,8 million remains to be recovered from beneficiaries from the end of that financial year; notes that the recovery rate of 43 % is significantly affected by the low recovery rates (below 30 %) displayed by six Member States (13); calls on those Member States to take adequate measures to ensure a significantly higher rate of recovery; |
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35. |
Recognises that cohesion policy has, over several financial years to date, proven to be the most critical sector, with regional development policy in particular being affected, but that at least the number of irregularities reported as fraudulent has been stable for the past three years; notes that the proportion of cases of established fraud — 4 % over the period 2008-2012 — is lower than the overall average; welcomes the fact that the efforts made by the Commission with the national authorities in recent years to raise awareness about fraud in this sector appear to have borne fruit and that Union legislation contributed in 59 % of cases to the detection of fraudulent irregularity; asks the Commission to step up and consolidate the joint anti-fraud strategy initiated in 2008; welcomes also the fact that cases of fraud are being reported sooner after they are detected; |
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36. |
Regrets, however, the lack of information on the amounts to be recovered and the recovery rates related to cohesion policy for the financial year 2012; calls on the Commission to provide detailed information in this respect in its future annual report; |
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37. |
Welcomes the fact that the number of cases of irregularity reported in relation to pre-accession assistance (PAA) has fallen steadily over the past three years and notes that EU-12 Member States have made a phased exit from PAA programmes, which are virtually complete; observes, however, that there was a significant increase in monetary terms, due to two cases reported by the same Member State; notes also that that there has been a slight decrease in the current programming period in the reported incidence of fraudulent irregularity in connection with the Instrument for Pre-accession Assistance (IPA), most likely a reflection of the delay in its implementation; |
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38. |
Highlights the ever-increasing wide divergence in Member States’ approaches to fraud, reflecting chiefly legal and organisational differences, both among Member States and between administrations in the same country, but also the fact that fraud detection is approached in a variety of ways; is greatly concerned that in cases of fraudulent irregularities some Member States limit their actions to the application of financial corrections instead of investigating the potential criminal offence; emphasises that such failure to investigate criminal offences could encourage fraudulent behaviours, thereby undermining the fight against fraud and fraudsters; calls on those Member States concerned to invest more resources to combat fraud, including through criminal proceedings; asks the Commission to continue to monitor closely the workings and effectiveness of Member States’ current surveillance and control systems and stresses how important it is that the Commission should establish uniform reporting principles for all of the Member States; calls on the Member States to implement the Commission’s recommendations, in particular with regard to early detection, simplification of rules and rapid reporting; |
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39. |
Points out, furthermore, that Member States are still failing to forward data on time or are supplying inaccurate data; recalls, moreover that Member States use different definitions for similar types of offence and do not all collect similar and detailed statistical data following common criteria, thereby making it difficult to collect reliable and comparable statistics at EU level, thus impeding comparison and objective country-by-country evaluation of the scale of fraud; reiterates its regret that as a consequence, Parliament, the Commission and OLAF cannot properly fulfil their task of assessing the actual overall scale of irregularities and fraud in individual Member States and formulating recommendations; regrets that this situation prevents the identification and discipline of those Member States with the highest level of irregularities and fraud, as has been repeatedly requested by Parliament; notes that the Commission invited Member States to improve upon their fraud statistics and committed itself to placing greater emphasis on the issue; stresses how important it is that the Commission establish uniform reporting principles in all Member States in order to ensure that the data collected are comparable, reliable and sufficient; calls, therefore, on the Commission to inform Parliament on the measures initiated to introduce a higher degree of uniformity and comparability between the statistical data gathered at national level; urges the Member States to submit in a timely manner exhaustive information which adequately reflects the actual level of fraud; asks the Court of Auditors to follow up on its previous special reports on the performance of OLAF in order to determine the effects of the reorganisation; |
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40. |
Underlines the fact that greater transparency allowing for proper scrutiny is key to detecting fraud schemes; recalls that in previous years Parliament urged the Commission to take action to ensure one-stop transparency for all beneficiaries of EU funds from all Member States by publishing on the Commission’s site a list of all beneficiaries, independent of the administrator of the funds and based on standard categories of information to be provided by all Member States in at least one working language of the Union; calls on the Member States to cooperate with and provide full and reliable information to the Commission regarding the beneficiaries of the EU funds managed by Member States; regrets that this measure has not been implemented and calls on the Commission to implement it as a matter of urgency; |
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41. |
Notes that in 2012 OLAF made 54 recommendations for judicial action which were sent to national authorities and it was recommended that roughly EUR 284 000 000 be recovered; regrets the lack of information on the number of judicial proceedings launched and the amounts actually recovered based on OLAF recommendations, as well as the conviction rate for cases involving offences detrimental to the Union’s budget; reiterates its call on the Commission and the Member States to ensure the effective and timely implementation of the recommendations made as soon as cases have been investigated by OLAF; |
|
42. |
Is, however, seriously concerned that in some instances OLAF dismissed cases and transferred them back to directorate-generals for appropriate action to be taken, even though the latter do not have any investigative competencies; |
OLAF
|
43. |
Is satisfied that the reform of the rules governing the functioning of OLAF has finally been adopted, and welcomes the Commission Communication on ‘Improving OLAF’s governance and reinforcing procedural safeguards in investigations: a step-by-step approach to accompany the establishment of the European Public Prosecutor’s Office’; notes the initial effects of the reorganisation and restructuring of OLAF’s investigative procedures which are supposed to lead to a clarification of the procedural rights of those who are subject to investigation, better cooperation and dialogue with OLAF’s partners, more efficient investigation procedures and a shortening of the average length of time for processing investigations, in particular at the stage of case selection; notes, nevertheless, that on 1 February 2012 a total of 421 cases were opened all at once and later closed during 2012, with most of them not carrying any recommendations; notices, furthermore, that many cases older than 24 months were closed in 2012, with the risk that recommendations may not have been made at the time of closing; notes, furthermore, that this one-time effect is responsible for a shorter average duration of investigations; |
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44. |
Notes that since 2012 OLAF has established investigation policy priorities (IPPs) on a yearly basis in order to improve its investigation selection procedure; observes significant changes between the IPPs selected in 2012, 2013 and 2014, and is therefore concerned over the risk of a lack of consistency in the overall investigation selection procedure; is of the opinion that future IPPs should always be subject to a thorough evaluation based on concrete needs, measurable indicators and lessons learnt from past IPPs; calls on OLAF to provide detailed information on the way in which it decides on IPPs; |
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45. |
Takes note of the OLAF 2012 annual report and notes that, over this period, OLAF opened 431 investigations and 287 coordination cases, closed 465 cases, recommended legal proceedings to the national authorities in 54 cases and recommended the recovery of almost EUR 284 million (EUR 165,8 million in revenue and EUR 118,2 million in expenditure), and:
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46. |
Takes note of Opinion 1/2014 of the supervisory committee on OLAF’s IPPs and endorses its recommendations, especially with regard to establishing guidelines on the application of financial indicators as a proportionality criterion which would provide the unit responsible for case selection with clearer guidance in this respect; expects, furthermore, that the future evolution of the IPPs will involve regular dialogue between the Director-General of OLAF and the directors-general whose policy areas are covered by the IPPs and the financial indicators therein; |
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47. |
Takes note of the supervisory committee’s remarks as regards OLAF’s de minimis policy; recalls that the de minimis policy is not the only criterion for case selection and that its objective is to ensure that OLAF concentrates its efforts and resources on more serious and complex cases, and that human resources are allocated in order to maximise the recovery of the amounts unduly spent from the EU budget; calls on the Director-General to take the supervisory committee’s views into consideration when reviewing OLAF’s de minimis policy; expects to be duly informed of the Director-General’s decision in this respect; |
|
48. |
Calls for an improvement in OLAF’s governance through the continual revision and consolidation of its core investigative processes; emphasises, in this connection, that it attaches particular importance to monitoring the observance of procedural safeguards and the fundamental rights of persons affected by investigations; |
New-look European anti-fraud policy and programmes
|
49. |
Welcomes all of the Commission initiatives to fight fraud in a generally more effective manner, with innovative actions to be taken as regards penalties, complementing the efforts directed at prevention and detection; sees the introduction of anti-fraud clauses in international agreements, administrative cooperation agreements and in the field of public procurement as a further significant step in terms of defending the Union’s financial interests and combating corruption; |
|
50. |
Recalls that under Article 5 of Commission Regulation (EC) No 1848/2006 of 14 December 2006, Member States must provide information on the initiation or abandonment of any procedures for imposing administrative or criminal sanctions related to the reported irregularities as well as of the main results of such procedures; recalls, furthermore, that this information must also indicate the character of the sanctions applied and/or whether the sanctions in question relate to the application of Community and/or national legislation, including a reference to the Community and/or national rules in which the sanctions are laid down; requests to be informed in detail with a comprehensive analysis on the reports received under Article 5 of Commission Regulation (EC) No 1848/2006; notes that Member States must introduce anti-fraud monitoring procedures and that statistics regarding criminal cases and their outcome are incomplete, making it difficult to evaluate fraud investigation and prosecution procedures in the Member States and the effectiveness of future basic policies; |
|
51. |
Welcomes the publication in February 2014 of the first EU anti-corruption report by the Commission, which indicates that corruption affects all Member States in very different ways and costs the EU economy around EUR 120 billion annually, and also welcomes all of the suggestions for intensifying exchanges of current good practice and identifying relevant new measures to be taken at EU level; stresses, in this connection, that European citizens require guarantees of total integrity and transparency in public spending, especially given the current challenges arising from the underlying economic and financial crisis; agrees with the Commission that the results of the initiatives are very much uneven and that more should be done to prevent and punish corruption; regrets, however, that the content of the report presents a limited overview of corruption in the EU; calls for further efforts to be made, commensurate with the major social and economic issues at stake, to prevent and sanction efficiently corruption, which corrodes the European economy and social model, harms Member States’ revenue from taxation and undermines citizens’ trust in their institutions; |
|
52. |
Calls on the Court of Auditors to study the problem and make recommendations based on its own perspective and experience, in the form of one or more reports on the main issues identified by the Commission report on corruption, taking account, in particular, of findings for individual countries; |
|
53. |
Welcomes the proposal for a regulation on the establishment of the European Public Prosecutor’s Office; stresses the need to establish a consistent, complementary system for protecting the Union’s financial interests; urges the Commission to provide a clear EU-level definition of the roles of the future European Public Prosecutor’s Office, Eurojust and OLAF, delimiting their respective remits; |
|
54. |
Welcomes the publication of the Commission study entitled ‘Identifying and Reducing Corruption in Public Procurement in the EU’, upon Parliament’s request, which develops a methodology to measure the costs of corruption in public procurement as regards EU funds; notes that the overall direct costs of corruption in public procurement for 2010 was estimated at EUR 1,4 to 2,2 billion for the five sectors studied in 8 Member States (14); underlines the fact that the study recommended, inter alia, further transparency in public procurement, improved audit and evaluation mechanisms, the development of a central collection system for public procurement data, an update of the Tenders Electronic Daily database, and enhanced protection for whistle blowers; calls on the Commission to provide information on the policies and measures implemented in order to address those recommendations; |
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55. |
Notes that according to official estimates, Member States lose over EUR 11 billion per year in tax revenue as a result of cigarette smuggling to the benefit of organised crime networks, and insists that the levels of resources and expertise applied in this area in the past within OLAF should be restored; supports strongly the Commission and OLAF on the introduction of an action plan to combat cigarette smuggling; demands, in this connection, better cooperation between OLAF and Europol; |
|
56. |
Considers essential the development of OLAF’s network of liaison officers for the countries at highest risk from smuggling; |
|
57. |
Requests to be informed of any developments in the discussions of possible re-negotiation of the existing agreements, and calls for an independent study of the agreements with the tobacco industry, with a view to quantifying the impact of illicit tobacco sales on own resources, and a possible extension of the existing agreements to include manufacturers not currently covered by them, with the aim of making tobacco products more easily traceable from manufacture to distribution; |
|
58. |
Welcomes the adoption of the regulation establishing the Hercule III programme for the financial period 2014-2020; notes that with a budget of over EUR 104 million, the programme will provide co-finance for measures such as scanning equipment for the identification of smuggled goods in trucks, automated container-code and number-plate recognition systems in order to reinforce the fight against smuggling and counterfeiting; regrets the lack of transparency observed during the implementation of the Hercule II programme on the purchase and utilisation of technical equipment by the beneficiaries and recalls that the situation led Parliament to hold in reserve a certain amount of OLAF’s appropriations from the Union’s budget for 2013 and 2014, pending the receipt of appropriate information on the matter; calls on OLAF to continue providing this information, including details on the current status and impact of the financed equipment and to demonstrate greater transparency in the implementation of Hercule III; |
o
o o
|
59. |
Instructs its President to forward this resolution to the Council, the Commission, the Court of Justice of the European Union, the European Court of Auditors, the OLAF Supervisory Committee and OLAF. |
(1) OJ C 331, 14.11.2013, p. 1.
(2) OJ L 201, 26.7.2013, p. 4.
(3) OJ L 201, 26.7.2013, p. 1.
(6) OJ L 248, 18.9.2013, p. 1.
(7) OJ L 298, 26.10.2012, p. 1.
(8) OJ L 312, 23.12.1995, p. 1.
(9) Texts adopted, P7_TA(2013)0318.
(10) OJ C 51 E, 22.2.2013, p. 121.
(11) OJ C 161 E, 31.5.2011, p. 62.
(12) Texts adopted, P7_TA(2013)0444.
(13) Belgium (23 %), Bulgaria (4 %), Greece (18 %), France (22 %), Slovenia (25 %) and Slovakia (26 %).
(14) Road and rail, water and waste, urban and utility construction, training and research & development in France, Hungary, Italy, Lithuania, the Netherlands, Poland, Romania and Spain.
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/39 |
P7_TA(2014)0339
Situation in Iran
European Parliament resolution of 3 April 2014 on the EU strategy towards Iran (2014/2625(RSP))
(2017/C 408/05)
The European Parliament,
|
— |
having regard to its previous resolutions on Iran, in particular those of 10 March 2011 on the EU’s approach towards Iran (1), of 17 November 2011 on recent cases of human rights violations in Iran (2), of 2 February 2012 on Iran and its nuclear programme (3) and of 14 June 2012 on the situation of ethnic minorities in Iran (4), |
|
— |
having regard to the joint statement made by the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy (VP/HR), Catherine Ashton, and the Iranian Minister of Foreign Affairs, Mohammad Javad Zarif, on 24 November 2013 in Geneva, and to the statement by the VP/HR of 12 January 2014, |
|
— |
having regard to the Council conclusions of 15 October 2012 and of 16 December 2013, and to the amendments to the restrictive measures in place against Iran, as decided by the Council at its meeting of 20 January 2014, |
|
— |
having regard to the Council conclusions of 21 March 2011 announcing the implementation of restrictive measures targeting those responsible for grave human rights violations in Iran, |
|
— |
having regard to the statement by the VP/HR of 19 September 2013 on the liberation of Nasrin Sotoudeh and other prisoners of conscience in Iran, |
|
— |
having regard to the report of the UN Special Rapporteur on the situation of human rights in the Islamic Republic of Iran of 4 October 2013, to his recent statement of 22 January 2014 warning of the ‘sharp increase in hangings in Iran’, and to the report of the UN Secretary-General of 10 September 2013 on the situation of human rights in the Islamic Republic of Iran (5), |
|
— |
having regard to its resolution of 11 December 2012 on a digital freedom strategy in EU foreign policy (6), |
|
— |
having regard to the Declaration on Criteria for Free and Fair Elections, unanimously adopted on 26 March 1994 by the Inter-Parliamentary Union, of which the Iranian parliament is a member, |
|
— |
having regard to the UN General Assembly resolution of 18 December 2013 on the situation of human rights in the Islamic Republic of Iran (7), which ‘expresses deep concern at serious ongoing and recurring human rights violations in the Islamic Republic of Iran’, including but not limited to the arbitrary, frequent and ongoing use of the death penalty, |
|
— |
having regard to the UN General Assembly resolution of 18 December 2013 on a world against violence and violent extremism (8), |
|
— |
having regard to Rule 110(2) of its Rules of Procedure, |
|
A. |
whereas on 24 November 2013 in Geneva VP/HR Catherine Ashton, together with the foreign affairs ministers of the E3/EU+3, reached an interim agreement with the Islamic Republic of Iran (hereinafter referred to as Iran) on the nuclear issue (detailed in the Joint Plan of Action); whereas on 10 January 2014 the E3/EU+3 reached an agreement on the implementation modalities for the Joint Plan of Action; whereas the six-month implementation period for the Joint Plan of Action is crucial and requires simultaneous and reciprocal action from both sides; |
|
B. |
whereas the presidential elections were not held in accordance with the democratic standards valued by the EU; whereas, however, President Hassan Rouhani has signalled readiness for more open and constructive relations between Iran and the West; whereas, in addition to the nuclear deal, various topics — including human rights and regional security — need to be discussed by the EU and Iran; |
|
C. |
whereas the commitments made in the Joint Plan of Action are only a first step towards a more complete solution to the Iranian nuclear issue and aim to reduce immediate tensions, creating more time and space for a comprehensive diplomatic solution; whereas Iran’s nuclear activities were in contradiction to previous UN Security Council resolutions; |
|
D. |
whereas internal political developments in Iran and the interim agreement on the nuclear issue have opened a window of opportunity for both reforms within Iran and an improvement of its external relations with the EU; |
|
E. |
whereas negotiations on a comprehensive trade and cooperation agreement and on a political dialogue agreement between the EU and Iran started in 2002; whereas this process was interrupted in 2005 as a result of revelations concerning Iran’s clandestine nuclear activities and the country’s refusal to cooperate fully with the International Atomic Energy Agency (IAEA); |
|
F. |
whereas the human rights situation in Iran is still characterised by the continued, systematic violation of fundamental rights; |
|
G. |
whereas Iran has one of the youngest populations in the world, including more than 7 million children under the age of six; |
|
H. |
whereas Iran still refuses to cooperate with several UN bodies on the issue of human rights, for instance by denying a visa to the UN Special Rapporteur on the situation of human rights in the Islamic Republic of Iran and preventing him from fulfilling his mandate in an independent manner; |
On the nuclear issue
|
1. |
Welcomes the Geneva interim agreement between the E3/EU+3 and Iran on Iran’s nuclear programme; considers it vital that all parties continue to engage constructively in the negotiating process so that the final comprehensive agreement can be concluded within the agreed timeframe; |
|
2. |
Stresses that there can be no alternative to a peaceful negotiated solution that addresses the international community’s concerns regarding the exclusively peaceful nature of Iran’s nuclear programme and regional sensitivities as well as Iran’s security sensitivities; |
|
3. |
Welcomes the decisions taken by the Council at its meeting of 20 January 2014 with a view to implementing the Joint Plan of Action, in particular the provisions on partial sanction relief; stresses the crucial importance of reliably monitoring Iran’s implementation of its commitments under the Joint Plan of Action; believes that, once a comprehensive agreement ensuring the exclusively peaceful nature of Iran’s nuclear programme is reached, nuclear-related sanctions against Iran should be gradually removed; |
On prospects for EU–Iran relations
|
4. |
Stresses that more constructive relations with Iran are contingent on progress in the full implementation of Iran’s commitments under the Joint Plan of Action; hopes that the progress in the implementation of the Joint Plan of Action and in the negotiations for the Geneva agreement will pave the way for more constructive relations between the EU and Iran, including as regards issues of regional concern such as the civil war in Syria and the fight against all forms of terrorism and its causes, but also in areas such as economic development, trade agreements, the rule of law and the promotion of human rights; |
|
5. |
Calls on the European External Action Service (EEAS) to carry out all the preparatory work for the opening of a Union delegation in Tehran by the end of 2014; strongly believes that this would be an efficient tool for influencing Iranian policies and would also support the dialogue on issues such as human and minority rights; |
|
6. |
Invites the Council, subject to substantial progress being made in the negotiations on the nuclear issue, to start a discussion on specific steps that could lead to an improvement in bilateral relations between the EU and Iran, including a possible future contractual framework for these relations and the development of sectoral cooperation, focusing for example on the development of civil society and the private sector in Iran, as well as on the areas of the fight against narcotic drugs (while ensuring that suspects receive a fair trial and are not subjected to the death penalty), environmental cooperation, technology transfer, infrastructure development and planning, education and culture, child protection and health, and common initiatives to promote and protect human rights; is concerned about the possible outbreak of infectious diseases such as polio and measles, especially among children, and urges the EU to ease access to relevant medication which has otherwise been difficult to obtain because of the sanctions; |
|
7. |
Notes with particular concern the worsening environmental situation in Iran, in particular when it comes to water shortages, desertification and air pollution, and invites the EU to facilitate cooperation between European and Iranian research institutes, environmental organisations and cities; |
|
8. |
Notes the importance of trade with Iran for many medium-sized European companies and underlines the fact that such trade should make a positive contribution to the implementation of the Joint Plan of Action; |
|
9. |
Invites the Commission and the EEAS, in the meantime, to use all tools available to the EU to make a concerted effort to empower and develop civil society in Iran and to increase the number of exchanges for students, artists and other visitors, as well as cultural and academic exchanges, and to promote youth participation and civic engagement; calls, to this end, for greater exchange and cooperation between the EEAS and relevant branches of the Commission, such as its Directorate-General for Development Cooperation — EuropeAid; |
|
10. |
Calls for the EU to pursue a more independent policy towards Iran, while coordinating with allies and partners; |
On regional issues
|
11. |
Considers that Iran should use its considerable influence in Syria to stop the bloody civil war and calls on Iran’s leadership to adopt a constructive role in the international efforts to find a solution to the Syrian crisis; considers that Iran should be involved in all discussions to that end, provided that it shows commitment to finding a diplomatic solution to the crises in Syria and in the region; |
|
12. |
Considers that greater engagement between the EU and Iran on the basis of credible implementation of the Joint Plan of Action and, in the future, of the comprehensive agreement, could be beneficial in terms of stabilising the situation in the Middle East; encourages the EU, in particular, to facilitate dialogue between Iran and members of the Gulf Cooperation Council; |
|
13. |
Takes the view that the EU, the US and Iran should develop their cooperation in Afghanistan, in particular on the issue of drug trafficking and on humanitarian issues such as the protection of refugees, and with a view to ensuring the protection of human rights gains in order to achieve a sustainable peaceful solution to the conflict; recalls that Iran is hosting approximately 3 million Afghan refugees, and calls on Iran, UN agencies and the international community to ensure respect for their basic rights; |
On human rights
|
14. |
Welcomes the release of several prisoners of conscience in Iran, including the human rights lawyer and Sakharov Prize winner Nasrin Sotoudeh, and calls on the Iranian authorities to release all imprisoned human rights defenders, political prisoners, trade unionists and labour activists, and those detained after the 2009 presidential elections; notes with interest President Hassan Rouhani’s initiative of formulating a Charter of Citizens’ Rights; expresses continued grave concern, however, regarding the human rights situation in Iran, in particular the widespread allegations of torture, unfair trials –– including of lawyers and human rights defenders — and impunity for human rights violations; expresses alarm with regard to the high number of executions in 2013 and 2014, including of minors; notes that most of the 2013 executions were carried out during the last five months of the year; condemns the restrictions on freedom of information, freedom of association, freedom of expression, freedom of assembly, freedom of religion, academic freedom, freedom of education and freedom of movement, as well as the repression and discrimination on the basis of religion, belief, ethnicity, gender or sexual orientation that persist, inter alia against the Baha’i community, Christians, apostates and converts; |
|
15. |
Takes the view that the Charter of Citizens’ Rights should comply fully with Iran’s international obligations, particularly as regards non-discrimination and the right to life, strengthening the prohibition of torture, ensuring full freedom of religion and belief, and guaranteeing freedom of expression, which is currently restricted by the vaguely formulated provision on the ‘national-security-related offence’; |
|
16. |
Calls, therefore, for the EU to mainstream human rights in all aspects of its relations with Iran; believes that a high-level and inclusive human rights dialogue with Iran should be part of the future policy framework for bilateral EU–Iran relations; calls for the EU to start a human rights dialogue with Iran that includes the judiciary and security forces and establishes clearly defined benchmarks against which progress can be measured; calls for the EU to support fully the work of the UN Special Rapporteur on the situation of human rights in the Islamic Republic of Iran, and calls on Iran to grant him an immediate and unconditional entry visa; encourages UN High Commissioner Navi Pillay to take up the Iranian authorities’ invitation to visit Iran; calls on Iran to declare a moratorium on the death penalty; |
|
17. |
Underlines the fact that any future Parliament delegations to Iran should be committed to meeting members of the political opposition and civil society activists, and to having access to political prisoners; |
|
18. |
Emphasises the importance of creating an environment conducive to the proper functioning of civil society organisations, including a reformed legal framework; calls for the EU to make maximum global use of the EU human rights guidelines, including the EU Guidelines on human rights defenders, of the new flexibility provided by the European Instrument for the Promotion of Democracy and Human Rights (EIDHR) 2014-2020, and of the potential of the European Endowment for Democracy newly established by the EU and its Member States, in order to support Iranian human rights defenders and civil society organisations; |
|
19. |
Joins the urgent call of 772 Iranian journalists on the Iranian President to live up to his promise and allow the reopening of the Association of Iranian Journalists; |
|
20. |
Encourages the EU to explore the possibility of extending technical assistance, in partnership with international organisations, to Iran with a view to assisting in the reform of the Code of Criminal Procedure currently envisaged by the Iranian parliament; expresses concern, in particular, over detainees’ inability to access an attorney during interrogations, over the serious allegations of abuse during pre-charge and pre-trial detention, and over the trials of civilians before revolutionary courts; stresses that independence from political interference and ensuring a free trial are key in developing a modern code of criminal procedure and essential in addressing human rights issues; |
|
21. |
Calls on Iran to cooperate with international human rights bodies and its own NGOs by acting upon the recommendations of the UN and the Universal Periodic Review (UPR) and enabling international human rights organisations to carry out their missions; |
|
22. |
Takes the view that women’s rights should, without fail, remain an area of special focus in any dialogue between the EU and Iran; considers that, despite the progress already made, the situation of women in Iran remains marred by unacceptable discrimination, in particular on legal matters, as well as with regard to family law and women’s participation in economic and political life; |
o
o o
|
23. |
Instructs its President to forward this resolution to the Council, the Commission, the European External Action Service, the governments and parliaments of the Member States and the Government and Parliament of the Islamic Republic of Iran. |
(1) OJ C 199 E, 7.7.2012, p. 163.
(2) OJ C 153 E, 31.5.2013, p. 157.
(3) OJ C 239 E, 20.8.2013, p. 43.
(4) OJ C 332 E, 15.11.2013, p. 102.
(5) A/68/377.
(6) Texts adopted, P7_TA(2012)0470.
(7) A/RES/68/184.
(8) A/RES/68/127.
RECOMMENDATIONS
European Parliament
Wednesday 2 April 2014
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/43 |
P7_TA(2014)0258
Common visa restrictions for Russian officials involved in the Sergei Magnitsky case
European Parliament recommendation to the Council of 2 April 2014 on establishing common visa restrictions for Russian officials involved in the Sergei Magnitsky case (2014/2016(INI))
(2017/C 408/06)
The European Parliament,
|
— |
having regard to Article 215 TFEU, |
|
— |
having regard to the proposal for a recommendation to the Council by Guy Verhofstadt and Kristiina Ojuland, on behalf of the ALDE Group, on establishing common visa restrictions for Russian officials involved in the Sergei Magnitsky case (B7-0473/2013), |
|
— |
having regard to its recommendation of 2 February 2012 to the Council on a consistent policy towards regimes against which the EU applies restrictive measures (1), |
|
— |
having regard to its recommendation of 23 October 2012 to the Council on establishing common visa restrictions for Russian officials involved in the Sergei Magnitsky case (2), |
|
— |
having regard to the statement by the Vice-President of the Commission/High Representative of the Union for Foreign affairs and Security Policy (VP/HR), Catherine Ashton, of 20 March 2013 on the Magnitsky case in the Russian Federation, |
|
— |
having regard to the statement by the spokesperson of VP/HR Catherine Ashton of 12 July 2013 on the case of Sergei Magnitsky, |
|
— |
having regard to the resolution and recommendation of the Parliamentary Assembly of the Council of Europe of 28 January 2014 on refusing impunity for the killers of Sergei Magnitsky, |
|
— |
having regard to the decisions by the United States to impose travel restrictions on a number of officials involved in the Sergei Magnitsky case and to similar considerations in a number of other countries, |
|
— |
having regard to its resolution of 11 December 2013 on the Annual Report on Human Rights and Democracy in the World 2012 and the European Union’s policy on the matter (3), |
|
— |
having regard to Rule 121(3) of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Foreign Affairs (A7-0215/2014), |
|
A. |
whereas the arrest and subsequent death in custody of Sergei Magnitsky represent a well-documented and significant case of disrespect for human rights and fundamental freedoms in Russia, have cast doubt on the independence and impartiality of its judicial institutions, and serve as a reminder of the many documented shortcomings in respect for the rule of law in Russia; |
|
B. |
whereas two independent investigations, conducted respectively by the Public Oversight Commission for Human Rights Observance in Moscow Detention Centres and by the Russian Presidential Council on the Development of Civil Society and Human Rights, have revealed that Sergei Magnitsky was subjected to inhumane conditions, deliberate neglect and torture; |
|
C. |
whereas Russia, as a member of several international organisations such as the Council of Europe, the Organisation for Security and Cooperation in Europe and the United Nations, has committed itself to the protection and promotion of human rights, fundamental freedoms and the rule of law, and whereas the European Union has repeatedly offered additional assistance and expertise to help Russia to modernise and abide by its constitutional and legal order, in line with Council of Europe standards; |
|
D. |
whereas there is an increasing need for a firm, coherent and comprehensive EU policy towards Russia, supported by all the Member States, with support and assistance backed up by firm and fair criticism, including sanctions and restrictive measures where necessary; |
|
E. |
whereas visa restrictions and other restrictive measures are not traditional judicial sanctions per se but nevertheless constitute a political signal of the EU’s concern to a greater target audience and thus remain a necessary and legitimate foreign-policy tool; |
|
F. |
whereas the High Representative has failed to place this issue on the agenda of the Foreign Affairs Council and whereas the recommendation by the European Parliament of 26 October 2012 has not received any official follow-up; |
|
1. |
Addresses the following recommendations to the Council:
|
|
2. |
Instructs its President to forward this recommendation to the Council and the Commission, to the governments of the Member States, and to the State Duma and the Government of Russia. |
(1) OJ C 239 E, 20.8.2013, p. 11.
(2) OJ C 68 E, 7.3.2014, p. 13.
(3) Texts adopted, P7_TA(2013)0575.
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/46 |
P7_TA(2014)0259
69th Session of the United Nations General Assembly
European Parliament recommendation to the Council of 2 April 2014 on the 69th session of the United Nations General Assembly (2014/2017(INI))
(2017/C 408/07)
The European Parliament,
|
— |
having regard to the Treaty on European Union (TEU), in particular Articles 21 and 34 thereof, |
|
— |
having regard to the proposal for a recommendation to the Council on the 69th Session of the United Nations General Assembly (UNGA) by Alexander Graf Lambsdorff, on behalf of the ALDE Group (B7-0014/2014), |
|
— |
having regard to the 68th Session of the UNGA, |
|
— |
having regard to its recommendation to the Council of 11 June 2013 on the 68th Session of the UNGA (1), |
|
— |
having regard to the EU’s priorities for the 68th Session of the UNGA, as adopted by the Council on 24 June 2013 (2), |
|
— |
having regard to the UNGA resolution of 3 May 2011 on the participation of the European Union in the work of the United Nations (3), and to the European Parliament resolution of 11 May 2011 on ‘the EU as a global actor: its role in multilateral organisations’ (4), |
|
— |
having regard to its resolution of 25 November 2010 on the 10th anniversary of UN Security Council resolution 1325 (2000) on ‘Women, Peace and Security’ (5), |
|
— |
having regard to its resolution of 7 July 2011 on ‘EU external policies in favour of democratisation’ (6), |
|
— |
having regard to UN Security Council resolution 2106 of 24 June 2013, on ‘increasing the efforts against impunity for perpetrators of sexual violence’ and the previous resolutions on this topic (7), |
|
— |
having regard to its recommendation to the Council of 18 April 2013 on ‘the UN principle of the Responsibility to Protect’ (8), |
|
— |
having regard to its resolution of 8 October 2013 on ‘corruption in the public and private sectors: the impact on human rights in third countries’ (9), |
|
— |
having regard to its resolution of 7 February 2013 on the 22nd session of the UN Human Rights Council (10), |
|
— |
having regard to Rules 121(3) and 97 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Foreign Affairs and the opinion of the Committee on Development (A7-0250/2014), |
|
A. |
whereas the commitment to effective multilateralism, with the United Nations at its core, is an intrinsic element of the EU’s external policy, grounded in the belief that an effective multilateral system is required in order to reach common goals and address global crises, challenges and threats; |
|
B. |
whereas together the EU and its Member States are the single largest financial contributor to the UN system (regular budget, programmes and UN funds, and peacekeeping budget); |
|
C. |
whereas a solid and stable EU-UN partnership is fundamental to the work of the UN under all three pillars — peace and security, human rights and development — and is also key to the EU’s role as a global actor; |
|
D. |
whereas human rights and democracy are founding values of the EU and principles and objectives of European external action; whereas respect for, and the promotion and safeguarding of, the universality and indivisibility of human rights are cornerstones of European unity and integrity; |
|
E. |
whereas current emission trajectories are likely to lead to a 2 oC warming within 20 to 30 years and a 4 oC warming by 2100, according to the World Bank report ‘Turn Down the Heat’; whereas UN Secretary-General Ban Ki-moon has invited Heads of State to the Climate Summit in September 2014 with a view to making clear commitments to further action on climate change; |
|
F. |
whereas, as the world’s leading donor, the EU supports both intensified efforts to meet the 2015 Millennium Development Goals (MDGs) deadline and a joint approach targeting poverty eradication and sustainable development; |
|
G. |
whereas the priority theme of the 58th session of the Commission on the Status of Women will be the challenges and achievements in the implementation of the Millennium Development Goals for women and girls; |
|
H. |
whereas corruption in the public and private sectors perpetrates and aggravates inequalities and discrimination when it comes to equal enjoyment of civil, political, economic, social and cultural rights, and it is proven that acts of corruption and human rights violations involve the misuse of power, a lack of accountability and various forms of discrimination; |
|
I. |
whereas the development of the principle of Responsibility to Protect is an important step towards anticipating, preventing and responding to genocide, war crimes, ethnic cleansing and crimes against humanity; whereas this principle should be applied as consistently and uniformly as possible; |
|
J. |
whereas the ratification of both Kampala amendments by States and the granting of jurisdiction over the crime of aggression to the International Criminal Court will further contribute to ending impunity for the perpetrators of this crime; |
|
K. |
whereas in situations where Responsibility to Protect is applied, it is of the utmost importance to maintain the distinction of mandates between military and humanitarian actors, in order to safeguard the perception of the neutrality and impartiality of all humanitarian actors and avoid putting at risk the effective delivery of aid and assistance; |
|
1. |
Addresses the following recommendations to the Council: |
Human rights, democracy and the rule of law
|
(a) |
to actively promote the specific follow-up and implementation of the declaration of the High-level Meeting on the Rule of Law at National and International Levels of 24 September 2012, and explore to what extent the Rule of Law can be linked to the ongoing reflections on the post-2015 MDGs; |
|
(b) |
to strengthen international efforts aimed at ensuring that all human rights agreed under UN conventions are considered universal, indivisible, interdependent and interrelated, and that their respect is being enforced; to promote the mainstreaming of human rights and basic freedoms in all aspects of the UN’s work; |
|
(c) |
to seek to strengthen the process of the Universal Periodic Review (UPR) by embedding recommendations in bilateral and multilateral dialogues with UN members, particularly human rights dialogues; to foster an environment enabling NGOs to provide their input into the various stages of the UPR process; |
|
(d) |
to promote the extensive contribution of civil society to the different UN human rights mechanisms, including to the various stages of the Universal Periodic Review process; with a view to counter-pressure or even reprisals, and while closely monitoring such potential cases regarding NGOs and civil society, to provide support for capacity building for human rights institutions; |
|
(e) |
to reiterate its full support for the International Criminal Court, and remain vigilant regarding any attempts to undermine the legitimacy, universality and integrity of the Rome Statute system; to actively engage States not yet party to this system with a view to swift signature and ratification; to campaign for the ratification of the 2010 Kampala amendments on the crime of aggression, including by all Member States; |
|
(f) |
to actively campaign for the ratification of the UN Convention Against Corruption and the UN Convention against Transnational Organised Crime by all UN members; to step up efforts to conclude the negotiations on a comprehensive convention on international terrorism; to support the establishment of a UN Special Rapporteur on financial crime, corruption and human rights; |
|
(g) |
to call on the members of UNGA to make full transparency of corporate reporting and the combating of corruption, money laundering, tax havens, illicit financial flows and harmful tax structures an overriding priority in the agendas of international finance and development institutions; |
|
(h) |
to stress that development gains will not be sustainable without good governance and accountable and democratic institutions and the rule of law; to ensure, therefore, that a clear commitment to democratic governance is reflected in the new framework; |
|
(i) |
to promote the prevention of atrocities and other grave violations by transforming the UNHRC into an early warning and preventive mechanism, rather than a purely reactive body to prevent further escalation of human rights violations; |
|
(j) |
to introduce theme-specific initiatives, promoting accountability for human rights violations and taking relevant actions targeting key human rights concerns, including efforts towards the abolition of the death penalty and the protection of the rights of people in vulnerable situations, such as children, women, LGBTI persons or indigenous peoples; |
|
(k) |
to condemn the systematic human rights abuses in the Islamic Republic of Iran; |
Torture
|
(l) |
to reiterate the importance of fighting against torture and other forms of ill-treatment, and the priority that the EU places on this issue, especially with regard to children; to renew the Special Rapporteur’s mandate for another three years, and to ensure effective follow-up of past resolutions on torture; to demonstrate a common commitment to eradicating torture and supporting victims, notably by continuing or, where applicable, starting to contribute to the UN Voluntary Fund for Victims of Torture and the Special Fund established by the Optional Protocol to the Convention against Torture; |
Death penalty
|
(m) |
to continue fighting against the use of the death penalty and to strongly support the moratorium as a step towards abolition; to continue to push for abolition worldwide; to strongly urge countries still carrying out capital punishment to publish clear and accurate figures on the number of sentences and executions; |
LGBTI rights
|
(n) |
to express concern about the recent increase in discriminatory laws and practices, and acts of violence against individuals based on their sexual orientation and gender identity; to encourage close monitoring of the situation in Nigeria and Uganda, where new laws seriously threaten the freedom of sexual minorities; to reaffirm its support for the continuing work by the High Commissioner on Human Rights to combat these discriminatory laws and practices, and the work of the UN more generally on this issue; to recommend active participation in combatting the attempts to undermine these rights; |
Armed drones
|
(o) |
to support international efforts to promote greater transparency and accountability in the use of armed drones in line with the established international legal framework, and to continue supporting investigations into targeted killings; to carry on assisting inquiries into targeted killings and to follow up on the recommendations by the UN Special Rapporteurs on Extra-Judicial, Summary or Arbitrary Executions and Countering Terrorism; |
Peace and security
|
(p) |
with a view to equipping the UN with more efficient de-escalation tools, to support peace enforcement and peacekeeping missions by providing, where necessary, increased EU support (technical, financial, equipment or EU forces); |
|
(q) |
to ensure that peacekeeping mandates reflect long-term needs for state and institution building and democracy support, thereby focusing on a comprehensive approach in order to target the roots of conflict and state fragility; |
|
(r) |
to cooperate in strengthening the role and capacity of regional organisations in peacekeeping, conflict prevention, civilian and military crisis management, and conflict resolution; |
|
(s) |
to demand of all parties to an armed conflict that they fully respect their obligations under international law, including unhindered access to humanitarian assistance; |
|
(t) |
to ensure that the post-2015 development framework promotes sustainable peace by addressing key drivers of conflict in order to create the enabling conditions required for development and rights fulfilment; |
|
(u) |
to focus on ending terrorism, whether state sponsored or otherwise; |
|
(v) |
to ensure that the UN conference on the establishment of a Middle East zone free of weapons of mass destruction, which did not take place in 2012 as decided at the 2010 NPT Review Conference, takes place in 2014; |
|
(w) |
to support UNGA resolutions on depleted uranium weapons and to develop an EU Common Position that better reflects Parliament’s repeated calls for a precautionary global moratorium and the developing global consensus on the potential civilian health risks, complex post-conflict management burden and financial costs associated with their use; |
|
(x) |
to ensure that the 2015 review process of the UN peace-building architecture promotes the principle of Responsibility to Protect and the role of women in peace-building; |
Responsibility to protect
|
(y) |
to work towards establishing Responsibility to Protect as an international norm, while maintaining the delicate balance between the role of the states concerned and the international community, and while keeping at its core the principle of prevention of conflict and the use of armed force as a last resort; |
|
(z) |
to ensure, in this regard, that responsibility to prevent and stop genocide and mass atrocities lies primarily with the state concerned, but that the international community also has a role that supersedes the invocation of sovereignty; |
|
(aa) |
to promote the key concept that prevention requires apportioning responsibility to and promoting collaboration between the states involved and the international community; |
|
(ab) |
to ensure, in cooperation with all international partners, the full compliance and consistency of possible further developments of the Responsibility to Protect concept with international humanitarian law; |
|
(ac) |
to work towards the inclusion of the protection of civilians in the mandates of the peacekeeping missions conducted under the auspices of the UN; |
Women and children
|
(ad) |
to reaffirm its commitment to the implementation of UN Security Council resolutions on women, peace and security (11), which recognise the disproportionate impact of war on women, but also their cardinal role in conflict management, conflict resolution and sustainable peace; |
|
(ae) |
to strongly support and promote the full implementation of UN resolution 2106 on fighting impunity in conflict-related sexual violence, and to ensure the consolidation of further accountability and preventive measures, preventive measures regarding sexual crimes and abuses, and support to victims thereof; |
|
(af) |
to prioritise ending child marriage; |
|
(ag) |
to ensure that women are represented at all stages of peace processes, and involved in preventive diplomacy, early warning and security monitoring, and commissions of inquiry in post-conflict situations; |
|
(ah) |
to ensure a focus on education for girls; |
|
(ai) |
to actively participate in the 58th session of the Commission on the Status of Women in order not to undermine the ‘acquis’ of the UN Beijing Platform for Action, such as, for example, access to education and health as a basic human right; to strongly condemn the use of sexual violence against women as a tactic of war, including crimes such as mass rape, sexual slavery, enforced prostitution, gender-based forms of persecution including female genital mutilation, trafficking, early and forced marriages, honour killings and all other forms of sexual violence of comparable gravity; to sign and ratify the Council of Europe Convention on preventing and combating violence against women and domestic violence; |
|
(aj) |
to call on Member States to ratify the 3rd Optional Protocol to the UN Convention on the Rights of the Child, which will allow children to submit their complaints to the Committee; |
Post-2015 development agenda
|
(ak) |
to recognise that significant and substantial progress has been made towards achieving the Millennium Development Goals; to make the best use of the preparatory phase ahead of the September 2015 Summit on the post-2015 agenda, to ensure coherence and coordination between EU Member States on focus areas and goals the EU wants to promote, with a view to avoiding the inconsistency and illegibility stemming from too wide a list of objectives; to emphasise that special focus has to be directed towards the needs of the least developed countries and of conflict and post-conflict countries; to ensure ownership of these goals by developing countries; |
|
(al) |
to highlight the fact that the global efforts towards the achievement of the MDGs should be strengthened during the remaining time before the 2015 deadline, and focused on areas where the process is lagging behind the most; |
|
(am) |
to ensure that poverty eradication remains a priority in the new single and integrated framework, along with the fight against inequality, the promotion of sustainable development, food security and gender equality; |
|
(an) |
to work towards the adoption of a single, comprehensive and integrated post-2015 framework for the MDGs, with clear benchmarks incorporating the key development and sustainability issues; to make sure that this framework is universal and global in nature, promoting prosperity, human rights and well-being for all; |
|
(ao) |
to pursue a human rights-based approach and ensure that human rights in their universality will be at the core of the post-2015 framework; |
|
(ap) |
to call for a coherent and comprehensive international approach to financing beyond 2015, addressing in a predictable manner all dimensions of sustainable development, and, in line with the Council conclusions from December 2013, to further promote within the UN system reflections on alternative sources of financing and on other means of implementing assistance, especially private investment and non-financial means; |
|
(aq) |
to make sure that new ambitious goals will be backed up by equally ambitious and innovative development financing; |
|
(ar) |
given the fact that environmental and development issues tend to be dealt with separately at global level, to seek new ways to overcome this split and build bridges between these closely interlinked areas, including from an institutional point of view; |
|
(as) |
to recall the commitment made by the developed countries at the COP16 in Cancún (2010) to provide USD 100 billion in ‘new and additional’ financing annually by 2020, in order to address climate change needs in developing countries; to point out that this funding should ensure a balanced allocation between adaptation and mitigation; |
Others
Privacy in the digital age
|
(at) |
to take all necessary legislative and administrative measures to fully implement the recommendations of the UNGA resolution (12), in order to guarantee that citizens have the same rights offline and online, and in particular the review of procedures, practices and legislation, and the establishment of independent and effective oversight mechanisms, stressing the importance of data protection; |
|
(au) |
with a view to reaffirming the commitment of the EU on this issue on a worldwide scale, to actively promote specific follow-up of the resolution by all UN members; |
Arms Trade Treaty
|
(av) |
to actively promote the swift signing and ratification of the Arms Trade Treaty by all UN members, including all EU members, in order to enable the international community to effectively address the negative repercussions of lack of transparency and badly regulated trade in conventional arms and ammunition and dangerous technologies, which foment global armed conflicts and are used to breach human rights; to engage other relevant States, regional and international organisations and civil society with a view to promoting, in this respect, a further broadening of the scope of the Arms Trade Treaty; |
The EU at the UN
|
(aw) |
to actively support a comprehensive reform of the United Nations system, and especially its Security Council, in order to strengthen its legitimacy, regional representation, accountability and effectiveness; to work towards the long-term goal of the EU having a seat in an enlarged UNSC; |
|
(ax) |
to ensure the coherence and effectiveness of the EU as a global actor, with the aim of acting in a swift and comprehensive manner and delivering a ‘one-voice message’, by improving coordination of Member States’ positions and the cooperation between the EEAS and the Member States; in this regard, to encourage the EEAS, in particular through the EU delegations in New York and Geneva, to work towards greater EU coherence; |
|
(ay) |
to support the role of parliaments and regional assemblies in the UN system and global parliamentarism; |
|
(az) |
to continue the fruitful cooperation in support of multilateralism and global governance, and to highlight the importance of the strategic partnership between the EU and the UNDP, which celebrated its 10th anniversary in February 2014; |
|
(ba) |
to raise awareness of the fact that 2015 will be declared the European Year for Development, which will create an unprecedented momentum for improving public knowledge in Europe about the global challenges and the importance of the new development goals to be agreed upon; |
Climate change
|
(bb) |
to point out that global challenges remain and are expected to increase, and that climate change and environmental degradation are threatening to reverse the progress made in achieving the MDGs; to enhance action on climate change, therefore, at the 2014 UN Climate Summit, in order to build a solid foundation which will inform successful negotiations and sustained progress towards reducing emissions and strengthening adaptation strategies at the 2015 United Nations Framework Convention on Climate Change; to set an example and adopt an ambitious binding climate policy framework with targets in time for the Summit, to have a positive influence on the negotiations; |
|
(bc) |
to participate actively in the debate on the term ‘climate refugee’, including its possible legal definition in international law or in any legally binding international agreement; |
|
(bd) |
to reiterate, on the occasion of the Third International Conference in September 2014, the EU’s support to Small Island Developing States; |
Syria
|
(be) |
to work towards bringing about a sustainable political solution for Syria which will stop the violence and promote a democratic transition that meets the legitimate aspirations of the Syrian people; to support the full implementation of the conclusions of the Geneva I Conference and, bearing in mind the importance of the Geneva II Conference as a unique forum enabling direct negotiations for peace and democratic transition between parties in the conflict, to keep the Geneva II process going; |
|
(bf) |
to work towards including all relevant global and regional players in the Geneva II Conference, recognising that many different actors play a decisive role in the Syrian crisis; |
|
(bg) |
to convene an international conference on the Syrian refugee crisis focusing on humanitarian efforts, with priority being given to supporting host countries in the region and strengthening the EU’s involvement in the diplomatic efforts to end the conflict; |
|
(bh) |
to work urgently towards the rapid implementation of UNSC resolution 2139 on the humanitarian situation in Syria, so that safe, unhindered and immediate access to all people in need, including across conflict lines and borders, will at last be facilitated; to ensure that the removal, transfer and destruction of chemical weapons found in Syria take place in a fully transparent manner; |
|
(bi) |
to foster international cooperation as regards the destruction of Syria’s chemical weapons, and call for full implementation of the decision of the Executive Council of the Organisation for the Prohibition of Chemical Weapons of 27 September 2013; |
|
(bj) |
to support all efforts to ensure accountability for the violations of human rights and international humanitarian law in Syria and to actively promote the referral by the Security Council of the situation in Syria to the International Criminal Court; |
South Sudan
|
(bk) |
to encourage all parties to respect the cessation of hostilities agreement (ceasefire) signed on 23 January 2014, including provisions requiring conflict actors to refrain from attacks against civilians and ensure safe access by humanitarian workers to conflict-affected areas of South Sudan; to underline that this agreement is only the first step towards peace and reconciliation when taking into consideration the situation in South Sudan, including the political fight for leadership in the country, which has provoked increasing ethnic clashes and led to the displacement of over 650 000 people; |
|
(bl) |
to support the state-building agenda regarding South Sudan, as well as a genuine reconciliation and inclusive peace process to ensure lasting stability; to offer assistance in tackling the issue of corruption, which is an obstacle to the prospects of establishing a free and fair democracy, stability, sustainable development and economic growth; |
|
(bm) |
to condemn the widespread human rights violations and abuses committed; to welcome and support the efforts of the EU Special Representative for the Horn of Africa, Alexander Rondos, the UN Special Representative, Hilde Johnson, and the African Union, and the strengthening of the human rights investigation capacity of the UN Mission in the Republic of South Sudan; |
|
(bn) |
to condemn the attacks on aid workers and assets, the interference in relief activities and the large-scale looting of supplies that have taken place in South Sudan and that severely hamper efforts to reach civilian populations in need; |
|
(bo) |
to call for an independent international commission of inquiry to investigate all alleged violations of international human rights and humanitarian law since the conflict erupted; to insist that those responsible be held accountable; |
Central African Republic
|
(bp) |
to ensure good cooperation and complementarity of the international efforts required to stabilise the Central African Republic, and to work towards the adoption of a comprehensive approach to this multifaceted crisis; to support the process of political transition and contribute to putting in place functioning democratic institutions capable of fighting human rights violations, protecting citizens, ending violence and calming sectarian tensions in the country; to continue providing the necessary financial support in order to create viable economic development; to spearhead efforts aimed at responding to the unprecedented humanitarian crisis by providing adequate financial assistance; |
|
(bq) |
to support the efforts deployed by the international community, in particular the African Union, the UN and France, and by the Central African authorities to stabilise the country; to swiftly implement the EU decision of 20 January 2014 establishing EUFOR CAR and to accelerate the procedures to deploy the forces on the ground; |
Israeli-Palestinian conflict
|
(br) |
to support the ongoing negotiation process and current attempts to find solutions to the conflict, while working towards the Palestinian reconciliation process, in order to reunite Palestinians living in the West Bank, East Jerusalem, and the Gaza Strip; |
|
(bs) |
to make certain the UNGA provides, in cooperation with the EU and the USA, all instruments to ensure that a two-state solution, on the basis of the 1967 borders, with Jerusalem as capital of both States and with the State of Israel, with secure and recognised borders, and an independent, democratic, contiguous and viable State of Palestine living side by side in peace and security, is sustainable and effective; |
|
2. |
Instructs its President to forward this recommendation to the High Representative/Vice-President, the EU Special Representative on Human Rights, the Council and, for information, the Commission. |
(1) Texts adopted, P7_TA(2013)0234.
(2) Council of the European Union 11521/13.
(3) UNGA resolution A/RES/65/276.
(4) OJ C 377 E, 7.12.2012, p. 66..
(5) OJ C 99 E, 3.4.2012, p. 56.
(6) OJ C 33 E, 5.2.2013, p. 165.
(7) UN Security Council resolution S/RES/2106(2013).
(8) Texts adopted, P7_TA(2013)0180.
(9) Texts adopted, P7_TA(2013)0394.
(10) Texts adopted, P7_TA(2013)0055.
(11) UN Security Council resolutions S/RES/1325(2000), S/RES/1820(2008), S/RES/1888(2009), S/RES/1889 (2009), S/RES/1960(2010), S/RES/2106(2013) and S/RES/2122(2013).
(12) UNGA resolution A/C.3/68/L.45/Rev.1.
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/54 |
P7_TA(2014)0260
Role of broadcasting media in projecting the EU and its values
European Parliament recommendation to the Council, the Commission and the European External Action Service of 2 April 2014 on the role of broadcasting media in projecting the EU and its values (2013/2187(INI))
(2017/C 408/08)
The European Parliament,
|
— |
having regard to Articles 2 and 21 of the Treaty on European Union (TEU), |
|
— |
having regard to Article 167 of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the Universal Declaration of Human Rights adopted by the UN General Assembly on 10 December 1948 and to all relevant international human rights instruments, including the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights, |
|
— |
having regard to Protocol No 29, annexed to the Treaty of Lisbon, on the system of public broadcasting in the Member States, |
|
— |
having regard to the Charter of Fundamental Rights of the European Union, in particular Article 11 thereof, |
|
— |
having regard to the EU guidelines on human rights, |
|
— |
having regard to the Strategic Framework and Action Plan on Human Rights and Democracy adopted by the Council on 25 June 2012 (1), |
|
— |
having regard to the Commission communication of 3 October 2007 entitled ‘Communicating Europe in Partnership’ (COM(2007)0568) and to the Commission proposal of 3 October 2007 for an interinstitutional agreement on ‘Communicating Europe in Partnership’ (COM(2007)0569), |
|
— |
having regard to its resolution of 25 November 2010 on ‘public service broadcasting in the digital era: the future of the dual system’ (2), |
|
— |
having regard to Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (3), |
|
— |
having regard to its resolution of 12 May 2011 on the cultural dimensions of the EU’s external actions (4), |
|
— |
having regard to its resolution of 11 December 2012 on a digital freedom strategy in EU foreign policy (5), |
|
— |
having regard to its resolution of 13 June 2013 on freedom of the press and media in the world (6), |
|
— |
having regard to the its resolution of 24 October 2013 on the Annual Report from the Council to the European Parliament on the Common Foreign and Security Policy (7), |
|
— |
having regard to its resolution of 11 December 2013 on the Annual Report on Human Rights and Democracy in the World 2012 and the European Union’s policy on the matter (8), |
|
— |
having regard to the European Charter on Freedom of the Press, |
|
— |
having regard to its resolutions of 22 November 2012 on ‘Enlargement: policies, criteria and the EU’s strategic interests’ (9), of 12 December 2013 on the 2013 progress report on Albania (10), of 6 February 2014 on the 2013 progress report on Bosnia and Herzegovina (11), of 6 February 2014 on the 2013 progress report on the former Yugoslav Republic of Macedonia (12), of 16 January 2014 on the 2012 progress report on Iceland and the post-election perspectives (13), of 16 January 2014 on the European integration process of Kosovo (14), of 6 February 2014 on the 2013 progress report on Montenegro (15), of 16 January 2014 on the 2013 progress report on Serbia (16), of 12 March 2014 on the 2013 progress report on Turkey (17), of 23 October 2013 on ‘the European Neighbourhood Policy: towards a strengthening of the partnership. Position of the European Parliament on the 2012 reports’ (18), of 23 May 2013 on asset recovery by Arab Spring countries in transition (19), of 14 March 2013 on EU-China relations (20), and of 13 December 2012 containing the European Parliament’s recommendations to the Council, the Commission and the European External Action Service on the negotiations of the new EU-Russia Agreement (21), |
|
— |
having regard to Rule 97 of its Rules of Procedure, |
|
— |
having regard to the recommendation of the Committee on Foreign Affairs (A7-0248/2014), |
|
A. |
whereas independent European broadcasting media offer the public — in Europe and worldwide — a joint vision, support the values enshrined in the EU Treaties, such as human rights and fundamental freedoms, including freedom of expression, and promote pluralism, independent thought, cultural diversity, plurality of vision and the fundamental value of fostering non-violent conflict resolution, tolerance and respect, both within the EU and in the context of its external relations; |
|
B. |
whereas any threat to media independence, whether through government interference, intimidation of journalists, a lack of transparency in ownership structures or overriding commercial interests, upsets the overall state of media freedom and pluralism in any country; |
|
C. |
whereas governments bear the primary responsibility for guaranteeing and protecting freedom of expression and the media, notwithstanding the EU’s role in overseeing the application of Article 11 of the EU Charter of Fundamental Rights when Member States are implementing EU law; whereas it is enshrined in EU law, in particular in Protocol No 29 annexed to the TEU, that the system of public broadcasting in the Member States is directly related to the democratic, social and cultural needs of each society and to the need to preserve media pluralism; |
|
D. |
whereas radio and television broadcasting, increasingly complemented by online media services, is an effective and cost-efficient way to reach the public in Europe and in third countries, and constitutes the main source of information for most citizens in the EU and beyond; |
|
E. |
whereas new digital and online media platforms have contributed to increased diversity and pluralism and are of special significance in countries where access to more traditional sources of information is restricted; |
|
F. |
whereas European media broadcasting internationally can play an important role in communicating the values of democracy, media freedom and human rights throughout the world, in explaining different national perceptions, in communicating EU policies, in shaping a genuine European perspective and in providing audiences with reliable and high-quality information, most significantly by means of a firm and unyielding commitment to journalistic objectivity; |
|
G. |
whereas broadcasting for democratisation and promotion of human rights in third countries does not explicitly fall within the remit of EU media policy; |
|
H. |
whereas there is a need to establish a coherent European media broadcasting strategy in the EU’s external relations in order to promote the EU’s underpinning values and its goals as a global actor, as well as to shape debates and build understanding of foreign policy issues; |
|
I. |
whereas the EU’s provision of initial funding for ‘European Radio for Belarus’ and of continuous project-based support for independent broadcasting media in third countries are good examples of promoting freedom of expression and other fundamental rights and freedoms in the framework of the common foreign and security policy (CFSP); |
|
J. |
whereas setting up a worldwide European radio service could be very useful as a comprehensive tool for the EU’s external relations and the promotion of universal democratic values and human rights; whereas the use of online technologies could facilitate such an initiative; |
|
K. |
whereas the EU supports the international news channel Euronews, which is broadcast in 13 languages, is understood by 53 % of the world’s population, is distributed to 410 million households in 155 countries, has worldwide satellite coverage, is the leading channel in terms of potential audience in Europe and among non-Arabic news channels in Arab countries and sub-Saharan Africa, and is accessible free of charge worldwide via various mobile devices; |
|
L. |
whereas the EU has had a service contract with Euronews since 2005, providing it with core funding of EUR 5 million per year to produce and broadcast a number of programmes on European affairs; whereas two other service contracts, worth EUR 5 million per year over five years, were signed in 2007 and 2009 for Euronews broadcasts in Arabic and Farsi respectively; whereas in December 2010 the EU and Euronews signed a multiannual framework partnership agreement; whereas the Commission’s financial contribution to Euronews for 2013 was established by the Commission decision of 8 May 2013 concerning the adoption of the amended 2013 work programme in the field of communication, serving as a financing decision (C(2013)2631); whereas Euronews’s estimated revenue for 2014 is made up of shareholders’ licence fees (9 %), commercial profits (49 %) and funding from the Commission and its various directorates-general (42 %); |
|
M. |
whereas editorial independence from any political interference, along with impartiality, diversity and respect for viewers, is a key element of Euronews’s annual statement of commitment to viewers (22); |
|
N. |
whereas in 2009 the Commission carried out an evaluation of the Euronews core contract, which confirmed the unique and cost-effective status of Euronews as a pan-European news provider, reaching out to more viewers in Europe than its rival international news channels (23); |
|
1. |
Addresses the following recommendations to the Council, the Commission and the European External Action Service:
|
|
2. |
Instructs its President to forward this recommendation to the Council, the Commission and the European External Action Service and, for information, to the Member States. |
(1) Council document 11855/2012.
(2) OJ C 99 E, 3.4.2012, p. 50.
(4) OJ C 377 E, 7.12.2012, p. 135.
(5) Texts adopted, P7_TA(2012)0470.
(6) Texts adopted, P7_TA(2013)0274.
(7) Texts adopted, P7_TA(2013)0453.
(8) Texts adopted, P7_TA(2013)0575.
(9) Texts adopted, P7_TA(2012)0453.
(10) Texts adopted, P7_TA(2013)0596.
(11) Texts adopted, P7_TA(2014)0102.
(12) Texts adopted, P7_TA(2014)0103.
(13) Texts adopted, P7_TA(2014)0041.
(14) Texts adopted, P7_TA(2014)0040.
(15) Texts adopted, P7_TA(2014)0104.
(16) Texts adopted, P7_TA(2014)0039.
(17) Texts adopted, P7_TA(2014)0235.
(18) Texts adopted, P7_TA(2013)0446.
(19) Texts adopted, P7_TA(2013)0224.
(20) Texts adopted, P7_TA(2013)0097.
(21) Texts adopted, P7_TA(2012)0505.
(22) http://www.euronews.com/services-ue/
(23) http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=E-2010-3324
II Information
INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Parliament
Wednesday 2 April 2014
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/59 |
P7_TA(2014)0257
Request for defence of the parliamentary immunity of Mario Borghezio
European Parliament decision of 2 April 2014 on the request for defence of the immunity and privileges of Mario Borghezio (2013/2279(IMM))
(2017/C 408/09)
The European Parliament,
|
— |
having regard to the request by Mario Borghezio of 21 November 2013, announced in plenary on 21 November 2013, for the defence of his immunity in connection with investigations against him by the Court of Milan (ref. 47917/13), |
|
— |
having heard Carlo Casini, who represented Mario Borghezio in accordance with Rule 7(5) of its Rules of Procedure, and also Mario Borghezio in person, |
|
— |
having regard to Articles 1, 11 and 21 of the Charter of Fundamental Rights of the European Union, |
|
— |
having regard to Rule 153 of its Rules of Procedure, |
|
— |
having regard to Article 8 of Protocol No 7 on the Privileges and Immunities of the European Union, and Article 6(2) of the Act of 20 September 1976 concerning the election of the members of the European Parliament by direct universal suffrage, |
|
— |
having regard to the judgments of the Court of Justice of the European Union of 12 May 1964, 10 July 1986, 15 and 21 October 2008, 19 March 2010 and 6 September 2011 (1), |
|
— |
having regard to the Italian Criminal Code, |
|
— |
having regard to Rules 5(2), 6a and 7 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Legal Affairs (A7-0245/2014), |
|
A. |
whereas a Member of the European Parliament, Mario Borghezio, has requested the defence of his parliamentary immunity in connection with proceedings before an Italian court; |
|
B. |
whereas, according to Article 8 of the Protocol on the Privileges and Immunities of the European Union, Members of the European Parliament may not be subject to any form of inquiry, detention or legal proceedings in respect of opinions expressed or votes cast by them in the performance of their duties; |
|
C. |
whereas the purpose of this provision is to ensure that Members of the European Parliament enjoy freedom of speech as a matter of principle, but whereas this entitlement to free speech does not authorise slander, libel, incitement to hatred, questioning the honour of others, or any utterance contrary to Article 21 of the Charter of Fundamental Rights of the European Union; |
|
D. |
whereas the request by Mario Borghezio relates to criminal investigations against him being carried out by the Prosecutor’s Office at the Court of Milan in connection with statements he is alleged to have made in a radio interview of 8 April 2013; |
|
E. |
whereas Mario Borghezio was a Member of the European Parliament at the time of the interview; |
|
F. |
whereas, according to the notice served by the Prosecutor’s Office, the statements in question are punishable under Articles 81(1) and 595(1) of the Italian Criminal Code, Article 3(1) of Law No 205/1993 and Article 3(1)(a) of Law No 654/1975, that is to say for repeated public defamation and spreading discriminatory ideas founded on superiority or racial hatred; |
|
G. |
whereas the statements made concern supposed characteristics of the Roma ethnic group; |
|
H. |
whereas the records of Mario Borghezio’s parliamentary activities show that he has shown interest in Roma issues, but whereas the facts of the case, as manifested in the notice from the Prosecutor’s Office and in the hearing in the Committee on Legal Affairs, indicate that the statements he made in the interview have no direct and obvious connection with those parliamentary activities; |
|
I. |
whereas the statements alleged to have been made exceed the tone generally encountered in political debate and are, moreover, profoundly unparliamentary in nature; whereas they are contrary to Article 21 of the Charter of Fundamental Rights of the European Union and cannot therefore be deemed to have been made in the performance of the duties of a Member of the European Parliament; |
|
J. |
whereas, if made in a parliamentary sitting, statements such as those made by Mario Borghezio could have attracted penalties under Rule 153 of the Rules of Procedure; whereas parliamentary immunity should not therefore cover such statements when made outside Parliament; |
|
K. |
whereas Mario Borghezio cannot therefore be deemed to have been acting in the performance of his duties as a Member of the European Parliament; |
|
1. |
Decides not to defend the immunity and privileges of Mario Borghezio; |
|
2. |
Instructs its President to forward this decision and the report of its competent committee immediately to the relevant authorities of the Italian Republic and to Mario Borghezio. |
(1) Judgment of 12 May 1964 in Case 101/63, Wagner v Fohrmann and Krier (ECR 1964, p. 195); judgment of 10 July 1986 in Case 149/85, Wybot v Faure and others (ECR 1986, p. 2403); judgment of 15 October 2008 in Case T-345/05, Mote v Parliament (ECR 2008, p. II-2849); judgment of 21 October 2008 in Joined Cases C-200/07 and C-201/07, Marra v De Gregorio and Clemente (ECR 2008, p. I-7929); judgment of 19 March 2010 in Case T-42/06, Gollnisch v Parliament (ECR 2010, p. II-1135); judgment of 6 September 2011 in Case C-163/10, Patriciello (ECR 2011, p. I-7565).
III Preparatory acts
EUROPEAN PARLIAMENT
Wednesday 2 April 2014
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/61 |
P7_TA(2014)0261
Sound level of motor vehicles ***II
European Parliament legislative resolution of 2 April 2014 on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on the sound level of motor vehicles and of replacement silencing systems, and amending Directive 2007/46/EC and repealing Directive 70/157/EEC (17695/1/2013 — C7-0060/2014 — 2011/0409(COD))
(Ordinary legislative procedure: second reading)
(2017/C 408/10)
The European Parliament,
|
— |
having regard to the Council position at first reading (17695/1/2013 — C7-0060/2014), |
|
— |
having regard to the opinion of the European Economic and Social Committee of 25 April 2012 (1), |
|
— |
having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2011)0856), |
|
— |
having regard to Article 294(7) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 72 of its Rules of Procedure, |
|
— |
having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety (A7-0239/2014), |
|
1. |
Approves the Council position at first reading; |
|
2. |
Notes that the act is adopted in accordance with the Council position; |
|
3. |
Instructs its President to sign the act with the President of the Council, in accordance with Article 297(1) of the Treaty on the Functioning of the European Union; |
|
4. |
Instructs its Secretary-General to sign the act, once it has been verified that all the procedures have been duly completed, and, in agreement with the Secretary-General of the Council, to arrange for its publication in the Official Journal of the European Union; |
|
5. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 191, 29.6.2012, p. 76.
(2) Texts adopted of 6.2.2013, P7_TA(2013)0041.
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/62 |
P7_TA(2014)0262
Electronic identification of bovine animals ***I
European Parliament legislative resolution of 2 April 2014 on the amended proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 1760/2000 as regards electronic identification of bovine animals and deleting the provisions on voluntary beef labelling (COM(2012)0162 — C7-0114/2012 — 2011/0229(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/11)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2011)0525) and the amended proposal (COM(2012)0162), |
|
— |
having regard to Article 294(2), Article 43(2) and point b of Article 168(4) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0114/2012), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the opinion of the European Economic and Social Committee of 7 December 2011 (1), |
|
— |
after consulting the Committee of the Regions, |
|
— |
having regard to the undertaking given by the Council representative by letter of 10 July 2013 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Agriculture and Rural Development (A7-0199/2012), |
|
1. |
Adopts its position at first reading hereinafter set out (2); |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 43, 15.2.2012, p. 64.
(2) This position replaces the amendments adopted on 11 September 2012 (Texts adopted P7_TA(2012)0312).
P7_TC1-COD(2011)0229
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council amending Regulation (EC) No 1760/2000 as regards electronic identification of bovine animals and labelling of beef
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 653/2014.)
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/63 |
P7_TA(2014)0263
Computer databases which are part of the surveillance networks in the Member States ***I
European Parliament legislative resolution of 2 April 2014 on the proposal for a directive of the European Parliament and of the Council amending Council Directive 64/432/EEC as regards computer databases which are part of the surveillance networks in the Member States (COM(2011)0524 — C7-0229/2011 — 2011/0228(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/12)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2011)0524), |
|
— |
having regard to Article 294(2) and Article 43(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0229/2011), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the opinion of the European Economic and Social Committee of 7 December 2011 (1), |
|
— |
having regard to the undertaking given by the Council representative by letter of 10 July 2013 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Agriculture and Rural Development (A7-0201/2012), |
|
1. |
Adopts its position at first reading hereinafter set out; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 43, 15.2.2012, p. 64.
P7_TC1-COD(2011)0228
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Directive 2014/…/EU of the European Parliament and of the Council amending Council Directive 64/432/EEC as regards computer databases which are part of the surveillance networks in the Member States
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive 2014/64/EU.)
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/64 |
P7_TA(2014)0264
Application and enforcement of international trade rules ***I
European Parliament legislative resolution of 2 April 2014 on the proposal for a regulation of the European Parliament and of the Council concerning the exercise of the Union's rights for the application and enforcement of international trade rules (COM(2012)0773 — C7-0415/2012 — 2012/0359(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/13)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2012)0773), |
|
— |
having regard to Article 294(2) and Article 207 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0415/2012), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the undertaking given by the Council representative by letter of 5 February 2014 to approve Parliament's position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on International Trade (A7-0308/2013), |
|
1. |
Adopts its position at first reading hereinafter set out (1); |
|
2. |
Takes note of the Commission statement annexed to this resolution; |
|
3. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
4. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) This position replaces the amendments adopted on 23 October 2013 (Texts adopted P7_TA(2013)0439).
P7_TC1-COD(2012)0359
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council concerning the exercise of the Union's rights for the application and enforcement of international trade rules and amending Council Regulation (EC) No 3286/94 laying down Community procedures in the field of the common commercial policy in order to ensure the exercise of the Community's rights under international trade rules, in particular those established under the auspices of the World Trade Organization
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 654/2014.)
ANNEX TO THE LEGISLATIVE RESOLUTION
COMMISSION’S STATEMENT
The Commission welcomes the adoption of the Regulation of the European Parliament and of the Council concerning the exercise of the Union's rights for the application and enforcement of international trade rules and amending Council Regulation (EC) No 3286/94.
Under the Regulation, the Commission is empowered to adopt implementing acts in certain specific situations, on the basis of objective criteria and subject to the control of the Member States. In exercising that empowerment, the Commission intends to act in accordance with this Declaration.
When preparing draft implementing acts, the Commission will undertake extensive consultations with a view to ensuring that all relevant interests are duly taken into account. Through those consultations, the Commission expects to receive input from private stakeholders affected by third country measures or by possible commercial policy measures to be adopted by the Union. Similarly, the Commission expects to receive input from public authorities that may be involved in the implementation of possible commercial policy measures to be adopted by the Union. In the case of measures in the field of public procurement, in particular input from Member States’ public authorities will be duly taken into account in the preparation of draft implementing acts.
The Commission recognizes the importance of Member States receiving timely information when it is considering the adoption of implementing acts under this Regulation so as to enable them to contribute to fully informed decisions and will act to achieve this objective.
The Commission confirms that it will promptly transmit to the Parliament and to the Council draft implementing acts that it submits to the committee of Member States. Similarly, it will promptly transmit to the Parliament and the Council final draft implementing acts following the delivery of opinions in the committee.
The Commission will keep the Parliament and the Council regularly informed of international developments that may lead to situations requiring the adoption of measures under the Regulation. This will be done through the responsible committees in Council and in Parliament.
The Commission welcomes the Parliament’s intention to promote a structured dialogue on dispute settlement and enforcement issues and will fully engage in dedicated sessions with the responsible Parliamentary committee to exchange views on trade disputes and enforcement actions, including with regard to impacts on Union industries.
Finally, the Commission confirms that it attaches great importance to ensuring that the Regulation is an effective and efficient tool for the enforcement of the Union’s rights under international trade agreements, including in the field of trade in services. Therefore, the Commission will, in accordance with the provisions of the Regulation, review the scope of Article 5 with a view to covering additional commercial policy measures concerning trade in services as soon as the conditions for ensuring the workability and effectiveness of such measures are present.
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/66 |
P7_TA(2014)0265
‘Imports of rice from Bangladesh’ ***I
European Parliament legislative resolution of 2 April 2014 on the proposal for a regulation of the European Parliament and of the Council on imports of rice originating in Bangladesh (COM(2012)0172 — C7-0102/2012 — 2012/0085(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/14)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2012)0172), |
|
— |
having regard to Article 294(2) and Article 207 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0102/2012), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the undertaking given by the Council representative by letter of 17 February 2014 to approve Parliament's position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on International Trade (A7-0304/2013), |
|
1. |
Adopts its position at first reading hereinafter set out (1); |
|
2. |
Takes note of the Commission statement annexed to this resolution; |
|
3. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
4. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) This position replaces the amendments adopted on 10 December 2013 (Texts adopted P7_TA(2013)0542).
P7_TC1-COD(2012)0085
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council on imports of rice originating in Bangladesh and repealing Council Regulation (EEC) No 3491/90
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 539/2014.)
ANNEX TO THE LEGISLATIVE RESOLUTION
COMMISSION STATEMENT ON DELEGATED ACTS
In the context of Regulation (EU) No 539/2014 of the European Parliament and of the Council on imports of rice originating in Bangladesh and repealing Council Regulation (EEC) No 3491/90, the Commission recalls the commitment it has taken in paragraph 15 of the Framework Agreement on relations between the European Parliament and the European Commission to provide to the Parliament full information and documentation on its meetings with national experts within the framework of its work on the preparation of delegated acts.
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/68 |
P7_TA(2014)0266
Medical devices ***I
European Parliament legislative resolution of 2 April 2014 on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 — C7-0318/2012 — 2012/0266(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/15)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2012)0542), |
|
— |
having regard to Article 294(2) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0318/2012), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the opinion of the European Economic and Social Committee of 14 February 2013 (1), |
|
— |
after consulting the Committee of the Regions, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Employment and Social Affairs and the Committee on the Internal Market and Consumer Protection (A7-0324/2013), |
|
1. |
Adopts as its position at first reading the text adopted on 22 October 2013 (2); |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 133, 9.5.2013, p. 52.
(2) P7_TA(2013)0428.
P7_TC1-COD(2012)0266
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168(4)(c) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
|
(1) |
Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulatory framework for medical devices, other than in vitro diagnostic medical devices. However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. |
|
(1a) |
The desire to provide swift access to new medical devices for patients should never take precedence over the need to ensure patient safety. [Am. 1] |
|
(2) |
This Regulation aims to ensure the functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients, users and operators. At the same time, this Regulation sets high standards of quality and safety for medical devices to meet common safety concerns as regards these products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 TFEU, this Regulation harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the Union market which may then benefit from the principle of free movement of goods. As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for those medical devices by ensuring, among other things, that data generated in clinical investigations is reliable and robust and that the safety of the subjects participating in a clinical investigation is protected. [Am. 2] |
|
(2a) |
Council Directive 2010/32/EU (5) guarantees safety not just for patients but also for users of sharp needles. Directive 2010/63/EU of the European Parliament and of the Council (6) states that tests on vertebrate animals must be replaced, restricted or refined. [Ams. 3 and 4] |
|
(3) |
Key elements of the existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding devices should be introduced, to improve health and safety for health professionals, patients, users and operators, including in the waste disposal chain. [Am. 5] |
|
(3a) |
In the area of medical devices many SMEs are active. This should be taken into account when regulating the sector without compromising the safety and health aspects. [Am. 6] |
|
(4) |
To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative the International Medical Devices Regulators Forum, should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification criteria, conformity assessment procedures and clinical investigations. |
|
(5) |
For historic reasons active implantable medical devices, covered by Directive 90/385/EEC, and other medical devices, covered by Directive 93/42/EEC, were regulated in two separate legal instruments. In the interest of simplification, both directives, which have been amended several times, should be replaced by a single legislative act applicable to all medical devices other than in vitro diagnostic medical devices. |
|
(6) |
A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for divergent transposition by Member States. Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Union. |
|
(7) |
The scope of application of this Regulation should be clearly delimited from other Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and food. Therefore, Since in some cases it is difficult to distinguish between medical devices and cosmetic, medicinal or food products, the possibility to take a Union-wide decision regarding the regulatory status of a product should be introduced in Regulation (EC) No 1223/2009 of the European Parliament and of the Council (7), Directive 2004/27/EC of the European Parliament and of the Council (8), Regulation (EC) No 178/2002 of the European Parliament and of the Council (9) of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety and Directive 2002/46/EC of the European Parliament and of the Council (10). Those Union acts Authority and laying down procedures in matters of food safety should therefore be amended to exclude medical devices from its scope. [Am. 7] |
|
(7a) |
A multidisciplinary Medical Device Advisory Committee (MDAC) composed of experts and representatives of the relevant stakeholders should be set up to provide scientific advice to the Commission, the Medical Device Coordination Group (MDCG) and Member States on issues of medical technology, the regulatory status of devices and other aspects of implementation of this Regulation as necessary. [Am. 8] |
|
(8) |
It In order to ensure consistent classification across all Member States, particularly with regards to borderline cases, it should be the responsibility of the Member States Commission, having consulted the MDCG and the MDAC, to decide on a case-by-case basis whether or not a product falls or groups of products fall within the scope of this Regulation. If necessary, the Commission may decide, on a case-by-case basis, whether or not a product falls within the definition of a medical device or of an accessory to a medical device. Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility to take an EU-wide decision regarding the regulatory status of a product should also be introduced in Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products Member States should also have the possibility to request the Commission to take a decision on the appropriate regulatory status of a product, or category or group of products. [Am. 9] |
|
(9) |
Products which combine a medicinal product or substance and a medical device, are regulated either under this Regulation or under Directive 2001/83/EC of the European Parliament and of the Council (11). It should be ensured that appropriate interaction exists between the two legislative acts in terms of consultations during the pre-market assessment and exchange of information on vigilance cases occurring with combination products. For medicinal products that integrate a medical device part, compliance with the general safety and performance requirements of the device part should be adequately assessed in the context of the marketing authorisation. Directive 2001/83/EC should therefore be amended. |
|
(10) |
Union legislation is incomplete in respect of certain products manufactured utilising non-viable human tissues or cells that have undergone substantial manipulation and that are not covered by Regulation (EC) No 1394/2007 of the European Parliament and of the Council (12). Whilst donation, procurement and testing of the human tissues and cells used for the manufacture of those products should remain within the scope of Directive 2004/23/EC of the European Parliament and of the Council (13), the finished product should come under the scope of this Regulation. Human tissues and cells that are not substantially manipulated, such as human demineralised bone matrix, and products derived from such tissues and cells, should not be covered by this Regulation. |
|
(11) |
Certain implantable and other invasive products for which the manufacturer claims only an aesthetic or another non-medical purpose but which are similar to medical devices in terms of functioning and risks profile should be covered by this Regulation. |
|
(11a) |
Unregulated non-intrusive devices, such as non-corrective contact lenses for cosmetic purposes, can cause health complications — such as microbial keratitus — when manufactured or used incorrectly. Appropriate safety standards must be in place to protect the safety of consumers who decide to use such products. [Am. 10] |
|
(12) |
Like for products that contain viable tissues or cells of human or animal origin, that are explicitly excluded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that products that contain living biological substances of other origin that achieve their intended purpose by pharmacological, immunological or metabolic means are also not covered by this Regulation. [Am. 11] |
|
(12a) |
Devices for use in blood donation and blood therapy should meet the requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (14). [Am. 12] |
|
(12b) |
The advertising of cosmetic surgery should be better regulated, in order to ensure that patients are fully aware of the risks as well as the benefits. [Am. 13] |
|
(13) |
There is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices. In order to ensure a high level of health and safety protection for health professionals, operators and patients, as well as free movement of goods, and legal certainty for manufacturers and responsibility on their part, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU (15), with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and manufacture of medical devices, the manufacturers should take special care when using nanoparticles that can be which are intended to be intentionally released to in the human body and those devices should be subject to the most severe conformity assessment procedure. [Am. 14] |
|
(13a) |
Medical devices used in the donation of substances of human origin and their subsequent use for treatment must conform to Union public health legislation ensuring minimum standards for quality and safety, including Directive 2002/98/EC on minimum standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and its additional directives. [Am. 15] |
|
(14) |
Aspects addressed by Directive 2004/108/EC of the European Parliament and of the Council (16) and aspects addressed by Directive 2006/42/EC of the European Parliament and of the Council (17) are an integral part of the general safety and performance requirements for medical devices. Consequently, this Regulation should be considered a lex specialis in relation to those Directives. |
|
(15) |
This Regulation should include requirements regarding the design and manufacture of medical devices emitting ionizing radiation without affecting the application of Council Directive 96/29/Euratom (18) nor of Council Directive 97/43/Euratom (19) which pursue other objectives. |
|
(15a) |
This Regulation includes requirements regarding the design, safety and performance characteristics of medical devices intended to prevent occupational injuries as laid down in Directive 2010/32/EU. [Am. 16] |
|
(16) |
It should be made clear that the requirements of this Regulation also apply to the countries that have entered into international agreements with the Union which confer on that country the same status as a Member State for the purpose of application of this Regulation, as it is currently the case with the Agreement on the European Economic Area (20), the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (21) and the Agreement of 12 September 1963 establishing an association between the European Economic Community and Turkey (22). |
|
(17) |
It should be made clear that medical devices offered to persons in the Union by means of information society services within the meaning of Directive 98/34/EC of the European Parliament and of the Council (23) as well as devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union must comply with the requirements of this Regulation at the latest when the product is placed on the market or the service is provided in the Union. |
|
(18) |
It is appropriate to adapt the general safety and performance requirements to technical and scientific progress, for example for software that is specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device. |
|
(19) |
To recognise the important role of standardisation and traceability in the field of medical devices, compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (24) should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as quality and risk management. [Am. 17] |
|
(19a) |
With devices that consist of more than one implantable part, such as hip implants, compatibility of the parts of different manufacturers should be ensured in order to avoid the replacement of the functional part of the device and thus unnecessary risks and inconvenience for patients. The Commission should investigate the need for further measures to ensure the compatibility of the equivalent parts of hip implants from different manufacturers, bearing in mind that the hip operations are most often carried out on older people for whom the health risks of operations are higher. [Am. 18] |
|
(20) |
Directive 98/79/EC of the European Parliament and of the Council (25) allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices. In areas where no harmonised standards exist or where they are not sufficient, the Commission should be empowered to lay down technical specifications which provide a means to comply with general safety and performance requirements and requirements for clinical evaluation and/or post-market clinical follow-up. |
|
(21) |
The definitions in the field of medical devices, for example regarding economic operators, clinical investigations and vigilance, should be aligned with well-established practice at Union and international level in order to enhance legal certainty. |
|
(21a) |
Directive 2013/35/EU of the European Parliament and of the Council (26) should be the reference text for ensuring that people working in the vicinity of magnetic resonance imaging equipment when it is functioning are properly protected. [Am. 19] |
|
(22) |
The rules applicable to medical devices should be aligned, where appropriate, with the New Legislative Framework for the Marketing of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the Council (27) and Decision No 768/2008/EC of the European Parliament and of the Council (28). |
|
(23) |
The rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to medical devices and their accessories covered by this Regulation which does not prevent Member States from choosing the competent authorities to carry out those tasks. |
|
(24) |
It is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors as laid down in the New Legislative Framework for the Marketing of Products, without prejudice to the specific obligations laid down in the different parts of this Regulation, to enhance understanding of the legal requirements and thus to improve regulatory compliance by the relevant operators. Conditions enabling small and medium-sized enterprises with smart specialisation to have easier access to that market should be established. [Am. 20] |
|
(25) |
Several of the obligations on manufacturers, such as clinical evaluation or vigilance reporting, that were set out only in the annexes of Directives 90/385/EEC and 93/42/EEC should be incorporated into the enacting provisions of this Regulation to enhance legal certainty. |
|
(25a) |
To ensure that patients harmed are compensated for any damage and associated treatment as a result of a faulty medical device, that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by a faulty medical device, manufacturers should be obliged to take liability insurance with sufficient minimum coverage. [Am. 21] |
|
(26) |
To ensure that medical devices manufactured in series production continue to be in conformity with the requirements of this Regulation and that experience from the use of their medical devices is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance plan in place which should be proportionate to the risk class and the type of the medical device. |
|
(27) |
It should be ensured that supervision and control of the manufacture of medical devices is carried out within the manufacturer's organisation by a person who fulfils minimum conditions of qualification. In addition to regulatory compliance, that person could also be responsible for compliance in other fields such as manufacturing processes and quality assessment. The required qualifications of the person responsible for the regulatory compliance should be without prejudice to national provisions regarding professional qualifications, in particular for manufacturers of custom-made devices where such requirements could be met through different educational and professional training systems at national level. [Am. 22] |
|
(28) |
For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the medical devices produced by those manufacturers and in serving as their contact person established in the Union. The tasks of an authorised representative should be defined in a written mandate with the manufacturer which for example may allow the authorised representative to lodge an application for a conformity assessment procedure, to report events under the vigilance system or to register devices placed on the Union market. The mandate should empower the authorised representative to duly fulfil certain defined tasks. Considering the role of authorised representatives, the minimum requirements to be met by them should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's qualified person but, with a view to the authorised representative's tasks, could also be satisfied by a person with qualification in law. |
|
(29) |
To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to clarify when a distributor, importer or other person is to be considered the manufacturer of a medical device. |
|
(30) |
Parallel trade in products already placed on the market is a lawful form of trade within the internal market on the basis of Article 34 TFEU subject to the limitations set by the protection of health and safety and by the protection of intellectual property rights provided by Article 36 TFEU. Application of this principle is, however, subject to different interpretations in the Member States. The conditions, in particular the requirements for relabelling and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the European Court of Justice (29) in other relevant sectors and existing good practices in the field of medical devices. |
|
(31) |
The findings of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), established by Commission Decision 2008/721/EC (30), in its scientific opinion of 15 April 2010 on the safety of reprocessed medical devices marketed for single-use, and of the Commission in its report of 27 August 2010 to the European Parliament and the Council on the issue of reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC (31), call for regulation of the reprocessing of single-use devices in order to ensure a high level of protection of health and safety whilst allowing this practice to further develop under clear conditions. By reprocessing a single-use device its intended purpose is modified and the reprocessor should therefore be considered the manufacturer of the reprocessed device. |
|
(31a) |
The current possibility to reprocess medical devices labelled as single-use is not acceptable from a safety point of view. Only devices labelled as reusable should therefore be reprocessed. Consequently, medical devices labelled as single-use should be real single-use and there should be only two possibilities: single-use or reusable. In order to avoid any systematic labelling of devices as single-use, all devices should be reusable as a rule, except if they are included in a list established by the Commission, after consultation of the MDAC, of categories and groups of medical devices which are unsuitable for reprocessing. The reprocessing of devices encompasses various activities to ensure that a medical device can be safely reused, ranging from decontamination, sterilisation, cleaning, disassembly, repair, component replacement and packaging. These activities should be subject to comparable and transparent standards. [Am. 24] |
|
(32) |
Patients who are implanted with a device should be given clear and easily accessible essential information related to the implanted device allowing it to be identified and containing information about the principal characteristics of the device, and any necessary health risk warnings or precautions to be taken, for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls. [Am. 25] |
|
(33) |
Medical devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the Union and be put into service in accordance with their intended purpose. Member States should not create obstacles to their placing on the market or putting into service for reasons related to the requirements laid down in this Regulation. However, Member States should be allowed to decide whether to restrict the use of any specific type of medical device in relation to aspects that are not covered by this Regulation. [Am. 26] |
|
(34) |
The traceability of medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock-management by hospitals, wholesalers and pharmacists and be compatible with the safety features as referred to in Directive 2011/62/EU of the European Parliament and of the Council (32) and other authentication systems already in place in those settings. [Am. 27] |
|
(35) |
Transparency and better adequate access to information, appropriately presented for the intended user are essential to empower patients, users and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system. [Am. 28] |
|
(36) |
One key aspect is the creation of a central database that should integrate different electronic systems, with the UDI as an integral part of it, to collate and process information regarding medical devices on the market and the relevant economic operators, certificates, clinical investigations, vigilance and market surveillance. The objectives of the database are to enhance overall transparency through better access to information for the public and healthcare professionals, to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission, to avoid multiple reporting requirements and to enhance the coordination between Member States. Within an internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices (Eudamed) set up by Commission Decision 2010/227/EU (33). [Am. 29] |
|
(37) |
Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public to be adequately informed about devices on the Union market. Adequate levels of access for the public and healthcare professionals to those parts of Eudamed's electronic systems which provide key information on medical devices that may pose a risk to public health and safety is essential. Where such access is limited, it should be possible, upon a reasoned request, to disclose the existing information on medical devices, unless the limitation of access is justified on grounds of confidentiality. The electronic system on clinical investigations should serve as tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and, in this case, to report serious adverse events. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities. A regular overview of vigilance and market surveillance information should be made available to healthcare professionals and the public. [Am. 30] |
|
(38) |
In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the European Parliament and of the Council (34) applies to the processing of personal data carried out in the Member States, under the supervision of the Member States competent authorities, in particular the public independent authorities designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament and of the Council (35) applies to the processing of personal data carried out by the Commission within the framework of this Regulation, under the supervision of the European Data Protection Supervisor. In accordance with Article 2(d) of Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic systems. |
|
(39) |
For high-risk medical devices, in the interests of increased transparency, manufacturers should summarise the main draw up a report on the safety and performance aspects of the device and the outcome of the clinical evaluation in a document that. A summary of the safety and performance report should be publicly available via Eudamed. [Am. 31] |
|
(39a) |
According to the policy of the European Medicines Agency (EMA) on access to documents, the EMA releases documents submitted as part of applications for marketing authorisation for medicinal products, including clinical trial reports, on request once the decision-making process for the medicinal product in question has been completed. Corresponding standards on transparency and access to documents should be upheld and reinforced for high-risk medical devices, in particular as they are not subject to pre-market approval. For the purposes of this Regulation, in general the data included in clinical investigations should not be considered commercially sensitive once compliance of a device with the applicable requirements has been demonstrated following the applicable conformity assessment procedure. This should be without prejudice to intellectual property rights concerning the data in clinical investigations by the manufacturer with regard to the use of these data by other manufacturers. [Am. 32] |
|
(39b) |
As regards invasive devices with a diagnostic and measuring function, Member States should take all necessary measures to prevent the risk of infection and microbial contamination between patients. To this end, the Member States should eliminate the known or foreseeable risks to patient safety by advocating inter alia the safest levels of and guidelines for disinfection and ensure their effective implementation by users and health establishments. In accordance with this Regulation, the Commission should ensure that these preventive health protection measures are appropriate. [Am. 33] |
|
(40) |
The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection for health professionals, users and operators, including in the waste disposal chain, and for ensuring citizens' confidence in the system. Designation and monitoring of notified bodies by the Member States, and where applicable by the EMA, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level. [Am. 34] |
|
(41) |
The position of notified bodies vis-à-vis manufacturers should be strengthened, including their right and duty to carry out unannounced factory inspections and to conduct physical or laboratory tests on medical devices to ensure continuous compliance by manufacturers after receipt of the original certification. |
|
(42) |
For high risk medical devices, authorities should be informed at an early stage about devices which are subject to conformity assessment and be given the right, on scientifically valid grounds, to scrutinise the preliminary assessment conducted by notified bodies, in particular regarding novel devices, devices for which a novel technology is being used, devices belonging to a category of devices with increased serious incident rates, or devices for which significant discrepancies in the conformity assessments by different notified bodies have been identified in respect of substantially similar devices. The process foreseen in this Regulation does not prevent a manufacturer from informing voluntarily a competent authority of his intention to file an application for conformity assessment for a high risk medical device before submitting the application to the notified body. [Am. 35] |
|
(42a) |
For high-risk medical devices, such as devices in class III, implantable devices and devices intended to administer medicinal products when failure or malfunctioning of these devices would have a major impact on health and safety, the conformity assessment should be the responsibility of special notified bodies. Those special notified bodies should be designated by the EMA on the basis of the reinforced requirements on staff qualification and training as referred to in Section 3.5a of Annex VI. These special notified bodies should meet in a network in order in particular to exchange good practice and ensure convergence in their work. The Assessment Committee for Medical Devices (ACMD) shall provide an opinion on the robustness of the clinical data by way of an assessment in specific cases. The need for such additional assessment should decrease once the new rules have been fully implemented and applied in particular to all notified bodies and as common technical standards are developed. The Commission should therefore review the functioning of and the experience with the additional assessment procedure after five years with a view to assessing whether it can be further restricted. [Ams. 363 and 370] |
|
(42b) |
As this Regulation now combines active implantable medical devices covered by Directive 90/385/EEC, and implantable medical devices covered by Directive 93/42/EEC, and places all active implantable medical devices and implantable devices of public health concern in the highest risk class III category attracting the strictest controls, and as the vast majority of class IIb implantable medical devices such as pins, bone-screws, plates, staples etc., have a long history of safe implantation within the human body, and as special notified bodies will be specifically designated for such class IIb implantable devices, class IIb implantable devices need not be subject to the scrutiny procedure. [Am. 379] |
|
(42c) |
The ACMD should be composed of clinical experts in the medical fields relevant to the medical device being assessed, one representative of the EMA and one representative of patients' organisations. The ACMD should meet on request from the MDCG or the Commission and its meetings should be chaired by a Commission representative. The Commission should provide logistic support to the secretariat and operations of the ACMD. [Am. 364] |
|
(43) |
It is necessary, in particular for the purpose of the conformity assessment procedures, to maintain the division of medical devices into four product classes in line with international practice. The classification rules, which are based on the vulnerability of the human body taking into account the potential risks associated with the technical design and manufacture of the devices, need to be adapted to technical progress and experience gained from vigilance and market surveillance. To maintain the same level of safety as provided by Directive 90/385/EEC, active implantable medical devices and their accessories should be in the highest risk class. |
|
(44) |
The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products. For medical devices in classes IIa, IIb and III, an appropriate level of involvement of a notified body should be compulsory, with medical devices in class III requiring explicit prior approval of their design and manufacture before they can be placed on the market. |
|
(45) |
The conformity assessment procedures should be simplified strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field. [Am. 38] |
|
(46) |
To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements should be based on clinical data that, for class III medical devices and implantable medical devices should, as a general rule, be sourced from clinical investigations to be carried out under the responsibility of a sponsor who can be the manufacturer or another legal or natural person taking responsibility for the clinical investigation. |
|
(47) |
The rules on clinical investigations should be in line with major international guidance in this field, such as the international standard ISO 14155:2011, or any subsequent version of it, on good clinical practice for clinical investigations of medical devices for human subjects and the most recent (2008) version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects to ensure that clinical investigations conducted in the Union are accepted elsewhere and that clinical investigations conducted outside the Union in accordance with international guidelines can be accepted under this Regulation. [Am. 39] |
|
(47a) |
The Declaration of Helsinki of the World Medical Association (36) states in Article 23 that ‘The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins’. Clinical investigations involving risk for the subject should only be allowed after assessment and approval by an ethics committee. The reporting Member State and the other concerned Member States need to organise themselves in a way that the competent authority concerned receives approval by an ethics committee on the clinical performance study protocol. [Am. 40] |
|
(48) |
An electronic system should be set up at Union level to ensure that every clinical investigation is registered in a publicly accessible database. To protect the right to the protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union, no personal data of subjects participating in a clinical investigation should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations on medical devices should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use. |
|
(48a) |
For the sake of transparency, sponsors should submit the results of a clinical investigation together with a layperson summary within the deadlines specified by the regulation. The Commission should be empowered to adopt delegated acts on the preparation of the layperson's summary and the communication of the clinical investigation report. The Commission should provide guidelines for managing and facilitating the sharing of raw data from all clinical investigations. [Am. 41] |
|
(49) |
Sponsors of clinical investigations to be conducted in more than one Member State should be given the possibility to submit a single application in order to reduce administrative burden. In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety related aspects of the investigational device and of the scientific design of the clinical investigation to be conducted in several Member Stats, such single application should facilitate the coordination between the Member States under the direction of a coordinating Member State. The coordinated assessment should not include the assessment of intrinsically national, local and ethical aspects of a clinical investigation, including informed consent. Each Member State should retain the ultimate responsibility for deciding whether the clinical investigation may be conducted on its territory. |
|
(50) |
Sponsors should report certain adverse events occurring during clinical investigations to the Member States concerned, which should shall have the possibility to terminate or suspend the investigations if considered necessary to ensure a high level of protection of the subjects enrolled in a clinical investigation. Such information should shall be communicated to the other Member States, the MDCG and the Commission. [Am. 43] |
|
(51) |
This Regulation should only cover clinical investigations which pursue regulatory purposes laid down in this Regulation. |
|
(51a) |
Strict rules for persons unable to give informed consent such as children and incapacitated persons should be established at the same level as in Directive 2001/20/EC of the European Parliament and of the Council (37). [Am. 44] |
|
(52) |
In order to better protect the health and safety of health professionals, patients, users and operators, including in the waste disposal chain, regarding devices on the market, the vigilance system for medical devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions. [Am. 45] |
|
(53) |
Member States should take all necessary measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents. Healthcare professionals, users and patients should be empowered and enabled to report suspected serious incidents at national level using harmonised formats. The and guaranteeing anonymity, where appropriate. In order to minimise the recurrence of such incidents, the national competent authorities should inform manufacturers, and, if appropriate, their subsidiaries and sub-contractors, and share report the information with their peers via the respective electronic system in Eudamed when they confirm that a serious an incident has occurred in order to minimise recurrence of those incidents. [Am. 46] |
|
(54) |
The assessment of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one Member State coordination, with the objective of sharing resources and ensuring consistency regarding the corrective action, and transparency of procedures should be ensured. [Am. 47] |
|
(54a) |
Manufacturers should report periodically on medical devices classified as class III as regards the data relevant to the risk benefit ratio and the exposition of the population in order to evaluate whether any action concerning the medical device concerned is necessary. [Am. 48] |
|
(55) |
The reporting of serious adverse events during clinical investigations and the reporting of serious incidents occurring after a medical device has been placed on the market should be clearly distinguished to avoid double reporting. |
|
(56) |
Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures. The Commission should clearly define the way these inspections should be conducted in order to ensure a full and harmonised implementation within the Union. [Am. 49] |
|
(57) |
The Member States shall should levy fees for the designation and monitoring of notified bodies to ensure sustainability of the monitoring of those bodies by Member States and to establish a level playing field for notified bodies. These fees should be comparable across Member States and should be made public. [Am. 50] |
|
(57a) |
Member States are invited to set and enforce serious penalties for manufacturers that commit fraud and cheat with regard to medical devices. Those penalties should be at least as large as the revenue gains from fraud or cheating. Penalties may include imprisonment. [Am. 51] |
|
(58) |
Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level, Member States should inform the Commission and the other Member States before they adopt a comparable level and structure of the fees to ensure transparency. [Am. 52] |
|
(58a) |
Member States should adopt provisions on standard fees for notified bodies, which should be comparable across Member States. The Commission should provide guidelines to facilitate the comparability of those fees. Member States should transmit their list of standard fees to the Commission and ensure that the notified bodies registered on their territory make the lists of standard fees for their conformity assessment activities publicly available. [Am. 53] |
|
(59) |
An expert committee, the Medical Device Coordination Group (A MDCG), composed of persons designated by the Member States based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices should be established to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) […/…] on in vitro diagnostic medical devices (38), to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation. [Am. 54] |
|
(60) |
Closer coordination between national competent authorities through information exchange and coordinated assessments under the direction of a coordinating authority is fundamental for ensuring a consistently high level of health and safety within the internal market, in particular in the areas of clinical investigations and vigilance. This should also lead to more efficient use of scarce resources at national level. |
|
(61) |
The Commission should provide scientific, technical and corresponding logistic support to the coordinating national authority and ensure that the regulatory system for medical devices is effectively and uniformly implemented at Union level based on sound scientific evidence. [Am. 55] |
|
(62) |
The Union should actively participate in international regulatory cooperation in the field of medical devices to facilitate the exchange of safety-related information regarding medical devices and to foster the further development of international regulatory guidelines promoting the adoption of regulations in other jurisdictions with a level of health and safety protection equivalent to that set by this Regulation. |
|
(63) |
This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably human dignity, the integrity of the person, the principle of free and informed consent, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property, as well as the European Convention on Human Rights. This Regulation should be applied by the Member States in accordance with those rights and principles. [Am. 56] |
|
(64) |
In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the products subject to this Regulation that are similar to medical devices but do not necessarily have a medical purpose; adaptation of the definition of nanomaterial to technical progress and to developments at Union and international level; adaptation to technical progress of the general safety and performance requirements, of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certificates issued by notified bodies, of the minimum requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical investigations; the establishment of the UDI system; the information to be submitted for the registration of medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical investigations; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them. However, basic aspects of this Regulation such as general safety and performance requirements, stipulations on technical documentation and the requirements for CE marking certification, as well as any amendments or additions to it, should be provided for only through the ordinary legislative procedure. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. [Am. 57] |
|
(65) |
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (39). |
|
(66) |
The advisory procedure should be used for the adoption of the form and presentation of the data elements of the manufacturers' summary of safety and clinical performance; of the codes defining the notified bodies' scopes of designation; and of the model for certificates of free sale, given that those acts have a procedural character and do not directly impact the health and safety at Union level. |
|
(67) |
The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the extension to the territory of the Union of a national derogation from the applicable conformity assessment procedures in exceptional cases; relating to the Commission's position whether a provisional national measure against a medical device presenting a risk or a provisional national preventive health protection measure is justified or not; and relating to the adoption of a Union measure against a medical device presenting a risk, imperative grounds of urgency so require. |
|
(68) |
To allow economic operators, notified bodies, Member States and the Commission especially SMEs, to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements to be taken for its proper application. However, parts of the Regulation that affect directly Member States and the Commission should be implemented as soon as possible. It is particularly important that by the date of application, a sufficient number of notified bodies are designated in accordance with the new requirements to avoid any shortage of medical devices on the market. Also at the date of application, existing notified bodies that handle class III devices, shall be subject to an application for notification in accordance with this Regulation. [Am. 58] |
|
(69) |
In order to ensure a smooth transition to the registration of medical devices, of relevant economic operators and of certificates, the obligation to submit the relevant information to the electronic systems put in place by this Regulation at Union level should become fully effective only 18 months after the date of application of this Regulation. During this transitional period, Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC should remain in force. However, economic operators and notified bodies who register in the relevant electronic systems provided for at Union level should be considered in compliance with the registration requirements adopted by the Member States pursuant to those provisions of the Directives to avoid multiple registrations. |
|
(70) |
Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the placing of medical devices on the market and the related aspects covered by this Regulation. |
|
(71) |
Since the objective of this Regulation, namely to ensure high standards of quality and safety for medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale of the measure, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. |
|
(71a) |
The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 8 February 2013 (40), |
HAVE ADOPTED THIS REGULATION:
Chapter I
Scope and definitions
Article 1
Scope
1. This Regulation establishes rules to be complied with by medical devices for human use, and accessories to medical devices and medical devices for aesthetic purposes that are placed on the market or put into service in the Union for human use. [Am. 59]
For the purposes of this Regulation, medical devices and, accessories to medical devices and devices for aesthetic purposes shall hereinafter be referred to as ‘devices’. [Am. 60]
2. This Regulation shall not apply to:
|
(a) |
in vitro diagnostic medical devices covered by Regulation (EU) […/…]; |
|
(b) |
medicinal products covered by Directive 2001/83/EC and advanced therapy medicinal products covered by Regulation (EC) No 1394/2007. In deciding whether a product falls under Directive 2001/83/EC or Regulation (EC) No 1394/2007 or under this Regulation, particular account shall be taken of the principal mode of action of the product; |
|
(c) |
human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or used in accordance with the manufacturer's instructions, such blood products, plasma or cells, except for devices referred to in paragraph 4; |
|
(d) |
cosmetic products covered by Regulation (EC) No 1223/2009; |
|
(e) |
transplants, tissues or cells of human or animal origin or their derivatives, or products containing or consisting of them, unless a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or are rendered non-viable. However, human tissues and cells that are non-viable or are rendered non-viable and that have undergone only non-substantial manipulation, in particular those listed in Annex I of Regulation (EC) No 1394/2007, and products derived from such tissues and cells, shall not be considered devices manufactured utilising tissues or cells of human origin or their derivatives; |
|
(f) |
all products that contain or consist of biological substances or organisms other than those referred to in points (c) and (e) that are viable and that achieve their intended purpose by pharmacological, immunological or metabolic means, including certain living micro-organisms, bacteria, fungi or virus; [Am. 61] |
|
(g) |
food covered by Regulation (EC) No 178/2002. |
3. Any device which, when placed on the market or used in accordance with the manufacturer's instructions, incorporates as an integral part an in vitro diagnostic medical device as defined in Article 2 of Regulation (EU) […/…] [on in vitro diagnostic medical devices] shall be governed by this Regulation, unless it is covered by Article 1(3) of that Regulation. The relevant general safety and performance requirements set out in Annex I of that Regulation shall apply as far as the safety and performance of the in vitro diagnostic medical device part are concerned.
4. Where a device, when placed on the market or used in accordance with the manufacturer's instructions, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in Article 1(10) of that Directive, with action ancillary to that of the device, that device shall be assessed and authorised in accordance with this Regulation following consultation with the national medicine agency or with the EMA. [Am. 62]
However, if the action of the medicinal substance is not ancillary to that of the device, the product shall be governed by Directive 2001/83/EC. In this case, the relevant general safety and performance requirements set out in Annex I of this Regulation shall apply as far as the safety and performance of the device part are concerned.
5. Where a device is intended to administer a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, that device shall be governed by this Regulation, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.
However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, the product shall be governed by Directive 2001/83/EC. In this case, the relevant general safety and performance requirements set out in Annex I of this Regulation shall apply as far as the safety and performance of the device part are concerned.
5a. This Regulation shall not impede the continued application of measures within Directive 2002/98/EC and its five daughter Directives setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components.
Articles 10 (Personnel), 14 (Traceability), 15 (Notification of serious adverse events and reactions), 19 (Examination of donors) and 29 (Technical requirements and their adaptation to technical and scientific progress) of Directive 2002/98/EC ensure donor and patient safety and as such those existing standards shall be maintained. [Am. 63]
6. This Regulation is a specific Union legislation within the meaning of Article 1(4) of Directive 2004/108/EC and within the meaning of Article 3 of Directive 2006/42/EC.
7. This Regulation shall not affect the application of Directive 96/29/Euratom nor of Directive 97/43/Euratom.
7a. The regulation of medical devices at Union level shall not interfere with the freedom of Member States to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation. [Am. 64]
8. This Regulation shall not affect national laws which require that certain devices may only be supplied on a medical prescription.
9. References to a Member State in this Regulation shall be understood as including any other country with which the Union has concluded an agreement which confers on that country the same status as a Member State for the purpose of application of this Regulation.
Article 2
Definitions
1. For the purposes of this Regulation, the following definitions shall apply:
Definitions related to devices:
|
(1) |
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific direct or indirect medical purposes of: [Am. 65]
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The implantable or other invasive products, as well as products using external physical agents, intended to be used for human beings, which are listed on a non-exhaustive basis in Annex XV, shall be considered medical devices for the purposes of this Regulation, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose. [Am. 67] |
|
(2) |
‘accessory to a medical device’ means an article which, whilst not being a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable or assist the device(s) to be used in accordance with its/their intended purpose(s); or to specifically assist the medical functionality of the medical device(s) in view of its/their intended purpose(s); [Am. 68] |
|
(2a) |
‘device for aesthetic purposes’ means any instrument, apparatus, appliance, software, implant, material, substance or other article, intended by the manufacturer to be used, alone or in combination, for the purposes of modifying the physical appearance of human beings, without any therapeutic or reconstructive intent, by implanting it in the human body, attaching it to the surface of the eye or using it to induce a tissue or cell reaction on external or non-external parts of the human body. Tattooing products and piercings shall not be considered devices for aesthetic purposes. [Am. 69] |
|
(3) |
‘custom-made device’ means any device specifically made in accordance with by an appropriately qualified person exclusively to meet a specific patient’s individual requirements and needs. In particular a ‘custom-made device’ may be produced on the basis of a written prescription of a doctor of medicine, of a dental practitioner or of any other person authorised by national law by virtue of this person's professional qualifications which gives, under his responsibility, specific design characteristics, and is intended for the sole use of a particular patient. However, mass-produced devices which need to be adapted to meet the specific requirements of a doctor of medicine, a dental practitioner or any other professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of doctors of medicine, dental practitioners or any other authorised person shall not be considered to be custom-made devices; [Am. 70] |
|
(4) |
‘active device’ means any device, the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or by gravity and which acts by changing the density of or converting this energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be considered to be active devices. [Am. 71] Stand alone software shall be considered an active device; [Am. 72] |
|
(5) |
‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended
by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be considered an implantable device; |
|
(6) |
‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body; |
|
(7) |
‘generic device group’ means a set of devices having the same or similar intended purposes or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics; |
|
(8) |
‘single-use device’ means a device that is intended to be used on an individual patient during a single procedure and which has been tested and demonstrated to be impossible to reuse. [Am. 73] The single procedure may involve several uses or prolonged use on the same patient; |
|
(8a) |
‘reusable device’ means a device that is suitable for reprocessing and that is intended to be used on multiple patients or during multiple procedures; [Am. 357] |
|
(9) |
‘single-use device for critical use’ means a single-use device intended to be used for surgically invasive medical procedures; [Am. 75] |
|
(10) |
‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the clinical evaluation, to be reflected in the conformity certificate, the product label, in the instructions for use or and if applicable in promotional or sales materials or statements; [Am. 354] |
|
(11) |
‘label’ means the written, printed, or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices; |
|
(12) |
‘instructions for use’ means the information provided by the manufacturer to inform the user of the device's intended purpose and proper use and of any precautions to be taken; |
|
(13) |
‘Unique Device Identification’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market; |
|
(14) |
‘non-viable’ means having no potential for metabolism or multiplication; |
|
(15) |
‘nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials. For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:
|
Definitions related to the making available of devices:
|
(16) |
‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; [Am. 76] |
|
(17) |
‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market; |
|
(18) |
‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose; |
Definitions related to economic operators, users and specific processes:
|
(19) |
‘manufacturer’ means the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under his name or trademark. For the purposes of the definition of manufacturer, fully refurbishing is defined as the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it in conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device; |
|
(20) |
‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under this Regulation; |
|
(21) |
‘importer’ means any natural or legal person established within the Union who places a device from a third country on the Union market; |
|
(22) |
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market; |
|
(23) |
‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor; |
|
(24) |
‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health; [Am. 77] |
|
(25) |
‘user’ means any healthcare professional or lay person who uses a device; |
|
(26) |
‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline; |
|
(27) |
‘reprocessing’ means the process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoration of the technical and functional safety of the used device; routine device maintenance service activities are not included in this definition; [Am. 78] |
Definitions related to conformity assessment:
|
(28) |
‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled; |
|
(29) |
‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection; |
|
(30) |
‘notified body’ means a conformity assessment body designated in accordance with this Regulation; |
|
(31) |
‘CE marking of conformity’ or ‘CE marking’ means a marking by which the manufacturer indicates that the device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing; |
|
(31a) |
‘performance’ means any technical characteristics, any effects and any benefit of the device when used for the intended purpose and in accordance with the instructions of use; [Am. 79] |
|
(31b) |
‘benefit’ means the positive health impact of a medical device based on clinical and non-clinical data; [Am. 80] |
Definitions related to clinical evaluation and clinical investigations:
|
(32) |
‘clinical evaluation’ means the assessment and analysis of clinical data pertaining to a device in order to verify the safety, and performance and clinical benefits of the device when used as intended by the manufacturer; [Am. 82] |
|
(33) |
‘clinical investigation’ means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;. Clinical investigations for medical devices, where made compulsory in accordance with this Regulation, shall include clinical investigations in the appropriate target population and well-controlled investigations. [Am. 83] |
|
(34) |
‘investigational device’ means any device being assessed for safety and/or performance in a clinical investigation; |
|
(35) |
‘clinical investigation plan’ means the document(s) setting out the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation; |
|
(36) |
‘clinical data’ means all the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following: [Am. 84]
|
|
(37) |
‘sponsor’ means an individual, company, institution or organisation which takes responsibility for the initiation and management, conduct or financing of a clinical investigation; [Am. 86] |
|
(37a) |
‘conformity assessment’ means, in relation to a clinical study, the checking by the authorities responsible of the relevant official documentation, facilities and records and of the existence of sufficient insurance cover. Such checking may be carried out on the premises of the sponsor and/or the research establishment or wherever the authority responsible may deem checks to be necessary. [Am. 87] |
|
(37b) |
‘ethics committee’ means an independent body in a Member State, consisting of health-care professionals and non-medical members including at least one well-experienced, knowledgeable patient or patient representative. Its responsibility is to protect the rights, safety, physical and mental integrity, dignity and well-being of subjects involved in clinical investigations and to provide public assurance of that protection in full transparency. In cases of such investigations involving minors, the ethics committee shall include at least one healthcare professional with paediatric expertise; [Am. 88] |
|
(38) |
‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device; |
|
(39) |
‘serious adverse event’ means any adverse event that led to any of the following:
|
|
(40) |
‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational a device, as defined in points 1 to 6 of this paragraph including malfunction, use errors or inadequacy in the information supplied by the manufacturer; [Am. 91] |
Definitions related to vigilance and market surveillance:
|
(41) |
‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user; |
|
(42) |
‘withdrawal’ means any measure aimed at preventing a device in the supply chain from further being made available on the market; |
|
(43) |
‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, any inadequacy in the information supplied by the manufacturer and any unexpected undesirable side-effect; |
|
(44) |
‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:
|
|
(45) |
‘corrective action’ means action taken to eliminate the cause of a potential or real non-conformity or other undesirable situation; |
|
(46) |
‘field safety corrective action’ means corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market; |
|
(47) |
‘field safety notice’ means the communication sent by the manufacturer to users or customers in relation to a field safety corrective action; |
|
(48) |
‘market surveillance’ means the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection; |
|
(48a) |
‘unannounced inspection’ means an inspection conducted without advance notice; [Am. 92] |
Definitions related to standards and other technical specifications:
|
(49) |
‘harmonised standard’ means a European standard as defined in Article 2(1)(c) of Regulation (EU) No […/…]; |
|
(50) |
‘common technical specifications’ means a document other than a standard that prescribes technical requirements that provide a means to comply with the legal obligation applicable to a device, process or system. |
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 to amend the list in Annex XV referred to in the last subparagraph of number (1) of paragraph 1, in the light of technical progress and taking into account the similarity between a medical device and a product without a medical purpose in respect of their characteristics and risks.
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to adapt the definition of nanomaterial set out in number (15) of paragraph 1 in view of technical and scientific progress and taking into account definitions agreed at Union and international level.
Article 3
Regulatory status of products
1. The Commission may on its own initiative or shall, at the request of a Member State or on its own initiative, by means of implementing acts on the basis of the opinions of the MDCG and the MDAC referred to in Articles 78 and 78a respectively, determine whether or not a specific product, or category or group of products, including borderline products, falls within the definitions of ‘medical device’ or ‘accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
2. The Commission shall ensure the sharing of expertise between Member States in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products in order to determine the appropriate regulatory status of a product, or category or group of products. [Am. 93]
Chapter VII
Classification and conformity assessment of medical devices [Am. 260]
Article 41
Classification of medical devices
1. Devices shall be divided into classes I, IIa, IIb and III, taking into account their intended purpose and inherent risks. Classification shall be carried out in accordance with the classification criteria set out in Annex VII.
2. Any dispute between the manufacturer and the notified body concerned, arising from the application of the classification criteria, shall be referred for a decision to the competent authority of the Member State where the manufacturer has his registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State where the authorised representative referred to in the last indent of point (b) of Section 3.2. of Annex VIII has his registered place of business.
At least 14 days prior to any decision, the competent authority shall notify the MDCG and the Commission of its envisaged decision. The final decision shall be made publicly available in the Eudamed. [Am. 150]
3. The Commission may, at the request of a Member State or on its own initiative, by means of implementing acts, decide on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices, with a view to determining their classification. Such decision should in particular be taken in order to resolve diverging decisions between Member States. [Am. 151]
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). Before adopting implementing acts, the Commission shall consult with relevant stakeholders and take into account their suggestions. [Am. 152]
4. In the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission, having consulted relevant stakeholders, including organisations of healthcare professionals, shall be empowered to adopt delegated acts in accordance with Article 89 as regards the following: [Am. 153]
|
(a) |
deciding that a device, or category or group of devices, should, by way of derogation from the classification criteria set out in Annex VII, be classified in another class; |
|
(b) |
amending or supplementing the classification criteria set out in Annex VII. |
Chapter IIa
Conformity assessment [Am. 261]
Article 26
Summary of safety Safety and clinical performance report
1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of report on the safety and clinical performance. It of the device based on the full information collected during the clinical investigation. The manufacturer shall also draw up a summary of that report which shall be written in a way that is clear to the intended user easy for a lay person to understand in the official language(s) of the country where the medical device is made available on the market. The draft of this summary report shall be part of the documentation to be submitted to and validated by the special notified body involved in the conformity assessment in accordance with Article 42 and shall be validated by that body 43a.
1a. The summary referred to in paragraph 1 shall be made available to the public through Eudamed in accordance with provisions under point (b) of Article 27(2) and point 18 of Annex V Part A.
2. The Commission may, by means of implementing acts, set out the form and the format of the presentation of the data elements to be included in both the report and the summary of safety and clinical performance referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(2). [Am. 130]
Article 42
Conformity assessment procedures
1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device. The conformity assessment procedures are set out in Annexes VIII to XI.
2. Manufacturers of devices classified as class III, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance and design dossier examination as specified in Annex VIII. Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex IX coupled with a conformity assessment based on product conformity verification as specified in Annex X.
In the case of devices referred to in the first subparagraph of Article 1(4), the notified body shall follow the consultation procedure as specified in Section 6.1 of Chapter II of Annex VIII or Section 6 of Annex IX, as applicable.
In the case of devices that are covered by this Regulation in accordance with point (e) of Article 1(2), the notified body shall follow the consultation procedure as specified in Section 6.2 of Chapter II of Annex VIII or Section 6 of Annex IX, as applicable.
3. Manufacturers of devices classified as class IIb, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance as specified in Annex VIII, except for its Chapter II, with assessment of the design documentation within the technical documentation on a representative basis. Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex IX coupled with a conformity assessment based on product conformity verification as specified in Annex X.
4. Manufacturers of devices classified as class IIa, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance as specified in Annex VIII, except for its Chapter II, with assessment of the prototype and the design documentation within the technical documentation on a representative basis. Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annex II coupled with a conformity assessment based on product conformity verification as specified in Section 7 of Part A or Section 8 of Part B of Annex X. [Am. 154]
5. Manufacturers of devices classified as class I, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17 after drawing up the technical documentation set out in Annex II. If the devices are placed on the market in sterile condition or have a measuring function, the manufacturer shall apply the procedures set out in Annex VIII, except for its Chapter II, or in Part A of Annex X. However, involvement of the notified body shall be limited:
|
(a) |
in the case of devices placed on the market in sterile condition, to the aspects of manufacture concerned with securing and maintaining sterile conditions, |
|
(b) |
in the case of devices with a measuring function, to the aspects of manufacture concerned with the conformity of the devices with the metrological requirements. |
6. Manufacturers may choose to apply a conformity assessment procedure applicable to devices of a higher class than the device in question.
7. Manufacturers of custom-made devices shall follow the procedure set out in Annex XI and draw up the statement set out in that Annex before placing the device on the market.
8. The Member State in which the notified body is established may determine that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 6 shall be available in an official Union language. Otherwise they shall be available in an official Union language acceptable to the notified body.
9. Investigational devices shall be subject to the requirements set out in Articles 50 to 60.
10. The Commission may shall, by means of implementing acts, specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects: [Am. 155]
|
— |
the frequency and the sampling basis of the assessment of the design documentation within the technical documentation on a representative basis as set out in Sections 3.3(c) and 4.5 of Annex VIII in the case of devices of classes IIa and IIb, and in Section 7.2 of Part A of Annex X in the case of devices of class IIa; |
|
— |
the minimum frequency of unannounced factory inspections and sample checks to be conducted by notified bodies in accordance with Section 4.4 of Annex VIII, taking into account the risk-class and the type of device; [Am. 156] |
|
— |
the physical, laboratory or other tests to be carried out by notified bodies in the context of sample checks, design dossier examination and type examination in accordance with Sections 4.4 and 5.3 of Annex VIII, Section 3 of Annex IX and Section 5 of Part B of Annex X. |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
10a. Unannounced inspections, in terms of their nature and extent, may be counted as regular inspections, with offsetting of economic operators’ costs resulting from unannounced inspections, provided that no significant non-conformities are recorded during unannounced inspections. Account must be taken at all times, when ordering unannounced inspections and carrying them out, of the proportionality principle, with due regard, in particular, for the risk potential of each individual product. [Am. 157]
11. In the light of technical progress and any information which becomes available in the course of the designation or monitoring of notified bodies set out in Articles 28 to 40, or of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the conformity assessment procedures set out in Annexes VIII to XI. [Am. 158]
Article 44
Mechanism for scrutiny of certain conformity assessments
1. Notified bodies shall notify the Commission of applications for conformity assessments for devices classified as class III, with the exception of applications to supplement or renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG.
2. Within 28 days of receipt of the information referred to in paragraph 1, the MDCG may request the notified body to submit a summary of the preliminary conformity assessment prior to issuing a certificate. Upon suggestion by any of its members or by the Commission, the MDCG shall decide on making such request in accordance with the procedure set out in Article 78(4). In its request the MDCG shall indicate the scientifically valid health reason for having selected the specific file for submission of a summary of the preliminary conformity assessment. When selecting a specific file for submission, the principle of equal treatment shall be duly taken into account.
Within 5 days after receipt of the request by the MDCG, the notified body shall inform the manufacturer thereof.
3. The MDCG may submit comments on the summary of the preliminary conformity assessment at the latest 60 days after submission of this summary. Within that period and at the latest 30 days after submission, the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the notified body's preliminary conformity assessment. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this subparagraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of comments.
4. The notified body shall give due consideration to any comments received in accordance with paragraph 3. It shall convey to the Commission an explanation of how they have been taken into consideration, including any due justification for not following the comments received, and its final decision regarding the conformity assessment in question. The Commission shall immediately transmit this information to the MDCG.
5. Where deemed necessary for the protection of patient safety and public health, the Commission, may determine, by means of implementing acts, specific categories or groups of devices, other than devices of class III, to which paragraphs 1 to 4 shall apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Measures pursuant to this paragraph may be justified only by one or more of the following criteria:
|
(a) |
the novelty of the device or of the technology on which it is based and the significant clinical or public health impact thereof; |
|
(b) |
an adverse change in the risk-benefit profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in case of failure; |
|
(c) |
an increased rate of serious incidents reported in accordance with Article 61 in respect of a specific category or group of devices; |
|
(d) |
significant discrepancies in the conformity assessments carried out by different notified bodies on substantially similar devices; |
|
(e) |
public health concerns regarding a specific category or group of devices or the technology on which they are based. |
6. The Commission shall make a summary of the comments submitted in accordance with paragraph 3 and the outcome of the conformity assessment procedure accessible to the public. It shall not disclose any personal data or information of commercially confidential nature.
7. The Commission shall set up the technical infrastructure for the data-exchange by an electronic means between notified bodies and MDCG for the purposes of this Article.
8. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the summary of the preliminary conformity assessment in accordance with paragraphs 2 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). [Am. 165]
Article 44a
Assessment procedure in specific cases
1. Special notified bodies shall notify the Commission of applications for conformity assessments for implantable Class III devices, Class IIb devices intended to administer and/or remove a medicinal product, as referred to in Article 1(5) and point 5.3. of Annex VII (Rule 11), and devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or are rendered non-viable with the exception of applications to renew or supplement existing certificates and devices for which specifications referred to in Articles 6 and 7 have been published for the clinical evaluation and the post-market clinical follow-up. The notification shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notification the special notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the Medical Device Coordination Group (MDCG) for an opinion. In making its opinion, the MDCG may seek a clinical assessment from the relevant experts of the Assessment Committee for Medical Devices (ACMD), referred to in Article 78.
2. Within 20 days of receipt of the information referred to in paragraph 1, the MDCG may decide to request the special notified body to submit the following documents prior to issuing a certificate:
|
— |
the clinical evaluation report as referred to in Annex XIII, including the clinical investigations report as referred to in Annex XIV, |
|
— |
the post market clinical follow-up plan referred to in Annex XIII, and |
|
— |
any information regarding the marketing or not of the device in third countries and, where available, the results of evaluation conducted by competent authorities in those countries. |
The members of the MDCG shall decide on making such a request only on the basis of the following criteria:
|
(a) |
the novelty of the device with possible major clinical or health impact; |
|
(b) |
an adverse change in the risk-benefit profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in the case of failure; |
|
(c) |
an increased rate of serious incidents reported in accordance with Article 61 in respect of a specific category or group of devices. |
In the light of technical progress and any information which becomes available, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing these criteria.
In its request the MDCG shall indicate the scientifically valid health reason for having selected the specific file.
In the absence of request from the MDCG within 20 days of receipt of the information referred to in paragraph 1, the special notified body may continue with the conformity assessment procedure.
3. The MDCG, following the consultation of the ACMD shall issue a MDCG opinion on the documents referred to in paragraph 2 at the latest 60 days after its submission. Within that period and at the latest 30 days after submission, the ACMD through the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the documents referred to in paragraph 2. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this paragraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of comments.
4. In its opinion the MDCG shall take into account the clinical assessment of the ACMD. The MDCG may recommend modifications of the documents referred to in paragraph 2.
5. The MDCG shall immediately inform the Commission, the special notified body and the manufacturer of its opinion.
6. Within 15 days after receipt of the opinion referred to in paragraph 5, the special notified body shall indicate whether or not it agrees with the opinion of the MDCG. In the latter case, it may give written notice to the MDCG. that it wishes to request a re-examination of the opinion. In that case, the special notified body shall forward to the MDCG the detailed grounds for the request within 30 days after receipt of the opinion. The MDCG shall immediately transmit this information to the ACMD and the Commission.
Within 30 days following receipt of the grounds for the request, the MCDG shall re-examine its opinion, after consultation of the ACMD where necessary. The reasons for the conclusion reached shall be annexed to the final opinion.
7. Immediately after its adoption, the MCDG shall send its final opinion to the Commission, the special notified body and the manufacturer.
8. In the case of a favourable opinion MDCG opinion, the special notified body may proceed with the certification.
However if the favourable MDCG opinion is dependent on the application of specific measures (e.g. adaptation of the post-market clinical follow-up plan, certification with a time limit), the special notified body shall issue the certificate of conformity only on the conditions that those measures are fully implemented.
Following the adoption of a favourable opinion, the Commission shall always explore the possibility of adopting, common technical standards for the device of group of devices concerned and adopt them where possible (in accordance with Article 7).
In the case of an unfavourable MDCG opinion, the special notified body shall not yet deliver the certificate of conformity. Nevertheless, the special notified body may submit new information in response to the explanation included in the MDCG assessment. If the new information is substantially different to that which has been previously submitted the MDCG shall reassess the application.
At the request of the manufacturer, the Commission shall organise a hearing allowing discussion on the scientific grounds for the unfavourable scientific assessment and any action that the manufacturer may take or data that may be submitted to address the MDCG concerns.
9. Where deemed necessary for the protection of patient safety and public health, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 to determine, specific categories or groups of devices, other than devices referred to in paragraph 1, to which paragraphs 1 to 8 shall apply during a predefined period of time.
Measures pursuant to this paragraph may be justified only by one or more of the criteria referred to in paragraph 2.
10. The Commission shall make a summary of the opinion referred to in paragraph 6 and 7 accessible to the public. It shall not disclose any personal data or information of commercially confidential nature.
11. The Commission shall set up the technical infrastructure for the data-exchange by electronic means between the MDCG, the special notified bodies and the ACMD, and between the ACMD and itself for the purposes of this Article.
12. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the documentation provided in accordance with this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
13. The company concerned shall not be charged for the additional cost due to this assessment. [Am. 374/rev]
Article 44b
Five years after the entry into force of this Regulation, the Commission shall publish a report on the experience acquired as a result of the operation of the procedure referred to in Article 44a. The report shall assess in particular how many products were subject to an additional assessment, what factors triggered the assessment and what was the final decision on the products. It shall also analyse the effects of the full impact of the new rules on special notified bodies vis-à-vis the additional assessments. [Am. 369]
Article 45
Certificates
1. Before issuing a certificate, the notified conformity assessment body shall take into account any findings set out in the clinical investigation report referred to in Article 59(4). The certificates issued by the notified bodies in accordance with Annexes VIII, IX and X shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates is set out in Annex XII. [Am. 167]
2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.
3. Where a notified body finds that requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision and shall notify them to the competent authorities of the Member States in which the medical device is manufactured and placed on the market, the Commission and the MDCG. [Am. 168]
4. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information on certificates issued by notified bodies. The notified body shall enter into this electronic system information regarding certificates issued, including amendments and supplements, and regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates. This information shall be accessible to the public.
5. In the light of technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the minimum content of the certificates set out in Annex XII.
Article 46
Voluntary change of notified body
1. In cases where a manufacturer terminates his contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the modalities of the change of notified body shall be clearly defined in an agreement between the manufacturer, the outgoing notified body and the incoming notified body. This agreement shall address at least the following aspects:
|
(a) |
the date of invalidity of certificates issued by the outgoing notified body; |
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(b) |
the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material; |
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(c) |
the transfer of documents, including confidentiality aspects and property rights; |
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(d) |
the date as of which the incoming notified body assumes full responsibility for the conformity assessment tasks. |
2. On their date of invalidity, the outgoing notified body shall withdraw the certificates it has issued for the device concerned.
2a. It shall notify the competent authorities of the Member States affected by the manufacture and placing on the market of the relevant medical device, the Commission and the MDCG. [Am. 169]
Article 47
Derogation from the conformity assessment procedures
1. By way of derogation from Article 42, any competent authority may authorise, on duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the procedures referred to in Article 42 have not been carried out and use of which is in the interest of public health or patient safety, provided that the MDCG has authorised it. This derogation shall be possible only if the manufacturer submits the requisite clinical data to the competent authority within the prescribed period. [Am. 170]
2. The Member State shall inform the Commission, the notified body responsible for assessing the relevant medical device, the MDCG and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient. [Am. 171]
3. Upon request by a Member State and where this is in the interest of public health or patient safety in more than one Member State, the Commission may, by means of implementing acts, extend for a determined period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 88(4).
Article 48
Certificate of free sale
1. For the purpose of export and upon request by a manufacturer, the Member State in which the manufacturer has its registered place of business shall issue a certificate of free sale declaring that the manufacturer is properly established and that the device in question bearing the CE-marking in accordance with this Regulation may be legally marketed in the Union. The certificate of free sale shall be valid for the period indicated on it which shall not exceed five years and shall not exceed the validity of the certificate referred to in Article 45 issued for the device in question.
2. The Commission may, by means of implementing acts, establish a model for certificates of free sale taking into account international practice as regards the use of certificates of free sale. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(2).
Chapter IV [Am. 259]
Notified bodies
SECTION 1 — NOTIFIED BODIES
Article 28
National authorities responsible for notified bodies
1. A Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out third-party conformity assessment tasks under this Regulation shall designate an authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, including subcontractors or subsidiaries of those bodies, hereinafter referred to as the ‘national authority responsible for notified bodies’.
2. The national authority responsible for notified bodies shall be established, organised and operated so as to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with conformity assessment bodies.
3. It shall be organised so that each decision relating to notification of a conformity assessment body is taken by personnel different from those who carried out the assessment of the conformity assessment body.
4. It shall not perform any activities that conformity assessment bodies perform nor provide consultancy services on a commercial or competitive basis.
5. The national authority responsible for notified bodies shall safeguard the confidentiality confidential aspects of the information it obtains. However, it shall exchange information on a notified body with other Member States and the Commission.
6. The national authority responsible for notified bodies shall have a sufficient number of permanent and competent personnel at its disposal ‘in house’ for the proper performance of its tasks. Compliance with that requirement shall be assessed in the peer-review referred to in paragraph 8.
In particular, the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out product related reviews shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3.2.5. of Annex VI.
Similarly, the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out audits of the manufacturer's quality management system shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3.2.6. of Annex VI.
Without prejudice to Article 33(3), Where a national authority is responsible for the designation of notified bodies in the field of products other than medical devices, the competent authority for medical devices shall be consulted on all aspects specifically related to medical devices.
7. The ultimate responsibility for the notified bodies and the national authority responsible for notified bodies lies with the Member State in which they are located. The Member State is required to check that the designated national authority responsible for notified bodies performs its work on the assessment, designation and notification of conformity assessment bodies and for the monitoring of the notified bodies properly and that the designated national authority responsible for notified bodies works impartially and objectively. Member States shall provide the Commission and the other Member States with all information they request on their procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and of any changes thereto. Such information shall be publicly available subject to provisions under Article 84.
8. The national authority responsible for notified bodies shall be peer-reviewed every second year. The peer-review shall include an on-site visit to a conformity assessment body or a notified body under the responsibility of the reviewed authority. In the case referred to in the second subparagraph of paragraph 6, the competent authority for medical devices shall participate in the peer-review.
The Member States shall draw up the annual plan for the peer-review, ensuring an appropriate rotation in respect of reviewing and reviewed authorities, and submit it to the Commission. The Commission may shall participate in the review. The outcome of the peer-review shall be communicated to all Member States and to the Commission and a summary of the outcome shall be made publicly available. [Am. 132]
Article 29
Requirements relating to notified bodies
1. Notified bodies shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this Regulation. In this respect, permanent in-house administrative, technical and scientific personnel, with medical, technical and where needed pharmacological knowledge shall be ensured. Permanent in-house personnel shall be used, but notified bodies may hire external experts on an ad hoc and temporary basis as and when needed. Minimum requirements to be met by notified bodies are set out in Annex VI. In particular, in accordance with point 1.2. of Annex VI, the notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities and avoid conflict of interests.
The notified body shall publish a list of its staff responsible for the conformity assessment and certification of medical devices. This list shall at least contain the qualifications, curriculum vitae and declaration of interests for each member of staff. The list shall be sent to the national authority responsible for notified bodies which shall check that the staff satisfy the requirements of this Regulation. The list shall also be sent to the Commission. [Am. 133]
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the minimum requirements in Annex VI, in the light of technical progress and considering the minimum requirements needed for the assessment of specific devices, or categories or groups of devices.
Article 30
Subsidiaries and subcontracting
-1. Notified bodies shall have permanent in-house competent personnel and expertise, both in technical fields linked with the assessment of the performance of the devices, and in the medical field. They shall have the capacity to evaluate in-house the quality of subcontractors.
Contracts may be awarded to external experts for the assessment of medical devices or technologies in particular where clinical expertise is limited.
1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the relevant requirements set out in Annex VI and shall inform the national authority responsible for notified bodies accordingly.
2. Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries.
2a. Notified bodies shall make publicly available the list of subcontractors or subsidiaries, the specific tasks for which they are responsible and the declarations of interest of their personnel.
3. Conformity assessment activities may be subcontracted or carried out by a subsidiary only with the explicit agreement of the legal or natural person that applied for conformity assessment.
4. At least once a year, notified bodies shall keep at the disposal of submit to the national authority responsible for notified bodies the relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.
4a. The annual assessment of notified bodies as provided for in Article 35(3) shall include verification of the compliance of the subcontractor(s) or the subsidiary/ies of notified bodies with the requirements set out in Annex VI. [Am. 134]
Article 30a
Electronic system on registration of subsidiaries and subcontractors
1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information on subcontractors and subsidiaries, as well as on the specific tasks for which they are responsible.
2. Before subcontracting can effectively take place, the notified body which intends to subcontract specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, shall register their name(s) together with their specific tasks.
3. Within one week of any change occurring in relation to the information referred to in paragraph 1, the relevant economic operator shall update the data in the electronic system.
4. The data contained in the electronic system shall be accessible to the public. [Am. 135]
Article 31
Application by a conformity assessment body for notification
1. A conformity assessment body shall submit an application for notification to the national authority responsible for notified bodies of the Member State in which it is established.
In case a conformity assessment body wants to be notified for devices referred to in Article 43a(1), it shall indicate so and submit an application for notification to the EMA in accordance with Article 43a. [Am. 136]
2. The application shall specify the conformity assessment activities, the conformity assessment procedures and the devices for which the body claims to be competent, supported by documentation proving compliance with all the requirements set out in Annex VI.
In respect of the organisational and general requirements and the quality management requirements set out in Sections 1 and 2 of Annex VI, the relevant documentation may be submitted in form of a valid certificate and the corresponding evaluation report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008. The conformity assessment body shall be presumed to be in conformity with the requirements covered by the certificate delivered by such accreditation body.
3. After being designated, the notified body shall update the documentation referred to in paragraph 2 whenever relevant changes occur in order to enable the national authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements set out in Annex VI.
Article 32
Assessment of the application
1. The national authority responsible for notified bodies shall check that the application referred to in Article 31 is complete and draw up a preliminary assessment report.
2. It shall submit the preliminary assessment report to the Commission which shall immediately transmit it to the Medical Device Coordination Group established by Article 78 (‘MDCG’). Upon request by the Commission, the report shall be submitted by the authority in up to three official Union languages.
3. Within 14 days of the submission referred to in paragraph 2, the Commission shall designate a joint assessment team made up of at least two three experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies and free of conflicts of interest with the applicant conformity assessment body. The list shall be drawn up by the Commission in cooperation with the MDCG. At least one of these experts shall be a representative of the Commission who, and at least one other shall come from a Member State other than the one in which the applicant conformity assessment body is established. The Commission representative shall lead the joint assessment team. In case the conformity assessment body has asked to be notified for devices referred to in Article 43a(1), the EMA shall also be part of the joint assessment team.
4. Within 90 days after designation of the joint assessment team, the national authority responsible for notified bodies and the joint assessment team shall review the documentation submitted with the application in accordance with Article 31 and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or sub-contractor, located inside or outside the Union, to be involved in the conformity assessment process. Such on-site assessment shall not cover requirements for which the applicant conformity assessment body has received a certificate delivered by the national accreditation body as referred to in Article 31(2), unless the Commission representative mentioned in Article 32(3) requests the on-site assessment.
Findings regarding non-compliance of a an applicant conformity assessment body with the requirements set out in Annex VI shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team with a view to finding common agreement with respect to the assessment of the application. Divergent opinions shall be identified in The national authority shall set out in the assessment report the measures that the notified body shall take to ensure compliance of that applicant conformity assessment body with the requirements set out in Annex VI. In the event of a disagreement, a separate opinion drawn up by the assessment team setting out its reservations regarding notification shall be appended to the assessment report of the national authority responsible.
5. The national authority responsible for notified bodies shall submit its assessment report and its draft notification to the Commission which shall immediately transmit those documents to the MDCG and to the members of the joint assessment team. If the assessment team draws up a separate opinion, this too shall be submitted to the Commission for forwarding to the MDCG. Upon request by the Commission, those documents shall be submitted by the authority in up to three official Union languages.
6. The joint assessment team shall provide its final opinion regarding the assessment report and, the draft notification and, where appropriate, the separate opinion drawn up by the assessment team, within 21 days of receipt of those documents and the Commission shall immediately submit this opinion to the MDCG. Within 21 days after receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft notification which the The relevant national authority shall duly take into consideration for base its decision on the designation of the notified body on the recommendation by the MDCG. In case where its decision differs from the MDCG recommendation, the relevant national authority shall provide the MDCG in writing with all the necessary justification for its decision. [Am. 137]
7. The Commission may, by means of implementing acts, adopt measures setting out the modalities for the application for notification referred to in Article 31 and the assessment of the application set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Article 33
Notification procedure
1. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they have designated, using the electronic notification tool developed and managed by the Commission.
2. Member States may shall notify only conformity assessment bodies which satisfy the requirements set out in Annex VI and for which the application assessment procedure has been completed in accordance with Article 32.
3. Where a national authority responsible for notified bodies is responsible for designation of notified bodies in the field of products other than medical devices, the competent authority for medical devices shall provide, prior to the notification, a positive opinion on the notification and its scope.
4. The notification shall clearly specify the scope of the designation indicating the conformity assessment activities, the conformity assessment procedures, the risk class and the type of devices which the notified body is authorised to assess.
The Commission may, by means of implementing acts, set up a list of codes and the corresponding risk-classes and types of devices to define the scope of the designation of notified bodies which the Member States shall indicate in their notification. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(2).
5. The notification shall be accompanied by the final assessment report of the national authority responsible for notified bodies, the opinion of the joint assessment team and the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it shall provide a duly substantiated justification.
6. The notifying Member State shall provide the Commission and the other Member States with documentary evidence regarding the arrangements in place to ensure that the notified body will be monitored regularly and will continue to satisfy the requirements set out in Annex VI. It shall furthermore submit evidence of the availability of competent personnel for monitoring the notified body in accordance with Article 28(6).
7. Within 28 days of a notification, a Member State or the Commission may raise written objections, setting out its arguments, with regard either to the notified body or to its monitoring by the national authority responsible for notified bodies.
8. When a Member State or the Commission raises objections in accordance with paragraph 7, the effect of the notification shall be immediately suspended. In this case, the Commission shall bring the matter before the MDCG within 15 days after expiry of the period referred to in paragraph 7. After consulting the parties involved, the MDCG shall give its opinion at the latest within 28 days after the matter has been brought before it. If the notifying Member State does not agree with the opinion of the MDCG, it may request the Commission to give its opinion.
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially, the Commission shall publish the notification accordingly.
The Commission shall also enter information on the notification of the notified body into the electronic system referred to in Article 27(2). That information shall be accompanied by the final assessment report of the national authority responsible for notified bodies, the opinion of the joint assessment team and the recommendation of the MDCG, as referred to in this Article.
The full details of the notification, including the class and the typology of devices, as well as the annexes, shall be made publicly available. [Am. 138]
10. The notification shall become valid the day after its publication in the database of notified bodies developed and managed by the Commission. The published notification shall determine the scope of lawful activity of the notified body.
Article 34
Identification number and list of notified bodies
1. The Commission shall assign an identification number to each notified body for which the notification is accepted in accordance with Article 33. It shall assign a single identification number even when the body is notified under several Union acts. If they are successfully renotified, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain the identification number assigned to them. [Am. 139]
2. The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified, easily accessible to the public. The Commission shall ensure that the list is kept up to date. [Am. 140]
Article 35
Monitoring of notified bodies
1. The national authority responsible for notified bodies, and where applicable the EMA, shall continuously monitor the notified bodies to ensure ongoing compliance with the requirements set out in Annex VI. The notified bodies shall, on request, supply all relevant information and documents, required to enable the authority to verify compliance with those criteria.
Notified bodies shall, without delay, and within 15 days at the latest, inform the national authority responsible for notified bodies of any changes, in particular regarding their personnel, facilities, subsidiaries or subcontractors, which may affect compliance with the requirements set out in Annex VI or their ability to conduct the conformity assessment procedures relating to the devices for which they have been designated.
2. Notified bodies shall respond without delay, and within 15 days at the latest, to requests relating to conformity assessments they have carried out, submitted by their or another Member State's authority or by the Commission. The national authority responsible for notified bodies of the Member State in which the body is established shall enforce requests submitted by authorities of any other Member State or by the Commission unless. Where there is a legitimate reason for not doing so in which case both sides may, the notified bodies shall explain these reasons in writing and shall consult the MDCG. The notified body or their national authority responsible for notified bodies may request that any information transmitted to the authorities of another Member State or to the Commission shall be treated confidential, which shall then issue a recommendation. The national authority responsible for notified bodies shall comply with the MDCG's recommendation.
3. At least once a year, the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in Annex VI, including an assessment of whether its subcontractor(s) and subsidiary/-ies satisfy these requirements. This assessment shall include an unannounced inspection through an on-site visit to each notified body, and to each subsidiary or subcontractor within or outside the Union, if relevant.
The assessment shall also include a review of samples of the design dossier assessments carried out by the notified body to determine the ongoing competence of the notified body and quality of its assessments, in particular the notified body's ability to evaluate and assess clinical evidence.
4. Three Two years after notification of a notified body, and again every third second year thereafter, the assessment to determine whether the notified body and its subsidiaries and subcontractors still satisfies satisfy the requirements set out in Annex VI shall be conducted by the national authority responsible for notified bodies of the Member State in which the body is established and a joint assessment team designated in accordance with the procedure described in Article 32(3) and (4). At the request of the Commission or of a Member State, the MDCG may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body, or a subsidiary or subcontractor of a notified body, with the requirements set out in Annex VI.
For special notified bodies under Article 43a, the assessment referred to in this paragraph shall be performed every year.
The comprehensive results of the assessments shall be published.
5. The Member States shall report to the Commission and to the other Member States, at least once a year, on their monitoring activities. This report shall contain a summary which shall be made publicly available.
5a. Every year, the notified bodies shall forward an annual activity report setting out the information referred to in point 3.5 of Annex VI to the competent authority and to the Commission, which shall forward it to the MDCG. [Am. 141]
Article 35a
Penalties
Member States shall ensure they have a system of penalties in place in case notified bodies do not fulfil the minimum requirements. This system should be transparent and proportionate to the nature and level of the non-compliance. [Am. 142]
Article 36
Changes to notifications
1. The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification. The procedures described in Article 32(2) to (6) and in Article 33 shall apply to changes where they entail an extension of the scope of the notification. In all other cases, the Commission shall immediately publish the amended notification in the electronic notification tool referred to in Article 33(10).
2. Where a national authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VI, or that it is failing to fulfil its obligations, the authority shall suspend, restrict, or fully or partially withdraw the notification, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A Suspension shall not exceed a period of one year, renewable once for the same period apply until a decision to annul the suspension has been reached by the MDCG, which shall follow an assessment by a joint assessment team designated in accordance with the procedure described in Article 32(3). Where the notified body has ceased its activity, the national authority responsible for notified bodies shall withdraw the notification.
The national authority responsible for notified bodies shall immediately and within 10 days at the latest, inform the Commission and, the other Member States and the relevant manufacturers and health professionals of any suspension, restriction or withdrawal of a notification.
3. In the event of restriction, suspension or withdrawal of a notification, the Member State shall inform the Commission and shall take appropriate steps to ensure that the files of the notified body concerned are either processed by another notified body or kept available for the national authorities responsible for notified bodies and for market surveillance at their request.
4. The national authority responsible for notified bodies shall assess whether the reasons which gave rise to the change to suspension, restriction or withdrawal of the notification have an impact on the certificates issued by the notified body and, within three months after having notified the changes to the notification, shall submit a report on its findings to the Commission and the other Member States. Where necessary to ensure the safety of devices on the market, that authority shall instruct the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, and at the latest 30 days after the publication of the report, any certificates which were unduly issued. If the notified body fails to do so within the determined period of time, or has ceased its activity, the national authority responsible for notified bodies itself shall suspend or withdraw the certificates unduly issued.
With a view to verifying whether the reasons for the suspension, restriction or withdrawal of the notification have implications for the certificates issued, the national authority responsible shall ask the relevant manufacturers to supply evidence of conformity at notification, and the manufacturers shall have 30 days in which to respond to that request.
5. The certificates, other than those unduly issued, which were issued by the notified body for which the notification has been suspended, restricted or withdrawn shall remain valid in the following circumstances:
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(a) |
in the case of suspension of a notification: on condition that, within three months of the suspension, either the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate is established, or another notified body confirm in writing that it is assuming the functions of the notified body during the period of suspension; |
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(b) |
in the case of restriction or withdrawal of a notification: for a period of three months after the restriction or withdrawal. The competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate is established may extend the validity of the certificates for further periods of three months, which altogether may not exceed twelve months, provided it is assuming the functions of the notified body during this period. |
The authority or the notified body assuming the functions of the notified body affected by the change of notification shall immediately and within 10 days at the latest, inform the Commission, the other Member States and the other notified bodies thereof.
The Commission shall immediately and within 10 days at the latest enter information on the changes to the notification of the notified body into the electronic system referred to in Article 27(2). [Am. 143]
Article 37
Challenge to the competence of notified bodies
1. The Commission shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body of the requirements set out in Annex VI or the obligations to which it is subject. It may also commence such investigations on its own initiative.
2. The notifying Member State shall provide the Commission, on request, with all information regarding the notification of the notified body concerned.
3. Where the Commission ascertains that a notified body no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the notification if necessary. The Commission shall make a report with the opinions of Member States publicly available after the assessment. [Am. 144]
Where the Member State fails to take the necessary corrective measures, the Commission may, by means of implementing acts, suspend, restrict or withdraw the notification. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). It shall notify the Member State concerned of its decision and update the database and list of notified bodies.
Article 38
Exchange of experience between national authorities responsible for notified bodies
The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the national authorities responsible for notified bodies under this Regulation.
Article 39
Coordination of notified bodies
The Commission, in consultation with the MDCG, shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices. This group shall meet on a regular basis and at least twice a year. [Am. 145]
The bodies notified under this Regulation shall participate in the work of that group.
The Commission or the MDCG may request the participation of any notified body. [Am. 146]
The Commission may, by means of implementing acts, adopt measures setting out the modalities for the functioning of the coordination group of notified bodies as set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3). [Am. 147]
Article 40
Fees for the activities of national authorities
1. The Member State where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies. These fees shall, wholly or partly, cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this Regulation.
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 setting out the structure and the level of the fees referred to in paragraph 1, taking into account the objectives of protection of human health and safety, support of innovation and, cost-effectiveness and the need to create a level-playing field across Member States. Particular attention shall be paid to the interests of notified bodies that submitted a valid certificate delivered by the national accreditation body as referred to in Article 31(2) and notified bodies that are small and medium-sized enterprises as defined by Commission Recommendation 2003/361/EC (41).
These fees shall be proportionate and consistent with national standards of living. The level of fees shall be made public. [Am. 148]
Article 40a
Transparency on fees charged by notified bodies for conformity assessment activities
1. Member States shall adopt provisions on standard fees for notified bodies.
2. Fees shall be comparable across Member States. The Commission shall provide guidelines to facilitate comparability of those fees within 24 months from the date of entry into force of this Regulation.
3. Member States shall transmit their list of standard fees to the Commission.
4. The national authority shall ensure that the notified bodies make the lists of standard fees for the conformity assessment activities publicly available. [Am. 149]
SECTION 2 — CONFORMITY ASSESSMENT
Article 43
Involvement of notified bodies in conformity assessment procedures
1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer of devices other than those listed in Article 43a(1) may apply to a notified body of his choice, provided that the body is notified for the conformity assessment activities, the conformity assessment procedures and the devices concerned. Where a manufacturer applies to a notified body located in a Member State other than the one where it is registered, the manufacturer shall inform its national authority responsible for the notified bodies of the application. An application may not be lodged in parallel with more than one notified body for the same conformity assessment activity. [Am. 159]
2. The notified body concerned shall inform the other notified bodies of any manufacturer who withdraws his application prior to the notified body's decision regarding the conformity assessment. It shall also inform all of the competent national bodies without delay. [Am. 160]
3. The notified body may require any information or data from the manufacturer which is necessary in order to properly conduct the chosen conformity assessment procedure.
4. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities.
SECTION 2A — ADDITIONAL PROVISIONS FOR THE CONFORMITY ASSESSMENT OF HIGH-RISK DEVICES: INVOLVEMENT OF SPECIAL NOTIFIED BODIES [AM. 161]
Article 43a
Involvement of the special notified bodies in the conformity assessment procedures of high-risk devices
1. Only special notified bodies shall be entitled to conduct conformity assessments for the following devices:
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(a) |
implantable devices; |
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(b) |
devices incorporating a substance, as referred to in Article 1(4) and point 6.1. of Annex VII (Rule 13); |
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(c) |
Class IIb devices intended to administer and/or remove a medicinal product, as referred to in Article 1(5) and point 5.3. of Annex VII (Rule 11); |
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(d) |
devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or are rendered non-viable; or |
|
(e) |
all other class III devices. |
2. Applicant special notified bodies which consider they fulfil the requirements for special notified bodies referred to in Annex VI, point 3.6, shall submit their application to the EMA.
3. The application shall be accompanied by the fee payable to the EMA to cover the costs relating to the examination of the application.
4. The EMA shall designate the special notified body or bodies in accordance with requirements listed in Annex VI, and adopt its opinion on the authorisation to perform conformity assessments for devices listed in paragraph 1 within 90 days and send it to the Commission.
5. The Commission shall then publish the notification accordingly and the name of the special notified body or bodies.
6. This notification shall become valid the day after its publication in the database of notified bodies developed and managed by the Commission. The published notification shall determine the scope of lawful activity of the special notified body.
This notification shall be valid for five years and subject to renewal every five years, following a new application to the EMA.
7. The manufacturer of devices listed in paragraph 1 may apply to a special notified body of his choice, whose name appears in the electronic system of Article 43b.
8. An application may not be lodged in parallel with more than one special notified body for the same conformity assessment activity.
9. The special notified body shall notify the Commission of applications for conformity assessments for devices listed in paragraph 1.
10. Article 43 (2), (3) and (4) apply to special notified bodies. [Ams. 360 and 371]
Article 43b
Electronic system on special notified bodies
1. The Commission shall establish and regularly update an electronic registration system for:
|
— |
the registration of applications and granted authorisations to perform conformity assessments as special notified bodies under this Section and to collate and process information on the name of the special notified bodies; |
|
— |
the exchange of information with national authorities; and |
|
— |
the publication of assessment reports. |
2. The information collated and processed in the electronic system which relates to the application process for special notified bodies shall be entered into the electronic registration system by the EMA.
3. The information collated and processed in the electronic system and which relates to special notified bodies shall be accessible to the public.
4. The Commission shall regularly update the system. [Am. 372]
Article 43c
Network of special notified bodies
1. The Commission and the MDCG shall establish, host, coordinate and manage the network of special notified bodies.
2. The network shall have the following objectives:
|
(a) |
to help realise the potential of European cooperation regarding highly specialised medical technologies in the area of medical devices; |
|
(b) |
to contribute to the pooling of knowledge regarding medical devices; |
|
(c) |
to encourage the development of conformity assessment benchmarks and to help develop and spread best practice within and outside the network; |
|
(d) |
to help identify the experts in innovative fields; |
|
(e) |
to develop and update rules on conflicts of interest; |
|
(f) |
to find common answers to similar challenges concerning the conduct of conformity assessment procedures in innovative technologies; and |
|
(g) |
to identify and notify significant discrepancies in the conformity assessments carried out by different Special notified bodies on substantially similar devices and to communicate these to the MDCG. |
3. Meetings of the network shall be convened whenever requested by at least two of its members or by the EMA. It shall meet at least twice a year. [Ams. 361 and 373]
Chapter VIV [Am. 262]
Clinical evaluation and clinical investigations
Article 49
Clinical evaluation
1. Manufacturers shall conduct a clinical evaluation in accordance with the principles set out in this Article and Part A of Annex XIII.
2. A clinical evaluation shall follow a defined and methodologically sound procedure based on either of the following:
|
(a) |
a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where the following conditions are satisfied:
|
|
(b) |
a critical evaluation of the results of all clinical investigations performed in accordance with Articles 50 to 60 and Annex XIV; |
|
(c) |
a critical evaluation of the combined clinical data referred to in points (a) and (b). |
3. Except for class III devices, where demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer’s risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performances intended and the claims of the manufacturer. The adequacy of demonstration of conformity with the general safety and performance requirements based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, has to be duly substantiated in the technical documentation referred to in Annex II.
Exemption from demonstration of conformity with general safety and performance requirements based on clinical data under the first subparagraph shall be subject to prior approval by the competent authority. [Am. 172]
4. The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer's post-market surveillance plan referred to in Article 8(6).
5. The clinical evaluation and its outcome shall be documented in a clinical evaluation report referred to in Section 6 of Part A of Annex XIII which shall be included or fully referenced in the technical documentation referred to in Annex II relating to the device concerned.
For devices classified as class III and implantable devices, the summary of safety and clinical performance referred to in Article 26(1) shall be updated at least annually with clinical evaluation reports. [Am. 173]
Article 50
General requirements regarding clinical investigations
1. Clinical investigations shall be subject to Articles 50-60 and Annex XIV if they are conducted for one or more of the following purposes:
|
(a) |
to verify that, under normal conditions of use, devices are designed, manufactured and packaged in such a way that they are suitable for one or more of the specific purposes of a medical device referred to in number (1) of Article 2(1), and achieve the performances intended as specified by the manufacturer or sponsor; [Am. 174] |
|
(b) |
to verify that devices achieve the intended benefits to the patient as specified by the manufacturer the clinical safety and efficacy of the device, including the intended benefits to the patient, when used for the intended purpose, in the target population and in accordance with the instructions of use; [Am. 175] |
|
(c) |
to determine any undesirable side-effects, under normal conditions of use, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device. |
2. Where the sponsor is not established in the Union, he shall ensure that a contact person is established in the Union. That contact person shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication to that contact person shall be considered as communication to the sponsor.
3. Clinical investigations shall be designed and conducted in a way that the rights, safety and well-being of the subjects participating in a clinical investigation are protected and that the clinical data generated in the clinical investigation are going to be reliable and robust.
4. Clinical investigations shall be designed, conducted, recorded and reported in accordance with the provisions of Articles 50 to 60 and of Annex XIV.
Article 51
Application for clinical investigations
1. Before making the first application, the sponsor shall procure from the electronic system referred to in Article 53 a single identification number for a clinical investigation conducted in one site or multiple sites, in one or more than one Member State. The sponsor shall use this single identification number when registering the clinical investigation in accordance with Article 52.
2. The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the investigation is to be conducted accompanied by the documentation referred to in Chapter II of Annex XIV. Within six 14 days after receipt of the application, the Member State concerned shall notify the sponsor whether the clinical investigation falls within the scope of this Regulation and whether the application is complete.
Where there is more than one Member State concerned, and where a Member State disagrees with the coordinating Member State on whether the clinical investigation should be approved, on grounds other than intrinsically national, local or ethical concerns, the Member States concerned shall make an attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision after having consulted the Member States concerned, and if appropriate, having taken advice from the MDCG. In cases where the concerned Member States object to the clinical investigation for intrinsically national, local or ethical concerns the clinical investigation should not take place in the Member States concerned.
Where the Member State has not notified the sponsor within the time period referred to in the first subparagraph, the clinical investigation shall be considered as falling within the scope of this Regulation and the application shall be considered complete. [Am. 177]
3. Where the Member State finds that the clinical investigation applied for does not fall within the scope of this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a maximum of six days for the sponsor to comment or to complete the application.
Where the sponsor has not provided comments nor completed the application within the time-period referred to in the first subparagraph, the application shall be considered as withdrawn.
Where the Member State has not notified the sponsor according to paragraph 2 within three six days following receipt of the comments or of the completed application, the clinical investigation shall be considered as falling within the scope of this Regulation and the application shall be considered complete. [Am. 178]
4. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 2 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the time periods referred to in paragraphs 2 and 3.
5. The sponsor may start the clinical investigation in the following circumstances:
|
(a) |
in the case of investigational devices classified as class III and implantable or long-term invasive devices classified as class IIa or IIb, as soon as the Member State concerned has notified the sponsor of its approval; |
|
(b) |
in the case of investigational devices other than those referred to in point (a) immediately after the date of application provided that the Member State concerned has so decided and that evidence is provided that the rights, safety and well-being of the subjects to the clinical investigation are protected; |
|
(c) |
after the expiry of 35 60 days after the validation date referred to in paragraph 4, unless the Member State concerned has notified the sponsor within that period of its refusal based on considerations of public health, patient safety or public policy. [Am. 179] |
6. Member States shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor, the institution of the investigation site(s) and the investigators involved, as well as free of any other undue influence.
Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patient patients shall be taken into account.
The list of the reviewers should be made available to the sponsor. [Am. 180]
6a. Every step in the clinical investigation, from first consideration of the need and justification for the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, such as those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects adopted by the 18th World Medical Assembly in Helsinki in 1964 and last amended by the 59th World Medical Association General Assembly in Seoul in 2008.
6b. Authorisation by the concerned Member State for conducting a clinical investigation under this Article shall be granted only after examination and approval by an independent ethics committee in accordance with the World Medical Association's Declaration of Helsinki.
6c. The examination of the ethics committee shall cover in particular the medical justification for the clinical investigation, the consent of the test subjects participating in the clinical investigation following the provision of full information about the clinical investigation and the suitability of the investigators and investigation facilities.
The ethics committee shall act in accordance with the respective laws and regulations of the country or countries in which the investigation is to be conducted and must abide by all relevant international norms and standards. It shall also work with such efficiency as to enable the Member State concerned to comply with the procedural deadlines set out in this Chapter.
The ethics committee shall be made up of an appropriate number of members, who together are in possession of the relevant qualifications and experience in order to be able to assess the scientific, medical and ethical aspects of the clinical investigation under scrutiny.
The members of the ethics committee assessing the application for a clinical investigation shall be independent from the sponsor, the institution of the investigation site, and the investigators involved, as well as free of any other undue influence. Names, qualifications, and declaration of interest of the assessors of the application shall be made publicly available.
6d. Member States shall take the necessary measures to establish ethics committees in the field of clinical investigations where such committees do not exist, and to facilitate their work.
6e. The Commission shall facilitate cooperation of ethics committees and the sharing of best practices on ethical issues including the procedures and principles of ethical assessment.
The Commission shall develop guidelines on patient involvement in ethics committees, drawing upon existing good practices. [Am. 181]
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing, in the light of technical progress and global regulatory developments, the requirements for the documentation to be submitted with the application for the clinical investigation that is laid down in Chapter II of Annex XIV.
Article 52
Registration of clinical investigations
1. Before commencing the clinical investigation, the sponsor shall enter in the electronic system referred to in Article 53 the following information regarding the clinical investigation:
|
(a) |
the single identification number of the clinical investigation; |
|
(b) |
the name and contact details of the sponsor and, if applicable, his contact person established in the Union; |
|
(c) |
the name and contact details of the natural or legal person responsible for the manufacture of the investigational device, if different from the sponsor; |
|
(d) |
the description of the investigational device; |
|
(e) |
the description of the comparator(s), if applicable; |
|
(f) |
the purpose of the clinical investigation; |
|
(g) |
the status of the clinical investigation; |
|
(ga) |
the methodology to be used, the number of subjects involved and the intended result of the study. [Am. 182] |
2. Within one week of any change occurring in relation to the information referred to in paragraph 1, the sponsor shall update the relevant data in the electronic system referred to in Article 53.
2a. Upon completion of the clinical investigation, the sponsor shall enter in the electronic system referred to in Article 53a summary of its results drawn up in a way that is easy for a lay person to understand. [Am. 183]
3. The information shall be accessible to the public, through the electronic system referred to in Article 53, unless, for all or parts of that information, confidentiality of the information is justified on any of the following grounds:
|
(a) |
protection of personal data in accordance with Regulation (EC) No 45/2001; |
|
(b) |
protection of commercially sensitive information; data on adverse events and safety data shall not be considered commercially sensitive information; [Am. 184] |
|
(c) |
effective supervision of the conduct of the clinical investigation by the Member State(s) concerned. |
4. No personal data of subjects participating in clinical investigations shall be publicly available.
Article 53
Electronic system on clinical investigations
1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to create the single identification numbers for clinical investigations referred to in Article 51(1) and to collate and process the following information:
|
(a) |
the registration of clinical investigations in accordance with Article 52; |
|
(b) |
the exchange of information between the Member States and between them and the Commission in accordance with Article 56; |
|
(c) |
the information related to clinical investigations conducted in more than one Member State in case of a single application in accordance with Article 58; |
|
(d) |
reports on serious adverse events and device deficiencies referred to in Article 59(2) in case of a single application in accordance with Article 58; |
|
(da) |
the clinical investigation report and summary submitted by the sponsor in accordance with Article 57(3). |
2. When setting up the electronic system referred in paragraph 1, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article […] of Regulation (EU) No [Ref. of future Regulation on clinical trials]. With the exception of the information referred to in Article 52 and in points (d) and (da) of paragraph 1, the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission. The Commission shall also ensure that healthcare professionals have access to the electronic system.
The information referred to in points (d) and (da) of paragraph 1 shall be accessible to the public in accordance with Article 52(3) and (4).
2a. Upon a reasoned request, all information on a specific medical device available in the electronic system shall be made accessible to the party requesting it, save where the confidentiality of all or parts of the information is justified in accordance with Article 52(3). [Am. 185]
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 determining which other information regarding clinical investigations collated and processed in the electronic system shall be publicly accessible to allow interoperability with the EU database for clinical trials on medicinal products for human use set up by Regulation (EU) No […/…]. Article 52(3) and (4) shall apply.
Article 54
Clinical investigations with devices authorised to bear the CE marking
1. Where a clinical investigation is to be conducted to further assess a device which is authorised in accordance with Article 42 to bear the CE marking and within its intended purpose referred to in the relevant conformity assessment procedure, hereinafter referred to as ‘post-market clinical follow-up investigation’, the sponsor shall notify the Member States concerned at least 30 days prior to their commencement if the investigation would submit subjects to additionally invasive or burdensome procedures. Article 50(1) to (3), Article 52, Article 55, Article 56(1), Article 57(1), the first subparagraph of Article 57(2) and the relevant provisions of Annex XIV shall apply.
2. If the aim of the clinical investigation regarding a device which is authorised in accordance with Article 42 to bear the CE marking is to assess such device for a purpose other than that referred to in the information supplied by the manufacturer in accordance with Section 19 of Annex I and in the relevant conformity assessment procedure, Articles 50 to 60 shall apply.
Article 55
Substantial modifications to a clinical investigation
1. If the sponsor introduces modifications to a clinical investigation that are likely to have a substantial impact on the safety or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, he shall notify the Member State(s) concerned of the reasons for and the content of those modifications. The notification shall be accompanied by an updated version of the relevant documentation referred to in Chapter II of Annex XIV.
2. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 30 days after notification, unless the Member State concerned has notified the sponsor of its refusal based on considerations of public health, patient safety or public policy.
2a. Assessment by the Member State of the request by the sponsor for a substantial modification to a clinical investigation shall be in accordance with Article 51(6). [Am. 186]
Article 56
Information exchange between Member States
1. Where a Member State has refused, suspended or terminated a clinical investigation, or has called for a substantial modification or temporary halt of a clinical investigation, or has been notified by the sponsor of the early termination of a clinical investigation on safety or efficacy grounds, that Member State shall communicate such facts and its decision and the grounds therefor for that decision to all Member States and the Commission by means of the electronic system referred to in Article 53. [Am. 187]
2. Where an application is withdrawn by the sponsor prior to a decision by a Member State, that Member State shall inform all the other Member States and the Commission of that fact, by means of the electronic system referred to in Article 53.
Article 57
Information by the sponsor in the event of temporary halt or termination of a clinical investigation
1. If the sponsor has temporarily halted a clinical investigation on safety or efficacy grounds, he shall inform the Member States concerned within 15 days of the temporary halt. [Am. 188]
2. The sponsor shall notify each Member State concerned of the end of a clinical investigation in relation to that Member State, providing a justification in the event of early termination, so that all Member States can inform sponsors conducting similar clinical investigations at the same time within the Union of the results of that clinical investigation. That notification shall be made within 15 days from the end of the clinical investigation in relation to that Member State.
If the investigation is conducted in more than one Member State the sponsor shall notify all Member States concerned of the early termination in one Member State and of the overall end of the clinical investigation. Information on the reasons for the early termination of the clinical investigation shall also be provided to all Member States, so that all Member States can inform sponsors conducting similar clinical investigations at the same time within the Union of the results of that clinical investigation. That notification shall be made within 15 days from the overall end of the clinical investigation in one or more Member States. [Am. 189]
3. Within Irrespective of the outcome of the clinical investigation, within one year from the end of the clinical investigation performance study or from its early termination, the sponsor shall submit to the Member States concerned a summary of the results of the clinical investigation in form of a clinical investigation report referred to in Section 2.7 of Chapter I of Annex XIV. It shall be accompanied by a summary presented in terms that are easily understandable to a layperson. Both the report and the summary shall be submitted by the sponsor by means of the electronic system referred to in Article 53. Where, for justified scientific reasons, it is not possible to submit the clinical investigation report within one year, it shall be submitted as soon as it is available. In this case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XIV shall specify when the results of the clinical investigation are going to be submitted, together with an explanation a justification.
3a. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to define the content and structure of the layperson's summary.
The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to establish rules for the communication of the clinical investigation report.
For cases where the sponsor decides to share raw data on a voluntary basis, the Commission shall produce guidelines for the formatting and sharing of the data. [Am. 190]
Article 58
Clinical investigations conducted in more than one Member State
1. By means of the electronic system referred to in Article 53, the sponsor of a clinical investigation to be conducted in more than one Member State may submit, for the purpose of Article 51, a single the application that, upon receipt, is transmitted electronically to the Member States concerned. [Am. 191]
2. In the single application, the sponsor shall propose one of the Member States concerned Concerned as coordinating Member State States . If that Member State does not wish to be the coordinating Member State, it shall agree, within six days of submission of the single application, with another which Member State concerned that the latter shall be the coordinating Member State. If no other Member State accepts to be the coordinating Member State, the Member State proposed by the sponsor shall be the coordinating Member State. If another Member State than the one proposed by the sponsor becomes States and the Commission shall agree, in the framework of the attributions of the MDCG, on clear rules for designating the coordinating Member State, the deadline referred to in Article 51(2) shall start on the day following the acceptance. [Am. 192]
3. Under the direction of the coordinating Member State referred to in paragraph 2, the Member States concerned shall coordinate their assessment of the application, in particular of the documentation submitted in accordance with Chapter II of Annex XIV, except for Sections 3.1.3, 4.2, 4.3 and 4.4 thereof which shall be assessed separately by each Member State concerned.
The coordinating Member State shall:
|
(a) |
within 6 days of receipt of the single application notify the sponsor whether the clinical investigation falls within the scope of this Regulation and whether the application is complete, except for the documentation submitted in accordance with Sections 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XIV for which each Member State shall verify the completeness. Article 51(2) to (4) shall apply to the coordinating Member State in relation to the verification that the clinical investigation falls within the scope of this Regulation and that the application is complete, except for the documentation submitted in accordance with Sections 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XIV. Article 51(2) to (4) shall apply to each Member State in relation to the verification that the documentation submitted in accordance with Sections 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XIV is complete; |
|
(b) |
establish the results of the coordinated assessment in a report to be taken into account approved by the other Member States concerned when deciding on the sponsor's application in accordance with Article 51(5). [Am. 193] |
4. The substantial modifications referred to in Article 55 shall be notified to the Member States concerned by means of the electronic system referred to in Article 53. Any assessment as to whether there are grounds for refusal as referred to in Article 55 shall be carried out under the direction of the coordinating Member State.
5. For the purpose of Article 57(3), the sponsor shall submit the clinical investigation report to the Member States concerned by means of the electronic system referred to in Article 53. [Am. 194]
6. The Commission shall provide secretarial support to the coordinating Member State in the accomplishment of its tasks provided for in this Chapter.
Article 59
Recording and reporting of events occurring during clinical investigations
1. The sponsor shall fully record any of the following:
|
(a) |
an adverse event identified in the clinical investigation plan as critical to the evaluation of the results of the clinical investigation in view of the purposes referred to in Article 50(1); |
|
(b) |
a serious adverse event; |
|
(c) |
a device deficiency that might have led to a serious adverse event if suitable action had not been taken, intervention had not occurred, or circumstances had been less fortunate; |
|
(d) |
new findings in relation to any event referred to in points (a) to (c). |
Information regarding incidents that are caused by user errors shall also be collected, as they are a major source of incidents with medical devices. This information shall contribute to improve the safety and knowledge of the device. [Am. 195]
Member States shall put in place non-electronic formats of reporting to ensure that patients who do not have online access are able to report. [Am. 196]
2. The sponsor shall report to all Member States where a clinical investigation is conducted without delay any of the following:
|
(a) |
a serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible; |
|
(b) |
a device deficiency that might have led to a serious adverse event if suitable action had not been taken, intervention had not occurred, or circumstances had been less fortunate; |
|
(c) |
new findings in relation to any event referred to in points (a) to (b). |
The time period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial incomplete report followed up by a complete report.
3. The sponsor shall also report to the Member States concerned any event referred to in paragraph 2 occurring in third countries in which a clinical investigation is performed under the same clinical investigation plan as the one applying to a clinical investigation covered by this Regulation.
4. In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 58, the sponsor shall report any event as referred to in paragraph paragraphs 1 and 2 by means of the electronic system referred to in Article 53. Upon receipt, this report shall be transmitted electronically to all Member States concerned. [Am. 197]
Under the direction of the coordinating Member State referred to in Article 58(2), the Member States shall coordinate their assessment of serious adverse events and device deficiencies to determine whether a clinical investigation needs to be terminated, suspended, temporarily halted or modified.
This paragraph shall not affect the rights of the other Member States to perform their own evaluation and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating Member State and the Commission shall be kept informed of the outcome of any such evaluation and the adoption of any such measures.
5. In the case of post-market clinical follow-up investigations referred to in Article 54(1), the provisions on vigilance contained in Articles 61 to 66 shall apply instead of this Article.
Article 60
Implementing acts
The Commission may, by means of implementing acts, adopt the modalities and procedural aspects necessary for the implementation of this Chapter as regards the following:
|
(a) |
harmonised forms for the application for clinical investigations and their assessment as referred to in Articles 51 and 58, taking into account specific categories or groups of devices; |
|
(b) |
the functioning of the electronic system referred to in Article 53; |
|
(c) |
harmonised forms for the notification of post-market clinical follow-up investigations as referred to in Article 54(1), and of substantial modifications as referred to in Article 55; |
|
(d) |
the exchange of information between Member States as referred to in Article 56; |
|
(e) |
harmonised forms for the reporting of serious adverse events and device deficiencies as referred to in Article 59; |
|
(f) |
the timelines for the reporting of serious adverse events and device deficiencies, taking into account the severity of the event to be reported as referred to in Article 59. |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Chapter II VI [Am. 256]
Making available of devices, obligations of economic operators, reprocessing, CE marking, free movement
Article 4
Placing on the market and putting into service
1. A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
2. A device shall meet the general safety and performance requirements which apply to it, taking into account its intended purpose. General safety and performance requirements are set out in Annex I.
3. Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 49.
4. Devices that are manufactured and used within a single health institution shall be considered as being put into service. The provisions regarding CE marking referred to in Article 18 and the obligations laid down in Articles 23 to, 26 and 27 shall not apply to those devices, provided that manufacture and use of those devices occur under the health institution's single quality management system. [Am. 94]
5. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing, in the light of technical progress and considering the intended users or patients, the general safety and performance requirements set out in Annex I, including the information supplied by the manufacturer. [Am. 95]
Article 5
Distance sales
1. A device offered by means of information society services as defined in Article 1(2) of Directive 98/34/EC to a natural or legal person established in the Union shall comply with this Regulation at the latest when by the day on which the device is placed on the market. [Am. 96]
2. Without prejudice to national legislation regarding the exercise of the medical profession, a device that is not placed on the market but used in the context of a commercial activity for the provision of a diagnostic or therapeutic service offered by means of information society services as defined in Article 1(2) of Directive 98/34/EC or by other means of communication to a natural or legal person established in the Union shall comply with this Regulation.
2a. Service providers providing means of distance communication shall be obliged, upon receiving a request from the competent authority, to disclose the details of entities engaging in distance selling. [Am. 97]
2b. There shall be a prohibition on the marketing, placing in use, distribution, delivery and making available of products whose names, labelling or instructions for use may mislead with regard to the product’s characteristics and effects by:
|
(a) |
ascribing characteristics, functions and effects to the product which the product does not have; |
|
(b) |
creating the false impression that treatment or diagnosis using the product is sure to be successful, or failing to inform of a likely risk associated with the use of the product in line with its intended use or for a longer-than-anticipated period; |
|
(c) |
suggesting uses or characteristics of the product other than those declared when the conformity assessment was carried out. |
Promotional materials, presentations and information about the products may not mislead in the manner referred to in the first subparagraph. [Am. 98]
Article 6
Harmonised standards
1. Devices which are in conformity with the relevant harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.
The first subparagraph shall also apply to system or process requirements to be fulfilled by economic operators or sponsors in accordance with this Regulation, including those related to the quality management system, risk management, the post-market surveillance plan, clinical investigations, clinical evaluation or post-market clinical follow-up.
2. Reference to harmonised standards also includes the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, notably on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products.
Article 7
Common technical specifications
1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient there is a need to address public health concerns, the Commission, after having consulted the MDCG and the MDAC, shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evaluation and post-market clinical follow-up set out in Annex XIII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 88(3).
1a. Before adopting CTS referred to in paragraph 1, the Commission shall ensure that the CTS have been developed with the appropriate support of the relevant stakeholders and that they are coherent with the European and international standardisation system. CTS are coherent if they do not conflict with European standards, meaning they cover areas where no harmonised standards exist, the adoption of new European standards is not envisaged within a reasonable period, where existing standards have not gained market uptake or where those standards have become obsolete or have been demonstrated as clearly insufficient according to vigilance or surveillance data, and where the transposition of the technical specifications into European standardisation deliverables is not envisaged within a reasonable period. [Am. 99]
2. Devices which are in conformity with the CTS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CTS or parts thereof.
3. Manufacturers shall comply with the CTS unless they can duly justify that they have adopted solutions ensuring a level of safety and performance that is at least equivalent thereto.
Article 8
General obligations of the manufacturer
1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.
2. Manufacturers shall draw up the technical documentation which shall allow assessment of the conformity of the device with the requirements of this Regulation. The technical documentation shall include the elements set out in Annex II.
The Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing, in the light of technical progress, the elements in the technical documentation set out in Annex II. [Am. 100]
3. Where compliance of a device with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration of conformity in accordance with Article 17 and affix the CE marking of conformity in accordance with Article 18.
4. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate including any supplement, issued in accordance with Article 45, available to the competent authorities for a period of at least five years after the last device covered by the declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.
Where the technical documentation is voluminous or held in different locations, the manufacturer shall provide, upon request by a competent authority, a summary technical documentation (STED) and grant access to the full technical documentation upon request.
5. Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in product design or characteristics and changes in the harmonised standards or CTS by reference to which conformity of a product is declared shall be adequately taken into account. Proportionate to the risk class and the type of device, manufacturers of devices, other than custom-made or investigational devices, shall institute and keep up to date a quality management system that shall address at least the following aspects:
|
(a) |
the responsibility of the management; |
|
(b) |
resource management, including selection and control of suppliers and sub-contractors; |
|
(c) |
product realisation; |
|
(d) |
processes for monitoring and measurement of output, data analysis and product improvement. |
6. Proportionate to the risk class and the type of device, manufacturers of devices, other than custom-made devices, shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service and to apply any necessary corrective action, hereinafter referred to as ‘post-market surveillance plan’. The post-market surveillance plan shall set out the process for collecting, recording and investigating complaints and reports from healthcare professionals, patients or users on suspected incidents related to a device, keeping a register of non-conforming products and product recalls or withdrawals, and if deemed appropriate due to the nature of the device, sample testing of marketed devices. Part of the post-market surveillance plan shall be a plan for post-market clinical follow-up in accordance with Part B of Annex XIII. Where post-market clinical follow-up is not deemed necessary, this shall be duly justified and documented in the post-market surveillance plan.
If in the course of the post-market surveillance a need for corrective action is identified, the manufacturer shall implement the appropriate measures, including immediate notification to Eudamed as established by Article 27. [Am. 101]
7. Manufacturers shall ensure that the device is accompanied by the information to be supplied in accordance with Section 19 of Annex I in an official Union language which can be easily understood by the intended user or patient. The language(s) of the information to be supplied by the manufacturer may be determined by the law of the Member State where the device is made available to the user or patient.
8. Manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that product into conformity, withdraw it or recall it, as appropriate. They shall inform the distributors, the importers and, where applicable, the authorised representative accordingly. [Am. 102]
9. Manufacturers shall, in response to a reasoned request from a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service.
If a competent authority considers or has reason to believe that a device has caused damages, it shall ensure, where this is not already foreseen by national litigation or judicial proceedings, that the potentially harmed user, the user's successor in title, the user's health insurance company or other third parties affected by the damage caused to the user may request the information referred to in the first subparagraph from the manufacturer or his authorised representative while ensuring due respect to the intellectual property rights. [Am. 103]
10. Where manufacturers have their devices designed and manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 25.
10a. Before placing a medical device on the market, manufacturers shall ensure they are covered by an appropriate liability insurance covering any damages to patients or users that can be directly attributed to a manufacturing defect of the same medical device, with a level of coverage proportionate to the potential risk associated with the medical device produced, and in accordance with Council Directive 85/374/EEC (42). [Am. 104]
Article 9
Authorised representative
1. A manufacturer of a device that is placed on the Union market, or bears the CE marking without being placed on the Union market, who does not have a registered place of business in a Member State or does not carry out relevant activities at a registered place of business in a Member State, shall designate a single authorised representative.
2. The designation shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.
3. The authorised representative shall perform the tasks specified in the mandate agreed between the manufacturer and the authorised representative.
The mandate shall allow and require the authorised representative to perform at least the following tasks in relation to the devices that it covers:
|
(a) |
keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate including any supplement issued in accordance with Article 45 at the disposal of competent authorities for the period referred to in Article 8(4); |
|
(b) |
in response to a reasoned request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device; |
|
(c) |
cooperate with the competent authorities on any corrective action taken to eliminate the risks posed by devices; |
|
(d) |
immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated; |
|
(e) |
terminate the mandate if the manufacturer acts contrary to his obligations under this Regulation. |
To allow the authorised representative to fulfil the tasks mentioned in this paragraph, the manufacturer shall at least ensure that the authorised representative has permanent immediate access to the necessary documentation in one of the official Union languages.
4. The mandate referred to in paragraph 3 shall not include the delegation of the manufacturer's obligations laid down in Article 8(1), (2), (5), (6), (7) and (8).
5. An authorised representative who terminates the mandate on the grounds referred to in point (e) of paragraph 3 shall immediately inform the competent authority of the Member State in which he is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.
6. Any reference in this Regulation to the competent authority of the Member State where the manufacturer has his registered place of business shall be understood as a reference to the competent authority of the Member State where the authorised representative, designated by a manufacturer referred to in paragraph 1, has his registered place of business.
Article 10
Change of authorised representative
The modalities of a change of authorised representative shall be clearly defined in an agreement between the manufacturer, the outgoing authorised representative and the incoming authorised representative. This agreement shall address at least the following aspects:
|
(a) |
the date of termination of the mandate with the outgoing authorised representative and date of beginning of the mandate with the incoming authorised representative; |
|
(b) |
the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material; |
|
(c) |
the transfer of documents, including confidentiality aspects and property rights; |
|
(d) |
the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which he had been designated as authorised representative. |
Article 11
General obligations of importers
1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
2. Before placing a device on the market importers shall ensure the following:
|
(-a) |
that the manufacturer is identifiable and has the technical, scientific and financial capacity to produce a medical device compliant with this Regulation, and that importers make available to the national authorities and on their website a report on the investigation procedures attesting to the expertise of the manufacturer; [Am. 105]
|
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, he shall not place the device on the market until it has been brought into conformity. Where the device presents a risk, the importer shall inform the manufacturer and his authorised representative to that effect, as well as the competent authority of the Member State in which he is established.
3. Importers shall indicate their name, registered trade name or registered trade mark and the address of their registered place of business at which they can be contacted and their location can be established on the device or on its packaging or in a document accompanying the device. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
4. Importers shall ensure that the device is registered in the electronic system in accordance with Article 25(2).
5. Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I.
6. When deemed appropriate with regard to the risks presented by a device, importers shall, in order to protect the health and safety of patients and users, carry out sample testing of marketed products, investigate complaints and keep a register of complaints, of non-conforming products and of product recalls and withdrawals, and shall keep the manufacturer, authorised representative and distributors informed of such monitoring.
7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and his authorised representative and, if appropriate, take ensure that the necessary corrective action to bring that device into in conformity, withdraw or recall it, is taken and implement that action. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 45 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken they have implemented. [Am. 107]
8. Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and his authorised representative.
9. Importers shall, for the period referred to in Article 8(4), keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation and, if applicable, a copy of the relevant certificate including any supplement, issued in accordance with Article 45, can be made available to those authorities, upon request. By written mandate, the importer and the authorised representative for the device in question may agree that this obligation is delegated to the authorised representative.
10. Importers shall, in response to a request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product. This obligation shall be considered fulfilled when the authorised representative for the device in question provides the required information. Importers shall cooperate with a competent national authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.
Article 12
General obligations of distributors
1. When making a device available on the market, distributors shall act with due care in relation to the requirements applicable.
2. Before making a device available on the market distributors shall verify that the following requirements are met:
|
(a) |
the product bears the required CE marking of conformity; |
|
(b) |
the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7); |
|
(c) |
the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 24 and Article 11(3) respectively. [Am. 108] |
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, he shall not make the device available on the market until it has been brought into conformity. Where the device presents a risk, the distributor shall inform the manufacturer and, where applicable, his authorised representative and the importer to that effect, as well as the competent authority of the Member State in which he is established.
3. Distributors shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I.
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure, within the scope of their respective activities, that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non-compliance and of any corrective action taken. [Am. 109]
5. Distributors who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, his authorised representative.
6. Distributors shall, in response to a request from a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of a device. This obligation shall be considered fulfilled when the authorised representative for the device in question, where applicable, provides the required information. Distributors shall cooperate with competent national authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market.
Article 13
Person responsible for regulatory compliance
1. Manufacturers shall have available within their organisation at least one qualified person responsible for regulatory compliance who possesses expert knowledge the requisite expertise in the field of medical devices. The expert knowledge requisite expertise shall be demonstrated by either of the following qualifications:
|
(a) |
a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices; |
|
(b) |
five three years of professional experience in regulatory affairs or in quality management systems relating to medical devices. |
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate their expert knowledge referred to in the first subparagraph by at least two years of professional experience within the relevant field of manufacture.
This paragraph shall not apply to manufacturers of custom-made devices who are micro-enterprises as defined by Recommendation 2003/361/EC.
2. The qualified person responsible for regulatory compliance shall at least be responsible for ensuring the following matters:
|
(a) |
that the conformity of the devices is appropriately assessed before a batch is released; |
|
(b) |
that the technical documentation and the declaration of conformity are drawn up and kept up-to-date; |
|
(c) |
that the reporting obligations in accordance with Articles 61 to 66 are fulfilled; |
|
(d) |
in the case of investigational devices, that the statement referred to in point 4.1 of Chapter II of Annex XIV is issued. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1 and 2, their respective areas of responsibility shall be stipulated in writing. |
3. The qualified person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his duties.
4. Authorised representatives shall have available within their organisation at least one qualified person responsible for regulatory compliance who possesses expert knowledge the requisite expertise regarding the regulatory requirements for medical devices in the Union. The expert knowledge requisite expertise shall be demonstrated by either of the following qualifications:
|
(a) |
a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices; |
|
(b) |
five three years of professional experience in regulatory affairs or in quality management systems relating to medical devices. [Am. 110] |
Article 14
Cases in which obligations of manufacturers apply to importers, distributors or other persons
1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if he does any of the following:
|
(a) |
makes available on the market a device under his name, registered trade name or registered trade mark; |
|
(b) |
changes the intended purpose of a device already placed on the market or put into service; |
|
(c) |
modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. |
A distributor, importer or other natural or legal person shall assume the obligations incumbent on the manufacturer under point (a) of the first subparagraph only if the device in question was manufactured outside the Union. In the case of devices manufactured within the Union, the manufacturer’s proof of compliance with this Regulation shall suffice. [Am. 111]
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in number (19) of Article 2(1), assembles or adapts a device already on the market to its intended purpose for an individual patient.
2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:
|
(a) |
provision, including translation, of the information supplied by the manufacturer in accordance with Section 19 of Annex I relating to a device already placed on the market and of further information which is necessary in order to market the product in the relevant Member State; |
|
(b) |
changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the product in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the package that shall ensure the sterile condition is opened, damaged or otherwise negatively affected by the repackaging. |
3. A distributor or importer who carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate the activity carried out together with his name, registered trade name or registered trade mark and the address at which he can be contacted and his location can be established on the device or, where that is not possible, on its packaging or in a document accompanying the device.
He shall ensure that he has in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. Part of the quality management system shall be procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it in conformity with this Regulation.
4. At least 28 calendar days prior to making the relabelled or repackaged device available, the distributor or importer referred to in paragraph 3 shall inform the manufacturer and the competent authority of the Member State where he plans to make the device available and, upon request, shall provide them with a sample or a mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 calendar days, he shall submit to the competent authority a certificate, issued by a notified body referred to in Article 29, designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system complies with the requirements laid down in paragraph 3. [Am. 112]
Article 16
Implant card and information about implantable devices
1. The manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who has been implanted with the device. healthcare professional implanting the device who shall be responsible for:
|
— |
submitting the implant card to the patient, and |
|
— |
recording all the information contained on the implant card in the patient's medical records; |
The implant card shall also be made available by the manufacturer in an electronic format and Member States shall ensure that hospitals and clinics keep an electronic version on record.
The following implants shall be exempted from this obligation: sutures, staples, dentals implants, screws and plates.
The Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing this list of exempted implants.
2. This card shall contain the following:
|
(a) |
the information allowing identification of the device, including the Unique Device Identification; |
|
(b) |
any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences or environmental conditions; |
|
(ba) |
description of potential adverse effects; |
|
(c) |
any information about the expected lifetime of the device and any necessary follow-up; |
|
(ca) |
principal characteristics of the device, including the materials used. |
Member States may introduce national provisions requiring that the implant card includes also information on post-operative follow-up care measures.
The information shall be written in a way that is readily understood by a lay person. [Am. 120]
Article 17
EU declaration of conformity
1. The EU declaration of conformity shall state that fulfilment of the requirements specified in this Regulation has been demonstrated. It shall be continuously updated. The minimum content of the EU declaration of conformity is set out in Annex III. It shall be translated into the official Union language or languages required by the Member State(s) in which the device is made available.
2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union legislation which also requires a declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device containing all information required for identification of the Union legislation to which the declaration relates.
3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device.
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the minimum content of the EU declaration of conformity set out in Annex III in the light of technical progress.
Article 18
CE marking of conformity
1. Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex IV.
2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
3. The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile pack. Where that is not possible or not warranted on account of the nature of the device, it shall be affixed to the packaging. The CE marking shall also appear in the instructions for use and on the sales packaging where those are provided.
4. The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.
5. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 42. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the legal requirements for CE marking.
6. Where devices are subject to other Union legislation concerning other aspects which also provide for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the provisions of the other legislation.
Article 19
Devices for special purposes
1. Member States shall not create any obstacle to the following devices:
|
(a) |
investigational devices which are supplied to a doctor of medicine, a dental practitioner or an authorised person for the purpose of clinical investigation if they meet the conditions laid down in Articles 50 to 60 and in Annex XIV; |
|
(b) |
custom-made devices which are made available on the market if they comply with Article 42(7) and Annex XI. |
Those devices shall not bear the CE marking, with the exception of the devices referred to in Article 54.
2. Custom-made devices shall be accompanied by the statement referred to in Annex XI which shall be made available to the particular patient or user identified by name, an acronym or a numerical code.
Member States may require that the manufacturer of a custom-made device submit to the competent authority a list of such devices which have been made available in their territory.
3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create any obstacle to the showing of devices which do not comply with this Regulation, provided a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been made to comply with this Regulation.
Article 20
Systems and procedure packs
1. Any natural or legal person shall draw up a statement referred to in paragraph 2 if he puts devices bearing the CE marking together with the following other devices or products, in accordance with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:
|
— |
other devices bearing the CE marking; |
|
— |
in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) […/…]; |
|
— |
other products which are in conformity with the legislation applicable to those products. |
2. In the statement, the person referred to in paragraph 1 shall declare the following:
|
(a) |
that he verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers' instructions and has carried out his operations in accordance with those instructions; |
|
(b) |
that he packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together; |
|
(c) |
that the activity of putting devices and, if applicable, other products together as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation. |
3. Any natural or legal person who sterilises systems or procedure packs referred to in paragraph 1 for the purpose of placing them on the market shall, at his choice, follow one of the procedures referred to in Annex VIII or in Part A of Annex X. The application of those Annexes and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile package is opened or damaged. The person shall draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer's instructions.
4. Where the system or procedure pack incorporate devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, the system or procedure pack shall be treated as a device in its own right and shall be subjected to the relevant conformity assessment procedure pursuant to Article 42.
5. The systems or procedure packs referred to in paragraph 1 shall not themselves bear an additional CE marking but they shall bear the name, registered trade name or registered trade mark of the person referred to in paragraph 1 as well as the address at which he can be contacted and his location can be established. Systems or procedure packs shall be accompanied by the information referred to in Section 19 of Annex I. The statement referred to in paragraph 2 of this Article shall be kept at the disposal of the competent authorities, after the system or procedure pack has been put together, for the period that is applicable to the devices put together in accordance with Article 8(4). Where these periods differ, the longest period shall apply.
Article 21
Parts and components
1. Any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re-establish the function of the device without significantly changing its performance or safety characteristics, shall ensure that the article does not adversely affect the safety and performance of the device. When the article is a part of an implantable device, the natural or legal person who makes it available on the market shall cooperate with the manufacturer of the device to ensure its compatibility with the functioning part of the device in order to avoid the replacement of the whole device and its consequences for patient safety. Substantiating evidence shall be kept available to the competent authorities of the Member States. [Am. 121]
2. An article that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics of the device shall be considered as a device and shall meet the requirements laid down in this Regulation. [Am. 122]
Article 22
Free movement
Member States shall not refuse, prohibit or restrict the making available or putting into service within their territory of devices which comply with the requirements of this Regulation.
Chapter VIa
Labelling and safe reprocessing of medical devices [Am. 257]
Article 15
Single-use devices and their reprocessing
1. Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation.
2. Only single-use devices that have been placed on the Union market in accordance with this Regulation, or prior to [date of application of this Regulation] in accordance with Directive 90/385/EEC or Directive 93/42/EEC may be reprocessed.
3. In the case of reprocessing of single-use devices for critical use, only reprocessing that is considered safe according to the latest scientific evidence may be carried out.
4. The Commission, by means of implementing acts, shall establish and regularly update a list of categories or groups of single-use devices for critical use which may be reprocessed in accordance with paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
5. The name and address of the legal or natural person referred to in paragraph 1 and the other relevant information in accordance with Section 19 of Annex I shall be indicated on the label and, where applicable, in the instructions for use of the reprocessed device.
The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device.
6. A Member State may maintain or introduce national provisions prohibiting, within its territory, on grounds of protection of public health specific to that Member State the following:
|
(a) |
the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing; |
|
(b) |
the making available of reprocessed single-use devices. |
Member States shall notify the Commission and the other Member States of the national provisions and the grounds for introducing them. The Commission shall keep the information publicly available. [Am. 113]
Article 15a
General principles on safe reprocessing
1. Any natural or legal person, including health institutions as specified in Article 4(4), who wishes to reprocess a single-use device to make it suitable for further use within the Union, and who can provide scientific evidence that such a device could be safely reprocessed shall be considered to be the manufacturer of its reprocessed device and shall be held liable for its reprocessing activities. The natural or legal person shall ensure the traceability of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, with the exception of obligations linked to the conformity assessment procedure.
2. Only reusable devices that have been placed on the Union market in accordance with this Regulation, or prior to [date of application of this Regulation] in accordance with Directive 90/385/EEC or Directive 93/42/EEC may be reprocessed.
3. Unless they are placed on the list of single-use devices referred to in Article 15b, medical devices shall be considered as suitable for reprocessing and reusable devices in accordance with the provisions laid down in Article 15c, and provided the highest level of patient safety is guaranteed.
4. A Member State may maintain or introduce national provisions prohibiting, within its territory, on grounds of protection of public health specific to that Member State the following:
|
(a) |
the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing; |
|
(b) |
the making available of reprocessed single-use devices. |
Member States shall notify the Commission and the other Member States of the national provisions and the grounds for introducing them. The Commission shall keep the information publicly available. [Am. 358]
Article 15b
List of single-use devices unsuitable for reprocessing
1. In accordance with Article 15a(3), the Commission, after the mandatory consultation of the MDAC shall establish, by means of delegated acts, a list of medical devices or types of medical device which are unsuitable for reprocessing. The Commission shall regularly update that list, including by adding or removing items. A first list shall be established no later than six months before the date of entry into force of this Regulation.
2. The decision to include or remove any device or type of device from the list shall be made in particular by taking into account:
|
— |
their intended use in or on the human body and the body parts they will be in contact with; |
|
— |
the conditions of their use; |
|
— |
their intended purpose; |
|
— |
the material from which they are composed; |
|
— |
the severity of the disease that is being treated; |
|
— |
a genuine safety risk; and |
|
— |
the latest scientific and technological advancements in the relevant fields and disciplines. |
3. The delegated acts referred to in paragraph 1 shall be adopted in accordance with Article 89. [Am. 359]
Article 15c
Reprocessing of medical devices labelled as reusable
1. Any natural or legal person, including health institutions as specified in Article 4(4), who reprocesses a device labelled as ‘reusable’ shall:
|
— |
comply with the EU standards referred to in paragraph 2; |
|
— |
ensure that, where a single-use device is removed from the list referred to in Article 15b, the reusable device is reprocessed in accordance with the opinion of the EU reference laboratory; |
|
— |
ensure that the reusable device is not reprocessed beyond the maximum number of times specified for that device; |
2. The Commission shall, by means of implementing acts, and in collaboration with the International Medical Devices Regulatory Forum and international standardisation bodies, define a clear set of high quality and safety standards for reprocessing of single use devices, including specific requirements for the manufacturers of reprocessed devices.
3. In drawing up these quality and safety standards, the Commission shall notably include:
|
— |
cleaning, disinfection and sterilisation processes in line with the risk assessment for the respective devices, |
|
— |
requirements in relation to systems for hygiene, infection-prevention, quality management and documentation applicable to the natural or legal persons reprocessing the medical devices, |
|
— |
functionality testing of the devices after reprocessing. |
These standards shall be consistent with the latest scientific evidence and guarantee the highest level of quality and safety, in accordance with the severity of the condition, as reflected in European standards from the European standardisation organisations, where the latter take into account the provisions of relevant international standards, in particular those of ISO and IEC, or any other international technical standards able to guarantee, at the very least, a higher level of quality, safety and performance than ISO and IEC standards.
4. The natural or legal person referred to in paragraph 1 shall comply with EU standards referred to in paragraph 1 to ensure the quality of the reprocessing of medical devices labelled as ‘reusable’ and the safety of reprocessed devices.
5. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, the Commission shall be empowered to adopt CTS, as referred to in Article 7(1). [Am. 118]
Article 15d
Report on the functioning of the system
No later than four years after the date of application of this Regulation, the Commission shall assess and draw up an evaluation report. The report shall be submitted to the European Parliament and the Council. Where appropriate, the report shall be accompanied by a legislative proposal. [Am. 377]
Chapter III VIII
Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European databank on medical devices [Am. 258]
Article 23
Identification within the supply chain
For devices, other than custom-made or investigational devices, economic operators shall be able to identify the following, for the period referred to in Article 8(4):
|
(a) |
any economic operator to whom they have supplied a device; |
|
(b) |
any economic operator who has supplied them with a device; |
|
(c) |
any health institution or healthcare professional to whom they have supplied a device. |
Upon request, they shall inform the competent authorities thereof.
Article 24
Unique Device Identification system
1. For devices, other than custom-made and investigational devices, a single system for Unique Device Identification (UDI) shall be put in place in the Union. The UDI system shall allow the identification and traceability of devices, be coherent if possible with the global regulatory approach for UDI in medical devices, and shall consist of the following: [Am. 123]
|
(a) |
production of a UDI that comprises the following:
|
|
(b) |
placement of the UDI on the label of the device; |
|
(c) |
storage of the UDI by the economic operators and the health institutions through electronic means; |
|
(d) |
establishment of an electronic system on UDI. |
1a. The UDI system shall be updated with the results of the post-market clinical follow-up evaluation report referred to in Section 3 of Part B of Annex XIII. [Am. 124]
2. The Commission shall designate one or several entities that operate a system for assignment of UDIs pursuant to this Regulation and that satisfy all of the following criteria:
|
(a) |
the entity is an organisation with legal personality; |
|
(b) |
its system for the assignment of UDIs is adequate to identify a device through its distribution and use in accordance with the requirements of this Regulation; |
|
(c) |
its system for the assignment of UDIs conforms to the relevant international standards; |
|
(d) |
the entity gives access to its system for the assignment of UDIs to all interested users according to a set of predetermined and transparent terms and conditions; |
|
(e) |
the entity undertakes the following:
|
3. Before placing a device on the market, the manufacturer shall assign to the device a UDI provided by an entity designated by the Commission in accordance with paragraph 2, if that device belongs to the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 7.
4. The UDI shall be placed on the label of the device, in accordance with the conditions laid down by a measure referred to in point (c) of paragraph 7. It shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 61 and shall be included in the implant card referred to in Article 16. The device identifier shall appear on the EU declaration of conformity referred to in Article 17 and in the technical documentation referred to in Annex II.
5. Economic operators and health institutions shall store and keep, by electronic means, the device identifier and the production identifier of the devices which they have supplied or they have been supplied with, if they belong to the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 7.
6. The Commission, in cooperation with the Member States, shall set up and manage an electronic system on UDI to collate and process the information mentioned in Part B of Annex V. This information shall be accessible to the public.
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 89:
|
(a) |
determining the devices, categories or groups of devices whose identification shall be based on the UDI system as set out in paragraphs 1 to 6, and the timelines for implementing this. Following a risk-based approach, implementation of the UDI system shall be gradual, starting with devices falling in the highest risk class; |
|
(b) |
specifying the data to be included in the production identifier which, following a risk based approach, may vary depending on the risk class of the device; |
|
(c) |
defining the obligations of economic operators, of health institutions and of professional users, in particular regarding allocation of the numeric or alphanumeric characters, placement of the UDI on the label, storage of information in the electronic system on UDI and use of the UDI in documentation and reporting related to the device provided for in this Regulation; |
|
(d) |
amending or supplementing the list of information set out in Part B of Annex V in the light of technical progress. |
8. When adopting the measures referred to in paragraph 7, the Commission shall take into account the following:
|
(a) |
the protection of personal data; |
|
(b) |
the legitimate interest in protecting commercially sensitive information, provided that it does not conflict with public health protection; [Am. 126] |
|
(c) |
the risk-based approach; |
|
(d) |
the cost-effectiveness of the measures; |
|
(e) |
the convergence of UDI systems developed at international level; |
|
(ea) |
compatibility with other traceability systems used by the stakeholders involved with medical devices; [Am. 127] |
|
(eb) |
the compatibility of the UDI systems with the safety features established under Directive 2011/62/EU. [Am. 128] |
Article 25
Electronic system on registration of devices and economic operators
1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information that is necessary and proportionate to describe and identify the device and to identify the manufacturer and, where applicable, the authorised representative and the importer. The details regarding the information to be submitted by the economic operators are laid down in Part A of Annex V.
2. Before a device, other than a custom-made or investigational device, is placed on the market the manufacturer or his authorised representative shall submit to the electronic system the information referred to in paragraph 1.
Steps shall be taken to ensure that no additional national registration procedures are necessary. [Am. 129]
3. Within one week after placing a device, other than a custom-made or investigational device, on the market, importers shall submit to the electronic system the information referred to in paragraph 1.
4. Within one week of any change occurring in relation to the information referred to in paragraph 1, the relevant economic operator shall update the data in the electronic system.
5. Not later than two years after submission of the information in accordance with paragraphs 2 and 3, and then every second year, the relevant economic operator shall confirm the accuracy of the data. In the event of failure to confirm within six months of the due date, any Member State may take measures to suspend or otherwise restrict the making available of the device in question within its territory until the obligation referred to in this paragraph is complied with.
6. The data contained in the electronic system shall be accessible to the public.
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending the list of information to be submitted as set out in Part A of Annex V in the light of technical progress.
Article 27
European databank
1. The Commission shall develop and manage the European databank on medical devices (Eudamed) for the following purposes:
|
(a) |
to enable the public to be adequately informed about devices placed on or removed from the market, about the corresponding certificates issued by notified bodies and about the relevant economic operators, with due regard to commercial confidentiality where justified; |
|
(b) |
to enable traceability of devices within the internal market; |
|
(c) |
to enable the public to be adequately informed about clinical investigations, and to have an overview of vigilance data and market surveillance activities as well as to enable healthcare professionals to have adequate access to the results of clinical investigations, and to enable sponsors of clinical investigations to be conducted in more than one Member State to comply with information obligations under Articles 50 to 60; |
|
(d) |
to enable manufacturers to comply with information obligations under Articles 61 to 66; |
|
(e) |
to enable the competent authorities of the Member States and the Commission to carry out their tasks relating to this Regulation on a well informed basis and to enhance the cooperation between them. |
2. Eudamed shall include the following as integral parts:
|
(a) |
the electronic system on UDI referred to in Article 24; |
|
(b) |
the electronic system on registration of devices and economic operators referred to in Article 25; |
|
(c) |
the electronic system on information on certificates referred to in Article 45(4); |
|
(d) |
the electronic system on clinical investigations referred to in Article 53, |
|
(e) |
the electronic system on vigilance referred to in Article 62; |
|
(f) |
the electronic system on market surveillance referred to in Article 68; |
|
(fa) |
the electronic system on registration of subsidiaries and subcontracting referred to in Article 30a; |
|
(fb) |
the electronic system on special notified bodies referred to in Article 43b. |
3. The data shall be entered into Eudamed by the Commission, the Member States, notified bodies, economic operators and, sponsors and healthcare professionals as specified in the provisions concerning the electronic systems referred to in paragraph 2.
4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors, healthcare professionals and the public to the extent defined in the provisions referred to in paragraph 2.
5. Eudamed shall contain personal data only insofar as this is necessary for the electronic systems referred to in paragraph 2 to collate and process the information in accordance with this Regulation. Personal data shall be kept in a form which permits identification of the data subjects for no longer than the periods referred to in Article 8(4).
6. The Commission and the Member States shall ensure that the data subjects may effectively exercise their rights to information, to access, to rectify and to object in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall ensure that the data subjects may effectively exercise the right of access to data relating to them, and the right to have inaccurate or incomplete data corrected and erased. Within their respective responsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data is deleted, in accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as possible, but no later than within 60 days after a request is made by a data subject.
7. The Commission shall, by means of implementing acts, lay down the modalities necessary for the development and management of Eudamed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
7a. The information contained in the European Databank shall be robust, transparent and user-friendly, enabling the public and healthcare professionals to compare information on registered devices, economic operators, clinical investigations, vigilance data and market-surveillance activities.
When developing and managing Eudamed, the Commission shall, in consultation with relevant stakeholders including patient and consumer organisations, ensure that all publicly accessible parts of Eudamed are presented in a user-friendly format.
8. In relation to its responsibilities under this Article and the processing of personal data involved therein, the Commission shall be considered controller of Eudamed and its electronic systems. [Am. 131]
Chapter VII IX [Am. 263]
Vigilance and market surveillance
SECTION 1 — VIGILANCE
Article 61
Reporting of incidents and field safety corrective actions
1. Manufacturers of devices other than custom-made or investigational devices, shall report through the electronic system referred to in Article 62 the following:
|
(a) |
any serious incident, including date and place of incident, with an indication of whether it is serious in accordance with the definition under Article 2, in respect of devices made available on the Union market; where available, the manufacturer shall include information on the patient or user and healthcare professional involved in the incident; |
|
(b) |
any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market if the reason for the field safety corrective action is not limited to the device made available in the third country. |
Manufacturers shall make the report referred to in the first subparagraph without delay, and no later than 15 days after they have become aware of the event and the causal relationship with their device or that such causal relationship is reasonably possible. The time period for reporting shall take account of the severity of the incident. Where necessary to ensure timely reporting, the manufacturer may submit an initial incomplete report followed up by a complete report.
2. For similar serious incidents occurring with the same device or device type and for which the root cause has been identified or the field safety corrective action implemented, manufacturers may provide periodic summary reports instead of individual incident reports, on condition that the competent authorities referred to in points (a), (b) and (c) of Article 62(5) have agreed with the manufacturer on the format, content and frequency of the periodic summary reporting.
3. The Member States shall take all appropriate measures, including targeted information campaigns, to encourage and enable healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall inform the Commission of those measures.
The competent authorities of the Member States shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that inform the manufacturer of the device concerned is informed of the incident without delay. The manufacturer shall ensure the appropriate follow-up.
The competent authority of a Member State shall notify the reports referred to in the first subparagraph to the electronic system referred to in Article 62 without delay, unless the same incident has already been reported by the manufacturer.
The Commission, in cooperation with the Member States and in consultation with the relevant stakeholders, shall coordinate between them the development of develop standard web-based structured forms for electronic and non-electronic reporting of serious incidents by healthcare professionals, users and patients.
4. Manufacturers of custom-made devices shall immediately report any serious incidents and field safety corrective actions referred to in paragraph 1 to the competent authority of the Member State in which the device in question has been made available. [Am. 198]
Article 62
Electronic system on vigilance
1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information:
|
(a) |
the reports by manufacturers on serious incidents and field safety corrective actions referred to in Article 61(1); |
|
(b) |
the periodic summary reports by manufacturers referred to in Article 61(2); |
|
(c) |
the reports by competent authorities on serious incidents referred to in the second subparagraph of Article 63(1); |
|
(d) |
the reports by manufacturers on trends referred to in Article 64; |
|
(da) |
the periodic safety update reports drawn up by manufacturers, as referred to in Article 63a; |
|
(e) |
the field safety notices by manufacturers referred to in Article 63(5); |
|
(f) |
the information to be exchanged between the competent authorities of the Member States and between them and the Commission in accordance with Article 63(4) and (7). |
2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission, to the notified bodies, to healthcare professionals and also to manufacturers where the information pertains to their own product.
3. The Commission shall ensure that healthcare professionals and the public have has an appropriate levels level of access to the electronic system. In cases where information is requested on a specific medical device, that information shall be made available without delay and within 15 days at the latest.
4. On the basis of arrangements between the Commission and competent authorities of third countries or international organisations, the Commission may grant those competent authorities or international organisations access to the database at the appropriate level. Those arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent to those applicable in the Union.
5. The reports on serious incidents and field safety corrective actions referred to in points (a) and (b) of Article 61(1), the periodic summary reports referred to in Article 61(2), the reports on serious incidents referred to in the second subparagraph of Article 63(1) and the trend reports referred to in Article 64 shall be automatically transmitted upon receipt via the electronic system to the competent authorities of the following Member States:
|
(a) |
the Member State where the incident occurred; |
|
(b) |
the Member State where the field safety corrective action is being or is to be undertaken; |
|
(c) |
the Member State where the manufacturer has his registered place of business; |
|
(d) |
where applicable, the Member State where the notified body, that issued a certificate in accordance with Article 45 for the device in question, is established. |
5a. The reports and information referred to in Article 62(5), shall also be automatically transmitted for the device in question via the electronic system to the notified body that issued the certificate in accordance with Article 45. [Am. 199]
Article 63
Analysis of serious incidents and field safety corrective actions
1. Member States shall take the necessary steps to ensure that any information regarding a serious an incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 61 is, at national level, evaluated centrally by their competent authority, if possible together with the manufacturer. The competent authority shall take into account the views of all relevant stakeholders, including patient and healthcare professionals' organisations. [Am. 200]
If in the case of reports received in accordance with Article 61(3) the competent authority ascertains that the reports relate to a serious incident it shall notify without delay those reports to the electronic system referred to in Article 62, unless the same incident has already been reported by the manufacturer. [Am. 201]
2. The national competent authorities shall carry out a risk assessment with regard to reported serious incidents or field safety corrective actions, taking into account criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of harm and severity of harm, clinical benefit of the device, intended and potential users, and population affected. They shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action. They shall monitor the manufacturer's investigation of the incident, and they shall take into account patients' opinions. [Am. 202]
3. In the case of devices referred to in the first subparagraph of Article 1(4) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for medicinal products, or the European Medicines Agency (EMA), that was consulted by the notified body in accordance with the second subparagraph of Article 42(2). [Am. 203]
In the case of devices covered by this Regulation in accordance with point (e) of Article 1(2) and where the serious incident or field safety corrective action may be related to the tissues or cells of human origin utilised for the manufacture of the device, the competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for human tissues and cells that was consulted by the notified body in accordance with the third subparagraph of Article 42(2). [Am. 204]
4. After carrying out the assessment, the evaluating competent authority shall, through the electronic system referred to in Article 62, inform without delay the other competent authorities of the corrective action taken or envisaged by the manufacturer or imposed on him to minimise the risk of recurrence of a serious incident, including information on the underlying events and the outcome of its assessment. [Am. [Am. 205]]
5. The manufacturer shall ensure that the users of the device in question are informed without delay of the corrective action taken by means of a field safety notice. Except in case of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in cases referred to in paragraph 6 of this Article, the coordinating competent authority to allow them to make comments. Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.
The manufacturer shall enter the field safety notice in the electronic system referred to in Article 62 through which that notice shall be accessible to the public.
6. The competent authorities shall designate a coordinating competent authority to coordinate their assessments referred to in paragraph 2 in the following cases:
|
(a) |
where similar serious incidents related to the same device or type of device of the same manufacturer occur in more than one Member State; [Am. not concerning all languages] |
|
(b) |
where the field safety corrective action is being or is to be undertaken in more than one Member State. |
Unless otherwise agreed between the competent authorities, the coordinating competent authority shall be the one of the Member State where the manufacturer has his registered place of business.
The coordinating competent authority shall inform the manufacturer, the other competent authorities and the Commission that it has assumed the role of coordinating authority.
7. The coordinating competent authority shall carry out the following tasks:
|
(a) |
to monitor the investigation of the serious incident by the manufacturer and the corrective action to be taken; [Am. not concerning all languages] |
|
(b) |
to consult with the notified body that issued a certificate in accordance with Article 45 for the device in question regarding the impact of the serious incident on the certificate; [Am. 208] |
|
(c) |
to agree with the manufacturer and the other competent authorities referred to in points (a) to (c) of Article 62(5) on the format, content and frequency of periodic summary reports in accordance with Article 61(2); |
|
(d) |
to agree with the manufacturer and other competent authorities concerned on the implementation of the appropriate field safety corrective action; |
|
(e) |
to inform the other competent authorities and the Commission, through the electronic system referred to in Article 62, of the progress in and the outcome of its assessment. |
The designation of a coordinating competent authority shall not affect the rights of the other competent authorities to perform their own assessment and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating competent authority and the Commission shall be kept informed of the outcome of any such assessment and the adoption of any such measures.
8. The Commission shall provide secretarial support to the coordinating competent authority in the accomplishment of its tasks under this Chapter.
Article 63a
Periodic safety update reports
1. Manufacturers of medical devices classified as class III shall report to the electronic system referred to in Article 62:
|
(a) |
summaries of data relevant to the benefits and risks of the medical devices, including results of all studies with a consideration of their potential impact on the certification; |
|
(b) |
a scientific evaluation of the risk-benefit ratio of the medical device; |
|
(c) |
all data relating to the volume of sales of the medical devices including an estimate of the population exposed to the medical device. |
2. Manufacturers shall submit periodic safety update reports to the competent authorities immediately upon request or at least once a year during the first 2 years following initial placing on the market of that medical device.
3. The MDCG shall assess the periodic safety update reports to determine whether there are new risks or whether risks have changed, or whether there are changes to the risk-benefit ratio of the medical device.
4. Following the assessment of the periodic safety update reports, the MDCG shall consider whether any action regarding the medical device concerned is necessary. The MDCG shall inform the notified body in case of unfavourable scientific assessment. In this case, the notified body shall maintain, vary, suspend or revoke the authorisation as appropriate. [Am. 209]
Article 64
Trend reporting
Manufacturers of devices classified in class IIb and III shall report to the electronic system referred to in Article 62 any statistically significant increase in the frequency or severity of incidents that are not serious all incidents or of expected undesirable side-effects that have a significant impact on the risk-benefit analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons when weighted against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents or expected undesirable side-effects in respect of the device, or category or group of devices, in question during a specific time period as established in the manufacturer's conformity assessment. Article 63 shall apply. [Am. 210]
Article 64a
Medical devices which fall under legal acts of the European Union concerning the quality and safety of blood
1. This Regulation is without prejudice to existing and implemented provisions at European level relating to the collection, testing, processing, storage and distribution of blood and blood components.
2. This Regulation is without prejudice to national laws and Union legislation in the field of traceability and vigilance in the field of blood and blood components which have a higher standard than this Regulation. They should be retained in the interests of patients. [Am. 211]
Article 65
Documentation of vigilance data
Manufacturers shall update their technical documentation with information on incidents received from healthcare professionals, patients and users, serious incidents, field safety corrective actions, periodic summary reports referred to in Article 61, trend reports referred to in Article 64 and field safety notices referred to in Article 63(5). They shall make this documentation available to their notified bodies, which shall assess the impact of the vigilance data on the conformity assessment and the certificate issued.
Article 66
Implementing acts
The Commission may, by means of implementing acts, adopt the modalities and procedural aspects necessary for the implementation of Articles 61 to 65 as regards the following:
|
(a) |
typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices; [Am. 212] |
|
(b) |
harmonised forms for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports by manufacturers as referred to in Articles 61 and 64; [Am. 213] |
|
(c) |
timelines for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports by manufacturers, taking into account the severity of the event to be reported as referred to in Articles 61 and 64; [Am. 214] |
|
(d) |
harmonised forms for the exchange of information between competent authorities as referred to in Article 63. |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
In drafting the implementing acts, the Commission shall seek the prior advice of the MDAC. [Am. 215]
SECTION 2 — MARKET SURVEILLANCE
Article 67
Market surveillance activities
1. The competent authorities shall perform appropriate checks on the characteristics and performance of devices including, where appropriate, review of documentation and physical or laboratory checks on the basis of adequate samples. They shall take account of established principles regarding risk assessment and risk management, vigilance data and complaints. The competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and, where necessary and justified, enter and inspect the premises of economic operators and take the necessary samples of devices for analysis by an official laboratory. They may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary.
1a. The competent authorities shall designate inspectors who shall be empowered to carry out the checks referred to in paragraph 1. The checks shall be carried out by the inspectors of the Member State in which the economic operator is located. These inspectors may be assisted by experts appointed by the competent authorities.
1b. Unannounced inspections may also be carried out. The organisation and implementation of such inspections shall always take account of the principle of proportionality, particularly with reference to the hazard potential of a particular product.
1c. Following each inspection carried out under paragraph 1, the competent authority shall draw up a report on compliance by the economic operator inspected with the legal and technical requirements applicable under this Regulation and any corrective actions needed.
1d. The competent authority which carried out the inspection shall communicate the content of this report to the inspected economic operator. Before adopting the report, the competent authority shall give the inspected economic operator the opportunity to submit comments. The final inspection report as referred to in paragraph 1b shall be entered into the electronic system provided for in Article 68.
1e. Without prejudice to any international agreements concluded between the Union and third countries, checks as referred in paragraph 1 may also take place in the premises of an economic operator located in a third country, if the device is intended to be made available on the Union market.
2. The Member States shall draw up strategic surveillance plans covering their planned surveillance activities, as well as the human and material resources needed to carry these activities out. Member States shall periodically review and assess the functioning implementation of their surveillance activities plans. Such reviews and assessments shall be carried out at least every four two years and the results thereof shall be communicated to the other Member States and the Commission. The Commission may make recommendations for adjustments to the surveillance plans. The Member State concerned States shall make a summary of the results and of the Commission’s recommendations accessible to the public. [Am. 216]
3. The competent authorities of the Member States shall coordinate their market surveillance activities, cooperate with each other and share with each other and with the Commission the results thereof. Where appropriate, the competent authorities of the Member States shall agree on work-sharing and specialisation.
4. Where more than one authority in a Member State is responsible for market surveillance and external border controls, those authorities shall cooperate with each other, by sharing information relevant to their role and functions.
5. The competent authorities of the Member States shall cooperate with the competent authorities of third countries with a view to exchanging information and technical support and promoting activities relating to market surveillance.
Article 68
Electronic system on market surveillance
1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information:
|
(a) |
information in relation to non-compliant devices presenting a risk to health and safety referred to in Article 70(2), (4) and (6); |
|
(b) |
information in relation to compliant devices presenting a risk to health and safety referred to in Article 72(2); |
|
(c) |
information in relation to formal non-compliance of products referred to in Article 73(2); |
|
(d) |
information in relation to preventive health protection measures referred to in Article 74(2). |
2. The information mentioned in paragraph 1 shall be immediately transmitted through the electronic system to all competent authorities concerned and be accessible to the Member States and to the Commission, to the Commission, to the notified bodies, to the EMA and to healthcare professionals. The Commission shall also ensure that the public has an appropriate level of access to the electronic system. In particular, it shall ensure that, in case information is requested on a specific medical device, it is made available without delay and within 15 days. The Commission, in consultation with the Medical Devices Coordination Group, shall provide an overview of this information, every 6 months, for the public and healthcare professionals. This information shall be accessible through the European databank in Article 27. [Am. 217]
The information referred to in points (a), (b), (c) and (d) of paragraph 1 shall be made available to the MDCG who shall communicate it at the first meeting of the MDAC after the information becomes available. [Am. 218]
Article 69
Evaluation regarding devices presenting a risk to health and safety at national level
Where the competent authorities of a Member State, based on vigilance data or other information, have sufficient reason to believe that a device presents a risk to the health or safety of patients, users or other persons, they shall carry out an evaluation in relation to the device concerned covering all the requirements laid down in this Regulation that are relevant to the risk presented by the device. The relevant economic operators shall cooperate as necessary with the competent authorities. In connection with that evaluation, the competent authorities shall inform the notified assessment bodies, in the case of class IIa, IIb and III devices, and the other competent authorities of the findings of the evaluation and the measures that are to be taken on the basis of those findings. [Am. 219]
Where the competent authorities of a Member State, based on vigilance data or other information, have reason to believe that a device presents a risk to the health or safety of patients, users or other persons, they may carry out an evaluation in relation to the device concerned covering all the requirements laid down in this Regulation that are relevant to the risk presented by the device. The relevant economic operators shall cooperate as necessary with the competent authorities. [Am. 220]
Article 70
Procedure for dealing with non-compliant devices presenting a risk to health and safety
1. Where, having performed an evaluation pursuant to Article 69, the competent authorities find that the device, which presents a risk to the health or safety of patients, users or other persons, does not comply with the requirements laid down in this Regulation, they shall without delay immediately require the relevant economic operator to take all appropriate and duly justified corrective action to bring the device into compliance with those requirements, to prohibit or restrict the making available of the device on the market, to subject the making available of the device to specific requirements, to withdraw the device from the market, or to recall it within a reasonable period that is clearly defined and communicated to the relevant economic operator, proportionate to the nature of the risk. [Am. 221]
2. Where the competent authorities consider that non-compliance is not restricted to their national territory, they shall immediately inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operators to take, by means of the electronic system referred to in Article 68. [Am. 222]
3. The economic operators shall without delay ensure that all appropriate corrective action is taken in respect of all the devices concerned that they have made available on the market throughout the Union. [Am. 223]
Where the concerned devices are to be recalled, the economic operator shall make all reasonable efforts to complete the recall before the end of the clearly defined period communicated to it by the competent authority as referred to in paragraph 1. [Am. 224]
4. Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 1, the competent authorities shall take all appropriate provisional measures to prohibit or restrict the device's being made available on their national market, to withdraw the device from that market or to recall it.
They shall notify the Commission and the other Member States, without delay immediately, of those measures, by means of the electronic system referred to in Article 68. [Am. not concerning all languages]
5. The notification referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant device, the origin of the device, the nature of and the reasons for the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
6. Member States other than the Member State initiating the procedure shall without delay inform the Commission and the other Member States of any additional information at their disposal relating to the non-compliance of the device concerned and of any measures adopted by them in relation to the device concerned. In the event of disagreement with the notified national measure, they shall without delay immediately inform the Commission and the other Member States of their objections, by means of the electronic system referred to in Article 68. [Am. not concerning all languages]
7. Where, within two months one month of receipt of the notification referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified. [Am. 227]
8. All Member States shall ensure that appropriate restrictive measures are taken without delay immediately in respect of the device concerned. [Am. not concerning all languages]
Article 71
Procedure at Union level
1. Where, within two months one month of receipt of the notification referred to in Article 70(4), objections are raised by a Member State against a provisional measure taken by another Member State, or where the Commission considers the measure to be contrary to Union legislation, the Commission shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide, by means of implementing acts, whether or not the national measure is justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). [Am. 229]
2. If the national measure is considered justified, Article 70(8) shall apply. If the national measure is considered unjustified, the Member State concerned shall withdraw the measure. Where, in the situations referred to in Articles 70 and 72, a Member State or the Commission consider that the risk to health and safety emanating from a device cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, the Commission, at the request of a Member State or on its own initiative, may take, by means of implementing acts, the necessary and duly justified measures to ensure the protection of health and safety, including measures restricting or prohibiting the placing on the market and putting into service of the device concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
3. On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts referred to in paragraphs 1 and 2 in accordance with the procedure referred to in Article 88(4).
Article 72
Procedure for dealing with compliant devices presenting a risk to health and safety
1. Where, having performed an evaluation pursuant to Article 69, a Member State finds that although a device has been legally placed on the market or put into service, it presents a risk to the health or safety of patients, users or other persons or to other aspects of the protection of public health, it shall immediately require the relevant economic operator or operators to take all appropriate provisional measures to ensure that the device concerned, when placed on the market or put into service, no longer presents that risk, to withdraw the device from the market or to recall it within a reasonable period, proportionate to the nature of the risk. [Am. 230]
2. The Member State shall immediately notify the Commission and the other Member States of the measures taken, by means of the electronic system referred to in Article 68. That information shall include the data necessary for the identification of the device concerned, the origin and the supply chain of the device, the findings of the Member State's evaluation specifying the nature of the risk involved and the nature and duration of the national measures taken.
3. The Commission shall evaluate the provisional national measures taken. On the basis of the results of that evaluation, the Commission shall decide, by means of implementing acts, whether or not the measure is justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 88(4).
4. Where the national measure is considered justified, Article 70(8) shall apply. If the national measure is considered unjustified, the Member State concerned shall withdraw the measure.
Article 73
Formal non-compliance
1. Without prejudice to Article 70, a Member State shall require the relevant economic operator to put an end to the non-compliance concerned within a reasonable period that is clearly defined and communicated and that is proportionate to the non-compliance where it makes one of the following findings: [Am. 231]
|
(a) |
that the CE marking has been affixed in violation of the formal requirements laid down in Article 18; |
|
(b) |
that the CE marking has not been affixed to a device contrary to Article 18; |
|
(c) |
that the CE marking has been inappropriately affixed in accordance with procedures in this Regulation on a product that is not covered by this Regulation; |
|
(d) |
that the EU declaration of conformity has not been drawn up or is not complete; |
|
(e) |
that the information to be supplied by the manufacturer on the label or in the instructions for use is not available, not complete or not provided in the language(s) required; |
|
(f) |
that the technical documentation, including the clinical evaluation, is not available or not complete. |
2. Where the economic operator does not put an end to the non-compliance within the period referred to in paragraph 1, the Member State concerned shall immediately take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market. That Member State shall inform the Commission and the other Member States without delay immediately of those measures, by means of the electronic system referred to in Article 68. [Am. 232]
Article 74
Preventive health protection measures
1. Where a Member State, after having performed an evaluation which indicates a potential risk related to a device or a specific category or group of devices considers that the making available on the market or putting into service of such device or specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled in order to protect the health and safety of patients, users or other persons or other aspects of public health, it may shall take any necessary and justified provisional measures. [Am. 233]
2. The Member State shall immediately notify the Commission and all other Member States, giving the reasons for its decision, by means of the electronic system referred to in Article 68.
3. The Commission shall assess the provisional national measures taken. The Commission shall decide, by means of implementing acts, whether the national measures are justified or not. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission may adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 88(4).
4. Where the assessment referred to in paragraph 3 demonstrates that the making available on the market or putting into service of a device, specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled in all Member States in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 to take the necessary and duly justified measures.
Where in this case imperative grounds of urgency so require, the procedure provided for in Article 90 shall apply to delegated acts adopted pursuant to this paragraph.
Article 75
Good administrative practice
1. Any measure adopted by the competent authorities of the Member States pursuant to Articles 70 to 74 shall state the exact grounds on which it is based. Where it is addressed to a specific economic operator, it shall be notified without delay to the economic operator concerned, who shall at the same time be informed of the remedies available to him under the law of the Member State concerned and of the time limits to which such remedies are subject. Where the measure is of general scope, it shall be appropriately published.
2. Except in cases where immediate action is necessary for reasons of serious risk to human health or safety, the economic operator concerned shall be given the opportunity to make submissions to the competent authority within an appropriate period of time that is clearly determined before any measure is adopted. If action has been taken without the economic operator being heard, he shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter. [Am. 234]
3. Any measure adopted shall be immediately withdrawn or amended upon the economic operator's satisfactorily demonstrating that he has taken effective corrective action. [Am. 235]
4. Where a measure adopted pursuant to Articles 70 to 74 concerns a product for which a notified body has been involved in the conformity assessment, the competent authorities shall inform the relevant notified body of the measure taken.
Chapter VIII IXa
Cooperation between Member States, Medical Device Coordination Group, Medical Device Advisory Committee, EU reference laboratories, device registers [Am. 264]
Article 76
Competent authorities
1. The Member States shall designate the competent authority or authorities responsible for the implementation of this Regulation. They shall entrust their authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. The Member States shall communicate the competent authorities to the Commission which shall publish a list of competent authorities and their contact details. [Am. 236]
2. For the implementation of Articles 50 to 60, the Member States may designate a national contact point other than a national authority. In this case, references to a competent authority in this Regulation shall be understood as including the national contact point.
Article 77
Cooperation
1. The competent authorities of the Member States shall cooperate with each other and with the Commission and with the MDCG as appropriate and exchange with each other and the Commission the information necessary to enable this Regulation to be applied uniformly. [Am. 237]
2. Member States and the Commission shall participate in initiatives developed at international level with the aim of ensuring cooperation between regulatory authorities in the field of medical devices.
Article 78
Medical Device Coordination Group
1. A Medical Device Coordination Group (MDCG) is hereby established.
2. Each Member State shall appoint, for a three-year term which may be renewed, one member and one alternate providing expertise in the field of this Regulation, and one member and one alternate providing expertise in the field of Regulation (EU) No […/…] [on in vitro diagnostic medical devices]. A Member State may choose to appoint only one member and one alternate providing expertise in both fields.
The members of the MDCG shall be chosen for their competence and experience in the field of medical devices and in vitro diagnostic medical devices. They shall represent the competent authorities of the Member States. The names and affiliation of members shall be made public by the Commission.
The alternates shall represent and vote for the members in their absence.
The Commission shall verify the competence of the members of the MDCG. The Commission shall make public the results of its verification in each instance and provide information about the competence of the members of the MDCG. [Am. 238]
3. The MDCG shall meet at regular intervals and, where the situation requires, on a request from the Commission or a Member State. The meetings shall be attended either by the members appointed for their role and expertise in the field of this Regulation, or by the members appointed for their expertise in the field of Regulation (EU) No […/…] [on in vitro diagnostic medical devices], or by the members appointed for both Regulations, as appropriate.
4. The MDCG shall use its best endeavours to reach consensus. If such consensus cannot be reached, the MDCG shall decide by the majority of its members. Members with diverging positions may request that their positions and the grounds on which they are based are recorded in the MDCG's position.
5. The MDCG shall be chaired by a representative of the Commission. The chair shall not take part in votes of the MDCG.
6. The MDCG may invite, on a case-by-case basis, experts and other third parties to attend meetings or provide written contributions. [Am. 239]
7. The MDCG may establish standing or temporary sub-groups. Where appropriate, organisations representing the interests of the medical device industry, healthcare professionals, laboratories, patients and consumers at Union level shall be invited in such sub-groups in the capacity of observers.
8. The MDCG shall establish its rules of procedure which shall, in particular, lay down procedures for the following:
|
— |
the adoption of opinions or recommendations or other positions by the MDCG, including in cases of urgency; |
|
— |
the delegation of tasks to reporting and co-reporting members; |
|
— |
the functioning of sub-groups. |
The rules of procedure shall enter into force after receiving a favourable opinion from the Commission.
Article 78a
Medical Device Advisory Committee
1. The Commission shall establish a multidisciplinary MDAC composed of experts and representatives of the relevant stakeholders in order to provide support, advice and expertise to the MDCG, the Commission and Member States on technical, scientific, social and economic aspects of regulating medical devices and in vitro diagnostic medical devices, such as in the field of medical technology, borderline cases involving medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, as well as further aspects of the implementation of this Regulation.
2. When establishing the MDAC, the Commission shall ensure a broad, appropriate and balanced representation of the disciplines relevant for medical devices. The MDAC may establish under its responsibility expert panels for specific medical disciplines.
3. The MDAC shall be chaired by a representative of the Commission. The Commission shall provide the logistic support to its operations.
4. The MDAC shall establish its rules of procedure which shall enter into force after receiving a favourable opinion from the Commission.
5. The MDAC shall ensure an appropriate level of consultation of the EMA and the EFSA when deliberating on borderline cases involving medicinal and food products.
6. The MDAC shall disclose the declarations of interest of its members. [Am. 240]
Article 78b
Assessment Committee for Medical Devices
1. An Assessment Committee for Medical Devices (ACMD) is hereby established, under the principles of the highest scientific competences, impartiality, and transparency and to avoid potential conflicts of interest.
2. The ACMD shall be composed of:
|
— |
at least one member representing each of the medical fields referred to in paragraph 3. This member shall be a recognised expert in his/her field and be able to draw on additional expertise where necessary. These experts shall be appointed by way of a Commission call for interest, for a 3 year term that maybe renewed once; |
|
— |
one representative of the EMA; |
|
— |
one representative of the European Commission; |
|
— |
three representatives of patients ‘organizations appointed by the European Commission by way of a Commission call for interest. |
The ACMD shall meet on request from the MDCG and the Commission, and its meetings shall be chaired by a Commission representative.
The Commission shall ensure that the composition of the ACMD corresponds to the expertise needed for the purpose of the assessment procedure in specific cases.
The Commission shall ensure the secretariat of this Committee.
3. The members of the ACMD shall be chosen for their competence and experience in the corresponding field:
|
— |
anaesthesiology; |
|
— |
blood grouping or tissue typing; |
|
— |
blood transfusion and transplantation; |
|
— |
cardiology; |
|
— |
communicable diseases; |
|
— |
dentistry; |
|
— |
dermatology; |
|
— |
ear/nose/throat (ENT); |
|
— |
endocrinology; |
|
— |
gastroenterology; |
|
— |
general/plastic surgery; |
|
— |
medical genetics; |
|
— |
nephrology/urology; |
|
— |
neurology; |
|
— |
obstetrics/Gynaecology; |
|
— |
oncology; |
|
— |
ophthalmology; |
|
— |
orthopaedics; |
|
— |
physical medicine; |
|
— |
pulmonology/pneumology; |
|
— |
radiology. |
The Members of the ACMD shall perform their tasks with impartiality and objectivity. They shall be completely independent and shall neither seek nor take instructions from any government, notified body or manufacturer. Each member shall draw up a declaration of interests which shall be made publicly available.
In the light of technical progress and any information which becomes available, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending, deleting or supplementing the fields referred to in the first subparagraph.
4. The ACMD shall fulfil the tasks defined in Article 44a. When adopting a clinical assessment, the members of the ACMD shall use their best endeavours to reach consensus. If consensus cannot be reached, the ACMD shall decide by the majority of its members. In the case of the Coordination Group, the European Commission shall not take part in votes. Diverging opinion shall be annexed to the ACMD opinion.
5. The ACMD shall establish its rules of procedure which shall, in particular lay down procedures for the following:
|
— |
the adoption of the clinical assessments including in case of urgency; |
|
— |
the delegation of tasks to members. [Am. 367] |
Article 79
Support by the Commission
The Commission shall support the functioning of the cooperation between national competent authorities and provide technical, scientific and logistic support to the MDCG and its sub-groups. It shall organise the meetings of the MDCG and its sub-groups, participate in those meetings and ensure the appropriate follow-up.
Article 80
Tasks of the MDCG
The MDCG shall have the following tasks:
|
(-a) |
to provide regulatory opinions on the basis of a clinical assessment delivered in accordance with Article 44a; |
|
(a) |
to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV; |
|
(aa) |
to establish and document the high level principles of competence and qualification and procedures for selection and authorisation of persons involved in conformity assessment activities (knowledge, experience and other competence required) and the required training (initial and ongoing). The qualification criteria shall address the various functions within the conformity assessment process as well as the devices, technologies and areas covered by the scope of designation; |
|
(ab) |
to review and approve the criteria of the competent authorities of Member States in respect of point (aa) of this Article; |
|
(ac) |
to oversee the coordination group of notified bodies as specified in Article 39; |
|
(ad) |
to support the Commission in providing an overview of vigilance data and market surveillance activities, including any preventive health protection measures taken, on a six-monthly basis. This information shall be accessible through the European databank referred to in Article 27; |
|
(b) |
to contribute to the scrutiny of certain conformity assessments pursuant to Article 44; [Ams. 366 and 368] |
|
(c) |
to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of the clinical evaluation by manufacturers and the assessment by notified bodies; |
|
(d) |
to assist the competent authorities of the Member States in their coordination activities in the fields of clinical investigations, vigilance and market surveillance; |
|
(e) |
to provide advice and assist the Commission, at its request, in its assessment of any issue related to the implementation of this Regulation; |
|
(f) |
to contribute to harmonised administrative practice with regard to medical devices in the Member States. |
Article 81
European Union reference laboratories
1. For specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices, the Commission may designate, by means of implementing acts, one or more European Union reference laboratories, hereinafter referred to as ‘EU reference laboratories’, that satisfy the criteria set out in paragraph 3. The Commission shall only designate laboratories for which a Member State or the Commission's Joint Research Centre have submitted an application for designation.
2. Within the scope of their designation, the EU reference laboratories shall, where appropriate, have the following tasks:
|
(a) |
to provide scientific and technical assistance to the Commission, the Member States and notified bodies in relation to the implementation of this Regulation; |
|
(b) |
to provide scientific advice and technical assistance regarding the definition of the state of the art in relation to specific devices, or a category or group of devices; [Am. 243] |
|
(c) |
to set up and manage a network of national reference laboratories and publish a list of the participating national reference laboratories and their respective tasks; |
|
(d) |
to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and market surveillance; |
|
(e) |
to collaborate with notified bodies in the development of best practices for the performance of conformity assessment procedures; |
|
(f) |
to contribute to the development of standards at CTS as well as of international level standards; [Am. 244] |
|
(g) |
to provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation; |
|
(ga) |
to provide scientific opinions and technical assistance to the Commission in relation to the requalification of single-use devices as reusable devices. [Am. 245] |
3. EU reference laboratories shall satisfy the following criteria:
|
(a) |
to have appropriately qualified staff with adequate knowledge and experience in the field of the medical devices for which they are designated; |
|
(b) |
to possess the necessary equipment and reference material to carry out the tasks assigned to them; |
|
(c) |
to have the necessary knowledge of international standards and best practices; |
|
(d) |
to have an appropriate administrative organisation and structure; |
|
(e) |
to ensure that their staff observe the confidentiality of the information and data obtained in carrying out their tasks. |
4. EU reference laboratories may be granted a Union financial contribution.
The Commission may adopt, by means of implementing acts, the modalities and the amount of the grant of a Union financial contribution to EU reference laboratories, taking into account the objectives of protection of health and safety, support of innovation and cost-effectiveness. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
5. Where notified bodies or Member States request scientific or technical assistance or a scientific opinion from an EU reference laboratory, they may be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to a set of predetermined and transparent terms and conditions.
6. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 for the following purposes:
|
(a) |
amending or supplementing the tasks of EU reference laboratories referred to in paragraph 2 and the criteria to be satisfied by EU reference laboratories referred to in paragraph 3. |
|
(b) |
setting out the structure and the level of the fees referred to in paragraph 5 which may be levied by an EU Reference Laboratory for providing scientific opinions in response to consultations by notified bodies in accordance with this Regulation, taking into account the objectives of protection of human health and safety, support of innovation and cost-effectiveness. |
7. EU reference laboratories shall be subject to controls, including on-site visits and audits, by the Commission to verify compliance with the requirements of this Regulation. If these controls find that a laboratory is not complying with those requirements for which they have been designated, the Commission, by means of implementing acts, shall take appropriate measures, including the withdrawal of the designation.
Article 82
Conflict of interests
1. Members of the MDCG, of the advisory panels to the MDCG and staff of the EU reference laboratories shall not have financial or other interests in the medical device industry or in the supply chain which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner. They shall declare any direct and indirect interests they may have in the medical device industry or in the supply chain and update this declaration whenever a relevant change occurs. Upon request The declaration of interests shall be accessible to the public. This Article shall not apply to the representatives of stakeholder organisations participating in the sub-groups of the MDCG made publicly available on the Commission website. [Am. 246]
2. Experts and other third parties invited by the MDCG on a case-by-case basis participating in the advisory committee referred to in Article 78a shall be requested to declare their interests in the issue in question. [Am. 247]
Article 83
Device registers
The Commission and the Member States shall take all appropriate measures to encourage ensure the establishment of coordinated and harmonised registers for specific types of medical devices to gather post-market experience related to the use of such devices. Registers for medical devices in classes IIb and III shall be systematically established. Such registers shall contribute to the independent evaluation of the long-term safety and performance of devices. [Am. 248]
Chapter IX IXb [Am. 265]
Confidentiality, data protection, funding, penalties
Article 84
Confidentiality
1. Unless otherwise provided in this Regulation and without prejudice to existing national provisions and practices in the Member States on medical confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:
|
(a) |
personal data in compliance with Directive 95/46/EC and Regulation (EC) No 45/2001; |
|
(b) |
commercial interests of a natural or legal person, including intellectual property rights; |
|
(c) |
the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits. |
2. Without prejudice to paragraph 1, information exchanged between competent authorities and between competent authorities and the Commission on condition of confidentiality shall remain confidential unless the originating authority has agreed to its disclosure.
3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to exchange of information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.
4. The Commission and Member States may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Article 85
Data protection
1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.
2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.
Article 86
Levy of fees
This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities set out in this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of cost recovery principles. They shall inform the Commission and the other Member States at least three months before the structure and level of fees is to be adopted. The structure and level of fees shall be publicly available on request. [Am. 249]
Article 87
Penalties
The Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate, and dissuasive. The dissuasive nature of the penalty shall be determined in relation to the financial benefit obtained as a result of the infringement. The Member States shall notify those provisions to the Commission by [3 months prior to the date of application of the Regulation] and shall notify it without delay of any subsequent amendment affecting them. [Am. 250]
Chapter X
Final provisions
Article 88
Committee procedure
1. The Commission shall be assisted by a Committee on Medical Devices. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 or Article 5, as appropriate, shall apply.
Article 89
Exercise of the delegation
1. The power to adopt the delegated acts referred to in Articles 2(2) and (3), 4(5), 8(2), 15b(1), 16(1), 17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42(11), 44a(2), 44a(9), 45(5), 51(7), 53(3), 57(3a), 74(4), 78b(3) and 81(6) is conferred on the Commission subject to the conditions laid down in this Article. [Am. 251]
The Commission shall, in drafting delegated acts, seek the advice of the MDCG. [Am. 254]
2. The delegation of power referred to in Articles 2(2) and (3), 4(5), 8(2),15b(1), 16(1), 17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42(11), 44a(2), 44a(9), 45(5), 51(7), 53(3), 57(3a), 74(4), 78b(3)) and 81(6) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation. [Am. 252]
3. The delegation of power referred to in Articles 2(2) and (3), 4(5), 8(2), 15b(1), 16(1), 17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42(11), 44a(2), 44a(9), 45(5), 51(7), 53(3), 57(3a), 74(4), 78b(3) and 81(6) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. [Am. 253]
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to any of the Articles listed in paragraph 1 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period may be extended by two months at the initiative of the European Parliament or the Council.
Article 90
Urgency procedure for delegated acts
1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 89. In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or the Council.
Article 91
Amendments to Directive 2001/83/EC
In Annex I of Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following:
|
‘(12) |
Where a product is governed by this Directive in accordance with the second subparagraph of Article 1(4) or the second subparagraph of Article 1(5) of Regulation (EU) […/…] on medical devices (43), the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements of Annex I of that Regulation contained in the manufacturer's EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device. If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) […/…], the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements of Annex I of that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question, unless the authority is advised by its experts for medical devices that involvement of a notified body is not required.’ |
Article 92
Amendments to Regulation (EC) No 178/2002
In the third subparagraph of Article 2 of Regulation (EC) No 178/2002, the following point (i) is added:
|
‘(i) |
medical devices within the meaning of Regulation (EU) […/…] (44).’ |
Article 93
Amendments to Regulation (EC) No 1223/2009
In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:
‘4. In accordance with the regulatory procedure referred to in Article 32(2), the Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures to determine whether or not a specific product or group of products falls within the definition “cosmetic product”.’
Article 94
Transitional provisions
1. From the date of application of this Regulation any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.
2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to the entry into force of this Regulation shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex 4 of Directive 90/385/EEC or Annex IV of Directive 93/42/EEC which shall become void at the latest two years after the date of application of this Regulation.
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC after the entry into force of this Regulation shall become void at the latest two years after the date of application of this Regulation.
3. By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market before its date of application.
4. By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified before its date of application. Notified bodies which are designated and notified in accordance with this Regulation may apply the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation before its date of application if the relevant delegated acts and implementing acts have been implemented. [Am. 255]
5. By way of derogation from Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, manufacturers, authorised representatives, importers and notified bodies who, during the period from [date of application] until [18 months after date of application], comply with Article 25(2) and (3) and Article 45(4) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with, respectively, Article 10a of Directive 90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC and with, respectively, point (a) of Article 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article 14a(1) of Directive 93/42/EEC as specified in Decision 2010/227/EU.
6. Authorisations granted by competent authorities of the Member States in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC shall keep the validity indicated in the authorisation.
7. Devices falling within the scope of this Regulation in accordance with point (e) of Article 1(2) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to the application of this Regulation may continue to be placed on the market and put into service in the Member States concerned.
8. Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to the application of this Regulation may continue to be conducted. As of the application of this Regulation, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation.
Article 95
Evaluation
No later than seven years after the date of application, the Commission shall assess the application of this Regulation and establish an evaluation report on the progress towards achievement of the objectives of the Regulation including an assessment of resources required to implement this Regulation.
Article 96
Repeal
Directives 90/385/EEC and 93/42/EEC are repealed with effect from [date of application of this Regulation], with the exception of Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC which are repealed with effect from [18 months after date of application].
References to the repealed Council Directives shall be understood as reference to this Regulation and shall be read in accordance with the correlation table laid down in Annex XVI.
Article 97
Entry into force and date of application
1. This Regulation shall enter into force on the twentieth day after its publication in the Official Journal of the European Union.
2. It shall apply from [three years after entry into force].
3. By way of derogation from paragraph 2 the following shall apply:
|
(a) |
Article 25(2) and (3) and Article 45(4) shall apply from [18 months after date of application referred to in paragraph 2]; |
|
(b) |
Articles 28 to 40 and Article 78 shall apply from [six months after entry into force]. However, prior to [date of application as referred to in paragraph 2], the obligations on notified bodies emanating from the provisions in Articles 28 to 40 shall apply only to those bodies which submit an application for notification in accordance with Article 31 of this Regulation. |
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at …,
For the European Parliament
The President
For the Council
The President
(1) OJ C 133, 9.5.2013, p. 52.
(2) Position of the European Parliament of 2 April 2014.
(3) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).
(4) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
(5) Council Directive 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU (OJ L 134, 1.6.2010, p. 66).
(6) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
(7) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).
(8) Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, p. 34).
(9) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
(10) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).
(11) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(12) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(13) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(14) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30).
(15) Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial (OJ L 275, 20.10.2011, p. 38).
(16) Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (OJ L 390, 31.12.2004, p. 24).
(17) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
(18) Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation (OJ L 159, 29.6.1996, p. 1).
(19) Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure and repealing Directive 84/466/Euratom (OJ L 180, 9.7.1997, p. 22).
(21) OJ L 114, 30.4.2002, p. 369.
(22) OJ 217, 29.12.1964, p. 3687.
(23) Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (OJ L 204, 21.7.1998, p. 37), as amended by Directive 98/48/EC of the European Parliament and of the Council (OJ L 217, 5.8.1998, p. 18).
(24) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(25) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).
(26) Directive 2013/35/EU of the European Parliament and of the Council of 26 June 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) and repealing Directive 2004/40/EC (OJ L 179, 29.6.2013, p. 1).
(27) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(28) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(29) Judgment of the Court of 28 July 2011 in joined cases C-400/09 and C-207/10.
(30) Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC (OJ L 241, 10.9.2008, p. 21).
(31) COM(2010)0443.
(32) Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ L 174, 1.7.2011, p. 74).
(33) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p. 45).
(34) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(35) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
(36) WMA Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and lastly amended by the 59th WMA General Assembly, Seoul, Korea, October 2008
http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-media-type&footer-right=[page]/[toPage]
(37) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
(38) OJ L […], […], p. […].
(39) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(40) OJ C 358, 7.12.2013, p. 10.
(41) OJ L 124, 20.5.2003, p. 36
(42) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(43) OJ L […], […], p. […].
(44) OJ L […], […], p. […].
ANNEX I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
I. General requirements
|
1. |
Devices shall achieve the performance intended by the manufacturer and be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose, taking into account the generally acknowledged state of the art. They shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. This shall include:
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|
2. |
The solutions adopted by the manufacturer for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, the manufacturer shall manage the risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. The manufacturer shall apply the following principles in the priority order listed:
Points (a), (b), (c) and (d) of this point shall not reduce the necessity for clinical investigation and post-market clinical follow up to adequately address the risks, hazards and performance of devices. [Am. 267] |
|
3. |
The characteristics and performances of the device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions. When no lifetime is stated, the same applies for the lifetime reasonably to be expected of a device of that kind, having regard to the intended purpose and the anticipated use of the device. |
|
4. |
Devices shall be designed, manufactured and packaged in such a way that their characteristics and performances during their intended use will not be adversely affected by transport and storage conditions (for example, fluctuations of temperature and humidity) taking account of the instructions and information provided by the manufacturer. |
|
5. |
All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the benefits to the patient of the achieved performance of the device during normal conditions of use. |
|
6. |
For devices listed in Annex XV for which the manufacturer does not claim a medical purpose, the general requirements set out in Sections 1 and 5 shall be understood that the device, when used under the conditions and for the purposes intended, shall not present any risk or only the minimum acceptable risks related to the product's use which is consistent with a high level of protection for the safety and health of persons. |
|
6a. |
This Regulation now combines active implantable medical devices covered by Directive 90/385/EEC, and implantable medical devices covered by Directive 93/42/EEC, and places all active implantable medical devices and implantable devices of public health concern in the highest risk class III category attracting the strictest controls, and as the vast majority of class IIb implantable medical devices such as pins, bone-screws, plates, staples etc., have a long history of safe implantation within the human body, and as special notified bodies will be specifically designated for such class IIb implantable devices, class IIb implantable devices need not be subjected to the scrutiny procedure. [Am. 378] |
II. Requirements regarding design and construction
7. Chemical, physical and biological properties
|
7.1. |
The devices shall be designed and manufactured in such a way as to ensure the characteristics and performance referred to in Chapter I ‘General Requirements’. Particular attention shall be paid to:
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|
7.2. |
The devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed and to the duration and frequency of exposure. |
|
7.3. |
The devices shall be designed and manufactured in such a way that they can be used safely with the materials and substances, including gases, with which they enter into contact during their normal use or during routine procedures; if the devices are intended to administer medicinal products they shall be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing these medicinal products and that both the performance of the medicinal products and of the devices are maintained in accordance with their respective indications and intended use. |
|
7.4. |
The devices shall be designed and manufactured in such a way as to reduce as far as possible and appropriate the risks posed by substances that may leach or leak from the device. Special attention shall be given to Medical devices or parts thereof that are invasive or come into contact with the body of patients, or (re)administer medicines, body liquids or other substances, including gases, to/from the body, or transport or store such medicines, body fluids or substances , including gases, to be (re)administered to the body, shall not contain, in concentrations above 0,1 % by weight in homogeneous materials, substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (1), and to or substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and or which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2), or are endocrine disrupters pursuant to Commission Recommendation (…/…/EU) on criteria for the identification of endocrine disrupters. . The Commission shall be empowered to adopt delegated acts in accordance with Article 89 to allow the use of such substances for a period not exceeding four years where any of the following conditions is fulfilled:
The Commission shall be empowered to adopt delegated acts in accordance with Article 89 to renew the derogation if the criteria of the second subparagraph continue to be fulfilled. Manufacturers wishing to apply for a derogation, a renewal of a derogation or the revoking of a derogation shall submit the following information to the Commission:
If devices, or parts thereof, that are intended as referred to in the first subparagraph,
contain, in a concentration of 0,1 % by mass of the plasticised or above, in a homogeneous material or above, phthalates substances which are classified as carcinogenic, mutagenic or toxic to reproduction of category 1A or 1B in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008, these or substances identified as endocrine disrupters pursuant to the first subparagraph, and were granted a derogation pursuant to the second or third subparagraph, the devices shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as devices containing phthalates. If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women such substances. The manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures. [Am. 355] |
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7.5. |
Devices shall be designed and manufactured in such a way as to reduce as far as possible and appropriate risks posed by the unintentional ingress or egress of substances into or from the device taking into account the device and the nature of the environment in which it is intended to be used. |
|
7.6. |
The devices shall be designed and manufactured in such a way as to reduce to a minimum the risks linked to the size and the properties of particles used. Special care shall be applied when devices contain or consist of nanomaterial that can be released into the patient's or user's body. |
8. Infection and microbial contamination
|
8.1. |
The devices and manufacturing processes shall be designed in such a way as to eliminate or to reduce as far as possible the risk of infection to patients, users and, where applicable, other persons. The design shall:
|
|
8.2. |
Devices labelled as having a special microbiological state shall be designed, manufactured and packaged to ensure that they remain so when placed on the market and remain so under the transport and storage conditions specified by the manufacturer. |
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8.3. |
Devices delivered in a sterile state shall be designed, manufactured and packaged in a non-reusable pack, and/or according to appropriate procedures, to ensure that they are sterile when placed on the market and remain sterile, under the transport and storage conditions indicated by the manufacturer, until the protective packaging is damaged or opened. |
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8.4. |
Devices labelled either as sterile or as having a special microbiological state shall have been processed, manufactured and, if applicable, sterilised by appropriate, validated methods. |
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8.5. |
Devices intended to be sterilised shall be manufactured in appropriately controlled (e.g. environmental) conditions. |
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8.6. |
Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, if the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer. |
|
8.7. |
The labelling of the device shall distinguish between identical or similar products placed on the market in both sterile and non-sterile condition. |
|
8.7a. |
Medical device manufacturers shall notify their users of the levels of disinfection required to ensure patient safety and of all available methods for achieving those levels of disinfection. Manufacturers shall be required to test their devices using all methods designed to ensure patient safety and to substantiate any decision to reject a solution, either by demonstrating that it is ineffective or by demonstrating that it will cause damage impairing the medical usefulness of their devices to a significantly greater degree than other solutions that they themselves recommend. [Am. 273] |
9. Devices incorporating a substance considered to be a medicinal product and devices composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally. [Am. 274]
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9.1. |
In the case of devices referred to in the first subparagraph of Article 1(4), the quality, safety and usefulness of the substance which, if used separately, would be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC, shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC, as laid down in the applicable conformity assessment procedure in this Regulation. |
|
9.2. |
Devices that are composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body shall comply, by analogy, with the relevant requirements laid down in Annex I to Directive 2001/83/EC. [Am. 275] |
10. Devices incorporating materials of biological origin
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10.1. |
For devices manufactured utilising tissues or cells, or their derivatives, of human origin which are covered by this Regulation in accordance with point (e) of Article 1(2) the following applies:
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10.2. |
For devices manufactured utilising tissues or cells, or their derivatives, of animal origin which are non-viable or rendered non-viable the following applies:
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10.3. |
For devices manufactured utilising other non-viable biological substances the following applies: In the case of biological substances other than those referred to in Sections 10.1. and 10.2., the processing, preservation, testing and handling of those substances shall be carried out so as to provide optimal safety for patients, users and, where applicable, other persons , including in the waste disposal chain . In particular, safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process. [Am. 277] |
11. Interaction of devices with their environment
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11.1. |
If the device is intended for use in combination with other devices or equipment the whole combination, including the connection system shall be safe and shall not impair the specified performance of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use. Connections which the user has to handle, such as fluid, gas transfer or mechanical coupling, shall be designed and constructed in such a way as to minimize all possible risks from incorrect connection. |
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11.2. |
Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible and appropriate:
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|
11.2a. |
Devices which can transfer potentially fatal blood-borne infections to healthcare staff, patients or other persons, by unintended cuts and pricks such as needle stick injuries, shall incorporate appropriate safety-engineered protection mechanisms in accordance with Directive 2010/32/EU. However the specificities relating to the dental profession must be respected. [Am. 278] |
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11.3. |
Devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention shall be paid to devices whose intended purpose includes exposure to or use in association with flammable substances or substances which could cause combustion. |
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11.4. |
Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance, where such is necessary to achieve the performances intended, can be done safely. |
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11.5. |
Devices that are intended to be operated together with other devices or products shall be designed and manufactured in such as way that the interoperability is reliable and safe. |
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11.6. |
Any measurement, monitoring or display scale shall be designed in line with ergonomic principles, taking account of the intended purpose of the device. |
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11.7. |
Devices shall be designed and manufactured in such a way as to facilitate the safe disposal of the device and the substances to which the device has been exposed and /or of any waste substances by the user, patient or other person and, where possible and appropriate, replace with the use of devices and methods with improved safety features and characteristics to reduce as far as possible the exposure of patients, users and other persons to potentially harmful substances, such as chemical or nuclear material . [Am. 279] |
12. Devices with a diagnostic or measuring function
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12.1. |
Diagnostic devices and devices with a measuring function, shall be designed and manufactured in such a way as to provide sufficient accuracy, precision and stability for their intended purpose, based on appropriate scientific and technical methods. The limits of accuracy shall be indicated by the manufacturer. |
|
12.2. |
The measurements made by devices with a measuring function and expressed in legal units shall conform to the provisions of Council Directive 80/181/EEC (4). |
13. Protection against radiation
13.1. General
|
(a) |
Devices shall be designed and manufactured and packaged in such a way that exposure of patients, users and other persons to any emitted radiation shall be reduced as far as possible and appropriate, compatible with the intended purpose, and if possible these applications shall be replaced with applications with a higher safety standard, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes. [Am. 280] |
|
(b) |
The operating instructions for devices emitting radiation shall give detailed information as to the nature of the emitted radiation, means of protecting the patient and the user and on ways of avoiding misuse and of eliminating the risks inherent in installation. |
13.2. Intended radiation
|
(a) |
Where devices are designed to emit hazardous, or potentially hazardous, levels of visible and/or invisible radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the emission, it shall be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility of relevant variable parameters within an acceptable tolerance. |
|
(b) |
Where devices are intended to emit potentially hazardous, visible and/or invisible radiation, they shall be fitted, where possible, with visual displays and/or audible warnings of such emissions. |
13.3. Unintended radiation
Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible and appropriate : where possible, methods should be selected which reduce the exposure to radiation of patients, users and other persons who may be affected . [Am. 281]
13.4. Ionising radiation
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(a) |
Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure that, where possible, the quantity, geometry and energy distribution (or quality) of radiation emitted can be varied and controlled taking into account the intended use , and if possible, devices should be used that can at any time during and after treatment monitor the emission of radiation . [Am. 282] |
|
(b) |
Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in such a way as to achieve appropriate image and/or output quality for the intended medical purpose whilst minimising radiation exposure of the patient and user. |
|
(c) |
Devices emitting ionising radiation, intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam characteristics in terms of type of radiations, energy and, where appropriate, energy distribution. |
14. Software incorporated in devices and standalone software
|
14.1. |
Devices that incorporate electronic programmable systems, including software, or standalone software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance according to the intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible and appropriate consequent risks. |
|
14.2. |
For devices that incorporate software or for standalone software that are devices in themselves, the software shall be developed and manufactured according to the state of the art taking into account the principles of development life cycle, risk management, verification and validation. |
|
14.3. |
Software referred to in this Section that are intended to be used in combination with mobile computing platforms shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards to level of light or noise). |
15. Active devices and devices connected to them
|
15.1. |
For active devices, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible and appropriate consequent risks. |
|
15.2. |
Devices where the safety of the patients depends on an internal power supply shall be equipped with a means of determining the state of the power supply. |
|
15.3. |
Devices where the safety of the patients depends on an external power supply shall include an alarm system to signal any power failure. |
|
15.4. |
Devices intended to monitor one or more clinical parameters of a patient shall be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health. |
|
15.5. |
Devices shall be designed and manufactured in such a way as to reduce as far as possible and appropriate the risks of creating electromagnetic interference which could impair the operation of this or other devices or equipment in the intended environment. |
|
15.6. |
Devices shall be designed and manufactured in such a way as to provide an adequate level of intrinsic immunity to electromagnetic disturbance to enable them to operate as intended. |
|
15.7. |
Devices shall be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks to the patient, user or any other person, both during normal use of the device and in the event of a single fault condition in the device, provided the device is installed and maintained as indicated by the manufacturer. |
16. Protection against mechanical and thermal risks
|
16.1. |
Devices shall be designed and manufactured in such a way as to protect the patient and user against mechanical risks connected with, for example, resistance to movement, instability and moving parts. |
|
16.2. |
Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance. |
|
16.3. |
Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance. |
|
16.4. |
Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user or other person has to handle shall be designed and constructed in such a way as to minimise all possible risks. |
|
16.5. |
Errors likely to be made when fitting or refitting, or connecting or reconnecting, certain parts before or during use which could be a source of risk must be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings. The same information must be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk. |
|
16.6. |
Accessible parts of the devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use. |
17. Protection against the risks posed to the patient or user by supplied energy or substances
|
17.1. |
Devices for supplying the patient with energy or substances shall be designed and constructed in such a way that the delivered amount can be set and maintained accurately enough to assure the safety of the patient and of the user. |
|
17.2. |
Devices shall be fitted with the means of preventing and/or indicating any inadequacies in the delivered amount which could pose a danger. Devices shall incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances from an energy and/or substance source. |
|
17.3. |
The function of the controls and indicators shall be clearly specified on the devices. Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information shall be understandable to the user and, as appropriate, the patient. |
18. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons
|
18.1. |
Devices for use by lay persons shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to lay persons and the influence resulting from variation that can reasonably be anticipated in the lay person's technique and environment. The information and instructions provided by the manufacturer shall be easy for the lay person to understand and apply. |
|
18.2. |
Devices for use by lay persons shall be designed and manufactured in such a way as to
|
|
18.3. |
Devices for use by lay persons shall, where reasonably possible, include a procedure by which the lay person
|
III. Requirements regarding the information supplied with the device
19. Label and instructions for use
19.1. General requirements regarding the information supplied by the manufacturer
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and communicate safety and performance related information to the user, professional or lay, or other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, taking into account the following:
|
(a) |
The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams. Some devices may include separate information for the professional user and the lay person. |
|
(b) |
The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices. Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided. |
|
(c) |
For devices of class I and IIa, instructions for use are not needed or may be abbreviated if the device can be used safely and as intended by the manufacturer without any such instructions for use. |
|
(d) |
Labels shall be provided in a human-readable format but may and shall be supplemented by machine-readable forms, such as radio-frequency identification (RFID) or bar codes. [Am. 284] |
|
(e) |
Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent and under the conditions set out in Commission Regulation (EU) No 207/2012 (5). |
|
(f) |
Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contraindications, precautions or warnings in the information supplied by the manufacturer. |
|
(g) |
Where appropriate, this information should take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CTS. In areas for which no standards or CTS exist, the symbols and colours shall be described in the documentation supplied with the device. |
19.2. Information on the label
The label shall bear the following particulars:
|
(a) |
The name or trade name of the device. |
|
(aa) |
The statement ‘This product is a medical device’. [Am. 285] |
|
(b) |
The details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device and where applicable that the device is only to be used during a single procedure. [Am. 286] |
|
(c) |
The name, registered trade name or registered trade mark of the manufacturer and the address of his registered place of business at which he can be contacted and his location be established. |
|
(d) |
For imported devices, the name, registered trade name or registered trade mark of the authorised representative established within the Union and the address of his registered place of business at which he can be contacted and his location be established. |
|
(e) |
Where applicable, an indication that the device contains or incorporates
|
|
(f) |
Where applicable, an indication that the device incorporates or consists of nanomaterial unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient's or user's body when the device is used within its intended purpose. |
|
(g) |
The batch code/lot number or the serial number of the device preceded by the word LOT or SERIAL NUMBER or an equivalent symbol, as appropriate. |
|
(h) |
Where applicable, the unique device identification (UDI). |
|
(i) |
An unambiguous indication of the date until when the device may be used safely, expressed at least as the year and month, where this is relevant. |
|
(j) |
Where there is no indication of the date until when it may be used safely, the year of manufacture. This year of manufacture may be included as part of the batch or serial number, provided the date is clearly identifiable. |
|
(k) |
An indication of any special storage and/or handling condition that applies. |
|
(l) |
If the device is supplied sterile, an indication of its sterile state and the sterilisation method. |
|
(m) |
Warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device as relevant, and to any other person where appropriate. This information may be kept to a minimum in which case more detailed information should appear in the instructions for use. |
|
(n) |
If the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union. |
|
(o) |
If the device is a single use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles. [Am. 287] |
|
(p) |
If the device is custom made, an indication of that fact. |
|
(q) |
If the device is intended for clinical investigation only, an indication of that fact. |
19.3. Information in the instructions for use
The instructions for use shall contain the following particulars:
|
(a) |
The particulars referred to in points 19.2. a), c), e), f), k), l) and n). |
|
(b) |
The device's intended purpose including the intended user (e.g. professional or lay person), as appropriate. |
|
(c) |
The performance of the device intended by the manufacturer. |
|
(d) |
Any residual risks, contraindications and any expected and foreseeable undesirable side-effects, including information to be conveyed to the patient in this regard. |
|
(e) |
Specifications the user requires to use the device appropriately, e.g. if the device has a measuring function, the degree of accuracy claimed for it. |
|
(f) |
Details of any preparatory treatment or handling of the device before it is ready for use (e.g. sterilisation, final assembly, calibration, etc.). |
|
(g) |
Any requirements for special facilities, or special training, or particular qualifications of the device user and/or other persons. |
|
(h) |
The information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant:
|
|
(i) |
If the device is supplied sterile, instructions in the event of the sterile packaging being damaged before use. |
|
(j) |
If the device is supplied non-sterile with the intention that it is sterilised before use, the appropriate instructions for sterilisation. |
|
(k) |
If the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, decontamination, packaging, the maximum number of allowable reuses and, where appropriate, the validated method of re-sterilisation. Information should be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses. [Am. 288] |
|
(l) |
With the exception of devices referred to in Article 15b, if the device bears an indication that it is for single use, the evidence justifying that the device cannot be reprocessed safely as referred to in Article 15c(1), and which includes all information on characteristics and technical factors that could pose a risk if the device were to be re-used. If in accordance with point c) of Section 19.1 no instructions for use are needed, the information shall be made available to the user upon request. [Am. 289] |
|
(la) |
The instructions for use shall be lay-friendly and reviewed by the representatives of relevant stakeholders, including patient and healthcare professionals' organisations. [Am. 290] |
|
(m) |
For devices intended for use together with other devices and/or general purpose equipment:
|
|
(n) |
If the device emits hazardous, or potentially hazardous levels of radiation for medical purposes:
|
|
(o) |
Information that allows the user and/or patient to be informed of any warnings, precautions, measures to be taken and limitations of use regarding the device. This information should cover, where appropriate:
|
|
(p) |
Warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories and the consumables used with it, if any. This information should cover, where appropriate:
|
|
(q) |
For devices intended for use by lay persons, the circumstances when the user should consult with a healthcare professional. |
|
(r) |
For devices listed in Annex XV for which the manufacturer does not claim a medical purpose, information regarding the absence of a clinical benefit and the risks related to the use of the device. |
|
(s) |
Date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use. |
|
(t) |
A notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State where the user and/or patient is established. |
(1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
(2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
(3) Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
(4) OJ L 39, 15.2.1980, p. 40.
(5) Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, p. 28).
ANNEX II
TECHNICAL DOCUMENTATION
The technical documentation and, if applicable, the summary technical documentation (STED) to be drawn up by the manufacturer shall include in particular the following elements:
1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
1.1. Device description and specification
|
(a) |
product or trade name and a general description of the device including its intended purpose, |
|
(b) |
the UDI device identifier as referred to in item (i) of point (a) of Article 24(1) attributed by the manufacturer to the device in question, as soon as identification of this device shall be based on a UDI system, or otherwise clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability; |
|
(c) |
the intended patient population and medical condition to be diagnosed and/or treated and other considerations such as patient selection criteria; |
|
(d) |
principles of operation of the device; |
|
(e) |
risk class and the applicable classification rule according to Annex VII; |
|
(f) |
an explanation of any novel features; |
|
(g) |
a description of the accessories, other medical devices and other products that are not medical devices, which are intended to be used in combination with it; |
|
(h) |
a description or complete list of the various configurations/variants of the device that will be made available; |
|
(i) |
a general description of the key functional elements, e.g. its parts/components (including software if appropriate), its formulation, its composition, its functionality. Where appropriate, this shall include labelled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient explanation to understand the drawings and diagrams; |
|
(j) |
a description of the (raw) materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids; |
|
(k) |
technical specifications (features, dimensions and performance attributes) of the medical device and any variants and accessories that would typically appear in the product specification made available to the user, e.g. in brochures, catalogues and the like. |
1.2. Reference to previous and similar generations of the device
|
(a) |
an overview of the manufacturer's previous generation(s) of the device, if such exist; |
|
(b) |
an overview of the manufacturer's similar devices available on the EU or international markets, if such exist. |
2. INFORMATION SUPPLIED BY THE MANUFACTURER
|
(a) |
a complete set of
|
|
(b) |
a list of the language variants for the Member States where the device is envisaged to be marketed. |
3. DESIGN AND MANUFACTURING INFORMATION
|
(a) |
Information to allow a general understanding of the design stages applied to the device and the manufacturing processes such as production, assembly, final product testing, and packaging of the finished device. More detailed information needs to be provided for the audit of the quality management system or other applicable conformity assessment procedures; |
|
(b) |
identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed. |
4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
The documentation shall contain information regarding the solutions adopted to meet the general safety and performance requirements laid down in Annex I. This information may take the form of a checklist identifying
|
(a) |
the general safety and performance requirements that apply to the device and why others do not apply; |
|
(b) |
the method(s) used to demonstrate conformity with each applicable general safety and performance requirement; |
|
(c) |
the harmonised standards or CTS applied or other method(s) employed; |
|
(d) |
the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CTS or other method employed to demonstrate conformity with the general safety and performance requirements. This information shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation. |
5. RISK/BENEFIT ANALYSIS AND RISK MANAGEMENT
The documentation shall contain a summary of all available information concerning: [Am. 291]
|
(a) |
the risk/benefit analysis referred to in Sections 1 and 5 of Annex I, and |
|
(b) |
the solutions adopted and the results of the risk management referred to in Section 2 of Annex I. |
6. PRODUCT VERIFICATION AND VALIDATION
The documentation shall contain the results of verification and validation testing and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.
6.1. Pre-clinical and clinical data
|
(a) |
results of (engineering, laboratory, simulated use, animal) tests and evaluation of published literature applicable to the device or substantially similar devices regarding the pre-clinical safety of the device and its conformity with the specifications; |
|
(b) |
detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding
Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council (1) shall be demonstrated. Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision, e.g. biocompatibility testing on the identical materials was conducted when these were incorporated in a previous version of the device that has been legally placed on the market or put into service; |
|
(c) |
the report on the clinical evaluation in accordance with Article 49(5) and Part A of Annex XIII; |
|
(d) |
the PMCF plan and PMCF evaluation report, including a review of the PMCF evaluation report by an independent scientific body for class III medical devices , in accordance with Part B of Annex XIII or any justification why a PMCF is not deemed necessary or appropriate. [Am. 292] |
6.2. Additional information in specific cases
|
(a) |
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, referred to in the first subparagraph of Article 1(4), a statement indicating this fact. In this case, the documentation shall identify the source of that substance and contain the data of the tests conducted to assess its safety, quality and usefulness, taking account of the intended purpose of the device. |
|
(b) |
Where a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, that are covered by this Regulation in accordance with point (e) of Article 1(2), a statement indicating this fact. In this case, the documentation shall identify all materials of human or animal origin used and provide detailed information concerning the conformity with Sections 10.1. or 10.2., respectively, of Annex I. |
|
(c) |
In the case of devices placed on the market in a sterile or defined microbiological condition a description of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with respect to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues. |
|
(d) |
In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications. |
|
(e) |
If the device is to be connected to other device(s) in order to operate as intended, a description of this combination including proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer. |
(1) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).
ANNEX III
EU DECLARATION OF CONFORMITY
|
1. |
Name, registered trade name or registered trade mark of the manufacturer and, if applicable, his authorised representative, and the address of their registered place of business where they can be contacted and their location be established; |
|
2. |
A statement that the declaration of conformity is issued under the sole responsibility of the manufacturer; |
|
3. |
The UDI device identifier as referred to in item (i) of point (a) of Article 24(1) as soon as identification of the device that is covered by the declaration shall be based on a UDI system; |
|
4. |
Product or trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device that is covered by the declaration (it may include a photograph, where appropriate). Except for the product or trade name, the information allowing identification and traceability may be provided by the device identifier referred to in point 3; |
|
5. |
Risk class of the device in accordance with Annex VII; |
|
6. |
A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with other relevant Union legislation that make provision for the issuing of a declaration of conformity; |
|
7. |
References to the relevant harmonised standards or CTS used in relation to which conformity is declared; |
|
8. |
Where applicable, name and identification number of the notified body, description of the conformity assessment procedure performed and identification of the certificate(s) issued; |
|
9. |
Where applicable, additional information; |
|
10. |
Place and date of issue, name and function of the person who signs as well as indication for and on behalf of whom he/she signs, signature. |
ANNEX IV
CE MARKING OF CONFORMITY
|
1. |
The CE marking shall consist of the initials ‘CE’ accompanied by the term ‘Medical Device’ taking the following form: [Am. 293]
|
|
2. |
If the CE marking is reduced or enlarged the proportions given in the above graduated drawing shall be respected. |
|
3. |
The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices. |
ANNEX V
INFORMATION TO BE SUBMITTED WITH THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLE 25
AND
DATA ELEMENTS OF THE UDI DEVICE IDENTIFIER IN ACCORDANCE WITH ARTICLE 24
PART A
INFORMATION TO BE SUBMITTED WITH THE REGISTRATION OF DEVICES IN ACCORDANCE WITH ARTICLE 25
Manufacturers or, when applicable, authorised representatives, and, when applicable, importers shall submit the following information:
|
1. |
economic operator's role (manufacturer, authorised representative, or importer), |
|
2. |
name, address and contact details of the economic operator, |
|
3. |
where submission of information is completed by another person on behalf of any of the economic operators mentioned under point 1, the name, address and contact details of this person, |
|
4. |
UDI device identifier, or where identification of the device is not yet based on a UDI system, the data elements laid down in points 5 to 21 of Part B of this Annex, |
|
5. |
type, number and expiry date of certificate and name or identification number of the notified body that has issued the certificate (and link to the information on the certificate entered by the notified body in the electronic system on certificates), |
|
6. |
Member State where the device shall or has been placed on the market in the Union, |
|
7. |
in case of devices classified as classes IIa, IIb or III: Member States where the device is or shall be made available, |
|
8. |
in case of imported device: country of origin, |
|
9. |
risk class of the device, |
|
10. |
reprocessed single use device (y/n), |
|
11. |
presence of a substance which, if used separately, may be considered to be a medicinal product and name of this substance, |
|
12. |
presence of a substance which, if used separately, may be considered a medicinal product derived from human blood or human plasma and name of this substance, |
|
13. |
presence of human tissues or cells, or their derivatives (y/n), |
|
14. |
presence of animal tissues or cells, or their derivatives, as referred to in Regulation (EU) No 722/2012 (y/n), |
|
15. |
where applicable, single identification number of the clinical investigation(s) conducted in relation to the device (or link to the clinical investigation registration in the electronic system regarding clinical investigations), |
|
16. |
in case of devices listed in Annex XV, specification whether the intended purpose of the device is other than a medical purpose, |
|
17. |
in case of devices designed and manufactured by another legal or natural person as referred in Article 8(10), the name, address and contact details of that legal or natural person, |
|
18. |
in case of devices classified as class III or implantable devices, the summary of safety and clinical performance, |
|
19. |
status of the device (on the market, no longer manufactured, withdrawn from the market, recalled). |
PART B
DATA ELEMENTS OF THE UDI DEVICE IDENTIFIER IN ACCORDANCE WITH ARTICLE 24
The UDI device identifier shall provide access to the following information related to the manufacturer and the device model:
|
1. |
quantity per package configuration, |
|
2. |
if applicable, alternative or additional identifier(s), |
|
3. |
the way how the device production is controlled (expiration date or manufacturing date, lot or batch number, serialisation number), |
|
4. |
if applicable, the unit of use device identifier (when a UDI is not assigned to the device at the level of its unit of use, a ‘unit of use’ device identifier shall be assigned to associate the use of a device with a patient), |
|
5. |
name and address of the manufacturer (as indicated on the label), |
|
6. |
if applicable, name and address of the authorised representative (as indicated on the label), |
|
7. |
Global Medical Device Nomenclature (GMDN) code or internationally recognised nomenclature code, |
|
8. |
if applicable, trade/brand name, |
|
9. |
if applicable, device model, reference, or catalogue number, |
|
10. |
if applicable, clinical size (including volume, length, gauge, diameter), |
|
11. |
additional product description (optional), |
|
12. |
if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use), |
|
13. |
if applicable, additional trade names of the device, |
|
14. |
labelled as single use device (y/n), |
|
15. |
if applicable, restricted number of reuses, |
|
16. |
device packaged sterile (y/n), |
|
17. |
need for sterilisation before use (y/n), |
|
18. |
labelled as containing latex (y/n), |
|
19. |
labelled as containing DEHP (y/n), |
|
20. |
URL for additional information, e.g. electronic instructions for use (optional), |
|
21. |
if applicable, critical warnings or contraindications. |
ANNEX VI
MINIMUM REQUIREMENTS TO BE MET BY NOTIFIED BODIES
1. ORGANISATIONAL AND GENERAL REQUIREMENTS
1.1. Legal status and organisational structure
|
1.1.1. |
A notified body shall be established under the national law of a Member State, or under the law of a third country with which the Union has concluded an agreement in this respect, and shall have full documentation of its legal personality and status. This shall include information about ownership and the legal or natural persons exercising control over the notified body. |
|
1.1.2. |
If the notified body is a legal entity that is part of a larger organisation, the activities of this organisation as well as its organisational structure and governance, and the relationship with the notified body shall be clearly documented. |
|
1.1.3. |
If the notified body wholly or partly owns legal entities established in a Member State or in a third country, the activities and responsibilities of those entities, as well as their legal and operational relationships with the notified body, shall be clearly defined and documented. |
|
1.1.4. |
The organisational structure, distribution of responsibilities and operation of the notified body shall be such that it assures confidence in the performance and results of the conformity assessment activities conducted. The organisational structure and the functions, responsibilities and authority of its top-level management and of other personnel with influence upon the performance and results of the conformity assessment activities shall be clearly documented. This information shall be made publicly available. |
1.2. Independence and impartiality
|
1.2.1 |
The notified body shall be a third-party body that is independent of the manufacturer of the product in relation to which it performs conformity assessment activities. The notified body shall also be independent of any other economic operator having an interest in the product as well as of any competitor of the manufacturer. This does not preclude the notified body to perform conformity assessment activities for different economic operators producing different or similar products. |
|
1.2.2. |
The notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities. The notified body shall have procedures in place that effectively ensure identification, investigation and resolution of any case in which a conflict of interests may arise, including involvement in consultancy services in the field of medical devices prior to taking up employment with the notified body. |
|
1.2.3. |
The notified body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not
The notified body shall make publicly available the declarations of interest of its top-level management and the personnel responsible for carrying out the conformity assessment tasks. The national authority shall verify the compliance of the notified body with the provisions under this point and shall report to the Commission twice a year in full transparency. |
|
1.2.4. |
The impartiality of the notified bodies, of their top level management and, of the assessment personnel and subcontractors shall be guaranteed. The remuneration of the top level management and, assessment personnel and subcontractors of a notified body shall not depend on the results of the assessments. |
|
1.2.5 |
If a notified body is owned by a public entity or institution, independence and absence of any conflict of interests must be ensured and documented between, on the one hand, the national authority responsible for notified bodies and/or competent authority and, on the other hand, the notified body. |
|
1.2.6 |
The notified body shall ensure and document that the activities of its subsidiaries or subcontractors, or of any associated body, do not affect its independence, impartiality or objectivity of its conformity assessment activities. The notified body shall provide evidence to the national authority of compliance with this point. |
|
1.2.7. |
The notified body shall operate in accordance with a set of consistent, fair and reasonable terms and conditions, taking into account the interests of small and medium-sized enterprises as defined by Recommendation 2003/361/EC. |
|
1.2.8. |
The requirements of this section in no way preclude exchanges of technical information and regulatory guidance between a notified body and a manufacturer seeking their conformity assessment. |
1.3. Confidentiality
The personnel of a notified body shall observe professional secrecy with regard to information obtained in carrying out their tasks under this Regulation, only in justified cases and except in relation to the national authorities responsible for notified bodies, competent authorities or the Commission. Proprietary rights shall be protected. To this end, the notified body shall have documented procedures in place.
Where information and data are requested from the notified body by the public or healthcare professionals and where such request is declined, the notified body shall justify the reasons for non-disclosure and shall make publicly available its justification.
1.4. Liability
The notified body shall take out appropriate liability insurance that corresponds to the conformity assessment activities for which it is notified, including the possible suspension, restriction or withdrawal of certificates, and the geographic scope of its activities, unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.
1.5. Financial requirements
The notified body , including its subsidiaries, shall have at its disposal the financial resources required to conduct its conformity assessment activities and related business operations. It shall document and provide evidence of its financial capacity and its sustainable economic viability, taking into account specific circumstances during an initial start-up phase.
1.6. Participation in coordination activities
|
1.6.1. |
The notified body shall participate in, or ensure that its assessment personnel including subcontractors, is informed of and trained on the relevant standardisation activities and the activities of the notified body coordination group and that its assessment and decision making personnel are informed of all relevant legislation, standards , guidance and best practice documents adopted in the framework of this Regulation. The notified body shall keep a record of the actions it takes to inform its personnel. |
|
1.6.2. |
The notified body shall adhere to a code of conduct, addressing among other things, ethical business practices for notified bodies in the field of medical devices that is accepted by the national authorities responsible for notified bodies. The code of conduct shall provide for a mechanism of monitoring and verification of its implementation by notified bodies. |
2. QUALITY MANAGEMENT REQUIREMENTS
|
2.1. |
The notified body shall establish, document, implement, maintain and operate a quality management system that is appropriate to the nature, area and scale of its conformity assessment activities and capable of supporting and demonstrating the consistent achievement of the requirements of this Regulation. |
|
2.2. |
The quality management system of the notified body and its subcontractors shall at least address the following:
|
3. RESOURCE REQUIREMENTS
3.1. General
|
3.1.1. |
A notified body and its subcontractors shall be capable of carrying out all the tasks assigned to it by this Regulation with the highest degree of professional integrity and the requisite technical competence in the specific field, whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility. In accordance with Article 35, this requirement shall be monitored to ensure that it is of the requisite quality. In particular, it shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical , scientific and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified. This presupposes the permanent availability within its organisation of sufficient scientific personnel who possess experience , a university degree and the knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Regulation and, in particular, those set out in Annex I. Permanent in-house staff shall be used. However, in accordance with Article 30, notified bodies may hire external experts on an ad hoc and temporary basis provided they can make publicly available the list of these experts, as well as their declarations of interest and the specific tasks for which they are responsible. Notified bodies shall conduct unannounced inspections at least once a year of all premises at which the medical devices coming within their remit are manufactured. The notified body responsible for carrying out the assessment tasks shall notify the other Member States of the findings of the annual inspections carried out. Those findings shall be set out in a report. It shall also forward a record of the annual inspections carried out to the relevant national authority responsible. |
|
3.1.2. |
At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a notified body shall have within its organisation the necessary administrative, technical and scientific personnel with medical, technical and where needed pharmacological knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks, including the assessment of clinical data or the evaluation of an assessment made by a subcontractor. . |
|
3.1.3. |
The notified body shall clearly document the extent and the limits of the duties, responsibilities and authorities in relation of the personnel , including any subcontractors, subsidiaries and external experts , involved in conformity assessment activities and inform the personnel concerned about it. |
|
3.1.3.a |
The notified body shall make available the list of its personnel involved in conformity assessment activities and their expertise to the Commission and, upon request, to other parties. That list shall be kept up to date. [Am. 295] |
3.2. Qualification criteria in relation to personnel
|
3.2.1. |
The Notified Body MDCG shall establish and document the principles of high level competence and qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities (knowledge, experience and other competence required) and the required training (initial and ongoing training). The qualification criteria shall address the various functions within the conformity assessment process (e.g. auditing, product evaluation/testing, design dossier/file review, decision-making) as well as the devices, technologies and areas (e.g. biocompatibility, sterilisation, tissues and cells of human and animal origin, clinical evaluation , risk management ) covered by the scope of designation. |
|
3.2.2. |
The qualification criteria shall refer to the scope of the notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 33, providing sufficient level of detail for the required qualification within the subdivisions of the scope description. Specific qualification criteria shall be defined for the assessment of biocompatibility aspects, safety, clinical evaluation and the different types of sterilisation processes. |
|
3.2.3. |
The personnel responsible for authorising other personnel to perform specific conformity assessment activities and the personnel with overall responsibility for the final review and decision-making on certification shall be employed by the notified body itself and shall not be subcontracted. These personnel altogether shall have proven knowledge and experience in the following:
|
|
3.2.4. |
Clinical experts: notified bodies shall have available personnel with clinical expertise in clinical investigation design, medical statistics, clinical patient management, good clinical practice in the field of clinical investigations . Permanent ‘in-house’ staff shall be used. However, in accordance with Article 30, notified bodies may hire external experts on an ad hoc and temporary basis provided they can make publicly available the list of these experts, as well as the specific tasks for which they are responsible. This personnel shall be integrated in the notified body's decision-making process in a steady way in order to:
|
|
3.2.5. |
Product assessors: the personnel responsible for carrying out product related reviews (e.g. design dossier review, technical documentation review or type examination including aspects such as clinical evaluation, biological safety, sterilisation, software validation) shall have the specialist qualifications, which should include :
|
|
3.2.6. |
Auditor: The personnel responsible for carrying out audits of the manufacturer's quality management assurance system shall have specialist qualifications, which should include the following proven qualification:
|
3.3. Documentation of qualification, training and authorisation of personnel
|
3.3.1. |
The notified body shall have a process in place to fully document the qualification of each personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2. Where in exceptional circumstances the fulfilment of the qualification criteria set out in Section 3.2 cannot be fully demonstrated, the notified body shall appropriately justify the authorisation of these personnel to carry out specific conformity assessment activities. |
|
3.3.2. |
For its personnel referred to in Sections 3.2.3 to 3.2.6, the notified body shall establish and maintain up to date:
|
3.4. Subcontractors and external experts
|
3.4.1. |
Without prejudice to the limitations emanating from Section 3.2., notified bodies may subcontract clearly defined parts of the conformity assessment activities in particular where clinical expertise is limited. The subcontracting of the auditing of quality management systems or of product related reviews as a whole is not allowed. |
|
3.4.2. |
Where a notified body subcontracts conformity assessment activities either to an organisation or an individual, it shall have a policy describing the conditions under which subcontracting may take place. Any subcontracting or consultation of external experts shall be properly documented, be publicly available and be subject to a written agreement covering, among others, confidentiality and conflict of interests. |
|
3.4.3. |
Where subcontractors or external experts are used in the context of the conformity assessment, in particular regarding novel, invasive and implantable medical devices or technologies, the notified body shall have adequate own competence in each product area, each treatment or medical speciality for which it is designated to lead the conformity assessment, to verify the appropriateness and validity of expert opinions and make the decision on the certification. |
|
3.4.4. |
The notified body shall establish procedures for assessing and monitoring the competence of all subcontractors and external experts used. |
|
3.4.4a. |
The policy and procedures under points 3.4.2 and 3.4.4 shall be communicated to the national authority before any subcontracting takes place. [Am. 297] |
3.5. Monitoring of competences and training
|
3.5.1. |
The notified body shall appropriately monitor the satisfactory performance of the conformity assessment activities by its personnel. |
|
3.5.2. |
It shall review the competence of its personnel and identify training needs and ensure that necessary measures are taken accordingly, in order to maintain the required level of qualification and knowledge. [Am. 298] |
3.5a. Additional requirements for special notified bodies
3.5a.1. Clinical experts for special notified bodies
Special notified bodies shall have available personnel with expertise in clinical investigation design, medical statistics, clinical patient management, good clinical practice in the field of clinical investigations and pharmacology. Permanent in-house staff shall be used. However, in accordance with Article 30, notified bodies may hire external experts on an ad hoc and temporary basis provided they can make publicly available the list of these experts, as well as the specific tasks for which they are responsible. This personnel shall be integrated in the notified body's decision-making process in a steady way in order to:
|
— |
identify when specialist input is required for the assessment of the clinical investigation plans and the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts; |
|
— |
appropriately train external clinical experts in the relevant requirements of this Regulation, delegated and/or implementing acts, harmonised standards, CTS and guidance documents and ensure that the external clinical experts are fully aware of the context and implication of their assessment and advice provided; |
|
— |
be able to discuss the rationale of the planned study design, the clinical investigation plans and the selection of the control intervention with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation; |
|
— |
be able to scientifically challenge the clinical investigation plans and the clinical data presented, and the results of the external clinical experts' assessment of the manufacturer's clinical evaluation; |
|
— |
be able to ascertain the comparability and consistency of the clinical assessments conducted by clinical experts; |
|
— |
be able to make an objective clinical judgement about the assessment of the manufacturer's clinical evaluation and make a recommendation to the notified body's decision maker. |
|
— |
have an understanding of active substances. |
|
— |
ensure independence and objectivity and disclose potential conflicts of interest. |
3.5a.2. Product specialists for special notified bodies
The personnel responsible for carrying out product related reviews (for example design dossier review, technical documentation review or type examination) for devices referred to in Article 43a shall have the following proven product specialist qualifications:
|
— |
meet the requirement as stipulated above for product assessors; |
|
— |
have an advanced academic degree in field relevant to medical devices, or alternative have six years of relevant experience in medical devices or related sectors; |
|
— |
have an ability to identify key risks of products within the specialist’s product categories without prior reference to manufacturer’s specifications or risk analyses; |
|
— |
have an ability to assess against the essential requirements in the absence of harmonised or established national standards; |
|
— |
the professional experience should be gained in the first product category their qualification is based on, relevant to the product category of designation of the notified body, providing sufficient knowledge and experience to thoroughly analyse the design, the validation and verification testing and the clinical use with a sound understanding of the design, manufacture, testing, clinical use and risks associated with such a device; |
|
— |
missing professional experience for further product categories closely related to the first product category, may be substituted by internal product specific training programmes; |
|
— |
for product specialist with qualification in specific technology such as sterilisation, tissues and cells of human and animal origin, combination products, professional experience should be gained in the specific technology area, relevant to the scope of designation of the notified body. |
For each designated product category, the special notified body shall have a minimum of two product specialists of which at least one in house, to review devices referred to in Art. 43 a (new), first paragraph. For those devices, product specialists shall be available in house for the designated technology fields (for example combination products, sterilisation, tissues and cells of human or animal origin) covered by the scope of notification.
3.5a.3. Training for product specialists
Product specialists shall receive at minimum 36 hours of training in medical devices, the Medical Device Regulations, and assessment and certification principles, including training in the verification of manufactured products.
The notified body shall ensure that a product specialist to be qualified obtains adequate training in the relevant procedures of the notified body’s quality management system and is taken through a training plan consisting of sufficient design dossier reviews witnessed, performed under supervision and peer reviewed before doing a qualifying full independent review.
For each product category for which qualification is sought, the notified body must show evidence of appropriate knowledge in the product category. A minimum of five design dossiers (at least two of them initial applications or significant extensions of certification) shall be conducted for the first product category. For subsequent qualification in additional product categories evidence of adequate product knowledge and experience needs to be demonstrated.
3.5a.4. Maintenance qualification for product specialists
Qualifications of product specialists shall be reviewed on an annual basis; a minimum of four design dossier reviews, independent of the number of product categories qualified for shall be demonstrated as a four-year rolling average. Reviews of significant changes to the approved design (not full design examinations) count for 50 %, as do reviews supervised.
On an ongoing basis, the product specialist needs to show evidence of state-of-art product knowledge, review experience in each product category for which qualification exists. Annual training with regard to the latest status of Regulations, harmonised standards, relevant guidance documents, clinical evaluation, performance evaluation, CTS requirements needs to be demonstrated.
If the requirements for renewal of qualification are not met, the qualification shall be suspended. Then the first upcoming design dossier review shall be done under supervision, and re-qualification confirmed based on the outcome of this review. [Am. 299]
4. PROCESS REQUIREMENTS
|
4.1. |
The notified body's decision-making process shall be transparent and clearly documented and its outcome publicly available , including the process for the issue, suspension, reinstatement, withdrawal or refusal of conformity assessment certificates, their modification or restriction and the issue of supplements. [Am. 300] |
|
4.2. |
The notified body shall have in place a documented process for the conduct of the conformity assessment procedures for which it is designated taking into account their respective specificities, including legally required consultations, in respect of the different categories of devices covered by the scope of notification, ensuring transparency and the ability of reproduction of those procedures. |
|
4.3. |
The notified body shall have in place documented procedures that are publicly available covering at least:
|
|
4a. |
Recommended duration for conformity assessments conducted by notified bodies |
|
4a.1. |
Notified bodies shall identify the audit duration for the stage 1 and stage 2 initial audits, and surveillance audits for each applicant and certified client. |
|
4a.2. |
An audit duration shall be based, inter alia, on the effective number of personnel of the organization, the complexity of the processes within the organization, the nature and the characteristics of the medical devices included in the scope of the audit and the different technologies that are employed to manufacture and control the medical devices. The audit duration may be adjusted based on any significant factors that uniquely apply to the organization to be audited. The notified body shall ensure that any variation in audit duration does not compromise the effectiveness of audits. |
|
4a.3. |
The duration of any scheduled on site audit shall not be less than one auditor/day. |
|
4a.4. |
Certification of multiple sites under one quality assurance system shall not be based on a sampling system. [Am. 302] |
ANNEX VII
CLASSIFICATION CRITERIA
I. SPECIFIC DEFINITIONS FOR THE CLASSIFICATION RULES
1. DURATION OF USE
|
1.1. |
‘Transient’ means normally intended for continuous use for less than 60 minutes. |
|
1.2. |
‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days. |
|
1.3. |
‘Long term’ means normally intended for continuous use for more than 30 days. |
2. INVASIVE AND ACTIVE DEVICES
|
2.1. |
‘Body orifice’ means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma or permanent tracheotomy. |
|
2.2. |
‘Surgically invasive device’ means
|
|
2.3. |
‘Reusable surgical instrument’ means an instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which are intended by the manufacturer to be reused after appropriate procedures for cleaning and/or sterilization have been carried out. |
|
2.4. |
‘Active therapeutic device’ means any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability. |
|
2.5. |
‘Active device intended for diagnosis’ means any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. |
|
2.6. |
‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior. |
|
2.7. |
‘Central nervous system’ means the brain, meninges and spinal cord. |
II. Implementing rules for the classification rules
|
1. |
Application of the classification rules shall be governed by the intended purpose of the devices. |
|
2. |
If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used. |
|
3. |
Stand alone software, which drives a device or influences the use of a device, falls automatically in the same class as the device. If stand alone software is independent of any other device, it is classified in its own right. |
|
4. |
If the device is not intended to be used solely or principally in a specific part of the body, it shall be considered and classified on the basis of the most critical specified use. |
|
5. |
If several rules, or within the same rule several sub-rules, apply to the same device based on the device's intended purpose, the strictest rule and/or sub-rule resulting in the higher classification shall apply. |
|
6. |
In calculating the duration referred to in Chapter I, Section 1 continuous use means:
|
|
7. |
A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition by itself or when it provides decisive information for the diagnosis. |
III. Classification rules
3. NON-INVASIVE DEVICES
3.1. Rule 1
All non-invasive devices are in class I, unless one of the rules set out hereinafter applies.
3.2. Rule 2
All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in class IIa:
|
— |
if they may be connected to an active medical device in class IIa or a higher class, |
|
— |
if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues. |
In all other cases they are in class I.
3.3. Rule 3
All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or infusion into the body are in class IIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in class IIa.
All non-invasive devices intended to be used for in vitro fertilisation (IVF) or assisted reproduction technologies (ART) which are liable to act with close contact on the inner or outer cells during the IVF/ART, such as washing, separating, sperm immobilising, cryoprotecting solutions, are in class IIb.
3.4. Rule 4
All non-invasive devices which come into contact with injured skin:
|
— |
are in class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates, |
|
— |
are in class IIb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent, |
|
— |
are in class IIa in all other cases, including devices principally intended to manage the micro-environment of a wound. |
4. INVASIVE DEVICES
4.1. Rule 5
All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device classified as class I:
|
— |
are in class I if they are intended for transient use, |
|
— |
are in class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in class I, |
|
— |
are in class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in class IIa. |
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in class IIa or a higher class, are in class IIa.
4.2. Rule 6
All surgically invasive devices intended for transient use are in class IIa unless they:
|
— |
are intended to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in class III, |
|
— |
are reusable surgical instruments, in which case they are in class I, |
|
— |
are intended specifically for use in direct contact with the central nervous system, in which case they are in class III, |
|
— |
are intended to supply energy in the form of ionising radiation in which case they are in class IIb, |
|
— |
have a biological effect or are wholly or mainly absorbed in which case they are in class IIb, |
|
— |
are intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in class IIb. |
4.3. Rule 7
All surgically invasive devices intended for short-term use are in class IIa unless they:
|
— |
are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in class III, |
|
— |
are intended specifically for use in direct contact with the central nervous system, in which case they are in class III, |
|
— |
are intended to supply energy in the form of ionizing radiation in which case they are in class IIb, |
|
— |
have a biological effect or are wholly or mainly absorbed in which case they are in class III, |
|
— |
are intended to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in class IIb. |
4.4. Rule 8
All implantable devices and long-term surgically invasive devices are in class IIb unless they:
|
— |
are intended to be placed in the teeth, in which case they are in class IIa, |
|
— |
are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in class III, with the exception of sutures and staples, [Am. 303] |
|
— |
have a biological effect or are wholly or mainly absorbed, in which case they are in class III, |
|
— |
are intended to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in class III, |
|
— |
are active implantable medical devices or implantable accessories to active implantable medical devices, in which case they are in class III, |
|
— |
are breast implants, in which case they are in class III, |
|
— |
are hip, knee or shoulder total and partial joint replacements, in which case they are in class III, with the exception of ancillary components such as screws, wedges, plates and instruments, |
|
— |
are spinal disc replacement implants and implantable devices that come into contact with the spinal column, in which case they are in class III. |
5. ACTIVE DEVICES
5.1. Rule 9
All active therapeutic devices intended to administer or exchange energy are in class IIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are in class IIb.
All active devices intended to control or monitor the performance of active therapeutic devices in class IIb, or intended directly to influence the performance of such devices are in class IIb.
All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable medical devices are in class III.
5.2. Rule 10
Active devices intended for diagnosis are in class IIa:
|
— |
if they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient's body, in the visible spectrum, |
|
— |
if they are intended to image in vivo distribution of radiopharmaceuticals, |
|
— |
if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of central nervous system in which case they are in class IIb. |
Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in class IIb.
5.3. Rule 11
All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in class IIb.
5.4. Rule 12
All other active devices are in class I.
6. SPECIAL RULES
6.1. Rule 13
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, with action ancillary to that of the devices, are in class III.
6.2. Rule 14
All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in class IIb, unless they are implantable or long term invasive devices, in which case they are in class III.
6.3. Rule 15
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in class IIb.
All devices intended specifically to be used for disinfecting or sterilising medical devices are in class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are in class IIb.
This rule does not apply to devices that are intended to clean medical devices other than contact lenses by means of physical action only.
6.4. Rule 16
Devices specifically intended for recording of diagnostic images generated by X-ray, MRI, ultra-sound or other diagnostic devices are in class IIa.
6.5. Rule 17
All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable are in class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable that are intended to come into contact with intact skin only.
6.6. Rule 18
By derogation from other rules, blood bags are in class IIb.
6.7. Rule 19
All devices incorporating or consisting of nanomaterial are in class III unless the nanomaterial is encapsulated or bound in such a manner that it cannot deliberately intended to be released into the patient's or user's human body when the device is used within its intended purpose are in class III . [Am. 304]
6.8. Rule 20
All devices intended to be used for aphaeresis, such as aphaeresis machines, sets, connectors and solutions, are in class III. [Am. 305]
6.9. Rule 21
Devices that are composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body are in class III. [Am. 306]
ANNEX VIII
CONFORMITY ASSESSMENT BASED ON FULL QUALITY ASSURANCE AND DESIGN EXAMINATION
Chapter I: Full Quality Assurance System
|
1. |
The manufacturer shall ensure application of the quality management system approved for the design, manufacture and final inspection of the products concerned, as specified in Section 3 and is subject to audit as laid down in Sections 3.3 and 3.4 and to the surveillance as specified in Section 4. |
|
2. |
The manufacturer who fulfils the obligations imposed by Section 1 shall draw up and keep an EU declaration of conformity in accordance with Article 17 and Annex III for the device model covered by the conformity assessment procedure. By issuing a declaration of conformity the manufacturer ensures and declares that the devices concerned meet the provisions of this Regulation which apply to them. |
3. Quality management system
|
3.1. |
The manufacturer shall lodge an application for assessment of his quality management system with a notified body. The application shall include:
|
|
3.2. |
Application of the quality management system shall ensure that the devices conform to the provisions of this Regulation which apply to them at every stage, from design to final inspection and delivery . All the elements, requirements and provisions adopted by the manufacturer for his quality management system shall be documented in a systematic and orderly manner in the form of written policies and procedures such as quality programmes, quality plans, quality manuals and quality records. [Am. 307] Moreover, the documentation to be submitted for the assessment of the quality management system shall include an adequate description of, in particular:
In addition, the manufacturer shall grant the notified body access to the technical documentation referred to in Annex II. |
3.3. Audit
|
(a) |
The notified body shall audit the quality management system to determine whether it meets the requirements referred to in Section 3.2. Unless duly substantiated, it shall presume that quality management systems which satisfy the relevant harmonised standards or CTS conform to the requirements covered by the standards or CTS. |
|
(b) |
The assessment team shall include at least one member with past experience of assessments of the technology concerned. The assessment procedure shall include an audit on the manufacturer's premises and, if appropriate, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing and other relevant processes. |
|
(c) |
Moreover, in the case of devices falling into class IIa or IIb the audit procedure shall include an assessment, on a representative basis, of the design documentation within the technical documentation as referred to in Annex II of the device(s) concerned. In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Regulation. The notified body shall document its rationale for the sample(s) taken. |
|
(d) |
If the quality management system conforms to the relevant provisions of this Regulation, the notified body shall issue an EU full quality assurance certificate. The decision shall be notified to the manufacturer. It shall contain the conclusions of the audit and a reasoned assessment. |
|
3.4. |
The manufacturer shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system or the product-range covered. The notified body shall assess the changes proposed and verify whether after these changes the quality management system still meets the requirements referred to in Section 3.2. It shall notify the manufacturer of its decision which shall contain the conclusions of the audit and a reasoned assessment. The approval of any substantial change to the quality management system or the product-range covered shall take the form of a supplement to the EU full quality assurance certificate. |
4. Surveillance assessment
|
4.1. |
The aim of surveillance is to ensure that the manufacturer duly fulfils all the obligations imposed by the approved quality management system. [Am. 309] |
|
4.2. |
The manufacturer shall authorise the notified body to carry out all the necessary audits, including inspections, and supply it with all relevant information, in particular:
|
|
4.3. |
The notified body shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality management system and the post-market surveillance plan, and shall supply the manufacturer with an assessment report. This shall include inspections on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. At the time of such inspections, the notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. |
|
4.4. |
The notified body shall randomly perform at least once every five years and for each manufacturer and generic device group unannounced factory inspections to the manufacturer at the relevant manufacturing sites and, if appropriate, at the manufacturer's suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred to in Section 4.3. or be performed in addition to this surveillance assessment. The notified body shall establish a plan for the unannounced inspections which shall not take a periodicity lower than one inspection per year and must not be disclosed to the manufacturer. At the time of such inspections, the notified body shall carry out the tests or ask to carry them out in order to check that the quality management system is working properly. It shall provide the manufacturer with an inspection report and with a test report. [Am. 310] Within the context of such unannounced inspections, the notified body shall check an adequate sample from the production or the manufacturing process to verify that the manufactured device is in conformity with the technical documentation and/or design dossier. Prior to the unannounced inspection, the notified body shall specify the relevant sampling criteria and testing procedure. Instead of, or in addition to, the sampling from the production, the notified body shall take samples of devices from the market to verify that the manufactured device is in conformity with the technical documentation and/or design dossier. Prior to the sampling, the notified body shall specify the relevant sampling criteria and testing procedure. The notified body shall provide the manufacturer with an inspection report which shall include, if applicable, the result of the sample check. This report shall be made public . [Am. 311] |
|
4.5. |
In the case of devices classified as class IIa or class IIb, the surveillance assessment shall also include the assessment of the design documentation within the technical documentation of the device(s) concerned on the basis of further representative sample(s) chosen in accordance with the rationale documented by the notified body in accordance with point (c) of Section 3.3. In the case of devices classified as class III, the surveillance assessment shall also include a check of the approved parts and/or materials that are essential for the integrity of the device, including, where appropriate, the coherence between the quantities of produced or purchased parts and/or materials and the quantities of finished products. [Am. 312] |
|
4.6. |
The notified body shall ensure that the composition of the assessment team assures experience with the technology concerned, continuous objectivity and neutrality; this shall include a rotation of the members of the assessment team at appropriate intervals. As a general rule, a lead auditor shall not lead and attend an audit for more than three consecutive years in respect to the same manufacturer. |
|
4.7. |
If the notified body establishes a divergence between the sample taken from the production or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose restrictions on it. |
Chapter II: Design dossier examination
5. Examination of the design of the device, applicable to devices classified as class III
|
5.1. |
In addition to the obligations imposed by Section 3, the manufacturer shall lodge with the notified body referred to in Section 3.1 an application for examination of the design dossier relating to the device which he plans to manufacture and which falls into the device category covered by the quality management system referred to in Section 3. |
|
5.2. |
The application shall describe the design, manufacture and performances of the device in question. It shall include the technical documentation as referred to in Annex II; where the technical documentation is voluminous and/or held in different locations, the manufacturer shall submit a summary technical documentation (STED) and grant access to the full technical documentation upon request. |
|
5.3. |
The notified body shall examine the application employing staff with proven knowledge and experience regarding the technology concerned. The notified body shall ensure that the manufacturer’s application adequately describes the design, manufacture and performance of the device, allowing assessment of whether the product complies with the requirements set out in this Regulation. The notified bodies shall comment on the conformity of the following:
The notified body may require the application to be completed by further tests or other evidence to allow assessment of conformity with the requirements of the Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests. [Am. 313] The notified body shall provide the manufacturer with an EU design-examination report. |
|
5.3 a. |
For devices in class III the clinical part of the dossier shall be evaluated by an appropriate clinical expert among those contained in the list developed by the MDCG according to Article 80(g). [Am. 314] |
|
5.4. |
If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU design-examination certificate. The certificate shall contain the conclusions of the examination, the conditions of validity, the data needed for identification of the approved design, where appropriate, a description of the intended purpose of the device. |
|
5.5. |
Changes to the approved design shall receive further approval from the notified body which issued the EU design-examination certificate wherever the changes could affect conformity with the general safety and performance requirements of the Regulation or with the conditions prescribed for use of the device. The applicant shall inform the notified body which issued the EU design-examination certificate of any planned changes to the approved design. The notified body shall examine the planned changes, notify the manufacturer of its decision and provide him with a supplement to the EU design-examination report. The approval of any change to the approved design shall take the form of a supplement to the EU design-examination certificate. |
6. Specific procedures
6.1. Procedure in the case of devices incorporating a medicinal substance
|
(a) |
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, with action ancillary to that of the device, the quality, safety and usefulness of the substance shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC. |
|
(b) |
Before issuing an EU design-examination certificate, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC (hereinafter referred to as ‘medicinal products competent authority’) or the European Medicines Agency (hereinafter referred to as ‘EMA’), acting particularly through its Committee on Human Medicinal Products in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), on the quality and safety of the substance including the benefit/risk of the incorporation of the substance into the device. Where the device incorporates a human blood or plasma derivative or a substance that, if used separately may be considered to be a medicinal product falling exclusively within the scope of the Annex of Regulation (EC) No 726/2004, the notified body shall consult the EMA. |
|
(c) |
When issuing its opinion, the medicinal products competent authority or the EMA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body. |
|
(d) |
The opinion of the medicinal products competent authority or the EMA shall be drawn up
|
|
(e) |
The scientific opinion of the medicinal products competent authority or the EMA, and any possible update, shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision. The notified body shall not deliver the certificate if the scientific opinion is unfavourable. It shall convey its final decision to the medicinal products competent authority concerned or to the EMA. |
|
(f) |
Before changes are made with respect to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the manufacturer shall inform the notified body of the changes which shall consult the medicinal products competent authority that was involved in the initial consultation, in order to confirm that the quality and safety of the ancillary substance are maintained. The medicinal products competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk of the addition of the substance in the device. It shall provide its opinion within 30 days after receipt of the valid documentation regarding the changes. |
|
(g) |
When the medicinal products competent authority that was involved in the initial consultation has obtained information on the ancillary substance, which could have an impact on the established benefit/risk of the addition of the substance in the device, it shall provide the notified body with advice whether this information has an impact on the established benefit/risk of the addition of the substance in the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure. |
6.2. Procedure in the case of devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, that are non-viable or rendered non-viable
|
(a) |
For devices manufactured utilising tissues or cells of human origin, or their derivatives, that are covered by this Regulation in accordance with point (e) of Article 1(2), the notified body shall, prior to issuing an EU design-examination certificate, submit to the competent authority designated by the Member State in accordance with Directive 2004/23/EC (hereinafter referred to as ‘human tissues and cells competent authority’) in which it is established a summary of the preliminary conformity assessment which shall, among others, provide information about the non-viability of the human tissues or cells, their donation, procurement and testing and the benefit/risk of the incorporation of the human tissues or cells into the device. |
|
(b) |
Within 90 days after receipt of valid documentation, the human tissues and cells competent authority may submit comments on aspects related to the donation, procurement and testing and/or the benefit/risk of the incorporation of the human tissues or cells into the device. |
|
(c) |
The notified body shall give due consideration to any comments received in accordance with point (b). It shall convey to the human tissues and cells competent authority an explanation as regards this consideration, including any due justification not to follow the comment received, and its final decision regarding the conformity assessment in question. The comments of the human tissues and cells competent authority shall be included in the documentation of the notified body concerning the device. |
7. Batch verification in the case of devices incorporating a medicinal substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma referred to in Article 1(4)
Upon completing the manufacture of each batch of devices that incorporate a medicinal substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma referred to in the first subparagraph of Article 1(4), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.
Chapter III: Administrative provisions
|
8. |
The manufacturer or his authorised representative shall, for a period ending at least five years, and in the case of implantable devices at least 15 equivalent to the lifetime of the medical device as defined by the manufacturer, but not less than 10 years, after the last device has been placed on the market from the date of product release by the manufacturer , keep at the disposal of the competent authorities: [Am. 315]
|
|
9. |
Each Member State shall make provision that this documentation is kept at the disposal of the competent authorities for the period indicated in the first sentence of the preceding paragraph in case the manufacturer, or his authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of this period. |
(1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
ANNEX IX
CONFORMITY ASSESSEMENT BASED ON TYPE EXAMINATION
|
1. |
EU type-examination is the procedure whereby a notified body ascertains and certifies that a representative sample of the production covered fulfils the relevant provisions of this Regulation. |
2. Application
The application shall include:
|
— |
the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of the authorised representative, |
|
— |
the technical documentation referred to in Annex II needed to assess the conformity of the representative sample of the production in question, hereinafter referred to as the ‘type’, with the requirements of this Regulation; where the technical documentation is voluminous and/or held in different locations, the manufacturer shall submit a summary technical documentation (STED) and grant access to the full technical documentation upon request. The applicant shall make a ‘type’ available to the notified body. The notified body may request other samples as necessary, |
|
— |
a written declaration that no application has been lodged with any other notified body for the same type, or information about any previous application for the same type that has been refused by another notified body. |
3. Assessment
The notified body shall:
|
3.1. |
examine and assess the technical documentation and verify that the type has been manufactured in conformity with that documentation; it shall also record the items designed in conformity with the applicable specifications of the standards referred to in Article 6 or CTS, as well as the items not designed on the basis of the relevant provisions of the abovementioned standards; |
|
3.2. |
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether the solutions adopted by the manufacturer meet the general safety and performance requirements of this Regulation if the standards referred to in Article 6 or CTS have not been applied; if the device is to be connected to other device(s) in order to operate as intended, proof shall be provided that it conforms to the general safety and performance requirements when connected to any such device(s) having the characteristics specified by the manufacturer; |
|
3.3. |
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether, if the manufacturer has chosen to apply the relevant standards, these have actually been applied; |
|
3.4. |
agree with the applicant on the place where the necessary assessments and tests will be carried out. |
4. Certificate
If the type conforms to the provisions of this Regulation, the notified body shall issue an EU type-examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the assessment, the conditions of validity and the data needed for identification of the type approved. The relevant parts of the documentation shall be annexed to the certificate and a copy kept by the notified body.
5. Changes to the type
|
5.1. |
The applicant shall inform the notified body which issued the EU type-examination certificate of any planned change to the approved type. |
|
5.2. |
Changes to the approved product shall receive further approval from the notified body which issued the EU type-examination certificate wherever the changes may affect conformity with the general safety and performance requirements or with the conditions prescribed for use of the product. The notified body shall examine the planned changes, notify the manufacturer of its decision and provide him with a supplement to the EU type-examination report. The approval of any change to the approved type shall take the form of a supplement to the initial EU type-examination certificate. |
6. Specific procedures
The provisions regarding the specific procedures in the case of devices incorporating a medicinal substance, or devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, that are non-viable or rendered non-viable set out in Annex VIII, Section 6, apply with the proviso that any reference to an EU design-examination certificate shall be understood as reference to an EU type-examination certificate.
7. Administrative provisions
The manufacturer or his authorised representative shall, for a period ending at least five years, and in the case of implantable devices at least 15 equivalent to the lifetime of the medical device as defined by the manufacturer, but not less than 10 years, after the last device has been placed on the market, from the date of product release by the manufacturer , keep at the disposal of the competent authorities: [Am. 316]
|
— |
the documentation referred to in the second indent of Section 2, |
|
— |
the changes referred to in Section 5, |
|
— |
copies of EU type-examination certificates and their additions. |
Section 9 of Annex VIII shall apply.
ANNEX X
CONFORMITY ASSESSEMENT BASED ON PRODUCT CONFORMITY VERIFICATION
|
1. |
The objective of the conformity assessment based on product conformity verification is to ensure that devices conform to the type for which an EU type-examination certificate has been issued and meet the provisions of this Regulation which apply to them. |
|
2. |
Where an EU type-examination certificate has been issued in accordance with Annex IX, the manufacturer can either apply the procedure set out in part A (production quality assurance) or the procedure set out in part B (product verification). |
|
3. |
By way of derogation from Sections 1 and 2, this Annex can also be applied by manufacturers of devices classified as class IIa coupled with the drawing up of a technical documentation as set out in Annex II. |
PART A: PRODUCTION QUALITY ASSURANCE
|
1. |
The manufacturer shall ensure application of the quality management system approved for the manufacture of the devices concerned and carry out the final inspection, as specified in Section 3, and is subject to the surveillance referred to in Section 4. |
|
2. |
The manufacturer who fulfils the obligations imposed by Section 1 shall draw up and keep an EU declaration of conformity in accordance with Article 17 and Annex III for the device model covered by the conformity assessment procedure. By issuing an EU declaration of conformity the manufacturer ensures and declares that the devices concerned conform to the type described in the EU type-examination certificate and meet the provisions of this Regulation which apply to them. |
3. Quality management system
|
3.1. |
The manufacturer shall lodge an application for assessment of his quality management system with a notified body. The application shall include:
|
|
3.2. |
Application of the quality management system shall ensure that the devices conform to the type described in the EU type-examination certificate and to the provisions of this Regulation which apply to them at every stage. All the elements, requirements and provisions adopted by the manufacturer for his quality management system shall be documented in a systematic and orderly manner in the form of written policies and procedures such as quality programmes, quality plans, quality manuals and quality records. It shall, in particular, include an adequate description of all elements listed in points (a), (b), (d) and (e) of Section 3.2 of Annex VIII. |
|
3.3. |
The provisions of points (a) and (b) of Section 3.3 of Annex VIII apply. If the quality management system ensures that the devices conform to the type described in the EU type-examination certificate and conforms to the relevant provisions of this Regulation, the notified body shall issue an EU quality assurance certificate. The decision shall be notified to the manufacturer. It shall contain the conclusions of the inspection and a reasoned assessment. |
|
3.4. |
The provisions of Section 3.4 Annex VIII apply. |
4. Surveillance
The provisions of Section 4.1, the first, second and fourth indents of Section 4.2, Section 4.3, Section 4.4, Section 4.6 and Section 4.7 of Annex VIII apply.
In the case of devices classified as class III, the surveillance shall also include a check of the coherence between the quantity of produced or purchased raw material or crucial components approved for the type and the quantity of finished products. [Am. 317]
5. Batch verification in the case of devices incorporating a medicinal substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma referred to in Article 1(4)
Upon completing the manufacture of each batch of devices that incorporate a medicinal substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma referred to in the first subparagraph of Article 1(4), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.
6. Administrative provisions
The manufacturer or his authorised representative shall, for a period ending at least five years, and in the case of implantable devices at least 15 equivalent to the lifetime of the medical device as defined by the manufacturer, but not less than 10 years, after the last device has been placed on the market from the date of product release by the manufacturer , keep at the disposal of the competent authorities: [Am. 318]
|
— |
the declaration of conformity, |
|
— |
the documentation referred to in the fourth indent of Section 3.1 of Annex VIII, |
|
— |
the documentation referred to in the seventh indent of Section 3.1 of Annex VIII, including the EU type-examination certificate referred to in Annex IX, |
|
— |
the changes referred to in Section 3.4 of Annex VIII, and |
|
— |
the decisions and reports from the notified body as referred to in Sections 3.3, 4.3 and 4.4 of Annex VIII. |
Section 9 of Annex VIII shall apply.
7. Application to devices classified as class IIa
|
7.1. |
By way of derogation from Section 2, by virtue of the EU declaration of conformity the manufacturer ensures and declares that the devices in class IIa are manufactured in conformity with the technical documentation referred to in Annex II and meet the requirements of this Regulation which apply to them. |
|
7.2. |
For devices in class IIa the notified body shall assess, as part of the assessment in Section 3.3, on a representative basis, the technical documentation as referred in Annex II for compliance with the provisions of this Regulation; where the technical documentation is voluminous and/or held in different locations, the manufacturer shall submit a summary technical documentation (STED) and grant access to the full technical documentation upon request. In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties) that have been carried out in accordance with this Regulation. The notified body shall document its rationale for the sample(s) taken. |
|
7.3. |
If the assessment in accordance with Section 7.2. confirms that the devices in class IIa conform to the technical documentation referred to in Annex II and meet the requirements of this Regulation which apply to them, the notified body shall issue a certificate pursuant to this section of this Annex. |
|
7.4. |
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4. |
|
7.5. |
By way of derogation from Section 6, the manufacturer or his authorised representative shall, for a period ending at least five years after the last equivalent to the lifetime of the medical device has been placed on the market as defined by the manufacturer, but not less than 10 years from the date of product release by the manufacturer , keep at the disposal of the competent authorities: [Am. 319]
Section 9 of Annex VIII shall apply. |
PART B: PRODUCT VERIFICATION
|
1. |
Product verification is the procedure whereby after examination of every manufactured device the manufacturer, by issuing a EU declaration of conformity in accordance with Article 17 and Annex III, ensures and declares that the devices which have been subject to the procedure set out in Sections 4 and 5 conform to the type described in the EU type-examination certificate and meet the requirements of this Regulation which apply to them. |
|
2. |
The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices which conform to the type described in the EU type-examination certificate and to the requirements of the Regulation which apply to them. Before the start of manufacture, the manufacturer shall prepare documents defining the manufacturing process, in particular as regards sterilisation where necessary, together with all the routine, pre-established provisions to be implemented to ensure homogeneous production and, where appropriate, conformity of the products with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them. In addition, for devices placed on the market in sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer shall apply the provisions of Sections 3 and 4 of Part A of this Annex. |
|
3. |
The manufacturer shall undertake to institute and keep up to date a post-market surveillance plan, including a post-market clinical follow-up, and the procedures ensuring compliance with the obligations emanating from the provisions on vigilance set out in Articles 61 to 66. |
|
4. |
The notified body shall carry out the appropriate examinations and tests in order to verify assess the conformity of the device with the requirements of the Regulation by examining and testing every product as specified in Section 5 or by examination and testing of the products on a statistical basis as specified in Section 6 . [Am. 320] The aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility. |
5. Verification by examination and testing of every product
|
5.1. |
Every device is examined individually and the appropriate physical or laboratory tests defined in the relevant standard(s) referred to in Article 6 or equivalent tests shall be carried out in order to verify, where appropriate, the conformity of the devices with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them. |
|
5.2. |
The notified body shall affix, or have affixed its identification number to each approved device and shall draw up an EU product verification certificate relating to the tests carried out. |
|
5a. |
Statistical verification of conformity [Am. 321] |
|
5a.1. |
The manufacturer shall present the manufactured products in the form of homogeneous batches. The proof of homogeneity for the presented products shall be part of the batch documentation. [Am. 322] |
|
5a.2. |
A random sample is taken from each batch. The products which make up the sample shall be examined individually and the appropriate physical or laboratory tests defined in the relevant standard(s) referred to in Article 6 or equivalent tests shall be carried out in order to verify the conformity of the devices with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them. [Am. 323] |
|
5a.3. |
Statistical control of products shall be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards or equivalent tests referred to in Article 6, taking account of the specific nature of the product categories in question. [Am. 324] |
|
5a.4. |
The notified body shall affix, or have affixed, its identification number to each approved device and shall draw up an EU product verification certificate relating to the tests carried out.
All products in the batch may be put on the market except any in the sample which failed to conform. If a batch is rejected, the competent notified body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the notified body may suspend the statistical verification. [Am. 325] |
6. Batch verification in the case of devices incorporating a medicinal substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma referred to in Article 1(4)
Upon completing the manufacture of each batch of devices that incorporate a medicinal substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma referred to in the first subparagraph of Article 1(4), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.
7. Administrative provisions
The manufacturer or his authorised representative shall, for a period ending at least five years, and in the case of implantable devices at least 15 equivalent to the lifetime of the medical device as defined by the manufacturer, but not less than 10 years, after the last device has been placed on the market from the date of product release by the manufacturer , keep at the disposal of the competent authorities: [Am. 326]
|
— |
the declaration of conformity, |
|
— |
the documentation referred to in Section 2, |
|
— |
the certificate referred to in Section 5.2, |
|
— |
the EU type-examination certificate referred to in Annex IX. |
Section 9 of Annex VIII shall apply.
8. Application to devices classified as class IIa
|
8.1. |
By way of derogation from Section 1, by virtue of the EU declaration of conformity the manufacturer ensures and declares that the devices in class IIa are manufactured in conformity with the technical documentation referred to in Annex II and meet the requirements of this Regulation which apply to them. |
|
8.2. |
The verification conducted by the notified body in accordance with Section 4 is intended to confirm the conformity of the devices in class IIa with the technical documentation referred to in Annex II and with the requirements of this Regulation which apply to them. |
|
8.3. |
If the verification in accordance with Section 8.2. confirms that the devices in class IIa conform to the technical documentation referred to in Annex II and meet the requirements of this Regulation which apply to them, the notified body shall issue a certificate pursuant to this section of this Annex. |
|
8.4. |
By way of derogation from Section 7, the manufacturer or his authorised representative shall, for a period ending at least five years after the last equivalent to the lifetime of the medical device has been placed on the market as defined by the manufacturer, but not less than 10 years from the date of product release by the manufacturer , keep at the disposal of the competent authorities: [Am. 327]
Section 9 of Annex VIII shall apply. |
ANNEX XI
CONFORMITY ASSESSMENT PROCEDURE FOR CUSTOM-MADE DEVICES
|
1. |
For custom-made devices the manufacturer or his authorised representative shall draw up the statement containing the following information:
|
|
2. |
The manufacturer shall undertake to keep available for the competent national authorities the documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Regulation. The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation mentioned in the first paragraph; |
|
3. |
The information contained in the declaration concerned by this Annex shall be kept for a period of time of at least five years after the device has been placed on the market. In the case of implantable devices the period shall be at least 15 years. Section 9 of Annex VIII shall apply. |
|
4. |
The manufacturer shall undertake to review and document experience gained in the post-production phase, including a PMCF referred to in Part B of Annex XIII, and to implement appropriate means to apply any necessary corrective action. This undertaking shall include an obligation for the manufacturer to notify, in accordance with Article 61(4) the competent authorities of any serious incidents and/or field safety corrective actions immediately on learning of them. |
ANNEX XII
MINIMUM CONTENT OF CERTIFICATES ISSUED BY A NOTIFIED BODY
|
1. |
Name, address and identification number of the notified body; |
|
2. |
name and address of the manufacturer and, if applicable, of the authorised representative; |
|
3. |
unique number identifying the certificate; |
|
4. |
date of issue; |
|
5. |
date of expiry; |
|
6. |
data needed for the identification of the device(s) or categories of devices covered by the certificate, including the intended purpose of the device(s) and the GMDN code(s) or internationally recognised nomenclature code(s); |
|
7. |
if applicable, the manufacturing facilities covered by the certificate; |
|
8. |
reference to this Regulation and the relevant Annex according to which the conformity assessment has been carried out; |
|
9. |
examinations and tests performed, e.g. reference to relevant standards/test reports/audit report(s); |
|
10. |
if applicable, reference to the relevant parts of the technical documentation or other certificates required for the placing on the market of the device(s) covered; |
|
11. |
if applicable, information about the surveillance by the notified body; |
|
12. |
conclusions of the notified body's assessment, examination or inspection; |
|
13. |
conditions for or limitations to the validity of the certificate; |
|
14. |
legally binding signature of the notified body according to the applicable national law. |
ANNEX XIII
CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP
PART A: CLINICAL EVALUATION
|
1. |
To conduct a clinical evaluation, a manufacturer shall:
|
|
2. |
Confirmation of conformity with the requirements concerning the characteristics and performances referred to in Section 1 of Annex I, under the normal conditions of use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit/risk ratio referred to in Sections 1 and 5 of Annex I, shall be based on clinical data. Data from independent scientific institutions or medical societies based on their own collections of clinical data shall also be taken into account. [Am. 328] |
|
3. |
The clinical evaluation shall be thorough and objective, considering both favourable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended use, manufacturer's claims and risks of the device in question. |
|
4. |
Clinical data relating to another device may be relevant where equivalence is demonstrated of the device subject to clinical evaluation to the device to which the data relates. Equivalence can only be demonstrated when the device that is subject to clinical evaluation and the device to which the existing clinical data relates have the same intended purpose and when the technical and biological characteristics of the devices and the medical procedures applied are similar to such an extent that there would be not a clinically significant difference in the safety and performance of the devices. |
|
5. |
In the case of implantable devices and devices falling within class III Article 43a(1) , with the exception of those used for a short term, clinical investigations shall be performed unless it is duly justified to rely on existing clinical data alone. Demonstration of equivalence in accordance with Section 4 shall generally not be considered as sufficient justification within the meaning of the first sentence of this paragraph. [Am. 329] |
|
5a. |
All clinical data collected by the manufacturer as part of a PMCF should be made accessible to health professionals. [Am. 330] |
|
6. |
The results of the clinical evaluation and the clinical data on which it is based shall be documented in the clinical evaluation report which shall support the assessment of the conformity of the device. The clinical data together with non-clinical data generated from non-clinical testing methods and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general safety and performance requirements and shall be part of the technical documentation of the device in question. |
PART B: POST-MARKET CLINICAL FOLLOW-UP
|
1. |
Post-market clinical follow-up, hereinafter: PMCF, is a continuous process to update the clinical evaluation referred to in Article 49 and Part A of this Annex and shall be part of the manufacturer’s post-market surveillance plan. To this end, the manufacturer shall proactively collect , register in the electronic system on vigilance referred to in Article 62 and evaluate clinical data from the use in or on humans of a device which is authorised to bear the CE marking, within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence. [Am. 331] |
|
2. |
The PMCF shall be performed pursuant to a documented method laid down in a PMCF plan. |
|
2.1. |
The PMCF plan shall specify the methods and procedures to proactively collect and evaluate clinical data with the aim of
|
|
2.2. |
The PMCF plan shall lay down, in particular
|
|
3. |
The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the technical documentation and be sent periodically to the concerned Member States . For class III medical devices, the manufacturer's PMCF evaluation report shall be reviewed by a third party or external expert under the principles of highest scientific competence and impartiality. In order to conduct its review, the manufacturer shall provide the relevant data to the third party or external expert. Both the manufacturer's PMCF evaluation report and its review by an independent body shall be part of the technical documentation for class III medical devices. [Am. 332] |
|
4. |
The conclusions of the PMCF evaluation report, and where applicable its review by a third party or external experts as referred to in paragraph 3 , shall be taken into account for the clinical evaluation referred to in Article 49 and Part A of this Annex and in the risk management referred to in Section 2 of Annex I. If through the PMCF the need for corrective measures has been identified, the manufacturer shall implement them and inform the concerned Member States . [Am. 333] |
ANNEX XIV
CLINICAL INVESTIGATIONS
I. General requirements
1. Ethical considerations
Every step in the clinical investigation, from first consideration of the need and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, as for example those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th World Medical Association General Assembly in Helsinki, Finland, in 1964, and last amended by the 59th World Medical Association General Assembly in Seoul, Korea, in 2008. Conformity with the above principles shall be granted after an examination by the concerned ethics committee. Regulation of the detailed requirements relating to the participation of subjects in clinical trials shall be the responsibility of the Member States. [Am. 334]
2. Methods
|
2.1. |
Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the technical performance of the device, the clinical safety and efficacy of the device when used for the intended purpose in the target population and in accordance with the instructions of use, and the manufacturer's claims for the device as well as the safety, performance and benefit/risk related aspects referred to in Article 50(1); these investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions. [Am. 335] |
|
2.2. |
The procedures used to perform the investigations shall be appropriate to the device under examination. |
|
2.3. |
Clinical investigations shall be performed in circumstances similar to the normal conditions of use of the device for the intended purpose in the target population . [Am. 336] |
|
2.4. |
All the appropriate features, including those involving the safety and performances of the device, and its effect on patients shall be examined. |
|
2.5. |
The investigations shall be performed under the responsibility of a medical practitioner or another authorised qualified person in an appropriate environment. |
|
2.6. |
The medical practitioner or other authorised person shall have access to the technical and clinical data regarding the device. |
|
2.7. |
The clinical investigation report, signed by the medical practitioner or other authorised person responsible, shall contain a critical evaluation of all the all clinical data collected during the clinical investigation and a critical evaluation of such data , including negative findings. [Am. 337] |
1. Incapacitated subjects
In the case of incapacitated subjects who have not given, or who have not refused to give, informed consent before the onset of their incapacity, clinical investigations may be conducted only where, in addition to the general conditions, all of the following conditions are met:
|
— |
the informed consent of the legal representative has been obtained; consent shall represent the subject’s presumed will and may be revoked at any time, without detriment to the subject; |
|
— |
the incapacitated subject has received adequate information in relation to his or her capacity for understanding regarding the clinical investigation and its risks and benefits from the investigator or his/her representative, in accordance with the national law of the Member State concerned; |
|
— |
the explicit wish of an incapacitated subject, who is capable of forming an opinion and assessing this information, to refuse participation in, or to be withdrawn from, the clinical investigation at any time without giving a reason and with no liability or prejudice whatsoever being incurred by the subject or their legal representative as a result, shall be followed by the investigator; |
|
— |
no incentives or financial inducements are given except compensation for participation in the clinical investigation; |
|
— |
such research is essential to validate data obtained in a clinical investigation on persons able to give informed consent or by other research methods; |
|
— |
such research relates directly to the medical condition from which the person concerned suffers; |
|
— |
the clinical investigation has been designed to minimise pain, discomfort, fear, and any other foreseeable risk in relation to the disease and developmental stage and both the risk threshold and the degree of distress are specially defined and constantly observed; |
|
— |
the research is necessary to promote the health of the population concerned by the clinical performance study and cannot instead be performed on capacitated subjects; |
|
— |
there are grounds for expecting that participation in the clinical investigation will produce a benefit to the incapacitated subject outweighing the risks or will produce only a minimal risk; |
|
— |
an ethics committee, with expertise regarding the relevant disease and the patient population concerned, or that has taken advice on clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol; The test subject shall as far as possible take part in the consent procedure. [Am. 338] |
2. Minors
A clinical investigation may be conducted only where, in addition to the general conditions, all of the following conditions are met:
|
— |
the written informed consent of the legal representative or representatives has been obtained, whereby consent shall represent the minor’s presumed will; |
|
— |
the informed and express consent of the minor has been obtained, where they are able to give consent under national law, |
|
— |
the minor has received all relevant information in a way adapted to his or her age and maturity, from a medical doctor (either the investigator or member of the study team) trained or experienced in working with children, regarding the study, the risks and the benefits; |
|
— |
without prejudice to the second indent, the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from the clinical investigation at any time, is duly taken into consideration by the investigator; |
|
— |
no incentives or financial inducements are given except compensation for participation in the clinical investigation; |
|
— |
such research either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors; |
|
— |
the clinical investigation has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage, and both the risk threshold and the degree of distress are specially defined and constantly observed; |
|
— |
there are grounds to expect that some direct benefit for the category of patients concerned by the study may be obtained from the clinical investigation; |
|
— |
the corresponding scientific guidelines of the EMA have been followed; |
|
— |
the interest of the patient shall always prevail over those of science and society; |
|
— |
the clinical investigation does not replicate other studies based on the same hypothesis and age-appropriate technology is used; |
|
— |
an ethics committee, with paediatric expertise or that has taken advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol. |
The minor shall take part in the consent procedure in a manner adapted to his or her age and maturity. Minors who are able to give consent under national law shall also give their informed and express consent to participate in the study.
If during a clinical investigation the minor reaches the age of majority as defined in the national law of the Member State concerned, his/her express informed consent shall be obtained before the clinical investigation may continue. [Am. 339]
II. Documentation regarding the application for clinical investigation
For investigational devices covered by Article 50 the sponsor shall draw up and submit the application in accordance with Article 51 accompanied by the documentation as laid down below:
1. Application form
The application form shall be duly filled in, containing information regarding:
|
1.1. |
Name, address and contact details of the sponsor and, if applicable, name, address and contact details of his contact person established in the Union. |
|
1.2. |
If different from the Section 1.1., name, address and contact details of the manufacturer of the device intended for clinical investigation and, if applicable, of his authorised representative. |
|
1.3. |
Title of the clinical investigation. |
|
1.4. |
Single identification number in accordance with Article 51(1). |
|
1.5. |
Status of the clinical investigation (e.g. first submission, resubmission, significant amendment). |
|
1.6. |
If resubmission with regard to same device, previous date(s) and reference number(s) of earlier submission(s) or in the case of significant amendment, reference to the original submission. |
|
1.7. |
If parallel submission for a clinical trial on a medicinal product in accordance with Regulation (EU) No […/…] [on clinical trials on medicinal products for human use], reference to the official registration number of the clinical trial. |
|
1.8. |
Identification of the Member States, EFTA countries, Turkey and third countries in which the clinical investigation shall be conducted as part of a multicentre/multinational study at the time of application. |
|
1.9. |
Brief description of the investigational device (e.g. name, GMDN code or internationally recognised nomenclature code, intended purpose, risk class and applicable classification rule according to Annex VII). |
|
1.10. |
Information as to whether the device incorporates a medicinal substance, including a human blood or plasma derivative, or whether it is manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives. |
|
1.11. |
Summary of the clinical investigation plan (objective(s) of the clinical investigation, number and gender of subjects, criteria for subject selection, subjects under 18 years of age, design of the investigation such as controlled and/or randomised studies, planned dates of commencement and of completion of the clinical investigation). As randomised controlled investigations usually generate a higher level of evidence for clinical efficacy and safety, the use of any other design or study has to be justified. Also the choice of the control intervention shall be justified. Both justifications shall be provided by independent experts with the necessary qualifications and expertise. [Am. 340] |
|
1.12. |
If applicable, information regarding a comparator (e.g. identification of the comparator device or medicinal product). |
2. Investigator's Brochure
The investigator's brochure (IB) shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. It shall be clearly identified and contain in particular the following information:
|
2.1. |
Identification and description of the device, including information on the intended purpose, the risk classification and applicable classification rule according to Annex VII, design and manufacturing of the device and reference to previous and similar generations of the device. |
|
2.2. |
Manufacturer's instructions for installation, and use, including storage and handling requirements, as well as the label and instructions for use to the extent that this information is available. |
|
2.3. |
Pre-clinical testing and experimental data, in particular regarding in design calculations, in vitro tests, ex vivo tests, animal tests, mechanical or electrical tests, reliability tests, software verification and validation, performance tests, evaluation of biocompatibility and biological safety. |
|
2.4. |
Existing clinical data, in particular
|
|
2.5. |
Summary of the risk/benefit analysis and the risk management, including information regarding known or foreseeable risks, any undesirable effects, contra-indications and warnings. |
|
2.6. |
In the case of devices that incorporates a medicinal substance, including a human blood or plasma derivative, or devices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives, detailed information on the medicinal substance or on the tissues or cells, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to the substance or tissues or cells. |
|
2.7. |
Reference to harmonised or other internationally recognised standards complied with in full or in part. |
|
2.8. |
A clause that any updates to the IB or any other relevant information that is newly available shall be brought to the attention of the investigators. |
3. Clinical Investigation Plan
The clinical investigation plan (CIP) shall define the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation. It shall contain in particular the information as laid down below. If part of this information is submitted in a separate document, it shall be referenced in the CIP.
|
3.1. |
General |
|
3.1.1. |
Identification of the clinical investigation and the CIP. |
|
3.1.2. |
Identification of the sponsor. |
|
3.1.3. |
Information on the principal investigator, coordinating investigator, including their qualifications, and on the investigation site(s) , as well as information about the contract between the sponsor and the investigating establishment, together with details of the funding . [Am. 343] |
|
3.1.4. |
Overall synopsis of the clinical investigation in the national language of the country concerned . [Am. 344] |
|
3.2. |
Identification and description of the device, including its intended purpose, its manufacturer, its traceability, the target population, materials coming into contact with the human body, the medical or surgical procedures involved in its use and the necessary training and experience for its use. |
|
3.3. |
Justification for the design of the clinical investigation. |
|
3.4. |
Risks and benefits of the device and of the clinical investigation. |
|
3.5. |
Objectives and hypotheses of the clinical investigation. |
|
3.6. |
Design of the clinical investigation |
|
3.6.1. |
General information such as type of investigation with rationale for choice, endpoints, variables. |
|
3.6.2. |
Information on the device to be used for the clinical investigation, on any comparator and on any other device or medication. |
|
3.6.3. |
Information on subjects, including size of investigation population and, if applicable, information on vulnerable populations. |
|
3.6.4. |
Description of the procedures related to the clinical investigation. |
|
3.6.5. |
Monitoring plan. |
|
3.7. |
Statistical considerations. |
|
3.8. |
Data management. |
|
3.9. |
Information about any amendments to the CIP. |
|
3.10. |
Policy regarding deviations from the CIP. |
|
3.11. |
Accountability regarding the device, in particular control of access to the device, follow-up in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning devices. |
|
3.12. |
Statement of compliance with the recognised ethical principles for medical research involving humans and the principles of good clinical practice in the field of clinical investigations of medical devices as well as with the applicable regulatory requirements. |
|
3.13. |
Informed consent process. |
|
3.14. |
Safety reporting, including definitions of adverse events and serious adverse events, procedures and timelines for reporting. |
|
3.15. |
Criteria and procedures for suspension or early termination of the clinical investigation. |
|
3.15a. |
A plan for the further treatment of subjects after the clinical investigation. [Am. 347] |
|
3.16. |
Policy as regards the establishment of the clinical investigation report and publication of results in accordance with the legal requirements and the ethical principles referred to in Section 1 of Chapter I. |
|
3.17. |
Bibliography. |
4. Other information
|
4.1. |
A signed statement by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the subject. This statement may be supported by an attestation issued by a notified body. |
|
4.2. |
Where applicable according to national law, copy of the opinion(s) of the ethics committee(s) concerned as soon as available. |
|
4.3. |
Proof of insurance cover or indemnification of subjects in case of injury, according to the national law. |
|
4.4. |
Documents and procedures to be used to obtain informed consent. |
|
4.5. |
Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data, in particular:
|
III. Other sponsor's obligations
|
1. |
The sponsor shall undertake to keep available for the competent national authorities any documentation necessary to provide evidence for the documentation referred to in Chapter II of this Annex. If the sponsor is not the natural or legal person responsible for the manufacture of the investigational device, this obligation may be fulfilled by that person on behalf of the sponsor. |
|
2. |
The reportable events shall be provided by the investigator(s) in timely conditions. |
|
3. |
The documentation mentioned in this Annex shall be kept for a period of time of at least five years after the clinical investigation with the device in question has ended, or, when the device is subsequently placed on the market, at least five years after the last device has been placed on the market. In the case of implantable devices the period shall be at least 15 years. Each Member State shall make provision that this documentation is kept at the disposal of the competent authorities for the period indicated in the first sentence of the preceding paragraph in case the sponsor, or his contact person, established within its territory goes bankrupt or ceases its activity prior to the end of this period. |
ANNEX XV
LIST OF PRODUCTS COVERED BY THE LAST SUBPARAGRPAH OF THE DEFINITION OF MEDICAL DEVICE REFERRED TO IN NUMBER (1) OF ARTICLE 2(1)
|
1. |
Contact lenses; |
|
2. |
Implants for modification or fixation of body parts; |
|
3. |
Facial or other dermal or mucous membrane fillers; |
|
4. |
Equipment for liposuction; |
|
5. |
Invasive laser equipment intended to be used on the human body; |
|
6. |
Intense pulsed light equipment. |
ANNEX XVI
CORRELATION TABLE
|
Directive 90/385/EEC |
Directive 93/42/EEC |
This Regulation |
|
Article 1(1) |
Article 1(1) |
Article 1(1) |
|
Article 1(2) |
Article 1(2) |
Article 2(1) |
|
Article 1(3) |
Article 1(3) 1st subparagraph |
Article 1(5)1st subparagraph |
|
— |
Article 1(3) 2nd subparagraph |
Article 1(5)2nd subparagraph |
|
Article 1(4) and (4a) |
Article 1(4) and (4a) |
Article 1(4)1st subparagraph |
|
Article 1(5) |
Article 1(7) |
Article 1(6) |
|
Article 1(6) |
Article 1(5) |
Article 1(2) |
|
— |
Article 1(6) |
— |
|
|
Article 1(8) |
Article 1(7) |
|
Article 2 |
Article 2 |
Article 4(1) |
|
Article 3 1st subparagraph |
Article 3 1st subparagraph |
Article 4(2) |
|
Article 3 2nd subparagraph |
Article 3 2nd subparagraph |
— |
|
Article 4(1) |
Article 4(1) |
Article 22 |
|
Article 4(2) |
Article 4(2) |
Article 19(1) and (2) |
|
Article 4(3) |
Article 4(3) |
Article 19(3) |
|
Article 4(4) |
Article 4(4) |
Article 8(7) |
|
Article 4(5) point (a) |
Article 4(5) 1st subparagraph |
Article 18(6) |
|
Article 4(5) point (b) |
Article 4(5) 2nd subparagraph |
— |
|
Article 5(1) |
Article 5(1) |
Article 6(1) |
|
Article 5(2) |
Article 5(2) |
Article 6(2) |
|
Article 6(1) |
Article 5(3), Article 6 |
— |
|
Article 6(2) |
Article 7(1) |
Article 88 |
|
Article 7 |
Article 8 |
Articles 69 to 72 |
|
— |
Article 9 |
Article 41 |
|
Article 8(1) |
Article 10(1) |
Number (43) and (44) of Article 2(1), Article 61(1), Article 63(1) |
|
Article 8(2) |
Article 10(2) |
Article 61(3) and Article 63(1)2nd subparagraph |
|
Article 8(3) |
Article 10(3) |
Article 63(2) and (4) |
|
Article 8(4) |
Article 10(4) |
Article 66 |
|
Article 9(1) |
Article 11(1) |
Article 42(2) |
|
— |
Article 11(2) |
Article 42(4) |
|
— |
Article 11(3) |
Article 42(3) |
|
— |
Article 11(4) |
— |
|
— |
Article 11(5) |
Article 42(5) |
|
Article 9(2) |
Article 11 (6) |
Article 42(7) |
|
Article 9(3) |
Article 11(8) |
Article 9(3) |
|
Article 9(4) |
Article 11(12) |
Article 42(8) |
|
Article 9(5) |
Article 11(7) |
— |
|
Article 9(6) |
Article 11(9) |
Article 43(1) |
|
Article 9(7) |
Article 11(10) |
Article 43(3) |
|
Article 9(8) |
Article 11(11) |
Article 45(2) |
|
Article 9(9) |
Article 11(13) |
Article 47(1) |
|
Article 9(10) |
Article 11(14) |
— |
|
— |
Article 12 |
Article 20 |
|
— |
Article 12a |
Article 15 |
|
Article 9a(1) 1st indent |
Article 13(1) point (c) |
— |
|
Article 9a(1) 2nd indent |
Article 13(1) point (d) |
Article 3(1) |
|
— |
Article 13(1) point (a) |
Article 41(3) |
|
— |
Article 13(1) point (b) |
Article 41(4) point (a) |
|
Article 10 |
Article 15 |
Articles 50 to 60 |
|
Article 10a |
Article 14 |
Article 25 |
|
Article 10b |
Article 14a |
Article 27 |
|
Article 10c |
Article 14b |
Article 74 |
|
Article 11(1) |
Article 16(1) |
Articles 33 and 34 |
|
Article 11(2) |
Article 16(2) |
Article 29 |
|
Article 11(3) |
Article 16(3) |
Article 36(2) |
|
Article 11(4) |
Article 16(4) |
— |
|
Article 11(5) |
Article 16(5) |
Article 45(4) |
|
Article 11(6) |
Article 16(6) |
Article 45(3) |
|
Article 11(7) |
Article 16(7) |
Articles 31(2) and 35(1) |
|
Article 12 |
Article 17 |
Article 18 |
|
Article 13 |
Article 18 |
Article 73 |
|
Article 14 |
Article 19 |
Article 75 |
|
Article 15 |
Article 20 |
Article 84 |
|
Article 15a |
Article 20a |
Article 77 |
|
Article 16 |
Article 22 |
— |
|
Article 17 |
Article 23 |
— |
|
— |
Article 21 |
— |
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/222 |
P7_TA(2014)0267
In vitro diagnostic medical devices ***I
European Parliament legislative resolution of 2 April 2014 on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices (COM(2012)0541 — C7-0317/2012 — 2012/0267(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/16)
The European Parliament,
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having regard to the Commission proposal to the European Parliament and the Council (COM(2012)0541), |
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having regard to Article 294(2) and Articles 114 and Article 168(4)(c) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0317/2012), |
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having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
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having regard to the opinion of the European Economic and Social Committee of 14 February 2013 (1), |
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after consulting the Committee of the Regions, |
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having regard to Rule 55 of its Rules of Procedure, |
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having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Employment and Social Affairs and the Committee on the Internal Market and Consumer Protection (A7-0327/2013), |
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1. |
Adopts as its position at first reading the text adopted on 22 October 2013 (2); |
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2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text; |
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3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 133, 9.5.2013, p. 52.
(2) P7_TA(2013)0427.
P7_TC1-COD(2012)0267
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council on in vitro diagnostic medical devices
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national Parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
After consulting the European Data Protection Supervisor (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
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(1) |
Directive 98/79/EC of the European Parliament and of the Council (4) constitutes the Union regulatory framework for in vitro diagnostic medical devices. However, a fundamental revision of that Directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for devices which ensures a high level of safety and health whilst supporting innovation. |
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(2) |
This Regulation aims to ensure the functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients, users and operators . At the same time, this Regulation sets high standards of quality and safety for devices to meet common safety concerns as regards those products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU) , this Regulation harmonises the rules for the placing on the market and putting into service of in vitro diagnostic medical devices and their accessories on the Union market which may then benefit from the principle of free movement of goods. As regards Article 168(4)(c) of the Treaty on the Functioning of the European Union TFEU , this Regulation sets high standards of quality and safety for those devices by ensuring, among other things, that data generated in clinical performance studies is reliable and robust and that the safety of subjects participating in clinical performance studies is protected. [Am. 1] |
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(3) |
Key elements of the existing regulatory approach, such as the supervision of notified bodies, risk classification, conformity assessment procedures, clinical evidence investigations and clinical evaluation , vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding in vitro diagnostic medical devices should be introduced to improve health and safety for health professionals, patients, users and operators, including in the waste disposal chain . [Am. 2] |
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(4) |
To the extent possible, guidance developed for in vitro diagnostic medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative the International Medical Devices Regulators Forum, should be taken into account to promote the global convergence of regulations which contributes to a high level of safety worldwide and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification criteria, conformity assessment procedures and clinical evidence. |
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(5) |
There are specific features of in vitro diagnostic medical devices, in particular in terms of risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic medical device sector which require the adoption of a specific legislation, distinct from the legislation on other medical devices, whereas the horizontal aspects common to both sectors should be aligned without compromising the need for innovation in the Union . [Am. 3] |
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(5a) |
The high number of small and medium enterprises (SMEs) active in the area of in-vitro diagnostic medical devices should be taken into account when regulating that area, while avoiding the creation of health and safety risks. [Am. 4] |
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(6) |
A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for divergent transposition by Member States. Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Union. |
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(7) |
The scope of application of this Regulation should be clearly delimited from other legislation concerning products such as medical devices, general laboratory products and products for research use only. |
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(7a) |
A multidisciplinary Medical Device Advisory Committee (MDAC) composed of experts and representatives of the relevant stakeholders should be set up to provide scientific advice to the Commission, the Medical Device Coordination Group (MDCG) and Member States on issues of medical technology, the regulatory status of devices and other aspects of implementation of this Regulation as necessary. [Am. 5] |
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(8) |
It In order to ensure consistent classification across all Member States, particularly with regard to borderline cases, it should be the responsibility of the Member States Commission, having consulted the MDCG and the MDAC, to decide on a case-by-case basis whether or not a product falls or groups of products fall within the scope of this Regulation. If necessary, the Commission may decide, on a case-by-case basis, whether or not a product falls within the definition of an in vitro diagnostic medical device or of an accessory to an in vitro diagnostic medical device. Member States should also have the possibility to request the Commission to take a decision on the appropriate regulatory status of a product, or category or group of products. [Am. 6] |
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(9) |
To ensure the highest level of health protection, the rules governing in vitro diagnostic medical devices manufactured and used, including measurement and delivery of results, only within a single health institution should be clarified and strengthened. |
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(9a) |
In the case of urgent or unmet medical needs for patients, such as emerging pathogens and rare diseases, single health institutions should have the possibility of manufacturing, modifying and using devices in-house and thereby addressing, within a non-commercial and flexible framework, specific needs which cannot be met by an available CE-marked device. [Am. 7] |
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(9b) |
However, devices which are manufactured within non-health institution laboratories and put into service without being placed onto the market should be subject to this Regulation. [Am. 8] |
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(10) |
It should be clarified that software specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of an in vitro diagnostic medical device is qualified as an in vitro diagnostic medical device, while software for general purposes, even when used in a healthcare setting, or software intended for well-being applications is not qualified as an in vitro diagnostic medical device. |
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(11) |
It should be made clear that all tests that provide information on the predisposition to a medical condition or a disease (e.g. genetic tests) and tests that provide information to predict treatment response or reactions, such as companion diagnostics, are in vitro diagnostic medical devices. |
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(12) |
Aspects addressed by Directive 2004/108/EC of the European Parliament and of the Council (5) and aspects addressed by Directive 2006/42/EC of the European Parliament and of the Council (6) are an integral part of the general safety and performance requirements for in vitro diagnostic medical devices. Consequently, this Regulation should be considered a lex specialis in relation to those Directives. |
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(13) |
This Regulation should include requirements regarding the design and manufacture of in vitro diagnostic medical devices emitting ionising radiation without affecting the application of Council Directive 96/29/Euratom (7), nor of Council Directive 97/43/Euratom (8) which pursue other objectives. |
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(13a) |
Directive 2013/35/EU of the European Parliament and of the Council (9) should be the reference text for ensuring that people working in the vicinity of magnetic resonance imaging equipment when it is in operation are properly protected. [Am. 9] |
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(14) |
It should be made clear that the requirements of this Regulation also apply to the countries that have entered into international agreements with the Union which confer on that country the same status as a Member State for the purpose of application of this Regulation, as it is currently the case with the Agreement on the European Economic Area (10), the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (11) and the Agreement of 12 September 1963 establishing an association between the European Economic Community and Turkey (12). |
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(15) |
It should be made clear that in vitro diagnostic medical devices offered to persons in the Union by means of information society services within the meaning of Directive 98/34/EC of the European Parliament and of the Council (13) as well as devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union must comply with the requirements of this Regulation at the latest when the product is placed on the market or the service is provided in the Union. |
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(16) |
To recognise the important role of standardisation in the field of in vitro diagnostic medical devices, compliance with harmonised standards as defined in Regulation (EU) No [Ref. of future Regulation on European standardisation] on European standardisation (14) should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as quality and risk management. |
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(17) |
The definitions in the field of in vitro diagnostic medical devices, for example, regarding economic operators, clinical evidence and vigilance, should be aligned with well-established practice at Union and international level in order to enhance legal certainty. |
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(18) |
The rules applicable to in vitro diagnostic medical devices should be aligned, where appropriate, with the New Legislative Framework for the Marketing of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the Council (15) and Decision No 768/2008/EC of the European Parliament and of the Council (16). |
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(19) |
The rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to in vitro diagnostic medical devices and their accessories covered by this Regulation which does not prevent Member States from choosing the competent authorities to carry out those tasks. |
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(20) |
It is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors, as laid down in the New Legislative Framework for the Marketing of Products, without prejudice to the specific obligations laid down in the different parts of this Regulation, to enhance understanding of the legal requirements and thus to improve regulatory compliance by the relevant operators. |
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(21) |
To ensure that in vitro diagnostic medical devices manufactured in series production continue to be in conformity with the requirements of this Regulation and that experience from the use of their in vitro diagnostic medical devices is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance plan in place which should be proportionate to the risk class and the type of the in vitro diagnostic medical device. |
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(22) |
It should be ensured that supervision and control of the manufacture of in vitro diagnostic medical devices is carried out within the manufacturer's organisation by a person who fulfils minimum conditions of qualification. In addition to regulatory compliance, that person could also be responsible for compliance in other fields such as manufacturing processes and quality assessment. The required qualifications of the person responsible for the regulatory compliance should be without prejudice to national provisions regarding professional qualifications, in particular for manufacturers of custom-made devices where such requirements could be met through different educational and professional training systems at national level. [Am. 10] |
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(23) |
For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the in vitro diagnostic medical devices produced by those manufacturers and in serving as their contact person established in the Union. The tasks of an authorised representative should be defined in a written mandate with the manufacturer which for example may allow the authorised representative to lodge an application for a conformity assessment procedure, to report events under the vigilance system or to register devices placed on the Union market. The mandate should empower the authorised representative to duly fulfil certain defined tasks. Considering the role of authorised representatives, the minimum requirements to be met by them should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's qualified person but, with a view to the authorised representative's tasks, could also be satisfied by a person with qualification in law. |
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(24) |
To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to clarify when a distributor, importer or other person is to be considered the manufacturer of an in vitro diagnostic medical device. |
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(25) |
Parallel trade in products already placed on the market is a lawful form of trade within the internal market on the basis of Article 34 of the Treaty on the Functioning of the European Union subject to the limitations set by the protection of health and safety and by the protection of intellectual property rights provided by Article 36 of the Treaty on the Functioning of the European Union. Application of this principle is, however, subject to different interpretations in the Member States. The conditions, in particular the requirements for relabelling and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the European Court of Justice (17) in other relevant sectors and existing good practices in the field of in vitro diagnostic medical devices. |
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(25a) |
To ensure that patients harmed are compensated for any damage and associated treatment as a result of a faulty in vitro diagnostic medical device, that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by a faulty in vitro diagnostic medical device, manufacturers should be obliged to take liability insurance with sufficient minimum coverage. [Am. 11] |
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(26) |
In vitro diagnostic medical devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the Union and be put into service in accordance with their intended purpose. Member States should not create obstacles to their placing on the market or putting into service for reasons related to the requirements laid down in this Regulation. However Member States should be allowed to decide whether to restrict the use of any specific type of in-vitro diagnostic device in relation to aspects that are not covered by this Regulation. [Am. 12] |
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(27) |
The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock-management by hospitals purchasing and waste disposal policies and hospitals’, wholesalers’ and pharmacists’ management of stock and, where possible, be compatible with other authentication systems already in place in those settings . [Am. 13] |
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(28) |
Transparency and better adequate access to information , appropriately presented for the intended user, are essential to empower patients and healthcare professionals and all others concerned, and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system. [Am. 14] |
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(29) |
One key aspect is the creation of a central database that should integrate different electronic systems, with the UDI as an integral part of it, to collate and process information regarding in vitro diagnostic medical devices on the market and the relevant economic operators, certificates, interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies, vigilance and market surveillance. The objectives of the database are to enhance overall transparency, via better access to information for the public and healthcare professionals, to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission, to avoid multiple reporting requirements and to enhance the coordination between Member States. Within an internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices (Eudamed) by further developing the databank set up by Commission Decision 2010/227/EU (18). [Am. 15] |
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(30) |
Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public and healthcare professionals to be adequately informed about devices on the Union market. Adequate levels of access for the public and healthcare professionals to those parts of Eudamed's electronic systems which provide key information on in vitro diagnostic medical devices that may pose a risk to public health and safety is essential. Where such access is limited, it should be possible, upon a reasoned request, to disclose the existing information on in vitro diagnostic medical devices, unless the limitation of access is justified on grounds of confidentiality. The electronic system on clinical performance studies should serve as tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and, in this case, to report serious adverse events. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities. A regular overview of vigilance and market surveillance information should be made available to healthcare professionals and the public. [Am. 16] |
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(31) |
In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the European Parliament and of the Council (19) applies to the processing of personal data carried out in the Member States, under the supervision of the Member States competent authorities, in particular the public independent authorities designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament and of the Council (20), applies to the processing of personal data carried out by the Commission within the framework of this Regulation, under the supervision of the European Data Protection Supervisor. In accordance with Article 2(d) of Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic systems. |
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(32) |
For high-risk in vitro diagnostic medical devices, in the interests of increased transparency, manufacturers should summarise the main draw up a report on the safety and performance aspects of the device and the outcome of the clinical evaluation in a document that . A summary of the safety and performance report should be publicly available via Eudamed . [Am. 17] |
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(32a) |
According to the policy of the European Medicines Agency (EMA) on access to documents, the EMA releases documents submitted as part of applications for marketing authorisation for medicinal products, including clinical trial reports, on request once the decision-making process for the medicinal product in question has been completed. Corresponding standards on transparency and access to documents should be upheld and reinforced for high-risk in vitro diagnostic medical devices, in particular as they are not subject to pre-market approval. For the purposes of this Regulation, in general the data included in clinical performance studies should not be considered commercially sensitive provided that compliance of a device with the applicable requirements has been demonstrated following the applicable conformity assessment procedure. This should be without prejudice to intellectual property rights concerning the use by other manufacturers of data from clinical performance studies by the manufacturer. [Am. 18] |
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(33) |
The proper functioning of notified bodies is crucial for ensuring a high level of health and safety and citizens' confidence in the system. Designation and monitoring of notified bodies by the Member States, and where applicable by the EMA, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level. [Am. 19] |
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(34) |
The position of notified bodies vis-à-vis manufacturers should be strengthened, including their right and duty to carry out unannounced factory inspections and to conduct physical or laboratory tests on in vitro diagnostic medical devices to ensure continuous compliance by manufacturers after receipt of the original certification. |
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(35) |
For high risk in vitro diagnostic medical devices, authorities should be informed at an early stage about devices which are subject to conformity assessment and be given the right, on scientifically valid grounds, to scrutinise the preliminary assessment conducted by notified bodies, in particular regarding devices for which no common technical specifications exist, devices which are novel or for which a novel technology is being used, devices belonging to a category of devices with increased serious incident rates, or devices for which significant discrepancies in the conformity assessments by different notified bodies have been identified in respect of substantially similar devices. The process foreseen in this Regulation does not prevent a manufacturer from informing voluntarily a competent authority of his intention to file an application for conformity assessment for a high risk in vitro diagnostic medical device before submitting the application to the notified body. [Am. 20] |
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(36) |
To enhance patient safety and to take due account of technological progress, the risk classification system for in vitro diagnostic medical devices set out in Directive 98/79/EC should be fundamentally changed, in line with international practice, and the corresponding conformity assessment procedures should be accordingly adapted. |
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(37) |
It is necessary, in particular for the purpose of the conformity assessment procedures, to classify in vitro diagnostic medical devices into four risk classes and to establish a set of robust risk-based classification rules, in line with international practice. |
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(38) |
The conformity assessment procedure for class A in vitro diagnostic medical devices should be carried out, as a general rule, under the sole responsibility of the manufacturers, since such devices pose a low risk to patients. For in vitro diagnostic medical devices in classes B, C and D, the involvement of a notified body should be compulsory to the appropriate degree. |
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(39) |
The conformity assessment procedures should be further developed whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field. |
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(40) |
It is necessary to clarify the requirements regarding batch release verification for the highest risk in vitro diagnostic medical devices. |
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(40a) |
Clinical expertise and specialist product knowledge within notified bodies, special notified bodies and the MDCG should be appropriate for the specifications of in vitro diagnostic medical devices. Clinical experts should have expertise in clinical interpretation of in vitro diagnostic results, metrology and good laboratory practice. Clinical experts and product specialists should have expertise in fields such as virology, haematology, clinical analysis and genetics. [Am. 262] |
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(41) |
European Union reference laboratories should be enabled to verify compliance of such devices with the applicable common technical specifications, when such common technical specifications are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. |
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(42) |
To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements should be based on clinical evidence. It is necessary to clarify the requirements for such clinical evidence. As a general rule, clinical evidence should be sourced from clinical performance studies to be carried out under the responsibility of a sponsor who can be the manufacturer or another legal or natural person taking responsibility for the clinical performance study. |
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(43) |
The rules on clinical performance studies should be in line with major international guidance, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects and the most recent (2008) version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects to ensure that clinical performance studies conducted in the Union are accepted elsewhere and that clinical performance studies conducted outside the Union in accordance with international guidelines can be accepted under this Regulation. |
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(43a) |
The Declaration of Helsinki of the World Medical Association (21) states in Article 23 that ‘The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins.’ Interventional clinical performance studies and other clinical performance studies involving risk for the subject should only be allowed after assessment and approval by an ethics committee. The reporting Member State and the other concerned Member States need to organise themselves in a way that the competent authority concerned receives approval from an ethics committee on the clinical performance study protocol. [Am. 22] |
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(44) |
An electronic system should be set up at Union level to ensure that every interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies are registered in a publicly accessible database. To protect the right to protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union, no personal data of subjects participating in a clinical performance studies should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical performance studies on in vitro diagnostic medical devices should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use. |
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(44a) |
For the sake of transparency, sponsors should submit the results of a clinical performance study together with a ‘layperson’ summary within the deadlines specified by the regulation. The Commission should be empowered to adopt delegated acts on the preparation of the layperson's summary and the communication of the clinical performance study report. The Commission should provide guidelines for managing, and facilitating the sharing of, raw data from all clinical performance studies. [Am. 23] |
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(45) |
Sponsors of interventional clinical performance studies and other clinical performance studies involving risks for the subjects to be conducted in more than one Member State should be given the possibility to submit a single application in order to reduce administrative burden. In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety related aspects of the device for performance evaluation and of the scientific design of the clinical performance study to be conducted in several Member Stats, such single application should facilitate the coordination between the Member States under the direction of a coordinating Member State. The coordinated assessment should not include the assessment of intrinsically national, local and ethical aspects of a clinical performance study, including informed consent. Each Member State should retain the ultimate responsibility for deciding whether the clinical performance study may be conducted on its territory. [Am. 24] |
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(45a) |
Strict rules for persons unable to give informed consent such as children and incapacitated persons should be established at the same level as in Directive 2001/20/EC of the European Parliament and of the Council (22) . [Am. 25] |
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(46) |
Sponsors should report certain adverse events occurring during interventional clinical performance studies and other clinical performance studies involving risks for the subjects to the Member States concerned which should have the possibility to terminate or suspend these studies if considered necessary to ensure a high level of protection of the subjects enrolled in such studies. Such information should be communicated to the other Member States. |
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(47) |
This Regulation should only cover clinical performance studies which pursue regulatory purposes laid down in this Regulation. |
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(48) |
In order to better protect health and safety regarding devices on the market, the vigilance system for in vitro diagnostic medical devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions within and outside the Union . [Am. 26] |
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(49) |
Member States should take all necessary measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents. Healthcare professionals, users and patients should be empowered and enabled to report suspected serious incidents at national level using harmonised formats. The and guaranteeing anonymity, where appropriate . In order to minimise the recurrence of such incidents, the national competent authorities should inform manufacturers and, if appropriate, their subsidiaries and sub-contractors, and share report the information with their peers via the respective electronic system in Eudamed when they confirm that a serious an incident has occurred in order to minimise recurrence of those incidents. [Am. 27] |
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(50) |
The assessment of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one Member State, with the objective of sharing resources and ensuring consistency regarding the corrective action. |
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(51) |
The reporting of serious adverse events during interventional clinical performance studies and other clinical performance studies involving risks for the subjects, and the reporting of serious incidents occurring after an in vitro diagnostic medical device has been placed on the market should be clearly distinguished to avoid double reporting. |
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(52) |
Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures. |
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(53) |
The Member States shall should levy fees for the designation and monitoring of notified bodies to ensure sustainability of the monitoring of those bodies by Member States and to establish a level playing field for notified bodies. These fees should be comparable across Member States and should be made public. [Am. 28] |
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(54) |
Whilst this Regulation should not affect the right of the Member States to levy fees for activities at national level, Member States should inform the Commission and the other Member States before they adopt the comparable level and structure of the fees to ensure transparency. [Am. 29] |
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(54a) |
Member States should adopt provisions on standard fees for notified bodies, which should be comparable across Member States. The Commission should provide guidelines to facilitate the comparability of those fees. Member States should transmit their list of standard fees to the Commission and ensure that the notified bodies registered on their territory make the lists of standard fees for their conformity assessment activities publicly available. [Am. 30] |
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(55) |
An expert committee, the Medical Device Coordination Group A MDCG, composed of persons designated by the Member States, based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices, should be established in accordance with the conditions and modalities defined in Article 78 of Regulation (EU) …/…[Ref. of future Regulation on medical devices] on medical devices (23) to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) …/… [Ref. of future Regulation on medical devices] on medical devices, to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation. Prior to taking up their duties, members of the MDCG should make available a declaration of commitment and a declaration of interests indicating either the absence of any interests which could be considered prejudicial to their independence or any direct or indirect interests which could be prejudicial to their independence. Those declarations should be verified by the Commission. [Am. 31] |
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(56) |
Closer coordination between national competent authorities through information exchange and coordinated assessments under the direction of a coordinating authority is fundamental for ensuring a uniform high level of health and safety within the internal market, in particular in the areas of clinical performance studies and vigilance. This should also lead to more efficient use of scarce resources at national level. |
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(57) |
The Commission should provide scientific, technical and corresponding logistic support to the coordinating national authority and ensure that the regulatory system for in vitro diagnostic medical devices is effectively implemented at Union level based on sound scientific evidence. |
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(58) |
The Union should actively participate in international regulatory cooperation in the field of in vitro diagnostic medical devices to facilitate the exchange of safety-related information regarding in vitro diagnostic medical devices and foster the further development of international regulatory guidelines promoting the adoption of regulations in other jurisdictions with a level of health and safety protection equivalent to that set by this Regulation. |
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(59) |
This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably human dignity, the integrity of the person, the principle of free and informed consent of the person concerned, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property , as well as the European Convention on Human Rights and Biomedicine as well as the Additional Protocol to that Convention concerning Genetic Testing for Health Purposes . This Regulation should be applied by the Member States in accordance with those rights and principles. [Am. 32] |
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(59a) |
Clear rules on the application of DNA tests are important. It is however advisable to regulate only on some basic elements and leave room for the Member States for more specific regulation in this area. Member States should for example regulate, that all devices providing an indication of a genetic disease which develops in adulthood or affects family planning may not be used on minors unless preventive treatment is available. [Am. 33] |
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(59b) |
While genetic counselling should be mandatory in specific cases it should not be mandatory in cases where a diagnosis of a patient already suffering from a disease is confirmed by a genetic test or where a companion diagnostic is used. [Am. 34] |
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(59c) |
This Regulation is in keeping with the United Nations Convention on the Rights of Persons with Disabilities of 13 December 2006, ratified by the European Union on 23 December 2010, pursuant to which the signatories commit themselves, in particular, to promote, protect and guarantee the full and equal exercise of all human rights and basic freedoms by all persons with disabilities and to promote the respect of their inherent dignity, inter alia by raising awareness about the abilities of disabled persons and the contribution they make. [Am. 35] |
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(59d) |
Whereas, in view of the need to protect the integrity of the human person during the sampling, collection and use of substances derived from the human body, it is appropriate to apply the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine. [Am. 270] |
|
(60) |
In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the adaptation to technical progress of the general safety and performance requirements, of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certificates issued by notified bodies, of the minimum requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical performance studies; the establishment of the UDI system; the information to be submitted for the registration of in vitro diagnostic medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical performance studies; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them. However, basic aspects elements of this Regulation such as general safety and performance requirements , elements to be addressed in technical documentation, the minimum content of the Union declaration of conformity, amending or supplementing the conformity assessment procedures, should only be amended through the ordinary legislative procedure . It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. [Am. 36] |
|
(61) |
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (24). |
|
(62) |
The advisory procedure should be used for the adoption of the form and presentation of the data elements of the manufacturers' summary of safety and performance, of the codes defining the notified bodies' scopes of designation and of the model for certificates of free sale, given that those acts have a procedural character and do not directly impact the health and safety at Union level. |
|
(63) |
The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the extension to the territory of the Union of a national derogation from the applicable conformity assessment procedures in exceptional cases; relating to the Commission's position whether a provisional national measure against an in vitro diagnostic medical device presenting a risk or a provisional national preventive health protection measure is justified or not; and relating to the adoption of a Union measure against an in vitro diagnostic medical device presenting a risk, imperative grounds of urgency so require. |
|
(64) |
To allow economic operators, notified bodies, Member States and the Commission especially SMEs, to adapt to the changes introduced by this Regulation and to ensure its proper application , it is appropriate to provide for a sufficient transitional period for that adaptation and for the to allow for organisational arrangements to be taken for its proper application to be made. However, parts of the Regulation that concern Member States and the Commission should be implemented as soon as possible . It is particularly important that by the date of application, a sufficient number of notified bodies are designated is designated in accordance with the new requirements, as soon as possible, to avoid any shortage of in vitro diagnostic medical devices on the market. [Am. 37] |
|
(65) |
In order to ensure a smooth transition to the registration of in vitro diagnostic medical devices, of relevant economic operators and of certificates, the obligation to submit the relevant information to the electronic systems put in place by this Regulation at Union level should become fully effective only 18 months after the date of application of this Regulation. During this transitional period, Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC should remain in force. However, operational as soon as possible. Economic operators and notified bodies who register in the relevant electronic systems provided for at Union level should be considered in compliance with the registration requirements adopted by the Member States pursuant to those provisions of the Directive to avoid multiple registrations. [Am. 38] |
|
(66) |
Directive 98/79/EC should be repealed to ensure that only one set of rules applies to the placing of in vitro diagnostic medical devices on the market and the related aspects covered by this Regulation. |
|
(67) |
Since the objective of this Regulation, namely to ensure high standards of quality and safety for in vitro diagnostic medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot sufficiently be achieved by the Member States and can, by reason of the scale of the measure, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. |
|
(67a) |
It is a long standing policy of the Union not to interfere with national policy allowing, prohibiting or limiting at national level ethically controversial technologies, such as pre-implantation genetic testing. This Regulation should not interfere with this principle, and the decision to allow, prohibit or restrict such technologies should therefore remain at national level. Where a Member State allows such technologies whether with or without restriction, the standards laid down in this Regulation should apply. [Am. 39] |
|
(67b) |
Although internationally certified reference materials and materials used for external quality assessment schemes are not covered by this Regulation, calibrators and control materials needed by the user to establish or verify performances of devices are in vitro diagnostic medical devices. [Am. 272] |
HAVE ADOPTED THIS REGULATION:
Chapter I
Scope and definitions
Article 1
Scope
1. This Regulation establishes rules to be complied with by in vitro diagnostic medical devices and accessories to in vitro diagnostic medical devices that are placed on the market or put into service in the Union for human use.
For the purposes of this Regulation, in vitro diagnostic medical devices and accessories to in vitro diagnostic medical devices shall hereinafter be referred to as ‘devices’.
2. This Regulation shall not apply to:
|
(a) |
products for general laboratory use, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; |
|
(b) |
invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen; |
|
(c) |
higher metrological order reference materials. |
3. Any device which, when placed on the market or used in accordance with the manufacturer's instructions, incorporates as an integral part a medical device as defined in Article 2 of Regulation (EU) …/… [Ref. of future Regulation on medical devices] on medical devices without being an in vitro diagnostic medical device, shall be governed by this Regulation, provided that the principal intended purpose of the combination is that of an in vitro diagnostic medical device referred to in Article 2(2) of this Regulation. The relevant general safety and performance requirements set out in Annex I to Regulation (EU) …/… [Ref. of future Regulation on medical devices] shall apply as far as the safety and performance of the medical device part that is not an in vitro diagnostic medical device are concerned.
4. This Regulation is a specific Union legislation within the meaning of Article 1(4) of Directive 2004/108/EC and within the meaning of Article 3 of Directive 2006/42/EC.
5. This Regulation shall not affect the application of Directive 96/29/Euratom, nor of Directive 97/43/Euratom.
6. This Regulation provides that certain devices may only be supplied on a medical prescription but it shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this Regulation shall be illegal.
The following devices may only be supplied on a medical prescription:
|
1) |
Class D devices; |
|
2) |
Class C devices in the following categories:
|
By derogation, justified by the attainment of a high level of public health protection, Members States may maintain or introduce national provisions allowing special class D tests to also be available without a medical prescription. In that case, they shall duly inform the Commission.
The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide that other class C tests may only be supplied on a medical prescription after consultation with stakeholders. [Am. 268]
7. References to a Member State in this Regulation shall be understood as including any other country with which the Union has concluded an agreement which confers on that country the same status as a Member State for the purpose of application of this Regulation.
7a. The regulation of in-vitro diagnostic medical devices at Union level shall not interfere with the freedom of Member States to decide whether to restrict the use of any specific type of in-vitro diagnostic device in relation to aspects that are not covered by this Regulation. [Am. 41]
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
Definitions related to devices:
|
(1) |
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific direct or indirect medical purposes of:
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. [Ams 42 and 43] |
|
(2) |
‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
Specimen receptacles are considered to be in vitro diagnostic medical devices. For the purposes of this Regulation, ‘specimen receptacle’ means devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. In vitro diagnostic medical devices used for DNA-testing shall be subject to this Regulation. [Am. 45] |
|
(3) |
‘accessory to an in vitro diagnostic medical device’ means an article which, whilst not being an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable or assist the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s); |
|
(4) |
‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons , including testing services offered to lay persons by means of information society services ; [Am. 46] |
|
(5) |
‘device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient; |
|
(6) |
‘companion diagnostic’ means a device specifically intended to select for and essential to the selection of patients with a previously diagnosed condition or predisposition as eligible suitable or unsuitable for a targeted specific therapy with a medicinal product or a range of medicinal products ; [Am. 47] |
|
(7) |
‘generic device group’ means a set of devices having the same or similar intended purposes or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics; |
|
(8) |
‘single-use device’ means a device that is intended to be used on an individual patient during a single procedure; The single procedure may involve several uses or prolonged use on the same patient. |
|
(9) |
‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements; |
|
(10) |
‘label’ means the written, printed, or graphic information appearing either on the device itself, or on the packaging of each unit, or on the packaging of multiple devices; |
|
(11) |
‘instructions for use’ means the information provided by the manufacturer to inform the user of the device’s intended purpose and proper use and of any precautions to be taken; |
|
(12) |
‘Unique Device Identification’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market; |
|
(12a) |
‘novel device’ means:
|
|
(12b) |
‘device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development; [Am. 49] |
Definitions related to the making available of devices:
|
(13) |
‘making available on the market’ means any supply of a device, other than a device for performance evaluation, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; |
|
(14) |
‘placing on the market’ means the first making available of a device, other than a device for performance evaluation, on the Union market; |
|
(15) |
‘putting into service’ means the stage at which a device, other than a device for performance evaluation, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose; |
|
(15a) |
‘Information society service’ means any service, normally provided for remuneration, at a distance, by electronic means and at the individual request of a recipient of services; [Am. 50] |
Definitions related to economic operators, users and specific processes:
|
(16) |
‘manufacturer’ means the natural or legal person who manufactures or with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under that person's own name, regardless of whether those operations are carried out by that person or on that person's behalf by a third party. The obligations of this Regulation to be met by manufacturers also apply to natural or legal persons who assemble, package, process, fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device refurbish or label one or more ready-made products and/or assign to them their intended purpose as devices with a view to their being placed on the market under his that person's own name or trademark. [Am. 51] For the purposes of the definition of manufacturer, fully refurbishing is defined as the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it in conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device; |
|
(17) |
‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under this Regulation; |
|
(18) |
‘importer’ means any natural or legal person established within the Union who places a device from a third country on the Union market; |
|
(19) |
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market; |
|
(20) |
‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor; |
|
(21) |
‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health and which has the legal capacity to carry out such activities ; commercial laboratories which provide diagnostic services shall not be considered to be health institutions ; [Am. 52] |
|
(22) |
‘user’ means any healthcare professional or lay person who uses a device; |
|
(23) |
‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline; |
Definitions related to conformity assessment:
|
(24) |
‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled; |
|
(25) |
‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection; [Am. 53] |
|
(26) |
‘notified body’ means a conformity assessment body designated in accordance with this Regulation; |
|
(27) |
‘CE marking of conformity’ or ‘CE marking’ means a marking by which the manufacturer indicates that the device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing; |
Definitions related to clinical evidence:
|
(28) |
‘clinical evidence’ means the information that supports data, positive and negative, supporting the evaluation of the scientific validity and performance for the use of a device as intended by the manufacturer; [Am. 54] |
|
(29) |
‘scientific validity of an analyte’ means the association of an analyte to a clinical condition or a physiological state; |
|
(30) |
‘performance of a device’ means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the attainment of technical capabilities, analytical performance and, where applicable, the clinical performance supporting the intended purpose of the device; [Am. 55] |
|
(31) |
‘analytical performance’ means the ability of a device to correctly detect or measure a particular analyte; |
|
(32) |
‘clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological state in accordance with the target population and intended user; |
|
(33) |
‘clinical performance study’ means a study undertaken to establish or confirm the clinical performance of a device; |
|
(34) |
‘clinical performance study protocol’ means the document(s) setting out the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical performance study; |
|
(35) |
‘performance evaluation’ means the assessment and analysis of data to establish or verify the that the device performs as intended by the manufacturer, including the technical, analytical and, where applicable, the clinical performance of a device; [Am. 56] |
|
(36) |
‘device for performance evaluation’ means a device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside the manufacturer's own premises. Devices intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation; |
|
(37) |
‘interventional clinical performance study’ means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment; |
|
(37a) |
‘ethics committee’ means an independent body in a Member State, consisting of health-care professionals and non-medical members including at least one well-experienced, knowledgeable patient or patient representative. Its responsibility is to protect the rights, safety, physical and mental integrity, dignity and well-being of subjects involved in interventional clinical performance studies and other clinical performance studies involving risk for the subject and to provide public assurance of that protection in full transparency. In cases of such studies involving minors, the ethics committee shall include at least one healthcare professional with paediatric expertise. [Am. 57] |
|
(38) |
‘diagnostic specificity’ means the ability of a device to recognize the absence of a target marker associated with a particular disease or condition; |
|
(39) |
‘diagnostic sensitivity’ means the ability of a device to identify the presence of a target marker associated with a particular disease or condition; |
|
(40) |
‘predictive value’ means the probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition; |
|
(41) |
‘positive predictive value’ means the ability of a device to separate true positive results from false positive results for a given attribute in a given population; |
|
(42) |
‘negative predictive value’ means the ability of a device to separate true negative results from false negative results for a given attribute in a given population; |
|
(43) |
‘likelihood ratio’ means the likelihood that a given result would be expected in an individual with the target clinical condition or physiological state compared to the likelihood that the same result would be expected in an individual without that clinical condition or physiological state; |
|
(43a) |
‘calibrator’ means a measurement standard used in the calibration of a device; [Am. 58] |
|
(44) |
‘calibrators and control materials material ’' means any a substance, material or article intended by the its manufacturer either to establish measurement relationships or to be used to verify the performance characteristics of a device in conjunction with the intended purpose of that device; [Am. 59] |
|
(45) |
‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation and management , conduct or financing of a clinical performance study; [Am. 60] |
|
(46) |
‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons in the context of a clinical performance study, whether or not related to the device for performance evaluation; |
|
(47) |
‘serious adverse event’ means any adverse event that led to any of the following:
|
|
(48) |
‘device deficiency’ means any inadequacy in the identity, quality, durability stability , reliability, safety or performance of a device for performance evaluation, including malfunction, use errors or inadequacy in the information supplied by the manufacturer; [Am. 62] |
|
(48a) |
‘inspection’ means an official review, carried out by a competent authority, of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by that authority to be related to a clinical performance study and that may be located at the site of the trial, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect; [Am. 63] |
Definitions related to vigilance and market surveillance:
|
(49) |
‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user; |
|
(50) |
‘withdrawal’ means any measure aimed at preventing a device in the supply chain from further being made available on the market; |
|
(51) |
‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, any inadequacy in the information supplied by the manufacturer and any unexpected undesirable effect; |
|
(52) |
‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:
|
|
(53) |
‘corrective action’ means action taken to eliminate the cause of a potential or real non-conformity or other undesirable situation; |
|
(54) |
‘field safety corrective action’ means corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market; |
|
(55) |
‘field safety notice’ means the communication sent by the manufacturer to users , waste disposal operators or customers in relation to a field safety corrective action; [Am. 64] |
|
(56) |
‘market surveillance’ means the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection; |
|
(56a) |
‘unannounced inspection’ means an inspection conducted without advance notice; [Am. 65] |
Definitions related to standards and other technical specifications:
|
(57) |
‘harmonised standard’ means a European standard as defined in Article 2(1)(c) of Regulation (EU) No …/… [Ref. of future Regulation on European standardisation]; |
|
(58) |
‘common technical specifications’ means a document other than a standard that prescribes technical requirements that provide a means to comply with the legal obligations applicable to a device, process or system. |
Article 3
Regulatory status of products
1. The Commission may on its own initiative or shall at the request of a Member State or on its own initiative, by means of implementing acts on the basis of the opinions of the MDCG and the MDAC referred to in Articles 76 and 76a respectively , determine whether or not a specific product, or category or group of products, including borderline products, falls within the definitions of an in vitro diagnostic medical devices or of an accessory to an in vitro diagnostic medical device. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
2. The Commission shall ensure the sharing of expertise between Member States in the fields of in vitro diagnostic medical devices, medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products in order to determine the appropriate regulatory status of a product, or category or group of products. [Am. 66]
SECTION 1 CHAPTER II
CLASSIFICATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES [AM. 135]
Article 39
Classification of in vitro diagnostic medical devices
1. Devices shall be divided into class A, B, C and D, taking into account their intended purpose , novelty, complexity and inherent risks. Classification shall be carried out in accordance with the classification criteria set out in Annex VII. [Am. 136]
2. Any dispute between the manufacturer and the notified body concerned, arising from the application of the classification criteria, shall be referred for a decision to the competent authority of the Member State where the manufacturer has his registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State where the authorised representative referred to in the last indent of point (b) of Section 3.2. of Annex VIII has his registered place of business.
At least 14 days prior to any decision, the competent authority shall notify the MDCG and the Commission of its envisaged decision. That decision shall be made publicly available in the European databank . [Am. 137]
3. The Commission may, on its own initiative or shall at the request of a Member State or on its own initiative, by means of implementing acts, decide on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices with a view to determining their classification. Such a decision shall in particular be taken in order to resolve divergent decisions as regards the classification of devices between Member States. [Am. 138]
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
4. In the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in Articles 59 to 73, the Commission , having consulted relevant stakeholders, including healthcare professionals' organisations, and manufacturers’ associations, shall be empowered to adopt delegated acts in accordance with Article 85 as regards the following: [Am. 139]
|
(a) |
deciding that a device, or category or group of devices, should, by way of derogation from the classification criteria set out in Annex VII, be classified in another class, |
|
(b) |
amending or supplementing the classification criteria set out in Annex VII. |
Chapter V III
Classification and conformity Conformity assessment [Am. 134]
SECTION 2 — CONFORMITY ASSESSMENT
Article 40
Conformity assessment procedures
1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device. The conformity assessment procedures are set out in Annexes VIII to X.
2. Manufacturers of devices classified as class D, other than devices for performance evaluation, shall be subject to a conformity assessment based on full quality assurance, design dossier examination and batch verification, as specified in Annex VIII. Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex IX, coupled with a conformity assessment based on production quality assurance including batch verification, as specified in Annex X.
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX as specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. Laboratory tests performed by a reference laboratory shall focus on, in particular, analytic sensitivity and specificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established infection . [Am. 140]
For companion diagnostics intended to be used to assess the patient eligibility for treatment with a specific medicinal product, the notified body shall consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council (25) or the European Medicines Agency (EMA) in accordance with the procedures set out in Section 6.2 of Annex VIII and in Section 3.6 of Annex IX.
3. Manufacturers of devices classified as class C, other than devices for performance evaluation, shall be subject to a conformity assessment based on full quality assurance, as specified in Annex VIII, with assessment of the design documentation within the technical documentation on a representative basis. Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination, as specified in Annex IX coupled with conformity assessment based on production quality assurance, as specified in Annex X.
In addition, for devices for self-testing and near-patient testing, the manufacturer shall fulfil the supplementary requirements set out in Section 6.1 of Annex VIII or in Section 2 of Annex IX.
For companion diagnostic intended to be used to assess the patient eligibility to a treatment with a specific medicinal product, the notified body shall consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the European Medicines Agency (EMA) in accordance with the procedures set out in Section 6.2 of Annex VIII and in Section 3.6 of Annex IX.
4. Manufacturers of devices classified as class B, other than devices for performance evaluation, shall be subject to a conformity assessment based on full quality assurance, as specified in Annex VIII.
In addition, for devices for self-testing and near-patient testing, the manufacturer shall fulfil the supplementary requirements set out in Section 6.1 of Annex VIII. [Am. 141]
5. Manufacturers of devices classified as class A, other than devices for performance evaluation, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 15, after drawing up the technical documentation set out in Annex II.
However, if the devices are intended for near-patient testing, or if they are placed on the market in sterile condition or have a measuring function, the manufacturer shall apply the procedures set out in Annex VIII or in Annex X. Involvement of the notified body shall be limited:
|
(a) |
in the case of devices for near-patient testing, to the requirements set out in Section 6.1 of Annex VIII, [Am. 142] |
|
(b) |
in the case of devices placed on the market in sterile condition, to the aspects of manufacture concerned with securing and maintaining sterile conditions, |
|
(c) |
in the case of devices with a measuring function, to the aspects of manufacture concerned with the conformity of the devices with the metrological requirements. [Am. 143] |
6. Manufacturers may choose to apply a conformity assessment procedure applicable to devices of a higher class than the device in question.
7. Devices for performance evaluation shall be subject to the requirements set out in Articles 48 to 58.
8. The Member State in which the notified body is established may determine that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 6 shall be available in an official Union language. Otherwise they shall be available in an official Union language acceptable to the notified body.
9. The Commission may, by means of implementing acts, specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies, for any of the following aspects:
|
— |
the frequency and the sampling basis of the assessment of the design documentation within the technical documentation on a representative basis as set out in Sections 3.3.(c) and 4.5 of Annex VIII, in the case of devices classified as class C; |
|
— |
the minimum frequency of unannounced factory inspections and sample checks to be conducted by notified bodies in accordance with Section 4.4 of Annex VIII, taking into account the risk-class and the type of device; |
|
— |
the frequency of samples of the manufactured devices or batches of devices classified as class D to be sent to a reference laboratory designated under Article 78 in accordance with Section 5.7 of Annex VIII and Section 5.1 of Annex X, or |
|
— |
the physical, laboratory or other tests to be carried out by notified bodies in the context of sample checks, design dossier examination and type examination in accordance with Sections 4.4 and 5.3 of Annex VIII and Sections 3.2 and 3.3 of Annex IX. |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
10. In the light of technical progress and any information which becomes available in the course of the designation or monitoring of notified bodies set out in Articles 26 to 38, or of the vigilance and market surveillance activities described in Articles 59 to 73, the Commission shall be empowered to adopt delegated acts in accordance with Article 85 amending or supplementing the conformity assessment procedures set out in Annexes VIII to X. [Am. 144]
Article 41
Involvement of notified bodies in conformity assessment procedures
1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer of devices other than those listed in Article 41a(1), may apply to a notified body of his choice, provided that the body is notified for the conformity assessment activities, the conformity assessment procedures and the devices concerned. Where a manufacturer applies to a notified body located in a Member State other than the one where it is registered, the manufacturer shall inform its national authority responsible for notified bodies of the application. An application may not be lodged in parallel with more than one notified body for the same conformity assessment activity. [Am. 145]
2. The notified body concerned shall inform the other notified bodies of any manufacturer who withdraws his application prior to the notified body's decision regarding the conformity assessment.
3. The notified body may require any information or data from the manufacturer which is necessary in order to properly conduct the chosen conformity assessment procedure.
4. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities.
SECTION 2A — ADDITIONAL PROVISIONS FOR THE CONFORMITY ASSESSMENT OF HIGH-RISK DEVICES: INVOLVEMENT OF SPECIAL NOTIFIED BODIES [Am. 146]
Article 41a
Involvement of special notified bodies in conformity assessment procedures of high-risk devices
1. Only special notified bodies (SNB) shall be entitled to conduct conformity assessments for class D devices.
2. Applicant special notified bodies which consider they fulfil the requirements for special notified bodies referred to in Annex VI, point 3.6, shall submit their application to the EMA.
3. The application shall be accompanied by the fee payable to the EMA to cover the costs relating to the examination of the application.
4. The EMA shall select the special notified bodies among applicants, in accordance with requirements listed in Annex VI, and adopt its opinion on the authorisation to perform conformity assessments for devices referred to in paragraph 1 within 90 days and send it to the Commission.
5. The Commission shall then publish the notification accordingly and the names of the special notified bodies.
6. This notification shall become valid the day after its publication in the database of notified bodies developed and managed by the Commission. The published notification shall determine the scope of lawful activity of the special notified body.
This notification shall be valid for five years and subject to renewal every five years, following a new application to the EMA.
7. The manufacturer of devices specified in paragraph 1 may apply to a special notified body of its choice, whose name appears in the electronic system of Article 41b.
8. An application may not be lodged in parallel with more than one special notified body for the same conformity assessment activity.
9. The special notified body shall notify the EMA and the Commission of applications for conformity assessments for devices specified in paragraph 1.
10. Article 41(2), (3) and (4) apply to special notified bodies. [Am. 147]
Article 41b
Electronic system on special notified bodies
1. The Commission, in collaboration with the Agency, shall establish and regularly update an electronic registration system for:
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— |
the registration of applications and granted authorisations to perform conformity assessments as special notified bodies under this Section and to collate and process information on the name of the special notified bodies; |
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— |
the exchange of information with national authorities; and |
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— |
the publication of assessment reports. |
2. The information collated and processed in the electronic system which relates to special notified bodies shall be entered into the electronic registration system by the EMA.
3. The information collated and processed in the electronic system and which relates to special notified bodies shall be accessible to the public. [Am. 148]
Article 41c
Network of special notified bodies
1. The EMA shall establish, host, coordinate and manage the network of special notified bodies.
2. The network shall have the following objectives:
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(a) |
to help realise the potential of European cooperation regarding highly specialised medical technologies in the area of in vitro diagnostic medical devices; |
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(b) |
to contribute to the pooling of knowledge regarding in vitro diagnostic medical devices; |
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(c) |
to encourage the development of conformity assessment benchmarks and to help develop and spread best practice within and outside the network; |
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(d) |
to help identify the experts in innovative fields; |
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(e) |
to develop and update rules on conflicts of interest; and |
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(f) |
to find common answers to similar challenges concerning the conduct of conformity assessment procedures in innovative technologies. |
3. Meetings of the network shall be convened whenever requested by at least two of its members or by the EMA. It shall meet at least twice a year. [Am. 149]
Article 42
Mechanism for scrutiny of certain conformity assessments
1. Notified bodies shall notify the Commission of applications for conformity assessments for devices classified as class D, with the exception of applications to supplement or renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 17.3 of Annex I and the draft summary of safety and performance referred to in Article 24. In its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG.
2. Within 28 days of receipt of the information referred to in paragraph 1, the MDCG may request the notified body to submit a summary of the preliminary conformity assessment prior to issuing a certificate. Upon suggestion by any of its members or by the Commission, the MDCG shall decide on making such request in accordance with the procedure set out in Article 78(4) of Regulation [Ref. of future Regulation on medical devices]. In its request the MDCG shall indicate the scientifically valid health reason for having selected the specific file for submission of a summary of the preliminary conformity assessment. When selecting a specific file for submission, the principle of equal treatment shall be duly taken into account.
Within 5 days after receipt of the request by the MDCG, the notified body shall inform the manufacturer thereof.
3. The MDCG may submit comments on the summary of the preliminary conformity assessment at the latest 60 days after submission of this summary. Within that period and at the latest 30 days after submission, the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the notified body's preliminary conformity assessment. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this subparagraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of comments.
4. The notified body shall give due consideration to any comments received in accordance with paragraph 3. It shall convey to the Commission an explanation of how they have been taken into consideration, including any due justification for not following the comments received, and its final decision regarding the conformity assessment in question. The Commission shall immediately transmit this information to the MDCG.
5. Where deemed necessary for the protection of patient safety and public health, the Commission may determine, by means of implementing acts, specific categories or groups of devices, other than devices classified as class D, to which paragraphs 1 to 4 shall apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
Measures pursuant to this paragraph may be justified only by one or more of the following criteria:
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(a) |
the novelty of the device or of the technology on which it is based and the significant clinical or public health impact thereof; |
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(b) |
an adverse change in the risk-benefit profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in case of failure; |
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(c) |
an increased rate of serious incidents reported in accordance with Article 59 in respect of a specific category or group of devices; |
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(d) |
significant discrepancies in the conformity assessments carried out by different notified bodies on substantially similar devices; |
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(e) |
public health concerns regarding a specific category or group of devices or the technology on which they are based. |
6. The Commission shall make a summary of the comments submitted in accordance with paragraph 3 and the outcome of the conformity assessment procedure accessible to the public. It shall not disclose any personal data or information of commercially confidential nature.
7. The Commission shall set up the technical infrastructure for the data-exchange by an electronic means between notified bodies and MDCG for the purposes of this Article.
8. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the summary of the preliminary conformity assessment in accordance with paragraphs 2 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3). [Am. 150]
Article 42a
Case-by-case assessment procedure for the conformity assessments of certain high-risk devices
1. Special notified bodies shall notify the Commission of applications for conformity assessments for Class D devices, with the exception of applications to renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 17.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 24. In its notification the special notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the Coordination Group (CG) of the Assessment Committee for Medical Devices (ACMD), referred to in Article 76a. The CG shall immediately transmit the notification and the accompanying documents to the relevant sub-groups.
2. Within 20 days of receipt of the information referred to in paragraph 1, the CG may decide, upon the suggestion of at least three of the members of the relevant sub-groups of the ACMD or by the Commission, to request the special notified body to submit the following documents prior to issuing a certificate:
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the summary of the preliminary conformity assessment; |
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the clinical evidence report and the clinical performance study report as referred to in Annex XII; |
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data obtained from the post-market follow-up referred to in Annex XII; and |
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any information regarding the marketing or not of the device in third countries and, where available, the results of evaluation conducted by competent authorities in those countries, |
The members of the relevant sub-groups of the ACMD shall decide on making such case-by-case requests notably on the basis of the following criteria:
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(a) |
the novelty of the device or of the technology on which it is based and the significant clinical or public health impact thereof; |
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(b) |
an adverse change in the risk-benefit profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in case of failure; |
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(c) |
an increased rate of serious incidents reported in accordance with Article 61 in respect of a specific category or group of devices; |
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(d) |
significant discrepancies in the conformity assessments carried out by different special notified bodies on substantially similar devices. |
In the light of technical progress and any information which becomes available, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing these criteria.
In its request the ACMD shall indicate the scientifically valid health reason for having selected the specific file.
In the absence of a request from the ACMD within 20 days of receipt of the information referred to in paragraph 1, the special notified body shall proceed with the conformity assessment procedure.
3. The ACMD, following the consultation of the relevant sub-groups, shall issue an opinion on the documents referred to in paragraph 2 at the latest 60 days after their submission. Within that period and at the latest 30 days after submission, the ACMD may request the submission of additional information that for scientifically valid grounds is necessary for the analysis of the special notified body's preliminary conformity assessment. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this paragraph shall be suspended. Subsequent requests for additional information from the ACMD shall not suspend the period for the submission of comments.
4. In its opinion the ACMD may recommend modifications of the documents referred to in paragraph 2.
5. The ACMD shall inform the Commission, the special notified body and the manufacturer of its opinion within five days of its adoption.
6. Within 15 days after receipt of the opinion referred to in paragraph 5, the special notified body shall indicate whether or not it agrees with the opinion of the ACMD. In the latter case, it may give written notice to the ACMD that it wishes to request a re-examination of the opinion. In that case, the special notified body shall forward to the ACMD the detailed grounds for the request within 30 days after receipt of the opinion. The ACMD shall immediately transmit this information to the Commission
Within 30 days following receipt of the grounds for the request, the ACMD shall re-examine its opinion. The reasons for the conclusion reached shall be annexed to the final opinion.
7. Within 15 days after its adoption, the ACMD shall send its final opinion to the Commission, the special notified body and the manufacturer.
8. Within 15 days after receipt of the opinion referred to in paragraph 6 in case of agreement by the special notified body or of the final opinion as referred to in paragraph 7, the Commission shall prepare, on the basis of the opinion, a draft of the decision to be taken in respect of the examined application for conformity assessment. This draft decision shall include or make reference to the opinion referred to in paragraphs 6 and 7 as applicable. Where the draft decision is not in accordance with the ACMD opinion, the Commission shall annex a detailed explanation of the reasons for the differences.
The draft decision shall be forwarded to the Member States, the special notified body and the manufacturer.
The Commission shall take a final decision in accordance with and within 15 days after the end of, the examination procedure referred to in Article 84(3).
9. Where deemed necessary for the protection of patient safety and public health, the Commission shall be empowered to adopt delegated acts in accordance with Article 85 to determine, specific categories or groups of devices, other than devices referred to in paragraph 1, to which paragraphs 1 to 8 shall apply during a predefined period of time.
Measures pursuant to this paragraph may be justified only by one or more of the criteria referred to in paragraph 2.
10. The Commission shall make a summary of the opinions referred to in paragraphs 6 and 7 accessible to the public. It shall not disclose any personal data or information of a commercially confidential nature.
11. The Commission shall set up the technical infrastructure for the data-exchange by electronic means between special notified bodies and the ACMD and between the ACMD and itself for the purposes of this Article.
12. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the documentation provided in accordance with this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
13. Special notified bodies shall notify the Commission of applications for conformity assessments for Class D devices, with the exception of applications to renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 17.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 24. In its notification the special notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the Coordination Group (CG) of the Assessment Committee for Medical Devices (ACMD), referred to in Article 76a. The CG shall immediately transmit the notification and the accompanying documents to the relevant sub-groups. [Am. 151]
Article 43
Certificates
1. The certificates issued by the notified bodies in accordance with Annexes VIII, IX and X shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates is set out in Annex XI.
2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.
3. Where a notified body finds that requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective measures taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision.
4. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information on certificates issued by notified bodies. The notified body shall enter into the electronic system information regarding certificates issued, including amendments and supplements, and information regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates. This information shall be accessible to the public.
5. In the light of technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 85 amending or supplementing the minimum content of the certificates set out in Annex XI.
Article 44
Voluntary change of notified body
1. In cases Where a manufacturer terminates decides to terminate his contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, it shall inform its national authority responsible for notified bodies of this change. The modalities of the change of notified body shall be clearly defined in an agreement between the manufacturer, the outgoing notified body and the incoming notified body. This agreement shall address at least the following aspects: [Am. 152]
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(a) |
the date of invalidity of certificates issued by the outgoing notified body; |
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(b) |
the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material; |
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(c) |
the transfer of documents, including confidentiality aspects and property rights; |
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(d) |
the date as of which the incoming notified body assumes full responsibility for the conformity assessment tasks. |
2. On their date of invalidity, the outgoing notified body shall withdraw the certificates it has issued for the device concerned.
Article 44a
Additional assessment procedure in extraordinary cases
1. Special notified bodies shall notify the Commission of applications for conformity assessments for Class D devices, where no CTS standard exists, with the exception of applications to renew or supplement existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 17.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 24. In its notification the special notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the Medical Device Coordination Group (MDCG) for an opinion. In making its opinion, the MDCG may seek a clinical assessment from the relevant experts of the Assessment Committee for Medical Devices (ACMD), referred to in Article 76a.
2. Within 20 days of receipt of the information referred to in paragraph 1, the MDCG may decide to request the special notified body to submit the following documents prior to issuing a certificate:
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— |
the clinical evidence report and the clinical performance study report as referred to in Annex XII, |
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data obtained from the post market follow-up referred to in Annex XII, and |
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— |
any information regarding the marketing or not of the device in third countries and, where available, the results of evaluation conducted by competent authorities in those countries, |
The members of the MDCG shall decide on making such a request on the basis of the following criteria:
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(a) |
the novelty of the device with possible major clinical or health impact |
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(b) |
an adverse change in the risk-benefit profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in case of failure; |
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(c) |
an increased rate of serious incidents reported in accordance with Article 61 in respect of a specific category or group of devices; In the light of technical progress and any information which becomes available, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing these criteria. In its request the MDCG shall indicate the scientifically valid health reason for having selected the specific file. In the absence of a request from the MDCG within 20 days of receipt of the information referred to in paragraph 1, the special notified body shall proceed with the conformity assessment procedure. |
3. The MDCG, following the consultation of the ACMD shall issue a MDCG opinion on the documents referred to in paragraph 2 at the latest 60 days after its submission. Within that period and at the latest 30 days after submission, the ACMD through the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the documents referred to in paragraph 2. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this paragraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of comments.
4. In its opinion the MDCG shall take into account the clinical assessment of the ACMD. The MDCG may recommend modifications of the documents referred to in paragraph 2.
5. The MDCG shall inform the Commission, the special notified body and the manufacturer of its opinion.
6. Within 15 days after receipt of the opinion referred to in paragraph 5, the special notified body shall indicate whether or not it agrees with the opinion of the MDCG. In the latter case, it may give written notice to the MDCG that it wishes to request a re-examination of the opinion. In that case, the special notified body shall forward to the MDCG the detailed grounds for the request within 30 days after receipt of the opinion. The MDCG shall immediately transmit this information to the Commission
Within 30 days following receipt of the grounds for the request, the MDCG shall re-examine its opinion. The reasons for the conclusion reached shall be annexed to the final opinion.
7. Immediately after its adoption, the MDCG shall send its final opinion to the Commission, the special notified body and the manufacturer.
8. In case of a favourable MDCG opinion, the special notified body may proceed with the certification.
However if the favourable MDCG opinion is dependent on the application of specific measures (e.g. adaptation of the post-market clinical follow-up plan, certification with a time limit), the special notified body shall issue the certificate of conformity only on condition that those measures are fully implemented.
Following the adoption of a favourable opinion, the Commission shall always explore the possibility of adopting, common technical standards for the device of group of devices concerned and adopt them where possible.
In case of an unfavourable MDCG opinion, the special notified body shall not deliver the certificate of conformity. Nevertheless, the special notified body may submit new information in response to the explanation included in the MDCG assessment. If the new information is substantially different to that which has been previously submitted the MDCG shall reassess the application.
At the request of the manufacturer, the Commission shall organise a hearing allowing discussion on the scientific grounds for the unfavourable scientific assessment and any action that the manufacturer may take or data that may be submitted to address the MDCG concerns.
9. Where deemed necessary for the protection of patient safety and public health, the Commission shall be empowered to adopt delegated acts in accordance with Article 85 to determine, specific categories or groups of devices, other than devices referred to in paragraph 1, to which paragraphs 1 to 8 shall apply during a predefined period of time.
Measures pursuant to this paragraph may be justified only by one or more of the criteria referred to in paragraph 2.
10. The Commission shall make a summary of the opinion referred to in paragraphs 6 and 7 accessible to the public. It shall not disclose any personal data or information of a commercially confidential nature.
11. The Commission shall set up the technical infrastructure for the data-exchange by electronic means between the MDCG, the special notified bodies and the ACMD and between the ACMD and itself for the purposes of this Article.
12. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the documentation provided in accordance with this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
13. The company concerned shall not be charged for the additional costs due to this assessment. [Ams 259 and 269]
Article 45
Derogation from the conformity assessment procedures
1. By way of derogation from Article 40, any competent authority may authorise, on duly justified request, the placing on the market or putting into service, within the territory of the Member State concerned, of a specific device for which the procedures referred to in Article 40 have not been carried out and use of which is in the interest of public health or patient safety.
2. The Member State shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient.
3. Upon request by a Member State and where this is in the interest of public health or patient safety in more than one Member State, the Commission may, by means of implementing acts, extend for a determined period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 84(4).
Article 46
Certificate of free sale
1. For the purpose of export and upon request by a manufacturer, the Member State in which the manufacturer has its registered place of business shall issue a certificate of free sale declaring that the manufacturer is properly established and that the device in question bearing the CE marking in accordance with this Regulation may be legally marketed in the Union. The certificate of free sale shall be valid for the period indicated on it which shall not exceed five years and shall not exceed the validity of the certificate referred to in Article 43 issued for the device in question.
2. The Commission may, by means of implementing acts, establish a model for certificates of free sale taking into account international practice as regards the use of certificates of free sale. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 84(2).
Chapter IV
Notified Bodies
Article 26
National authorities responsible for notified bodies
1. A Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out third-party conformity assessment tasks under this Regulation shall designate an authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, including subcontractors or subsidiaries of those bodies, hereinafter referred to as the ‘national authority responsible for notified bodies’.
2. The national authority responsible for notified bodies shall be established, organised and operated so as to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interest with conformity assessment bodies.
3. It shall be organised so that each decision relating to notification of a conformity assessment body is taken by personnel different from those who carried out the assessment of the conformity assessment body.
4. It shall not perform any activities that conformity assessment bodies perform nor provide consultancy services on a commercial or competitive basis.
5. The national authority responsible for notified bodies shall safeguard the confidentiality confidential aspects of the information it obtains. However, it shall exchange information on a notified body with other Member States and the Commission. [Am. 104]
6. The national authority responsible for notified bodies shall have a sufficient number of permanent and competent personnel at its disposal ‘in-house’, for the proper performance of its tasks. Compliance with that requirement shall be assessed in the peer-review referred to in paragraph 8.
In particular, the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out product related reviews shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3.2.5. of Annex VI.
Similarly, the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out audits of the manufacturer's quality management system shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3.2.6. of Annex VI.
Without prejudice to Article 31(3), where Where a national authority is responsible for the designation of notified bodies in the field of products other than in vitro diagnostic medical devices, the competent authority for in vitro diagnostic medical devices shall be consulted on all aspects specifically related to such devices. [Am. 105]
7. The ultimate responsibility for the notified bodies and the national authority responsible for notified bodies lies with the Member State in which they are located. The Member State shall check that the designated national authority responsible for notified bodies performs its work on the assessment, designation and notification of conformity assessment bodies and for the monitoring of the notified bodies properly and that the designated national authority responsible for notified bodies works impartially and objectively. Member States shall provide the Commission and the other Member States with all information they request on their procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and of any changes thereto. Such information shall be publicly available subject to Article 80. [Am. 106]
8. The national authority responsible for notified bodies shall be peer-reviewed every second year. The peer-review shall include an on-site visit to a conformity assessment body or a notified body under the responsibility of the reviewed authority. In the case referred to in the second subparagraph of paragraph 6, the competent authority for medical devices shall participate in the peer-review.
The Member States shall draw up the annual plan for the peer-review, ensuring an appropriate rotation in respect of reviewing and reviewed authorities, and submit it to the Commission. The Commission may shall participate in the review. The outcome of the peer-review shall be communicated to all Member States and to the Commission and a summary of the outcome shall be made publicly available. [Am. 107]
Article 27
Requirements relating to notified bodies
1. Notified bodies shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this Regulation. In this respect, permanent ‘in-house’ administrative, technical and scientific personnel, with medical, technical and, where needed, pharmacological knowledge shall be ensured. Permanent ‘in-house’ personnel shall be used, but notified bodies may hire external experts on an ad hoc and temporary basis as and when needed. Minimum requirements to be met by notified bodies are set out in Annex VI. In particular, in accordance with point 1.2. of Annex VI, the notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities and avoid conflict of interests.
The notified body shall publish a list of its staff responsible for the conformity assessment and certification of medical devices. This list shall at least contain the qualifications, CV and declaration of interests for each member of staff. The list shall be sent to the national authority responsible for notified bodies which shall check that the staff satisfy the requirements of this Regulation. The list shall also be sent to the Commission. [Am. 108]
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 amending or supplementing the minimum requirements in Annex VI, in the light of technical progress and considering the minimum requirements needed for the assessment of specific devices, or categories or groups of devices
Article 28
Subsidiaries and subcontracting
-1. Notified bodies shall have permanent ‘in-house’ competent personnel and expertise, both in technical fields linked with the assessment of the performance of the devices, and in the medical field. They shall have the capacity to evaluate ‘in-house’ the quality of subcontractors.
Contracts may be awarded to external experts for the assessment of in vitro diagnostic medical devices or technologies in particular where clinical expertise is limited.
1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the relevant requirements set out in Annex VI and shall inform the national authority responsible for notified bodies accordingly.
2. Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries.
2a. Notified bodies shall make publicly available the list of subcontractors or subsidiaries, the specific tasks for which they are responsible and the declarations of interest of their personnel.
3. Conformity assessment activities may be subcontracted or carried out by a subsidiary only with the explicit agreement of the legal or natural person that applied for conformity assessment.
4. At least once a year, notified bodies shall keep at the disposal of submit to the national authority responsible for notified bodies the relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.
4a. The annual assessment of notified bodies as provided for in Article 33(3) shall include verification of the compliance of the subcontractor(s) or the subsidiary/ies of notified bodies with the requirements set out in Annex VI. [Am. 109]
Article 28a
Electronic system on registration of subsidiaries and subcontractors
1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information on subcontractors and subsidiaries, as well as on the specific tasks for which they are responsible.
2. Before subcontracting can effectively take place, the notified body which intends to subcontract specific tasks connected with conformity assessment or have recourse to a subsidiary for specific tasks connected with conformity assessment, shall register their name(s) together with their specific tasks.
3. Within one week of any change occurring in relation to the information referred to in paragraph 1, the relevant economic operator shall update the data in the electronic system.
4. The data contained in the electronic system shall be accessible to the public. [Am. 110]
Article 29
Application by a conformity assessment body for notification
1. A conformity assessment body shall submit an application for notification to the national authority responsible for notified bodies of the Member State in which it is established.
In the event that a conformity assessment body wants to be notified for devices referred to in Article 41a(1), it shall indicate so and submit an application for notification to the EMA in accordance with Article 41a(2) [Am. 111]
2. The application shall specify the conformity assessment activities, the conformity assessment procedures and the devices for which the body claims to be competent, supported by documentation proving compliance with all the requirements set out in Annex VI.
In respect of the organisational and general requirements and the quality management requirements set out in Sections 1 and 2 of Annex VI, the relevant documentation may be submitted in form of a valid certificate and the corresponding evaluation report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008. The conformity assessment body shall be presumed to be in conformity with the requirements covered by the certificate delivered by such accreditation body.
3. After being designated, the notified body shall update the documentation referred to in paragraph 2 whenever relevant changes occur in order to enable the national authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements set out in Annex VI.
Article 30
Assessment of the application
1. The national authority responsible for notified bodies shall check that the application referred to in Article 29 is complete and draw up a preliminary assessment report.
2. It shall submit the preliminary assessment report to the Commission which shall immediately transmit it to the Medical Device Coordination Group (‘MDCG’) referred to in Article 76. Upon request by the Commission, the report shall be submitted by the authority in up to three official Union languages.
3. Within 14 days of the submission referred to in paragraph 2, the Commission shall designate a joint assessment team made up of at least two three experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies and free of conflicts of interest with the applicant conformity assessment body . The list shall be drawn up by the Commission in cooperation with the MDCG. At least one of these experts shall be a representative of the Commission who , and at least one other shall come from a Member State other than the one in which the applicant conformity assessment body is established. The Commission representative shall lead the joint assessment team. In case the conformity assessment body has asked to be notified for devices referred to in Article 41 a(1) , the EMA shall also be part of the joint assessment team. [Am. 112]
4. Within 90 days after designation of the joint assessment team, the national authority responsible for notified bodies and the joint assessment team shall review the documentation submitted with the application in accordance with Article 29 and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or sub-contractor, located inside or outside the Union, to be involved in the conformity assessment process. Such on-site assessment shall not cover requirements for which the applicant conformity assessment body has received a certificate delivered by the national accreditation body as referred to in Article 29(2), unless the Commission representative mentioned in Article 30(3) requests the on-site assessment.
Findings regarding non-compliance of a an applicant conformity assessment body with the requirements set out in Annex VI shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team with a view to finding common agreement with respect to the assessment of the application. Divergent opinions shall be identified in. The national authority shall set out in the assessment report the measures that the notified body shall take to ensure compliance by that applicant conformity assessment body with the requirements set out in Annex VI. In the event of a disagreement, a separate opinion drawn up by the assessment team setting out its reservations regarding notification shall be appended to the assessment report of the national authority responsible. [Am. 113]
5. The national authority responsible for notified bodies shall submit its assessment report and its draft notification to the Commission which shall immediately transmit those documents to the MDCG and to the members of the joint assessment team. If the assessment team draws up a separate opinion, that too shall be submitted to the Commission for forwarding to the MDCG. Upon request by the Commission, those documents shall be submitted by the authority in up to three official Union languages. [Am. 114]
6. The joint assessment team shall provide its final opinion regarding the assessment report and, the draft notification and, where appropriate, the separate opinion drawn up by the assessment team, within 21 days of receipt of those documents and the Commission shall immediately submit this opinion to the MDCG. Within 21 days after receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft notification which the. The relevant national authority shall duly take into consideration for base its decision on the designation of the notified body on the recommendation by the MDCG. Where its decision differs from the MDCG recommendation, the relevant national authority shall provide the MDCG in writing all the necessary justifications for its decision . [Am. 115]
7. The Commission may, by means of implementing acts, adopt measures setting out the modalities for the application for notification referred to in Article 29 and the assessment of the application set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
Article 31
Notification procedure
1. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they have designated, using the electronic notification tool developed and managed by the Commission.
2. Member States may shall notify only conformity assessment bodies which satisfy the requirements set out in Annex VI and for which the application assessment procedure has been completed in accordance with Article 30. [Am. 116]
3. Where a national authority responsible for notified bodies is responsible for designation of notified bodies in the field of products other than in vitro diagnostic medical devices, the competent authority for in vitro diagnostic medical devices shall provide, prior to the notification, a positive opinion on the notification and its scope. [Am. 117]
4. The notification shall clearly specify the scope of the designation indicating the conformity assessment activities, the conformity assessment procedures, the risk class and the type of devices which the notified body is authorised to assess. [Am. 118]
The Commission may, by means of implementing acts, set up a list of codes and the corresponding types of devices to define the scope of the designation of notified bodies which the Member States shall indicate in their notification. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 84(2).
5. The notification shall be accompanied by the final assessment report of the national authority responsible for notified bodies, the opinion of the joint assessment team and the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it shall provide a duly substantiated justification.
6. The notifying Member State shall provide the Commission and the other Member States with documentary evidence regarding the arrangements in place to ensure that the notified body will be monitored regularly and will continue to satisfy the requirements set out in Annex VI. It shall furthermore submit evidence of the availability of competent personnel for monitoring the notified body in accordance with Article 26(6).
7. Within 28 days of a notification, a Member State or the Commission may raise written objections, setting out its arguments, with regard either to the notified body or to its monitoring by the national authority responsible for notified bodies.
8. When a Member State or the Commission raises objections in accordance with paragraph 7, the effect of the notification shall be immediately suspended. In this case, the Commission shall bring the matter before the MDCG within 15 days after expiry of the period referred to in paragraph 7. After consulting the parties involved, the MDCG shall give its opinion at the latest within 28 days after the matter has been brought before it. If the notifying Member State does not agree with the opinion of the MDCG, it may request the Commission to give its opinion. [Am. 119]
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially, the Commission shall publish the notification accordingly.
The Commission shall also enter information on the notification of the notified body into the electronic system referred to in the second subparagraph of Article 25. That information shall be accompanied by the final assessment report of the national authority responsible for notified bodies, the opinion of the joint assessment team and the recommendation of the MDCG, as referred to in this article.
The full details of the notification, including the class and the typology of devices, as well as the annexes, shall be made publicly available. [Am. 120]
10. The notification shall become valid the day after its publication in the database of notified bodies developed and managed by the Commission. The published notification shall determine the scope of lawful activity of the notified body.
Article 32
Identification number and list of notified bodies
1. The Commission shall assign an identification number to each notified body for which the notification is accepted in accordance with Article 31. It shall assign a single identification number even when the body is notified under several Union acts.
2. The Commission shall make easily accessible to the public the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified and all documents for the notification procedure as referred to in Article 31(5) . The Commission shall ensure that the list is kept up to date. [Am. 121]
Article 33
Monitoring of notified bodies
1. The national authority responsible for notified bodies , and where applicable the EMA, shall continuously monitor the notified bodies to ensure ongoing compliance with the requirements set out in Annex VI. The notified bodies shall, on request, supply all relevant information and documents, required to enable the authority to verify compliance with those criteria.
Notified bodies shall, without delay, and within 15 days at the latest , inform the national authority responsible for notified bodies of any changes, in particular regarding their personnel, facilities, subsidiaries or subcontractors, which may affect compliance with the requirements set out in Annex VI or their ability to conduct the conformity assessment procedures relating to the devices for which they have been designated.
2. Notified bodies shall respond without delay and within 15 days at the latest, to requests relating to conformity assessments they have carried out, submitted by their or another Member State's authority or by the Commission. The national authority responsible for notified bodies of the Member State in which the body is established shall enforce requests submitted by authorities of any other Member State or by the Commission unless. Where there is a legitimate reason for not doing so in which case both sides may the notified bodies shall explain these reasons in writing and shall consult the MDCG. The notified body or their national authority responsible for notified bodies may request that any information transmitted to the authorities of another Member State or to the Commission shall be treated as confidential , which shall then issue a recommendation. The national authority responsible for notified bodies shall comply with the MDCG's recommendation .
3. At least once a year, the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in Annex VI , including an assessment of whether its subcontractor(s) and subsidiary/-ies satisfy those requirements. This assessment shall include an unannounced inspection through an on-site visit to each notified body , and to each subsidiary or subcontractor within or outside the Union, if relevant .
The assessment shall also include a review of samples of the design dossier assessments carried out by the notified body to determine the ongoing competence of the notified body and quality of its assessments, in particular the notified body's ability to evaluate and assess clinical evidence.
4. Three Two years after notification of a notified body, and again every third second year thereafter, the assessment to determine whether the notified body body and its subsidiaries and subcontractors still satisfies satisfy the requirements set out in Annex VI shall be conducted by the national authority responsible for notified bodies of the Member State in which the body is established and a joint assessment team designated in accordance with the procedure described in Article 30(3) and (4). At the request of the Commission or of a Member State, the MDCG may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body, or a subsidiary or subcontractor of a notified body, with the requirements set out in Annex VI.
For special notified bodies under Article 41a, the assessment referred to in this paragraph shall be performed every year.
The comprehensive results of the assessments shall be published.
5. The Member States shall report to the Commission and to the other Member States, at least once a year, on their monitoring activities. This report shall contain a summary which shall be made publicly available.
5a. Every year, the notified bodies shall forward an annual activity report setting out the information referred to in Annex VI, point 5 to the competent authority and to the Commission, which shall forward it to the MDCG. [Am. 122]
Article 34
Changes to notifications
1. The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification. The procedures described in Article 30(2) to (6) and in Article 31 shall apply to changes where they entail extension of the scope of the notification. In all other cases, the Commission shall immediately publish the amended notification in the electronic notification tool referred to in Article 31(10).
2. Where a national authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VI, or that it is failing to fulfil its obligations, the authority shall suspend, restrict, or fully or partially withdraw the notification, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A Suspension shall apply until a decision to annul the suspension has been reached by the MDCG, which shall not exceed a period of one year, renewable once for the same period follow an assessment by a joint assessment team designated in accordance with the procedure described in Article 30(3) . Where the notified body has ceased its activity, the national authority responsible for notified bodies shall withdraw the notification.
The national authority responsible for notified bodies shall immediately and within 10 days at the latest , inform the Commission and, the other Member States and the relevant manufacturers and health professionals of any suspension, restriction or withdrawal of a notification. [Am. 123]
3. In the event of restriction, suspension or withdrawal of a notification, the Member State shall inform the Commission and shall take appropriate steps to ensure that the files of the notified body concerned are either processed by another notified body or kept available for the national authorities responsible for notified bodies and for market surveillance at their request. [Am. 124]
4. The national authority responsible for notified bodies shall assess whether the reasons which gave rise to the change to suspension, restriction or withdrawal of the notification have an impact on the certificates issued by the notified body and, within three months after having notified the changes to the notification, shall submit a report on its findings to the Commission and the other Member States. Where necessary to ensure the safety of devices on the market, that authority shall instruct the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, and at the latest 30 days after the publication of the report , any certificates which were unduly issued. If the notified body fails to do so within the determined period of time, or has ceased its activity, the national authority responsible for notified bodies itself shall suspend or withdraw the certificates unduly issued.
With a view to verifying whether the reasons for the suspension, restriction or withdrawal of the notification have implications for the certificates issued, the national authority responsible shall ask the relevant manufacturers to supply evidence of conformity at notification, and the manufacturers shall have 30 days in which to respond to that request. [Am. 125]
5. The certificates, other than those unduly issued, which were issued by the notified body for which the notification has been suspended, restricted or withdrawn shall remain valid in the following circumstances:
|
(a) |
in the case of suspension of a notification: on condition that, within three months of the suspension, either the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate is established, or another notified body responsible for in vitro diagnostic medical devices confirms in writing that it is assuming the functions of the notified body during the period of suspension; |
|
(b) |
in the case of restriction or withdrawal of a notification: for a period of three months after the restriction or withdrawal. The competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate is established may extend the validity of the certificates for further periods of three months, which altogether may not exceed twelve months, provided it is assuming the functions of the notified body during this period. |
The authority or the notified body assuming the functions of the notified body affected by the change of notification shall immediately and within 10 days at the latest , inform the Commission, the other Member States and the other notified bodies thereof.
The Commission shall immediately and within 10 days at the latest enter information on the changes to the notification of the notified body into the electronic system referred to in the second paragraph of Article 25. [Am. 126]
Article 35
Challenge to the competence of notified bodies
1. The Commission shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body of the requirements set out in Annex VI or the obligations to which it is subject. It may also commence such investigations on its own initiative , including the unannounced inspection of the notified body by a joint assessment team whose composition meets the conditions set out in Article 30(3) . [Am. 127]
2. The notifying Member State shall provide the Commission, on request, with all information regarding the notification of the notified body concerned.
3. Where the Commission ascertains , in consultation with the MDCG, decides that a notified body no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the notification, if necessary , in line with Article 34(2) . [Am. 128]
Where the Member State fails to take the necessary corrective measures, the Commission may, by means of implementing acts, suspend, restrict or withdraw the notification. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3). It shall notify the Member State concerned of its decision and update the database and list of notified bodies.
Article 36
Exchange of experience between national authorities responsible for notified bodies
The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the national authorities responsible for notified bodies under this Regulation.
Article 37
Coordination of notified bodies
The Commission , in consultation with the MDCG, shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of the coordination group of notified bodies referred to in Article 39 of Regulation [Ref. of future Regulation on medical devices]. This group shall meet on a regular basis and at least twice a year. [Am. 129]
The bodies notified under this Regulation shall participate in the work of that group.
The Commission or the MDCG may request the participation of any notified body. [Am. 130]
The Commission may, by means of implementing acts, adopt measures setting out the modalities for the functioning of the coordination group of notified bodies as set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3). [Am. 131]
Article 38
Fees for the activities of national authorities
1. The Member State where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies. These fees shall, wholly or partly, cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this Regulation.
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 setting out the structure and the level of the fees referred to in paragraph 1, taking into account the objectives of protection of human health and safety, support of innovation and, cost-effectiveness and the need to create a level-playing field across Member States . Particular attention shall be paid to the interests of notified bodies that submitted a valid certificate delivered by the national accreditation body as referred to in Article 29(2) and notified bodies that are small and medium-sized enterprises as defined by Commission Recommendation 2003/361/EC (26).
These fees shall be proportionate and consistent with national standards of living. The level of fees shall be made public. [Am. 132]
Article 38a
Transparency on fees charged by notified bodies for conformity assessment activities
1. Member States shall adopt provisions on standard fees for notified bodies.
2. Fees shall be comparable across Member States. The Commission shall provide guidelines to facilitate comparability of those fees by … (*1).
3. Member States shall transmit their list of standard fees to the Commission.
4. The national authority shall ensure that the notified bodies make the lists of standard fees for the conformity assessment activities publicly available. [Am. 133]
Chapter VI V
Clinical evidence [Am. 153]
Article 47
General requirements regarding clinical evidence
1. The demonstration of conformity with the general safety and performance requirements set out in Annex I, under normal conditions of use, shall be based on clinical evidence, or additional safety data for general safety and performance requirements not covered by clinical evidence. [Am. 154]
2. The clinical evidence shall support the intended purpose of the device as stated by the manufacturer.
3. The clinical evidence shall include all the information supporting the scientific validity of the analyte, the analytical performance and, where applicable, the clinical performance of the device, as described in Section 1 of Part A of Annex XII.
3a. Where the manufacturer claims and/or describes a clinical use, evidence attesting to that use shall constitute part of the requirements. [Am. 155]
4. Where demonstration of conformity with the general safety and performance requirements based on clinical performance data or parts thereof is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the characteristics of the device and, in particular, its intended purpose(s), the intended performance and the claims of the manufacturer. The adequacy of demonstration of conformity with the general safety and performance requirements based on the results of analytical performance evaluation alone shall be duly substantiated in the technical documentation referred to in Annex II.
Exemption from demonstration of conformity with general safety and performance requirements based on clinical data under the first subparagraph shall be subject to prior approval by the competent authority. [Am. 156]
5. The scientific validity data, the analytical performance data and, where applicable, the clinical performance data shall be summarised as part of a clinical evidence report referred to in Section 3 of Part A of Annex XII. The clinical evidence report shall be included or fully referenced in the technical documentation referred to in Annex II relating to the device concerned. [Am. 157]
6. The clinical evidence and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from implementation of the manufacturer's post-market surveillance plan referred to in Article 8(6).
7. The manufacturer shall ensure that the device for performance evaluation complies with the general requirements of this Regulation apart from the aspects covered by the performance evaluation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient, user and other persons.
The manufacturer shall undertake to keep available to the competent authorities and the EU reference laboratories the documentation allowing an understanding of the design, manufacture and performances of the device, including its expected performance, so as to allow assessment of conformity with the requirements of this Regulation. This documentation shall be kept for at least five years after the performance evaluation of the device in question has ended.
Article 48
General requirements regarding clinical performance studies
1. Clinical performance studies shall be subject to this Regulation if they are conducted for one or more of the following purposes:
|
(a) |
to verify that, under normal conditions of use, the devices are designed, manufactured and packaged in such a way that they are suitable for one or more of the specific purposes of an in vitro diagnostic medical device referred to in number (2) of Article 2, and achieve the performance intended as specified by the manufacturers or sponsor ; [Am. 158] |
|
(b) |
to verify that devices achieve the clinical safety and efficacy of the device, including the intended benefits to the patient as specified by the manufacturer , when used for the intended purpose, in the target population and in accordance with the instructions of use ; [Am. 159] |
|
(c) |
to determine any limits to the performance of the devices, under normal conditions of use. |
2. Clinical performance studies shall be performed in circumstances similar to the normal conditions of use of the device.
3. Where the sponsor is not established in the Union, he shall ensure that a contact person is established in the Union. That contact person shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication to that contact person shall be considered as communication to the sponsor.
4. All clinical performance studies shall be designed and conducted in a way that the rights, safety and well-being of the subjects participating in such clinical performance studies are protected and that the clinical data generated in the clinical performance study are going to be reliable and robust. Such studies shall not be conducted if the risks associated with the investigation are not medically justifiable in terms of the potential benefits of the device. [Am. 160]
5. All clinical performance studies shall be designed, conducted, recorded and reported in accordance with Section 2 of Annex XII.
6. For interventional clinical performance studies, as defined in number (37) of Article 2, and for other clinical performance studies, where the conduct of the study, including specimen collection, involves invasive procedures or other risks for the subjects of the studies, the requirements set out in Articles 49 to 58 and in Annex XIII shall apply, in addition to the obligations laid down in this Article. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 concerning the provision of a list with negligible risks, which allows a derogation to be made from the relevant Article. [Am. 161]
Article 49
Application for interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies
1. Before making the first application, the sponsor shall procure from the electronic system referred to in Article 51 a single identification number for a clinical performance study conducted in one site or multiple sites, in one or more than one Member State. The sponsor shall use this single identification number when registering the clinical performance study in accordance with Article 50.
2. The sponsor of a clinical performance study shall submit an application to the Member State(s) in which the study is to be conducted accompanied by the documentation referred to in Annex XIII. Within six 14 days after receipt of the application, the Member State concerned shall notify the sponsor whether the clinical performance study falls within the scope of this Regulation and whether the application is complete.
In case of more than one Member State concerned, where a Member State disagrees with the coordinating Member State on whether the clinical performance study should be approved, on grounds other than intrinsically national, local or ethical concerns, the Member States concerned shall make an attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision after having consulted the Member States concerned, and if appropriate, having taken advice from the MDCG.
In cases where the Member States concerned object to the clinical performance study for intrinsically national, local or ethical concerns, the clinical performance study should not take place in the Member States concerned. [Am. 162]
Where the Member State has not notified the sponsor within the time period referred to in the first subparagraph, the clinical performance study shall be considered as falling within the scope of this Regulation and the application shall be considered complete.
3. Where the Member State finds that the clinical performance study applied for does not fall within the scope of this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a maximum of six ten days for the sponsor to comment or to complete the application. [Am. 163]
Where the sponsor has not provided comments nor completed the application within the time-period referred to in the first subparagraph, the application shall be considered as withdrawn.
Where the Member State has not notified the sponsor according to paragraph 2 within three seven days following receipt of the comments or of the completed application, the clinical performance study shall be considered as falling within the scope of this Regulation and the application shall be considered complete. [Am. 164]
4. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 2 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the time periods referred to in paragraphs 2 and 3.
5. The sponsor may start the clinical performance study in the following circumstances:
|
(a) |
in the case of devices for performance evaluation classified as class C or D, as soon as the Member State concerned has notified the sponsor of its approval; |
|
(b) |
in the case of devices for performance evaluation classified as class A or B immediately after the date of application, provided that the Member State concerned has so decided and that evidence is provided that the rights, safety and well-being of the subjects to the clinical performance study are protected; |
|
(c) |
after the expiry of 35 60 days after the validation date referred to in paragraph 4, unless the Member State concerned has notified the sponsor within that period of its refusal based on considerations of public health, patient safety or public policy. [Am. 165] |
5a. Member States shall ensure that a clinical performance study is suspended, cancelled or temporarily interrupted if in the light of new facts it would no longer be approved by the competent authority or if it would no longer receive a favourable opinion from the ethics committee. [Am. 166]
6. Member States shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor, the institution of the study site(s) and the investigators involved, as well as free of any other undue influence.
Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patient shall be taken into account.
6a. Every step in the clinical performance study, from first consideration of the need and justification for the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, such as those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects adopted by the 18th World Medical Assembly in Helsinki in 1964 and last amended by the 59th World Medical Association General Assembly in Seoul in 2008.
6b. Authorisation by the Member State concerned for conducting a clinical performance study under this Article shall be granted only after examination and approval by an independent ethics committee in accordance with the World Medical Association's Declaration of Helsinki.
6c. The examination of the ethics committee shall cover in particular the medical justification for the study, the consent of the test subjects participating in the clinical performance study following the provision of full information about the clinical performance study and the suitability of the investigators and investigation facilities.
The ethics committee shall act in accordance with the respective laws and regulations of the country or countries in which the study is to be conducted and shall abide by all relevant international norms and standards. It shall also work with such efficiency as to enable the Member State concerned to comply with the procedural deadlines set out in this Chapter.
The ethics committee shall be made up of an appropriate number of members, who together are in possession of the relevant qualifications and experience in order to be able to assess the scientific, medical and ethical aspects of the clinical investigation under scrutiny.
The members of the ethics committee assessing the application for a clinical performance study shall be independent from the sponsor, the institution of the performance study site, and the investigators involved, as well as free of any other undue influence. The names, qualifications, and declaration of interest of the assessors of the application shall be made publicly available.
6d. Member States shall take the necessary measures to establish ethics committees in the field of clinical performance studies where such committees do not exist, and to facilitate their work.
6e. The Commission shall facilitate cooperation of ethics committees and the sharing of best practices on ethical issues including the procedures and principles of ethical assessment.
The Commission shall develop guidelines on patient involvement in ethics committees, drawing upon existing good practices. [Am. 167]
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 amending or supplementing, in the light of technical progress and global regulatory developments, the requirements for the documentation to be submitted with the application for the clinical performance study that is laid down in Chapter I of Annex XIII.
Article 49a
Supervision by Member States
1. Member States shall appoint inspectors to supervise compliance with this Regulation and shall ensure that those inspectors are adequately qualified and trained.
2. Inspections shall be conducted under the responsibility of the Member State where the inspection takes place.
3. Where a Member State intends to carry out an inspection with regard to one or several interventional clinical performance studies which are conducted in more than one Member State, it shall notify its intention to the other Member States concerned, the Commission and the EMA, through the Union portal, and shall inform them of its findings after the inspection.
4. The MDCG shall coordinate cooperation on inspections between Member States and on inspections conducted by Member States in third countries.
5. Following an inspection, the Member State under whose responsibility the inspection has been conducted shall draw up an inspection report. That Member State shall make the inspection report available to the sponsor of the relevant clinical trial and shall submit the inspection report through the Union portal to the Union database. When making the inspection report available to the sponsor, the Member State concerned shall ensure that confidentiality is protected.
6. The Commission shall specify the details for the arrangement of the inspection procedures by means of implementing acts in accordance with Article 85. [Am. 168]
Article 50
Registration of interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies
1. Before commencing the clinical performance study, the sponsor shall enter in the electronic system referred to in Article 51 the following information regarding the clinical performance study:
|
(a) |
the single identification number of the clinical performance study; |
|
(b) |
the name and contact details of the sponsor and, if applicable, his contact person established in the Union; |
|
(c) |
the name and contact details of the natural or legal person responsible for the manufacture of the device for performance evaluation, if different from the sponsor; |
|
(d) |
the description of the device for performance evaluation; |
|
(e) |
the description of the comparator(s), if applicable; |
|
(f) |
the purpose of the clinical performance study; |
|
(g) |
the status of the clinical performance study. |
|
(ga) |
the methodology to be used, the number of subjects involved and the intended result of the study. [Am. 169] |
2. Within one week of any change occurring in relation to the information referred to in paragraph 1, the sponsor shall update the relevant data in the electronic system referred to in Article 51.
3. The information shall be accessible to the public, through the electronic system referred to in Article 51, unless, for all or parts of that information, confidentiality of the information is justified on any of the following grounds:
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(a) |
protection of personal data in accordance with Regulation (EC) No 45/2001, |
|
(b) |
protection of commercially sensitive information, |
|
(c) |
effective supervision of the conduct of the clinical performance study by the Member State(s) concerned. |
4. No personal data of subjects participating in the clinical performance study shall be accessible to the public.
Article 51
Electronic system on interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies
1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system on interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies to create the single identification numbers for such clinical performance studies referred to in Article 49(1) and to collate and process the following information:
|
(a) |
the registration of clinical performance studies in accordance with Article 50; |
|
(b) |
the exchange of information between the Member States and between them and the Commission in accordance with Article 54; |
|
(c) |
the information related to clinical performance studies conducted in more than one Member State in case of a single application in accordance with Article 56; |
|
(d) |
the reports on serious adverse events and device deficiencies referred to in Article 57(2) in case of single application in accordance with Article 56. |
|
(da) |
the clinical performance study report and summary submitted by the sponsor in accordance with Article 55(3). |
2. When setting up the electronic system referred in paragraph 1, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article […] of Regulation (EU) No …/… [Ref. of future Regulation on clinical trials]. With the exception of the information referred to in Article 50 and in points (d) and (da) of paragraph 1 of this Article , the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission . The Commission shall also ensure that healthcare professionals have access to the electronic system .
The information referred to in points (d) and (da) of paragraph 1 of this Article shall be accessible to the public in accordance with Article 50(3) and (4).
2a. Upon a reasoned request, all information on a specific in vitro diagnostic medical device available in the electronic system shall be made accessible to the party requesting it, save where the confidentiality of all or parts of the information is justified in accordance with Article 50(3). [Am. 170]
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 determining which other information regarding clinical performance studies collated and processed in the electronic system shall be publicly accessible to allow interoperability with the EU database for clinical trials on medicinal products for human use set up by Regulation (EU) No …/… [Ref. of future Regulation on clinical trials]. Article 50(3) and (4) shall apply.
Article 52
Interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies with devices authorised to bear the CE marking
1. Where a clinical performance study is to be conducted to further assess devices which are authorised in accordance with Article 40 to bear the CE marking and within its intended purpose referred to in the relevant conformity assessment procedure, hereinafter referred to as ‘post-market follow-up performance study’, the sponsor shall notify the Member States concerned at least 30 days prior to their commencement if the study would submit subjects to additionally invasive or burdensome procedures. Articles 48(1) to (5), 50, 53, 54(1) and 55(1), the first subparagraph of Article 55(2) and the relevant provisions of Annexes XII and XIII shall apply.
2. If the aim of the clinical performance study regarding a device which is authorised in accordance with Article 40 to bear the CE marking is to assess such device for a purpose other than that referred to in the information supplied by the manufacturer in accordance with Section 17 of Annex I and in the relevant conformity assessment procedure, Articles 48 to 58 shall apply.
Article 53
Substantial modifications to interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies
1. If the sponsor introduces modifications to a clinical performance study that are likely to have a substantial impact on the safety or rights of the subjects or on the robustness or reliability of the clinical data generated by the study, he shall notify the Member State(s) concerned of the reasons for and the content of those modifications. The notification shall be accompanied by an updated version of the relevant documentation referred to in Annex XIII.
2. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 30 days after notification, unless the Member State concerned has notified the sponsor of its refusal based on considerations of public health, patient safety or public policy.
Article 54
Information exchange between Member States on interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies
1. Where a Member State has refused, suspended or terminated a clinical performance study, or has called for a substantial modification or temporary halt of a clinical performance study, or has been notified by the sponsor of the early termination of a clinical performance study on safety or efficacy grounds, that Member State shall communicate such facts and its decision and the grounds therefor for that decision to all Member States and the Commission by means of the electronic system referred to in Article 51. [Am. 171]
2. Where an application is withdrawn by the sponsor prior to a decision by a Member State that Member State shall inform all the other Member States and the Commission of that fact, by means of the electronic system referred to in Article 51.
Article 55
Information by the sponsor in the event of temporary halt or termination of interventional clinical performance studies or of other clinical performance studies involving risks for the subjects of the studies
1. If the sponsor has temporarily halted a clinical performance study on safety or efficacy grounds, he shall inform the Member States concerned within 15 days of the temporary halt. [Am. 172]
2. The sponsor shall notify each Member State concerned of the end of a clinical performance study in relation to that Member State, providing a justification in the event of early termination , so that all Member States can inform sponsors conducting similar clinical performance studies at the same time within the Union of the results of that clinical performance study . That notification shall be made within 15 days from the end of the clinical performance study in relation to that Member State. [Am. 173]
If the study is conducted in more than one Member State, the sponsor shall notify all Member States concerned of the overall end of the clinical performance study. Information on the reasons for the early termination of the clinical performance study shall also be provided to all Member States, so that all Member States can inform sponsors conducting similar clinical performance studies, at the same time within the Union, of the results of the clinical performance study. That notification shall be made within 15 days from the overall end of the clinical performance study. [Am. 174]
3. Within Irrespective of the outcome of the clinical performance study, within one year from the end of the clinical performance study or from its early termination , the sponsor shall submit to the Member States concerned a summary of the results of the clinical performance study in form of a clinical performance study report referred to in Section 2.3.3 of Part A of Annex XII. It shall be accompanied by a summary presented in terms that are easily understandable to a layperson. Both the report and the summary shall be submitted by the sponsor by means of the electronic system referred to in Article 51.
Where, for justified scientific reasons, it is not possible to submit the clinical performance study report within one year, it shall be submitted as soon as it is available. In this case, the clinical performance study protocol referred to in Section 2.3.2 of Part A of Annex XII shall specify when the results of the clinical performance study are going to be submitted, together with an explanation a justification .
3a. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 in order to define the content and structure of the layperson's summary.
The Commission shall be empowered to adopt delegated acts in accordance with Article 85 in order to establish rules for the communication of the clinical performance study report.
For cases where the sponsor decides to share raw data on a voluntary basis, the Commission shall produce guidelines for the formatting and sharing of that data. [Am. 175]
Article 56
Interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies conducted in more than one Member State
1. By means of the electronic system referred to in Article 51, the sponsor of the clinical performance study to be conducted in more than one Member State may submit, for the purpose of Article 49, a single application that, upon receipt, is transmitted electronically to the Member States concerned.
2. In the single application, the sponsor shall propose one of The Member States concerned as coordinating Member State. If that Member State does not wish to be the coordinating Member State, it shall agree, within six days of submission of the single application, with another which Member State concerned that the latter shall be the coordinating Member State. If no other Member State accepts to be the coordinating Member State, the Member State proposed by the sponsor shall be the coordinating Member State. If another Member State than the one proposed by the sponsor becomes States and the Commission shall agree, in the framework of the attributions of the Medical Devices Coordination Group, on clear rules for designating the coordinating Member State, the deadlines referred to in Article 49(2) shall start on the day following the acceptance. [Am. 176]
3. Under the direction of the coordinating Member State referred to in paragraph 2, the Member States concerned shall coordinate their assessment of the application, in particular of the documentation submitted in accordance with Chapter I of Annex XIII, except for Sections 4.2, 4.3 and 4.4 thereof which shall be assessed separately by each Member State concerned.
The coordinating Member State shall:
|
(a) |
within 6 days of receipt of the single application notify the sponsor whether the clinical performance study falls within the scope of this Regulation and whether the application is complete, except for the documentation submitted in accordance with Sections 4.2, 4.3 and 4.4 of Chapter I of Annex XIII for which each Member State shall verify the completeness. Article 49(2) to (4) shall apply to the coordinating Member State in relation to the verification that the clinical performance study falls within the scope of this Regulation and that the application is complete, except for the documentation submitted in accordance with Sections 4.2, 4.3 and 4.4 of Chapter I of Annex XIII. Article 49(2) to (4) shall apply to each Member State in relation to the verification that the documentation submitted in accordance with Sections 4.2, 4.3 and 4.4 of Chapter I of Annex XIII is complete; |
|
(b) |
establish the results of the coordinated assessment in a report to be taken into account by the other Member States concerned when deciding on the sponsor's application in accordance with Article 49(5). |
4. The substantial modifications referred to in Article 53 shall be notified to the Member States concerned by means of the electronic system referred to in Article 51. Any assessment as to whether there are grounds for refusal as referred to in Article 53 shall be carried out under the direction of the coordinating Member State.
5. For the purpose of Article 55(3), the sponsor shall submit the clinical performance study report to the Member States concerned by means of the electronic system referred to in Article 51. [Am. 177]
6. The Commission shall provide secretarial support to the coordinating Member State in the accomplishment of its tasks provided for in this Chapter.
Article 57
Recording and reporting of events occurring during interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies
1. The sponsor shall fully record any of the following:
|
(a) |
an adverse event identified in the clinical performance study protocol as critical to the evaluation of the results of the clinical performance study in view of the purposes referred to in Article 48(1); |
|
(b) |
a serious adverse event; |
|
(c) |
a device deficiency that might have led to a serious adverse event if suitable action had not been taken, intervention had not occurred, or circumstances had been less fortunate; |
|
(d) |
new findings in relation to any event referred to in points (a) to (c). |
2. The sponsor shall report to all Member States where a clinical performance study is conducted without delay any of the following:
|
(a) |
a serious any adverse event that has a causal relationship with the device for performance evaluation, the comparator or the study procedure or where such causal relationship is reasonably possible; [Am. 178] |
|
(b) |
a device deficiency that might have led to a serious adverse event if suitable action had not been taken, intervention had not occurred, or circumstances had been less fortunate; |
|
(c) |
new findings in relation to any event referred to in points (a) to (b). |
The time period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial incomplete report followed up by a complete report.
3. The sponsor shall also report to the Member States concerned any event referred to in paragraph 2 occurring in third countries in which a clinical performance study is performed under the same clinical performance study protocol as the one applying to a clinical performance study covered by this Regulation.
4. In the case of a clinical performance study for which the sponsor has used the single application referred to in Article 56, the sponsor shall report any event as referred to in paragraph 2 by means of the electronic system referred to in Article 51. Upon receipt, this report shall be transmitted electronically to all Member States concerned.
Under the direction of the coordinating Member State referred to in Article 56(2), the Member States shall coordinate their assessment of serious adverse events and device deficiencies to determine whether a clinical performance study needs to be terminated, suspended, temporarily halted or modified.
This paragraph shall not affect the rights of the other Member States to perform their own evaluation and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating Member State and the Commission shall be kept informed of the outcome of any such evaluation and the adoption of any such measures.
5. In the case of post-market follow-up performance studies referred to in Article 52(1), the provisions on vigilance contained in Articles 59 to 64 shall apply instead of this Article.
Article 58
Implementing acts
The Commission may, by means of implementing acts, adopt the modalities and procedural aspects necessary for the implementation of this Chapter, as regards the following:
|
(a) |
harmonised forms for the application for clinical performance studies and their assessment as referred to in Articles 49 and 56, taking into account specific categories or groups of devices; |
|
(b) |
the functioning of the electronic system referred to in Article 51; |
|
(c) |
harmonised forms for the notification of post-market follow-up performance studies as referred to in Article 52(1), and of substantial modifications as referred to in Article 53; |
|
(d) |
the exchange of information between Member States as referred to in Article 54; |
|
(e) |
harmonised forms for the reporting of serious adverse events and device deficiencies as referred to in Article 57; |
|
(f) |
the timelines for the reporting of serious adverse events and device deficiencies, taking into account the severity of the event to be reported as referred to in Article 57. |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
Chapter II VI
Making available and application of devices, obligations of economic operators, CE marking, free movement [Am. 67]
Article 4
Placing on the market and putting into service
1. A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
2. A device shall meet the general safety and performance requirements which apply to it, taking into account its intended purpose. General safety and performance requirements are set out in Annex I.
3. Demonstration of conformity with the general safety and performance requirements shall be based on include clinical evidence in accordance with Article 47. [Am. 68]
4. Devices that are manufactured and used within a single health institution shall be considered as being put into service.
5. With the exception of Article 59(4), the requirements of this Regulation shall not apply to devices classified as class A, B and C, in accordance with the rules set out in Annex VII, and manufactured and used only within a single health institution, provided manufacture and use occur solely under the health institution's single quality management system, and the health institution is compliant accredited with standard EN ISO 15189 or any other equivalent recognised standard. However, the requirements of this Regulation shall continue to apply to clinical or commercial pathology laboratories which do not have health care (i.e. care and treatment of patients) or the promotion of public health as their primary purpose. Member States may shall require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may shall make the manufacture and use of the devices concerned subject to further safety requirements. [Am. 69]
Devices classified as class D in accordance with the rules set out in Annex VII, even if manufactured and used within a single health institution, shall comply with be exempt from the requirements of this Regulation. However, the provisions regarding CE marking set out in Article 16 and the obligations with the exception of Article 59(4) and general safety performance requirements set out in Annex I where the following conditions are met:
|
(a) |
the recipient patient or patient group’s specific needs cannot be met by an available CE-marked device as such, and therefore, either a CE-marked device needs to be modified or a new device needs to be manufactured; |
|
(b) |
the health institution is accredited with the ISO standard 15189 quality management system, or any other equivalent recognised standard; |
|
(c) |
the health institution provides the Commission and the competent authority referred to in Articles 21 to 25 Article 26 with a list of such devices, which shall not apply to those include a justification of their manufacturing, modification or use. This list shall be regularly updated. |
The Commission shall verify that the devices on that list are eligible for exemption in accordance with the requirements under this paragraph.
The information on exempt devices shall be made public.
Member States shall retain the right to restrict the in-house manufacture and use of any specific type of in-vitro diagnostic device in relation to aspects that are not covered by this Regulation, and may also make the manufacture and use of the devices concerned subject to further safety requirements . In such cases, Member States shall inform the Commission and the other Member States accordingly. [Am. 70]
6. The Commission shall be empowered to adopt delegated acts in accordance with Article 85, amending or supplementing, in the light of technical progress and considering the intended users or patients, the general safety and performance requirements set out in Annex I, including the information supplied by the manufacturer. [Am. 71]
Article 4a
Genetic information, counselling and informed consent
1. A device may only be used for the purpose of a genetic test if an indication is given by persons admitted to the medical profession under the applicable national legislation after a personal consultation.
2. A device may only be used for the purposes of a genetic test if the rights, safety and well-being of the subjects are protected and that the clinical data generated in the course of the genetic testing are going to be reliable and robust.
3. Information. Before using a device for the purpose of a genetic test the person referred to in paragraph 1 shall provide the person concerned with appropriate information on the nature, the significance and the implications of the genetic test.
4. Genetic counselling. Appropriate genetic counselling is mandatory before using a device for the purpose of predictive and prenatal testing and after a genetic condition has been diagnosed. It shall include medical, ethical, social, psychological and legal aspects and shall be provided by physicians or another person qualified under national law in genetic counselling.
The form and extent of this genetic counselling shall be defined according to the implications of the results of the test and their significance for the person or the members of his or her family.
5. Consent. A device may only be used for the purpose of a genetic test after the person concerned has given free and informed consent to it. The consent shall be given explicitly and in writing. It may be revoked at any time in writing or orally.
6. Testing of minors and incapacitated subjects. In the case of minors the informed consent of the parents or legal representative or minors themselves shall be obtained in accordance with national laws; consent shall represent the minor’s presumed will and may be revoked at any time, without detriment to the minor. In the case of incapacitated subjects not able to give informed legal consent, the informed consent of the legal representative shall be obtained; consent shall represent the presumed will of the incapacitated subject and may be revoked at any time, without detriment to the person.
7. A device may only be used for the determination of sex in connection with prenatal diagnosis, if the determination fulfils a medical purpose and if there is a risk of serious gender-specific hereditary diseases. By way of derogation from Article 2(1) and (2) this also applies to products which are not intended to fulfil a specific medical purpose.
8. The provisions of this Article on the use of devices for the purpose of genetic tests do not prevent the Member States from maintaining or introducing for reasons of health protection or public order more stringent national legislation in this field. [Am. 271
Article 5
Distance sales
1. A device offered by means of information society services as defined in Article 1(2) of Directive 98/34/EC to a natural or legal person established in the Union shall comply with this Regulation at the latest when the device is placed on the market.
2. Without prejudice to national legislation regarding the exercise of the medical profession, a device that is not placed on the market but is used in the context of a commercial activity for the provision of a diagnostic or therapeutic service offered by means of information society services as defined in Article 1(2) of Directive 98/34/EC or by other means of communication to a natural or legal person established in the Union shall comply with this Regulation.
2a. Service providers providing means of distance communication shall be obliged, upon receiving a request from the competent authority, to disclose the details of entities engaging in distance selling. [Am. 73]
2b. There shall be a prohibition on the marketing, placing in use, distribution, delivery and making available of products whose names, labelling or instructions for use may mislead with regard to the product’s characteristics and effects by:
|
(a) |
ascribing characteristics, functions and effects to the product which the product does not have; |
|
(b) |
creating the false impression that treatment or diagnosis using the product is sure to be successful, or failing to inform of a likely risk associated with the use of the product in line with its intended use or for a longer-than-anticipated period; |
|
(c) |
suggesting uses or characteristics of the product other than those declared when the conformity assessment was carried out. |
Promotional materials, presentations and information about the products may not mislead in the manner referred to in the first subparagraph. [Am. 74]
Article 6
Harmonised standards
1. Devices which are in conformity with the relevant harmonised standards, or parts thereof, the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.
The first subparagraph shall also apply to system or process requirements to be fulfilled by economic operators or sponsors in accordance with this Regulation, including those related to the quality management system, risk management, the post-market surveillance plan, clinical performance studies, clinical evidence or post-market follow-up.
2. Reference to harmonised standards also includes the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia.
Article 7
Common technical specifications
1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient there is a need to address public health concerns , the Commission, after having consulted the MDCG and the MDAC , shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evidence and post-market follow-up set out in Annex XII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 84(3).
1a. Before adopting CTS as referred to in paragraph 1, the Commission shall ensure that the CTS have been developed with the appropriate support of the relevant stakeholders and that they are coherent with the European and international standardisation system. CTS are coherent if they do not conflict with European standards, meaning they cover areas where no harmonised standards exist, the adoption of new European standards is not envisaged within a reasonable period, where existing standards have not gained market uptake or where those standards have become obsolete or have been demonstrated as clearly insufficient according to vigilance or surveillance data, and where the transposition of the technical specifications into European standardisation deliverables is not envisaged within a reasonable period. [Am. 75]
2. Devices which are in conformity with the CTS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CTS or parts thereof.
3. Manufacturers shall comply with the CTS unless they can duly justify that they have adopted solutions ensuring a level of safety and performance that is at least equivalent thereto.
Article 8
General obligations of the manufacturer
1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.
2. Manufacturers shall draw up the technical documentation which shall allow assessment of the conformity of the device with the requirements of this Regulation. The technical documentation shall include the elements set out in Annex II.
The Commission shall be empowered to adopt delegated acts in accordance with Article 85 amending or supplementing, in the light of technical progress, the elements in the technical documentation set out in Annex II. [Am. 76]
3. Where compliance of a device with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than devices for performance evaluation, shall draw up an EU declaration of conformity in accordance with Article 15 and affix the CE marking of conformity in accordance with Article 16.
4. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate including any supplement, issued in accordance with Article 43, available to the competent authorities for a period of at least five years after the last device covered by the declaration of conformity has been placed on the market.
Where the technical documentation is voluminous or held in different locations, the manufacturer shall provide, upon request by a competent authority, a summary technical documentation (STED) and grant access to the full technical documentation upon request.
5. Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in product design or characteristics and changes in the harmonised standards or CTS by reference to which conformity of a product is declared shall be adequately taken into account. Proportionate to the risk class and the type of device, manufacturers of devices, other than devices for performance evaluation, shall institute and keep up to date a quality management system that shall address at least the following aspects:
|
(a) |
the responsibility of the management; |
|
(b) |
resource management, including selection and control of suppliers and sub-contractors; |
|
(c) |
product realisation; |
|
(d) |
processes for monitoring and measurement of output, data analysis and product improvement. |
6. Proportionate to the risk class and the type of device, manufacturers of devices shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service, and to apply any necessary corrective action, hereinafter referred to as ‘post-market surveillance plan’. The post-market surveillance plan shall set out the process for collecting, recording , communicating to the electronic system on vigilance referred to in Article 60 and investigating complaints and reports from healthcare professionals, patients or users on suspected incidents related to a device, keeping a register of non-conforming products and product recalls or withdrawals, and if deemed appropriate due to the nature of the device, sample testing of marketed devices. Part of the post-market surveillance plan shall be a plan for post-market follow-up in accordance with Part B of Annex XII. Where post-market follow-up is not deemed necessary, this shall be duly justified and documented in the post-market surveillance plan and subject to approval by the competent authority . [Am.77]
If in the course of the post-market surveillance a need for corrective action is identified, the manufacturer shall implement the appropriate measures.
7. Manufacturers shall ensure that the device is accompanied by the information to be supplied for the device in accordance with Section 17 of Annex I is provided in an official Union language which can be easily understood by the intended user. The language(s) of the information to be supplied by the manufacturer may be determined by the law of the Member State where the device is made available to the user.
For devices for self-testing or near-patient-testing, the information supplied in accordance with Section 17 of Annex I shall be easily understandable and provided in the official Union language(s) of the Member State where the device reaches its intended user. [Ams 78, 79 and 263]
8. Manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that product into conformity, withdraw it or recall it, as appropriate. They shall inform the responsible national competent authority, the distributors , importers and, where applicable, the authorised representative accordingly. [Am. 80]
9. Manufacturers shall, in response to a reasoned request from a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service.
If a competent authority considers or has reason to believe that a device has caused damage, it shall ensure, where this is not already provided for by national litigation or judicial proceedings, that the potentially harmed user, the user's successor in title, the user's health insurance company or other third parties affected by the damage caused to the user may request the information referred to in the first subparagraph from the manufacturer or his authorised representative while ensuring due regard for the intellectual property rights. [Am. 81]
If facts exist that give reason to assume that an in-vitro medical device has caused damage, the potentially harmed user, his successor in title, his compulsory health insurance or other third parties affected by the damage may also demand the information referred to in the first subparagraph from the manufacturer or his authorised representative.
This right to information shall also exist, subject to the conditions set forth in the first subparagraph, against the competent authorities of the Member States which are responsible for the surveillance of the relevant medical device, as well as against any notified body that issued a certificate pursuant to Article 45 or was otherwise involved in the conformity assessment procedure of the medical device in question. [Am. 82]
10. Where manufacturers have their devices designed and manufactured by another legal or natural person, the information on the identity of that person shall be part of the information to be submitted in accordance with Article 23.
10a. Before placing an in vitro diagnostic medical device on the market, manufacturers shall ensure they are covered by appropriate liability insurance covering the risk of insolvency and any damage to patients or users that can be directly attributed to a manufacturing defect of the same medical device, with a level of coverage proportionate to the potential risk associated with the in vitro diagnostic medical device produced, and in accordance with Council Directive 85/374/EEC (27) . [Am. 83]
Article 9
Authorised representative
1. A manufacturer of a device that is placed on the Union market, or bears the CE marking without being placed on the Union market, who does not have a registered place of business in a Member State or does not carry out relevant activities at a registered place of business in a Member State, shall designate a single authorised representative.
2. The designation shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.
3. The authorised representative shall perform the tasks specified in the mandate agreed between the manufacturer and the authorised representative.
The mandate shall allow and require the authorised representative to perform at least the following tasks in relation to the devices that it covers:
|
(a) |
keep available the summary of technical documentation (STED) or on request the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any supplement, issued in accordance with Article 43 at the disposal of competent authorities for the period referred to in Article 8(4); [Am. 84] |
|
(b) |
in response to a reasoned request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device; |
|
(c) |
cooperate with the competent authorities on any corrective action taken to eliminate the risks posed by devices; |
|
(d) |
immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated; |
|
(e) |
terminate the mandate if the manufacturer acts contrary to his obligations under this Regulation. |
To allow the authorised representative to fulfil the tasks mentioned in this paragraph, the manufacturer shall at least ensure that the authorised representative has permanent immediate access to the necessary documentation in one of the official Union languages.
4. The mandate referred to in paragraph 3 shall not include the delegation of the manufacturer's obligations laid down in Article 8(1), (2), (5), (6), (7) and (8).
5. An authorised representative who terminates the mandate on the grounds referred to in point (e) of paragraph 3 shall immediately inform the competent authority of the Member State in which he is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.
6. Any reference in this Regulation to the competent authority of the Member State where the manufacturer has his registered place of business shall be understood as a reference to the competent authority of the Member State where the authorised representative, designated by a manufacturer referred to in paragraph 1, has his registered place of business.
Article 10
Change of authorised representative
The modalities of a change of authorised representative shall be clearly defined in an agreement between the manufacturer, the outgoing authorised representative and the incoming authorised representative. This agreement shall address at least the following aspects:
|
(a) |
the date of termination of the mandate with the outgoing authorised representative and date of beginning of the mandate with the incoming authorised representative; |
|
(b) |
the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material; |
|
(c) |
the transfer of documents, including confidentiality aspects and property rights; |
|
(d) |
the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or to the incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which he had been designated as authorised representative. |
Article 11
General obligations of importers
1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
2. Before placing a device on the market importers shall ensure the following:
|
(a) |
that the appropriate conformity assessment procedure has been carried out by the manufacturer; |
|
(b) |
that a manufacturer is identified and that an authorised representative in accordance with Article 9 has been designated by the manufacturer; [Am. 85] |
|
(c) |
that the EU declaration of conformity and the technical documentation has been drawn up by the manufacturer; |
|
(d) |
that the device bears the required CE marking of conformity; |
|
(e) |
that the device is labelled in accordance with this Regulation and accompanied by the required instructions for use and EU declaration of conformity; [Am. 86] |
|
(f) |
that, where applicable, a Unique Device Identification has been assigned by the manufacturer in accordance with Article 22. |
|
(fa) |
that the manufacturer has taken out appropriate liability insurance coverage pursuant to Article 8(10a) , unless the importer himself ensures sufficient coverage that meets the requirements of this provision. [Am. 87] |
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, he shall not place the device on the market until it has been brought into conformity. Where the device presents a risk, the importer shall inform the manufacturer and his authorised representative to that effect, as well as the competent authority of the Member State in which he is established.
3. Importers shall indicate their name, registered trade name or registered trade mark and the address of their registered place of business at which they can be contacted and their location can be established on the device or on its packaging or in a document accompanying the device. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
4. Importers shall ensure that the device is registered in the electronic system in accordance with Article 23(2).
5. Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I.
6. When deemed appropriate with regard to the risks presented by a device, importers shall, in order to protect the health and safety of patients and users, carry out sample testing of marketed products, investigate complaints and keep a register of complaints, of non-conforming products and of product recalls and withdrawals, and shall keep the manufacturer, authorised representative and distributors informed of such monitoring.
7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, and where applicable his authorised representative and, if appropriate, take ensure that the necessary corrective action to bring that device into conformity, withdraw or recall it is taken and, implement that action . Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 43 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken they have implemented . [Am. 88]
8. Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and his authorised representative.
9. Importers shall, for the period referred to in Article 8(4), keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation and, if applicable, a copy of the relevant certificate including any supplement, issued in accordance with Article 43, can be made available to those authorities, upon request. By written mandate, the importer and the authorised representative for the device in question may agree that this obligation is delegated to the authorised representative.
10. Importers shall, in response to a request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product. This obligation shall be considered fulfilled when the authorised representative for the device in question provides the required information. Importers shall cooperate with a competent national authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.
Article 12
General obligations of distributors
1. When making a device available on the market, distributors shall act with due care in relation to the requirements applicable.
2. Before making a device available on the market distributors shall verify that the following requirements are met:
|
(a) |
the product bears the required CE marking of conformity; |
|
(b) |
the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7); |
|
(c) |
the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 22 and Article 11(3) respectively. |
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, he shall not make the device available on the market until it has been brought into conformity. Where the device presents a risk, the distributor shall inform the manufacturer and, where applicable, his authorised representative and the importer to that effect, as well as the competent authority of the Member State in which he is established.
3. Distributors shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I.
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that , within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non-compliance and of any corrective action taken. [Am. 89]
5. Distributors who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, his authorised representative.
6. Distributors shall, in response to a request from a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of a device. This obligation shall be considered fulfilled when the authorised representative for the device in question, where applicable, provides the required information. Distributors shall cooperate with competent national authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market.
Article 13
Person responsible for regulatory compliance
1. Manufacturers shall have available within their organisation at least one qualified person responsible for regulatory compliance who possesses expert knowledge the requisite expertise in the field of in vitro diagnostic medical devices. The expert knowledge requisite expertise shall be demonstrated by either of the following qualifications:
|
(a) |
a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in law , natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices; |
|
(b) |
five three years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices. |
2. The qualified person responsible for regulatory compliance shall at least be responsible for ensuring the following matters:
|
(a) |
that the conformity of the devices is appropriately assessed before a batch is released; |
|
(b) |
that the technical documentation and the declaration of conformity are drawn up and kept up-to-date; |
|
(c) |
that the reporting obligations in accordance with Articles 59 to 64 are fulfilled. |
|
(d) |
in the case of devices for performance evaluation intended to be used in the context of interventional clinical performance studies or other clinical performance studies involving risks for the subjects, that the statement referred to in Section 4.1 of Annex XIII is issued; |
If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1 and 2, their respective areas of responsibility shall be stipulated in writing.
3. The qualified person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his duties.
4. Authorised representatives shall have available within their organisation at least one qualified person responsible for regulatory compliance who possesses expert knowledge the requisite expertise regarding the regulatory requirements for in vitro diagnostic medical devices in the Union. The expert knowledge requisite expertise shall be demonstrated by either of the following qualifications:
|
(a) |
a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices; |
|
(b) |
five three years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices. [Am. 90] |
Article 14
Cases in which obligations of manufacturers apply to importers, distributors or other persons
1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if he does any of the following:
|
(a) |
makes available on the market a device under his name, registered trade name or registered trade mark; |
|
(b) |
changes the intended purpose of a device already placed on the market or put into service; |
|
(c) |
modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. |
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in number (16) of Article 2, assembles or adapts a device already on the market to its intended purpose for an individual patient or a specific limited group of patients within a single healthcare institution. [Am. 91]
2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:
|
(a) |
provision, including translation, of the information supplied by the manufacturer in accordance with Section 17 of Annex I relating to a device already placed on the market and of further information which is necessary in order to market the product in the relevant Member State; |
|
(b) |
changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the product in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the package that shall ensure the sterile condition is opened, damaged or otherwise negatively affected by the repackaging. |
3. A distributor or importer who carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate the activity carried out together with his name, registered trade name or registered trade mark and the address at which he can be contacted and his location can be established on the device or, where that is not possible, on its packaging or in a document accompanying the device.
He shall ensure that he has in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. Part of the quality management system shall be procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it in conformity with this Regulation.
4. Prior to making the relabelled or repackaged device available, the distributor or importer referred to in paragraph 3 shall inform the manufacturer and the competent authority of the Member State where he plans to make the device available and, upon request, shall provide them with a sample or a mock-up of the relabelled or repackaged device, including any translated label and instructions for use. He shall submit to the competent authority a certificate, issued by a notified body referred to in Article 27, designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system complies with the requirements laid down in paragraph 3.
4a. Distributors or affiliates who carry out, on behalf of the manufacturer, one or more of the activities mentioned under paragraphs 2(a) and (b) — are exempted from additional requirements under paragraphs 3 and 4. [Am. 92]
Article 15
EU declaration of conformity
1. The EU declaration of conformity shall state that fulfilment of the requirements specified in this Regulation has been demonstrated. It shall be continuously updated. The minimum content of the EU declaration of conformity is set out in Annex III. It shall be translated into issued in one of the official Union language or languages required by the Member State(s) in which the device is made available. [Am. 264]
2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union legislation which also requires a declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device containing all information required for identification of the Union legislation to which the declaration relates.
3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device.
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 amending or supplementing the minimum content of the EU declaration of conformity set out in Annex III in the light of technical progress. [Am. 93]
Article 16
CE marking of conformity
1. Devices, other than devices for performance evaluation, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex IV.
2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
3. The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile pack. Where that is not possible or not warranted on account of the nature of the device, it shall be affixed to the packaging. The CE marking shall also appear in the instructions for use and on the sales packaging where those are provided.
4. The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.
5. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 40. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the legal requirements for CE marking.
6. Where devices are subject to other Union legislation concerning other aspects which also provide for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the provisions of the other legislation.
Article 17
Devices for special purposes
1. Member States shall not create any obstacle to devices for performance evaluation which are supplied for that purpose to laboratories or other institutions, if they meet the conditions laid down in Articles 48 to 58.
2. Those devices shall not bear the CE marking, with the exception of the devices referred to in Article 52.
3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create any obstacle to the showing of devices which do not comply with this Regulation, provided such devices are not used on specimens taken from the participants and a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been made to comply with this Regulation.
Article 18
Systems and procedure packs
1. Any natural or legal person shall draw up a statement referred to in paragraph 2 if he puts devices bearing the CE marking together with the following other devices or products, in accordance with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:
|
— |
other devices bearing the CE marking; |
|
— |
medical devices bearing the CE marking in conformity with Regulation (EU) …/… [Ref. of future Regulation on medical devices]; |
|
— |
other products which are in conformity with the legislation applicable to those products. |
2. In the statement, the person referred to in paragraph 1 shall declare the following:
|
(a) |
that he verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers' instructions and has carried out his operations in accordance with those instructions; |
|
(b) |
that he packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together; |
|
(c) |
that the activity of putting devices and, if applicable, other products together as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation. |
3. Any natural or legal person who sterilises systems or procedure packs referred to in paragraph 1 for the purpose of placing them on the market shall, at his choice, follow one of the procedures referred to in Annex VIII or in Annex X. The application of those Annexes and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile package is opened or damaged. The person shall draw up a statement declaring that the sterilisation has been carried out in accordance with the manufacturer's instructions.
4. Where the system or procedure pack incorporate devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, the system or procedure pack shall be treated as a device in its own right and shall be subjected to the relevant conformity assessment procedure pursuant to Article 40.
5. The systems or procedure packs referred to in paragraph 1 shall not themselves bear an additional CE marking but they shall bear the name, registered trade name or registered trade mark of the person referred to in paragraph 1 as well as the address at which he can be contacted and his location can be established. Systems or procedure packs shall be accompanied by the information referred to in Section 17 of Annex I. The statement referred to in paragraph 2 of this Article shall be kept at the disposal of the competent authorities, after the system or procedure pack has been put together, for the period that is applicable to the devices put together in accordance with Article 8(4). Where these periods differ, the longest period shall apply.
Article 19
Parts and components
1. Any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re-establish the function of the device, without significantly changing its performance or safety characteristics, shall ensure that the article does not adversely affect the safety and performance of the device. Substantiating evidence shall be kept available to the competent authorities of the Member States. [Am. 94]
2. An article that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics of the device shall be considered as a device and shall meet the requirements laid down in this Regulation. [Am. 95]
Article 20
Free movement
Member States shall not refuse, prohibit or restrict the making available or putting into service within their territory of devices which comply with the requirements of this Regulation.
Chapter III VII
Identification and traceability of devices, registration of devices and of economic operators, summary of safety and performance, European databank on medical devices [Am. 101]
Article 21
Identification within the supply chain
For devices, other than devices for performance evaluation, economic operators shall be able to identify the following, for the period referred to in Article 8(4):
|
(a) |
any economic operator to whom they have supplied a device; |
|
(b) |
any economic operator who has supplied them with a device; |
|
(c) |
any health institution or healthcare professional to whom they have supplied a device. |
Upon request, they shall inform the competent authorities thereof.
Article 22
Unique device identification system
1. For devices, other than devices for performance evaluation, a system for Unique Device Identification shall be put in place in the Union. The UDI system shall allow the identification and traceability of devices and shall consist of the following:
|
(a) |
production of a UDI that comprises the following:
|
|
(b) |
placement of the UDI on the label of the device; |
|
(c) |
storage of the UDI by the economic operators and the health institutions through electronic means; |
|
(d) |
establishment of an electronic system on UDI. |
2. The Commission shall designate one or several entities that operate a system for assignment of UDIs pursuant to this Regulation and that satisfy all of the following criteria:
|
(a) |
the entity is an organisation with legal personality; |
|
(b) |
its system for the assignment of UDIs is adequate to identify a device through its distribution and use in accordance with the requirements of this Regulation; |
|
(c) |
its system for the assignment of UDIs conforms to the relevant international standards; |
|
(d) |
the entity gives access to its system for the assignment of UDIs to all interested users according to a set of predetermined and transparent terms and conditions; |
|
(e) |
the entity undertakes the following:
|
3. Before placing a device on the market, the manufacturer shall assign to the device a UDI provided by an entity designated by the Commission in accordance with paragraph 2, if that device belongs to the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 7.
4. The UDI shall be placed on the label of the device, in accordance with the conditions laid down by a measure referred to in point (c) of paragraph 7. It shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 59. The device identifier shall appear on the EU declaration of conformity referred to in Article 15 and in the technical documentation referred to in Annex II.
5. Economic operators and health institutions shall store and keep, by electronic means, the device identifier and the production identifier of the devices which they have supplied or they have been supplied with, if they belong to the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 7.
6. The Commission, in cooperation with the Member States, shall set up and manage an electronic system on UDI to collate and process the information mentioned in Part B of Annex V. This information shall be accessible to the public.
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 85:
|
(a) |
determining the devices, categories or groups of devices, whose identification shall be based on the UDI system, as set out in paragraphs 1 to 6, and the timelines for implementing this. Following a risk-based approach, implementation of the UDI system shall be gradual, starting with devices falling in the highest risk class; |
|
(b) |
specifying the data to be included in the production identifier which, following a risk-based approach, may vary depending on the risk class of the device; |
|
(c) |
defining the obligations of economic operators, of health institutions and of professional users, in particular regarding allocation of the numeric or alphanumeric characters, placement of the UDI on the label, storage of information in the electronic system on UDI, and use of the UDI in documentation and reporting related to the device provided for in this Regulation; |
|
(d) |
amending or supplementing the list of information set out in Part B of Annex V in the light of technical progress. |
8. When adopting the measures referred to in paragraph 7, the Commission shall take into account the following:
|
(a) |
the protection of personal data; |
|
(b) |
the legitimate interest in protecting commercially sensitive information , to the extent that it does not undermine public health protection ; [Am. 97] |
|
(c) |
the risk-based approach; |
|
(d) |
the cost-effectiveness of the measures; |
|
(e) |
the convergence of UDI systems developed at international level. |
|
(ea) |
compatibility with medical device identification systems already on the market. [Am. 98] |
|
(eb) |
compatibility with the other traceability systems used by medical device stakeholders. [Am. 99] |
Article 23
Electronic system on registration of devices and economic operators
1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information that is necessary and proportionate to describe and identify the device and to identify the manufacturer and, where applicable, the authorised representative and the importer , and to ensure transparency and safe and effective use by making available to users current evidence concerning the clinical validity and, where applicable, utility of the device . The details regarding the information to be submitted by the economic operators are laid down in Part A of Annex V. [Am. 100]
2. Before a device, other than a device for performance evaluation, is placed on the market the manufacturer or his authorised representative shall submit to the electronic system the information referred to in paragraph 1.
3. Within one week after placing a device, other than a device for performance evaluation, on the market, importers shall submit to the electronic system the information referred to in paragraph 1.
4. Within one week of any change occurring in relation to the information referred to in paragraph 1, the relevant economic operator shall update the data in the electronic system.
5. Not later than two years after submission of the information in accordance with paragraphs 2 and 3, and then every second year, the relevant economic operator shall confirm the accuracy of the data. In the event of failure to confirm within six months of the due date, any Member State may take measures to suspend or otherwise restrict the making available of the device in question within its territory until the obligation referred to in this paragraph is complied with.
6. The data contained in the electronic system shall be accessible to the public.
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 amending the list of information to be submitted as set out in Part A of Annex V in the light of technical progress.
Article 24
Summary of safety Safety and clinical performance report
1. In the case of devices classified as class C and D, other than devices for performance evaluation, the manufacturer shall draw up a summary of report on the safety and clinical performance. It of the device based on the full information collected during the clinical performance study. The manufacturer shall also draw up a summary of that report which shall be written in a way that is clear to the intended user easy for a lay person to understand in the official language(s) of the country where the device is made available on the market . The draft of this summary report shall be part of the documentation to be submitted to and validated by the notified body, and where relevant by the special notified body , involved in the conformity assessment in accordance with Article Articles 40 and 43a and shall be validated by that body.
1a. The summary referred to in paragraph 1 shall be made available to the public through Eudamed in accordance with point (b) of the second paragraph of Article 25 and point 15 of Annex V, Part A.
2. The Commission may, by means of implementing acts, set out the form and format of the presentation of the data elements to be included in both the report and the summary of safety and performance referred to in paragraph 1 . Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 84(2). [Am. 102]
Article 25
European databank
The Commission shall develop and manage the European databank on medical devices (Eudamed) in accordance with the conditions and modalities established by Article 27 of Regulation (EU) [Ref. of future Regulation on medical devices].
Eudamed shall include the following as integral parts:
|
(a) |
the electronic system on UDI referred to in Article 22; |
|
(b) |
the electronic system on registration of devices and economic operators referred to in Article 23; |
|
(c) |
the electronic system on information on certificates referred to in Article 43(4); |
|
(d) |
the electronic system on interventional clinical performance studies and clinical performance studies involving risks for the subjects set up in Article 51; |
|
(e) |
the electronic system on vigilance referred to in Article 60; |
|
(f) |
the electronic system on market surveillance referred to in Article 66. |
|
(fa) |
the electronic system on registration of subsidiaries and subcontracting referred to in Article 28a. |
|
(fb) |
the electronic system on ‘special notified bodies’ referred to in Article 41b. [Am. 103] |
Chapter VII VIII
Vigilance and market surveillance [Am. 179]
SECTION 1 — VIGILANCE
Article 59
Reporting of incidents and field safety corrective actions
1. Manufacturers of devices, other than devices for performance evaluation, shall report through the electronic system referred to in Article 60 the following:
|
(a) |
any serious incident, including the date and place of the incident , with an indication of whether it is serious in accordance with the definition under Article 2, in respect of devices made available on the Union market; where available, the manufacturer shall include information on the patient or user and healthcare professional involved in the incident ; |
|
(b) |
any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market if the reason for the field safety corrective action is not limited to the device made available in the third country. |
Manufacturers shall make the report referred to in the first subparagraph without delay, and no later than 15 days after they have become aware of the event and the causal relationship with their device or that such causal relationship is reasonably possible. The time period for reporting shall take account of the severity of the incident. Where necessary to ensure timely reporting, the manufacturer may submit an initial incomplete report followed up by a complete report.
2. For similar serious incidents occurring with the same device or device type and for which the root cause has been identified or the field safety corrective action implemented, manufacturers may provide periodic summary reports instead of individual incident reports, on condition that the competent authorities referred to in points (a), (b) and (c) of Article 60(5) have agreed with the manufacturer on the format, content and frequency of the periodic summary reporting.
3. The Member States shall take all appropriate measures, including targeted information campaigns , to encourage and enable healthcare professionals, including doctors and pharmacists , users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall inform the Commission of those measures.
They The competent authorities of the Member States shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that inform the manufacturer of the device concerned is informed of the incident without delay . The manufacturer shall ensure the appropriate follow-up.
The competent authority of a Member State shall notify the reports referred to in the first subparagraph to the electronic system referred to in Article 60 without delay, unless the same incident has already been reported by the manufacturer .
The Commission, in cooperation with the Member States and in consultation with the relevant stakeholders, shall coordinate between them the development of develop standard web-based structured forms for electronic and non-electronic reporting of serious incidents by healthcare professionals, users and patients.
4. Health institutions manufacturing and using devices referred to in Article 4(4) shall immediately report any serious incidents and field safety corrective actions referred to in paragraph 1 to the competent authority of the Member State in which the health institution is located. [Am. 180]
Article 60
Electronic system on vigilance
1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information:
|
(a) |
the reports by manufacturers on serious incidents and field safety corrective actions referred to in Article 59(1); |
|
(b) |
the periodic summary reports by manufacturers referred to in Article 59(2); |
|
(c) |
the reports by competent authorities on serious incidents referred to in the second subparagraph of Article 61(1); |
|
(d) |
the reports by manufacturers on trends referred to in Article 62; |
|
(e) |
the field safety notices by manufacturers referred to in Article 61(4); |
|
(f) |
the information to be exchanged between the competent authorities of the Member States and between them and the Commission in accordance with Article 61(3) and (6). |
|
(fa) |
the reports by competent authorities on serious incidents and field safety corrective actions taken within health institutions involving devices referred to in Article 4(4) |
2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission, to the notified bodies, to healthcare professionals and also to manufacturers where the information pertains to their own product .
3. The Commission shall ensure that healthcare professionals and the public have has an appropriate levels level of access to the electronic system. Where information is requested on a specific in vitro diagnostic medical device, that information shall be made available without delay and within 15 days at the latest.
4. On the basis of arrangements between the Commission and competent authorities of third countries or international organisations, the Commission may grant those competent authorities or international organisations access to the database at the appropriate level. Those arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent to those applicable in the Union.
5. The reports on serious incidents and field safety corrective actions referred to in points (a) and (b) of Article 59(1), the periodic summary reports referred to in Article 59(2), the reports on serious incidents referred to in the second subparagraph of Article 61(1) and the trend reports referred to in Article 62 shall be automatically transmitted upon receipt via the electronic system to the competent authorities of the following Member States
|
(a) |
the Member State where the incident occurred; |
|
(b) |
the Member State where the field safety corrective action is being or is to be undertaken; |
|
(c) |
the Member State where the manufacturer has his registered place of business; |
|
(d) |
where applicable, the Member State where the notified body, that issued a certificate in accordance with Article 43 for the device in question, is established. |
5a. The reports and information referred to in Article 60(5), shall also be automatically transmitted for the device in question via the electronic system to the notified body that issued the certificate in accordance with Article 43. [Am. 181]
Article 61
Analysis of serious incidents and field safety corrective action
1. Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 59 is, at national level, evaluated centrally by their competent authority, if possible together with the manufacturer. The competent authority shall take into account the views of all relevant stakeholders, including patient and healthcare professionals' organisations and manufacturers’ associations. [Am. 182]
If in the case of reports received in accordance with Article 59(3) the competent authority ascertains that the reports relate to a serious incident it shall notify without delay those reports to the electronic system referred to in Article 60, unless the same incident has already been reported by the manufacturer. [Am. 183]
2. The national competent authorities shall carry out a risk assessment with regard to reported serious incidents or field safety corrective actions, taking into account criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of harm and severity of harm, clinical benefit of the device, intended and potential users, and population affected. They shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action. They shall monitor the manufacturer's investigation of the serious incident. [Am. 184]
3. After carrying out the assessment, the evaluating competent authority shall, through the electronic system referred to in Article 60, inform without delay the other competent authorities of the corrective action taken or envisaged by the manufacturer or imposed on him to minimise the risk of recurrence of a serious incident, including information on the underlying events and the outcome of its assessment.
4. The manufacturer shall ensure that the users of the device in question are informed without delay of the corrective action taken by means of a field safety notice. Except in case of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in cases referred to in paragraph 5 of this Article, the coordinating competent authority to allow them to make comments. Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.
The manufacturer shall enter the field safety notice in the electronic system referred to in Article 60 through which that notice shall be accessible to the public.
5. The competent authorities shall designate a coordinating competent authority to coordinate their assessments referred to in paragraph 2 in the following cases:
|
(a) |
where similar serious incidents related to the same device or type of device of the same manufacturer occur in more than one Member State; |
|
(b) |
where the field safety corrective action is being or is to be undertaken in more than one Member State. |
Unless otherwise agreed between the competent authorities, the coordinating competent authority shall be the one of the Member State where the manufacturer has his registered place of business.
The coordinating competent authority shall inform the manufacturer, the other competent authorities and the Commission that it has assumed the role of coordinating authority.
6. The coordinating competent authority shall carry out the following tasks:
|
(a) |
to monitor the investigation of the serious incident by the manufacturer and the corrective action to be taken; |
|
(b) |
to consult with the notified body that issued a certificate in accordance with Article 43 for the device in question regarding the impact of the serious incident on the certificate; |
|
(c) |
to agree with the manufacturer and the other competent authorities referred to in points (a) to (c) of Article 60(5) on the format, content and frequency of periodic summary reports in accordance with Article 59(2); |
|
(d) |
to agree with the manufacturer and other competent authorities concerned on the implementation of the appropriate field safety corrective action; |
|
(e) |
to inform the other competent authorities and the Commission, through the electronic system referred to in Article 60, of the progress in and the outcome of its assessment. |
The designation of a coordinating competent authority shall not affect the rights of the other competent authorities to perform their own assessment and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating competent authority and the Commission shall be kept informed of the outcome of any such assessment and the adoption of any such measures.
7. The Commission shall provide secretarial support to the coordinating competent authority in the accomplishment of its tasks under this Chapter.
Article 62
Trend reporting
Manufacturers of devices classified in class C or D shall report to the electronic system referred to in Article 60 any statistically significant increase in the frequency or severity of incidents that are not serious incidents or of expected undesirable effects that have a significant impact on the risk-benefit analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons when weighted against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents or expected undesirable effects in respect of the device, or category or group of devices, in question during a specific time period as established in the manufacturer’s conformity assessment. Article 61 shall apply.
Article 63
Documentation of vigilance data
Manufacturers shall update their technical documentation with information on incidents received from healthcare professionals, patients and users, serious incidents, field safety corrective actions, periodic summary reports referred to in Article 59, trend reports referred to in Article 62 and field safety notices referred to in Article 61(4). They shall make this documentation available to their notified bodies, which shall assess the impact of the vigilance data on the conformity assessment and the certificate issued.
Article 64
Implementing acts
The Commission may, by means of implementing acts, adopt the modalities and procedural aspects necessary for the implementation of Articles 59 to 63 as regards the following:
|
(a) |
typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices; |
|
(b) |
harmonised forms for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports by manufacturers as referred to in Articles 59 and 62; |
|
(c) |
timelines for the reporting of serious incidents and field safety corrective actions, periodic summary reports and trend reports by manufacturers, taking into account the severity of the event to be reported as referred to in Articles 59 and 62; |
|
(d) |
harmonised forms for the exchange of information between competent authorities as referred to in Article 61. |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
SECTION 2 — MARKET SURVEILLANCE
Article 65
Market surveillance activities
1. The competent authorities shall perform appropriate checks on the characteristics and performance of devices including, where appropriate, review of documentation and physical or laboratory checks on the basis of adequate samples. They shall take account of established principles regarding risk assessment and risk management, vigilance data and complaints. The competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities, and, where necessary and justified, enter and inspect the premises of economic operators and take the necessary samples of devices for analysis by an official laboratory . They may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary.
1a. The competent authorities shall designate inspectors who shall be empowered to carry out the checks referred to in paragraph 1. The checks shall be carried out by the inspectors of the Member State in which the economic operator is located. Those inspectors may be assisted by experts appointed by the competent authorities.
1b. Unannounced inspections may also be carried out. The organisation and implementation of such inspections shall always take account of the principle of proportionality, particularly with reference to the hazard potential of a particular product.
1c. Following each inspection carried out under paragraph 1, the competent authority shall draw up a report on compliance by the economic operator inspected with the legal and technical requirements applicable under this Regulation and any corrective actions needed.
1d. The competent authority which carried out the inspection shall communicate the content of this report to the inspected economic operator. Before adopting the report, the competent authority shall give the inspected economic operator the opportunity to submit comments. The final inspection report as referred to in paragraph 1b shall be entered into the electronic system provided for in Article 66.
1e. Without prejudice to any international agreements concluded between the Union and third countries, checks as referred to in paragraph 1 can also take place in the premises of an economic operator located in a third country, if the device is intended to be made available on the Union market.
2. The Member States shall draw up strategic surveillance plans covering their planned surveillance activities, as well as the human and material resources needed to carry those activities out . Member States shall periodically review and assess the functioning implementation of their surveillance activities plans . Such reviews and assessments shall be carried out at least every four two years and the results thereof shall be communicated to the other Member States and the Commission. The Commission may make recommendations for adjustments to the surveillance plans. The Member State concerned States shall make a summary of the results and of the Commission’s recommendations accessible to the public. [Am. 185]
3. The competent authorities of the Member States shall coordinate their market surveillance activities, cooperate with each other and share with each other and with the Commission the results thereof. Where appropriate, the competent authorities of the Member States shall agree on work-sharing and specialisation.
4. Where more than one authority in a Member State is responsible for market surveillance and external border controls, those authorities shall cooperate with each other, by sharing information relevant to their role and functions.
5. The competent authorities of the Member States shall cooperate with the competent authorities of third countries with a view to exchanging information and technical support and promoting activities relating to market surveillance.
Article 66
Electronic system on market surveillance
1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information:
|
(a) |
information in relation to non-compliant devices presenting a risk to health and safety referred to in Article 68(2), (4) and (6); |
|
(b) |
information in relation to compliant devices presenting a risk to health and safety referred to in Article 70(2); |
|
(c) |
information in relation to formal non-compliance of products referred to in Article 71(2); |
|
(d) |
information in relation to preventive health protection measures referred to in Article 72(2). |
2. The information mentioned in paragraph 1 shall be immediately transmitted through the electronic system to all competent authorities concerned and be accessible to the Member States , to the Commission, to the Agency and to healthcare professionals. The Commission shall also ensure that the public has an appropriate level of access to the electronic system. In particular, it shall ensure that, where information is requested on a specific in vitro diagnostic medical device, it is made available without delay and within 15 days. The Commission, in consultation with the Medical Devices Coordination Group, shall provide an overview of this information, every six months, for the public and healthcare professionals. This information shall be accessible through the European databank referred to in Article 25. [Am. 186]
Article 67
Evaluation regarding devices presenting a risk to health and safety at national level
Where the competent authorities of a Member State, based on vigilance data or other information, have sufficient reason to believe that a device presents a risk to the health or safety of patients, users or other persons, they shall carry out an evaluation in relation to the device concerned covering all the requirements laid down in this Regulation that are relevant to the risk presented by the device. The relevant economic operators shall cooperate as necessary with the competent authorities.
Article 68
Procedure for dealing with non-compliant devices presenting a risk to health and safety
1. Where, having performed an evaluation pursuant to Article 67, the competent authorities find that the device, which presents a risk to the health or safety of patients, users or other persons, does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate and duly justified corrective action to bring the device into compliance with those requirements, to prohibit or restrict the making available of the device on the market, to subject the making available of the device to specific requirements, to withdraw the device from the market, or to recall it within a reasonable period, proportionate to the nature of the risk.
2. Where the competent authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operators to take, by means of the electronic system referred to in Article 66.
3. The economic operators shall ensure that all appropriate corrective action is taken in respect of all the devices concerned that they have made available on the market throughout the Union.
4. Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 1, the competent authorities shall take all appropriate provisional measures to prohibit or restrict the device's being made available on their national market, to withdraw the device from that market or to recall it.
They shall notify the Commission and the other Member States, without delay, of those measures, by means of the electronic system referred to in Article 66.
5. The notification referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant device, the origin of the device, the nature of and the reasons for the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
6. Member States other than the Member State initiating the procedure shall without delay inform the Commission and the other Member States of any additional information at their disposal relating to the non-compliance of the device concerned and of any measures adopted by them in relation to the device concerned. In the event of disagreement with the notified national measure, they shall without delay inform the Commission and the other Member States of their objections, by means of the electronic system referred to in Article 66.
7. Where, within two months of receipt of the notification referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
8. All Member States shall ensure that appropriate restrictive measures are taken without delay in respect of the device concerned.
Article 69
Procedure at Union level
1. Where, within two months of receipt of the notification referred to in Article 68(4), objections are raised by a Member State against a provisional measure taken by another Member State, or where the Commission considers the measure to be contrary to Union legislation, the Commission shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide, by means of implementing acts, whether or not the national measure is justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
2. If the national measure is considered justified, Article 68(8) shall apply. If the national measure is considered unjustified, the Member State concerned shall withdraw the measure. Where, in the situations referred to in Articles 68 and 70, a Member State or the Commission consider that the risk to health and safety emanating from a device cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, the Commission, at the request of a Member State or on its own initiative, may take, by means of implementing acts, the necessary and duly justified measures to ensure the protection of health and safety, including measures restricting or prohibiting the placing on the market and putting into service of the device concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
3. On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts referred to in paragraphs 1 and 2 in accordance with the procedure referred to in Article 84(4).
Article 70
Procedure for dealing with compliant devices presenting a risk to health and safety
1. Where, having performed an evaluation pursuant to Article 67, a Member State finds that although a device has been legally placed on the market or put into service, it presents a risk to the health or safety of patients, users or other persons or to other aspects of the protection of public health, it shall require the relevant economic operator or operators to take all appropriate provisional measures to ensure that the device concerned, when placed on the market or put into service, no longer presents that risk, to withdraw the device from the market or to recall it within a reasonable period, proportionate to the nature of the risk.
2. The Member State shall immediately notify the Commission and the other Member States of the measures taken, by means of the electronic system referred to in Article 66. That information shall include the data necessary for the identification of the device concerned, the origin and the supply chain of the device, the findings of the Member State's evaluation specifying the nature of the risk involved and the nature and duration of the national measures taken.
3. The Commission shall evaluate the provisional national measures taken. On the basis of the results of that evaluation, the Commission shall decide, by means of implementing acts, whether or not the measure is justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3). On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 84(4).
4. Where the national measure is considered justified, Article 68(8) shall apply. If the national measure is considered unjustified, the Member State concerned shall withdraw the measure.
Article 71
Formal non-compliance
1. Without prejudice to Article 68, a Member State shall require the relevant economic operator to put an end to the non-compliance concerned within a reasonable period that is proportionate to the non-compliance where it makes one of the following findings:
|
(a) |
that the CE marking has been affixed in violation of the formal requirements laid down in Article 16; |
|
(b) |
that the CE marking has not been affixed to a device contrary to Article 16; |
|
(c) |
that the CE marking has been inappropriately affixed in accordance with procedures in this Regulation on a product that is not covered by this Regulation; |
|
(d) |
that the EU declaration of conformity has not been drawn up or is not complete; |
|
(e) |
that the information to be supplied by the manufacturer on the label or in the instructions for use is not available, not complete, or not provided in the language(s) required; |
|
(f) |
that the technical documentation, including the clinical evaluation, is not available or not complete. |
2. Where the economic operator does not put an end to the non-compliance within the period referred to in paragraph 1, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market. That Member State shall inform the Commission and the other Member States without delay of those measures, by means of the electronic system referred to in Article 66.
Article 72
Preventive health protection measures
1. Where a Member State, after having performed an evaluation which indicates a potential risk related to a device or a specific category or group of devices considers that the making available on the market or putting into service of such device or specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or, category or group of devices should be withdrawn from the market or recalled in order to protect the health and safety of patients, users or other persons or other aspects of public health, it may take any necessary and justified provisional measures.
2. The Member State shall immediately notify the Commission and all other Member States, giving the reasons for its decision, by means of the electronic system referred to in Article 66.
3. The Commission shall assess the provisional national measures taken. The Commission shall decide, by means of implementing acts, whether the national measures are justified or not. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission may adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 84(4).
4. Where the assessment referred to in paragraph 3 demonstrates that the making available on the market or putting into service of a device, specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled in all Member States in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission shall be empowered to adopt delegated acts in accordance with Article 85 to take the necessary and duly justified measures.
Where in this case imperative grounds of urgency so require, the procedure provided for in Article 86 shall apply to delegated acts adopted pursuant to this paragraph.
Article 73
Good administrative practice
1. Any measure adopted by the competent authorities of the Member States pursuant to Articles 68 to 72 shall state the exact grounds on which it is based. Where it is addressed to a specific economic operator, it shall be notified without delay to the economic operator concerned, who shall at the same time be informed of the remedies available to him under the law of the Member State concerned and of the time limits to which such remedies are subject. Where the measure is of general scope, it shall be appropriately published.
2. Except in cases where immediate action is necessary for reasons of serious risk to human health or safety, the economic operator concerned shall be given the opportunity to make submissions to the competent authority within an appropriate period of time before any measure is adopted. If action has been taken without the economic operator's being heard, he shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter.
3. Any measure adopted shall be immediately withdrawn or amended upon the economic operator's demonstrating that he has taken effective corrective action.
4. Where a measure adopted pursuant to Articles 68 to 72 concerns a product for which a notified body has been involved in the conformity assessment, the competent authorities shall inform the relevant notified body of the measure taken.
Chapter VIII IX
Cooperation between Member States, Medical Device Coordination Group, Medical Device Advisory Committee, EU reference laboratories, device registers [Am. 187]
Article 74
Competent authorities
1. The Member States shall designate the competent authority or authorities responsible for the implementation of this Regulation. They shall entrust their authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. The Member States shall communicate the competent authorities to the Commission which shall publish a list of competent authorities.
2. For the implementation of Articles 48 to 58, the Member States may designate a national contact point other than a national authority. In this case, references to a competent authority in this Regulation shall be understood as including the national contact point.
Article 75
Cooperation
1. The competent authorities of the Member States shall cooperate with each other and with the Commission and exchange with each other the information necessary to enable this Regulation to be applied uniformly.
2. Member States and the Commission shall participate in initiatives developed at international level with the aim of ensuring cooperation between regulatory authorities in the field of medical devices.
Article 76
Medical Device Coordination Group
The Medical Device Coordination Group (MDCG) established in accordance with the conditions and modalities defined in Article 78 of Regulation (EU) …/… [Ref. of future Regulation on medical devices] shall carry out, with the support of the Commission as provided in Article 79 of that Regulation, the tasks assigned to it by this Regulation.
Article 76a
Medical Device Advisory Committee
The Medical Device Advisory Committee (MDAC) established in accordance with the conditions and modalities defined in Article 78a of Regulation (EU) No .. . (*2) shall carry out, with the support of the Commission the tasks assigned to it by this Regulation. [Am. 188]
Article 76b
Assessment Committee for Medical Devices
1. An Assessment Committee for Medical Devices (ACMD) is hereby established, under the principles of highest scientific competence, impartiality, transparency and to avoid potential conflicts of interest.
2. When undertaking a clinical assessment for a specific device, the ACMD shall be composed of:
|
— |
a minimum of five clinical experts in the field of which a clinical assessment and recommendation have been requested; |
|
— |
one representative of the EMA; |
|
— |
one representative of the Commission; |
|
— |
one representative of patients' organisations appointed by the Commission in a transparent manner after a call for interest, for a three-year term which may be renewed. |
The ACMD shall meet on request from the MDCG and Commission, and its meetings shall be chaired by a Commission representative.
The Commission shall ensure that the composition of the ACMD corresponds to the expertise needed for the purpose of its clinical assessment and recommendation.
The Commission shall be responsible for providing the secretariat of this Committee.
3. The Commission shall establish a pool of clinical experts in the medical fields relevant to in vitro diagnostic medical devices being assessed by the ACMD.
In order to undertake the clinical assessment and recommendation procedure, each Member State may propose one expert, following a Union-wide call for expression of interest with a clear definition by the Commission of the requested profile. The publication of the call shall be widely advertised. Each expert shall be approved by the Commission and listed for a three-year term which may be renewed.
The Members of the ACMD shall be chosen for their competence and experience in the corresponding field. They shall perform their tasks with impartiality and objectivity. They shall be completely independent and shall neither seek nor take instructions from any government, notified body or manufacturer. Each member shall draw up a declaration of interests which shall be made publicly available.
In the light of technical progress and any information which becomes available, the Commission shall be empowered to adopt delegated acts in accordance with Article 85 amending or supplementing the fields referred to in the first subparagraph of this paragraph.
4. The ACMD shall fulfil the tasks defined in Article 44a. When adopting its clinical assessment and recommendation, the members of the ACMD shall use their best endeavours to reach consensus. If consensus cannot be reached, the ACMD shall decide by the majority of its members. Any diverging opinion shall be annexed to the ACMD opinion.
5. The ACMD shall establish its rules of procedure which shall, in particular, lay down procedures for the following:
|
— |
the adoption of opinions, including in case of urgency; |
|
— |
the delegation of tasks to reporting and co-reporting members. [Am. 260] |
Article 77
Tasks of the MDCG
The MDCG shall have the following tasks:
|
(-a) |
to provide regulatory opinions on the basis of a scientific assessment on certain types of in vitro diagnostic medical devices pursuant to Article 44a; |
|
(a) |
to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV; |
|
(aa) |
to establish and document the high level principles of competence and qualification and procedures for selection and authorisation of persons involved in conformity assessment activities (knowledge, experience and other competence required) and the required training (initial and ongoing). The qualification criteria shall address the various functions within the conformity assessment process as well as the devices, technologies and areas covered by the scope of designation; |
|
(ab) |
to review and approve the criteria of the competent authorities of Member States in respect of point (aa); |
|
(ac) |
to oversee the coordination group of notified bodies as specified in Article 37; |
|
(ad) |
to support the Commission in providing an overview of vigilance data and market surveillance activities, including any preventive health protection measures taken, on a six-monthly basis. This information shall be accessible through the European databank in Article 25; [Am. 261] |
|
(b) |
to contribute to the scrutiny of certain conformity assessments pursuant to Article 42; [Am. 190] |
|
(c) |
to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of the clinical evaluation by manufacturers and the assessment by notified bodies; |
|
(d) |
to assist the competent authorities of the Member States in their coordination activities in the fields of clinical performance studies, vigilance and market surveillance; |
|
(e) |
to provide advice and assist the Commission, at its request, in its assessment of any issue related to the implementation of this Regulation; |
|
(f) |
to contribute to harmonised administrative practice with regard to in vitro diagnostic medical devices in the Member States. |
Article 78
European Union reference laboratories
1. For specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices, the Commission may designate, by means of implementing acts, one or more European Union reference laboratories, hereinafter referred to as ‘EU reference laboratories’, that satisfy the criteria set out in paragraph 3. The Commission shall only designate laboratories for which a Member State or the Commission's Joint Research Centre have submitted an application for designation.
2. Within the scope of their designation, the EU reference laboratories shall, where appropriate, have the following tasks:
|
(a) |
to verify compliance of class D devices with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as provided for in the second subparagraph of Article 40(2); |
|
(b) |
to carry out appropriate laboratory tests on samples of manufactured class D devices or batches of class D devices, as provided for in the Section 5.7 of Annex VIII and in Section 5.1 of on request of competent authorities on samples collected during market surveillance activities under Article 65 and of notified bodies on samples collected during unannounced inspections under Annex X VIII section 4.4 ; [Am. 191] |
|
(c) |
to provide scientific and technical assistance to the Commission, the Member States and notified bodies in relation to the implementation of this Regulation; |
|
(d) |
to provide scientific advice and technical assistance regarding the definition of the state of the art in relation to specific devices, or a category or group of devices; [Am. 192] |
|
(e) |
to set up and manage a network of national reference laboratories and publish a list of the participating national reference laboratories and their respective tasks; |
|
(f) |
to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and , in particular for batch verification of class D devices and for market surveillance; [Am. 193] |
|
(g) |
to collaborate with notified bodies in the development of best practices for the performance of conformity assessment procedures; |
|
(h) |
to provide recommendations on suitable reference materials and reference measurement procedures of higher metrological order; |
|
(i) |
to contribute to the development of standards at CTS and of international level standards ; [Am. 194] |
|
(j) |
to provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation. |
3. EU reference laboratories shall satisfy the following criteria:
|
(a) |
to have appropriately qualified staff with adequate knowledge and experience in the field of the in vitro diagnostic medical devices for which they are designated; appropriate knowledge and experience shall be based on:
|
|
(b) |
to possess the necessary equipment and reference material to carry out the tasks assigned to them; |
|
(c) |
to have the necessary knowledge of international standards and best practices; |
|
(d) |
to have an appropriate administrative organisation and structure; |
|
(e) |
to ensure that their staff observe the confidentiality of the information and data obtained in carrying out their tasks; |
|
(f) |
to act in the public interest and in an independent manner; |
|
(g) |
to ensure that their staff do not have financial or other interests in the in vitro diagnostic medical device industry which could affect their impartiality, declare any other direct and indirect interests they may have in the in vitro diagnostic medical device industry and update this declaration whenever a relevant change occurs. |
4. EU reference laboratories may be granted a Union financial contribution.
The Commission may adopt, by means of implementing acts, the modalities and the amount of the grant of a Union financial contribution to EU reference laboratories, taking into account the objectives of protection of health and safety, support of innovation and cost-effectiveness. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
5. Where notified bodies or Member States request scientific or technical assistance or a scientific opinion from an EU reference laboratory, they may shall be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to a set of predetermined and transparent terms and conditions. [Am. 196]
6. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 for the following purposes:
|
(a) |
amending or supplementing the tasks of EU reference laboratories referred to in paragraph 2 and the criteria to be satisfied by EU reference laboratories referred to in paragraph 3. |
|
(b) |
setting out the structure and the level of the fees referred to in paragraph 5 which may be levied by an EU reference laboratory for providing scientific opinions in response to consultations by notified bodies in accordance with this Regulation, taking into account the objectives of protection of human health and safety, support of innovation and cost-effectiveness. |
7. EU reference laboratories shall be subject to controls, including on-site visits and audits, by the Commission to verify compliance with the requirements of this Regulation. If these controls find that a laboratory is not complying with those requirements for which they have been designated, the Commission, by means of implementing acts, shall take appropriate measures, including the withdrawal of the designation.
Article 79
Device registers
The Commission and the Member States shall take all appropriate measures to encourage ensure the establishment of registers for specific types of in vitro diagnostic devices to gather post-market experience related to the use of such devices . Registers for class C and D devices shall be systematically established . Such registers shall contribute to the independent evaluation of the long-term safety and performance of devices. [Am. 197]
Chapter IX X
Confidentiality, data protection, funding, penalties [Am. 200]
Article 80
Confidentiality
1. Unless otherwise provided in this Regulation and without prejudice to existing national provisions and practices in the Member States on medical confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:
|
(a) |
personal data in compliance with Directive 95/46/EC and Regulation (EC) No 45/2001; |
|
(b) |
commercial interests of a natural or legal person, including intellectual property rights; |
|
(c) |
the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits. |
2. Without prejudice to paragraph 1, information exchanged between competent authorities and between competent authorities and the Commission on condition of confidentiality shall remain confidential unless the originating authority has agreed to its disclosure.
3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to exchange of information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.
4. The Commission and Member States may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Article 81
Data protection
1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.
2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.
Article 82
Levy of fees
This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities set out in this Regulation, provided that the level of the fees is comparable and set in a transparent manner and on the basis of cost recovery principles. They shall inform the Commission and the other Member States at least three months before the structure and level of fees is to be adopted. [Am. 198]
Article 83
Penalties
The Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The dissuasive nature of the penalty shall be determined in relation to the financial benefit obtained as a result of the infringement. The Member States shall notify those provisions to the Commission by … (*3) and shall notify it without delay of any subsequent amendment affecting them. [Am. 199]
Chapter X XI
Final provisions [Am. 201]
Article 84
Committee procedure
1. The Commission shall be assisted by the Committee on Medical Devices set up by Article 88 of Regulation (EU) [Ref. of future Regulation on medical devices].
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 or Article 5, as appropriate, shall apply.
Article 85
Exercise of the delegation
1. The power to adopt the delegated acts referred to in Articles 4(6), 8(2), 15(4), 22(7), 23(7), 27(2), 38(2), 39(4), 40(10), 43(5), 49(7), 51(3), 72(4) and 78(6) is conferred on the Commission subject to the conditions laid down in this Article.
2. The delegation of power referred to in Articles 4(6), 8(2), 15(4), 22(7), 23(7), 27(2), 38(2), 39(4), 40(10), 43(5), 49(7), 51(3), 72(4) and 78(6) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
3. The delegation of power referred to in Articles 4(6), 8(2), 15(4), 22(7), 23(7), 27(2), 38(2), 39(4), 40(10), 43(5), 49(7), 51(3), 72(4) and 78(6) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to any of the Articles listed in paragraph 1 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period may be extended by two months at the initiative of the European Parliament or the Council.
Article 86
Urgency procedure for delegated acts
1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 85. In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or the Council.
Article 87
Transitional provisions
1. From … (*4) any publication of a notification in respect of a notified body in accordance with Directive 98/79/EC shall become void.
2. Certificates issued by notified bodies in accordance with Directive 98/79/EC prior to the entry into force of this Regulation shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex VI of Directive 98/79/EC which shall become void at the latest two years after the date of application of this Regulation.
Certificates issued by notified bodies in accordance with Directive 98/79/EC after the entry into force of this Regulation shall become void at the latest two years after the date of application of this Regulation.
3. By way of derogation from Directive 98/79/EC, devices which comply with this Regulation may be placed on the market before its date of application.
4. By way of derogation from Directive 98/79/EC, conformity assessment bodies which comply with this Regulation may be designated and notified before its date of application. Notified bodies which are designated and notified in accordance with this Regulation may apply the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation before its date of application.
5. By way of derogation from Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, manufacturers, authorised representatives, importers and notified bodies who, during the period from [date of application] until [18 months after date of application], comply with Article 23(2) and (3) and Article 43(4) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC as specified in Decision 2010/227/EU.
6. Authorisations granted by competent authorities of the Member States in accordance with Article 9(12) of Directive 98/79/EC shall keep the validity indicated in the authorisation.
Article 88
Evaluation
No later than … (*5), the Commission shall assess the application of this Regulation and establish an evaluation report on the progress towards achievement of the objectives of this Regulation including an assessment of resources required to implement this Regulation.
Article 89
Repeal
Directive 98/79/EC is repealed with effect from … (*6) with the exception of Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC which are repealed with effect from … (*7).
References to the repealed Directive shall be understood as reference to this Regulation and shall be read in accordance with the correlation table laid down in Annex XIV.
Article 90
Entry into force and date of application
1. This Regulation shall enter into force on the twentieth day after its publication in the Official Journal of the European Union.
2. It shall apply from … (*8).
3. By way of derogation from paragraph 2, the following shall apply:
|
(a) |
Article 23(2) and (3) and Article 43(4) (1) shall apply from … (*9) |
|
(b) |
Articles 26 to 38 shall apply from … (*10). However, prior to … (*11), the obligations on notified bodies emanating from the provisions in Articles 26 to 38 shall apply only to those bodies which submit an application for notification in accordance with Article 29 of this Regulation. |
|
(ba) |
Article 74 shall apply from (*12) ; |
|
(bb) |
Articles 75 to 77 shall apply from… (*13) ; |
|
(bc) |
Article 59 to 64 shall apply from… (*14); |
|
(bd) |
Article 78 shall apply from … (*14). |
3a. The implementing acts referred to in Articles 31(4), 40(9), 42(8), 46(2) and Articles 58 and 64 shall be adopted within … (*15) [Am. 202]
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at …
For the European Parliament
The President
For the Council
The President
(1) OJ C 133, 9.5.2013, p. 52.
(2) OJ C 358, 7.12.2013, p. 10.
(3) Position of the European Parliament of 2 April 2014.
(4) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices constitutes the Union regulatory framework for in vitro (OJ L 331, 7.12.1998, p. 1).
(5) Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (OJ L 390, 31.12.2004, p. 24).
(6) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
(7) Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation (OJ L 159, 29.6.1996, p. 1).
(8) Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure and repealing Directive 84/466/Euratom (OJ L 180, 9.7.1997, p. 22).
(9) Directive 2013/35/EU of the European Parliament and of the Council of 26 June 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) and repealing Directive 2004/40/EC (OJ L 179, 29.6.2013, p. 1).
(11) OJ L 114, 30.4.2002, p. 369.
(12) OJ 217, 29.12.1964, p. 3687.
(13) Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (OJ L 204, 21.7.1998, p. 37), as amended by Directive 98/48/EC of the European Parliament and of the Council (OJ L 217, 5.8.1998, p. 18).
(14) OJ L […], […], p. […].
(15) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(16) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(17) Judgment of the Court of 28 July 2011 in joined cases C-400/09 and C-207/10.
(18) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices. (OJ L 102, 23.4.2010, p. 45).
(19) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(20) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
(21) WMA Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and lastly amended by the 59th WMA General Assembly, Seoul, Korea, October 2008.
http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-media-type&footer-right=[page]/[toPage ]
(22) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
(23) OJ L […], […], p. […]
(24) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(25) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(26) OJ L 124, 20.5.2003, p. 36.
(*1) 24 months from the date of entry into force of this Regulation.
(27) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(*2) The reference and date etc.
(*3) 3 months prior to the date of application of this Regulation.
(*4) The date of application of this Regulation.
(*5) Five years after the date of application of this Regulation.
(*6) The date of application of this Regulation.
(*7) 18 months after the date of application of this Regulation.
(*8) five three years after entry into force of this Regulation.
(*9) 18 months 30 months after date of application referred to in paragraph 2 entry into force of this Regulation.
(*10) Six months after the entry into force of this Regulation.
(*11) The date of application of this Regulation.
(*12) Six months after the entry into force of this Regulation.
(*13) 12 months after the entry into force of this Regulation.
(*14) 24 months after the entry into force of this Regulation.
(*15) 12 months after the entry into force of this Regulation.
ANNEXES
|
I |
General safety and performance requirements |
|
II |
Technical documentation |
|
III |
EU Declaration of conformity |
|
IV |
CE marking of conformity |
|
V |
Information to be submitted with the registration of devices and economic operators in accordance with Article 23 and data elements of the UDI device identifier in accordance with Article 22 |
|
VI |
Minimum requirements to be met by Notified Bodies |
|
VII |
Classification criteria |
|
VIII |
Conformity assessment based on full quality assurance and design examination |
|
IX |
Conformity assessment based on type examination |
|
X |
Conformity assessment based on production quality assurance |
|
XI |
Minimum content of certificates issued by a notified body |
|
XII |
Clinical evidence and post-market follow-up |
|
XIII |
Interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies |
|
XIV |
Correlation table |
ANNEX I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
I. GENERAL REQUIREMENTS
|
1. |
The devices shall achieve the performance intended by the manufacturer and be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose, taking into account the generally acknowledged state of the art. They shall not compromise, directly or indirectly, the clinical condition or the safety of the patients, or the safety or health of users or, where applicable, other persons, provided that any risks or limits to performance which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. This shall include:
|
|
2. |
The solutions adopted by the manufacturer for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, the manufacturer shall manage the risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. The manufacturer shall apply the following principles in the priority order listed:
|
|
3. |
The characteristics and performances of the device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions. When no lifetime is stated, the same applies for the lifetime reasonably to be expected of a device of that kind, having regard to the intended purpose and the anticipated use of the device. |
|
4. |
The devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use will not be adversely affected by transport and storage conditions (for example, fluctuations of temperature and humidity) taking account of the instructions and information provided by the manufacturer. |
|
5. |
All known and foreseeable risks, and any undesirable effects, shall be minimised and be acceptable when weighed against the benefits to the patients of the intended performance of the device during normal conditions of use. |
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
6. Performance characteristics
|
6.1. |
The devices shall be designed and manufactured in such a way that the performance characteristics support the intended purpose, based on appropriate scientific and technical methods. They shall achieve the performances, as stated by the manufacturer and in particular, where appropriate:
|
|
6.2. |
The performance characteristics of the device need to be maintained during the lifetime of the device as indicated by the manufacturer. |
|
6.3. |
Where the performance of devices depends on the use of calibrators and/or control materials, the metrological traceability of values assigned for a given analyte to such calibrators and/or control materials shall be assured through available and suitable reference measurement procedures and/or available and suitable reference materials of a higher metrological order. The device shall be designed and manufactured to enable the user to provide measurement results in patient specimens metrologically traceable to available and suitable higher order reference materials and/or reference measurement procedures following the instructions and information provided by the manufacturer. |
7. Chemical, physical and biological properties
|
7.1. |
The devices shall be designed and manufactured in such a way as to ensure the characteristics and performance referred to in Chapter I ‘General Requirements’. Particular attention shall be paid to the possibility of impairment of analytical performance due to incompatibility between the materials used and the specimens and/or analyte to be detected (such as biological tissues, cells, body fluids and micro-organisms), taking account of the intended purpose of the device. |
|
7.2. |
The devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed and to the duration and frequency of exposure. |
|
7.3. |
The devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances that may leach or leak from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (1), and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2). |
|
7.4. |
The devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the unintentional ingress or egress of substances into or from the device, taking into account the device and the nature of the environment in which it is intended to be used. |
8. Infection and microbial contamination
|
8.1. |
The devices and their manufacturing processes shall be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user, professional or lay, or, where applicable, other persons. The design shall:
|
|
8.2. |
The devices labelled either as sterile or as having a special microbiological state shall be designed, manufactured and packaged to ensure that they remain so when placed on the market, and remain so under the transport and storage conditions specified by the manufacturer, until the protective packaging is damaged or opened. |
|
8.3. |
The devices labelled either as sterile or as having a special microbiological state shall have been processed, manufactured and, if applicable, sterilised by appropriate validated methods. |
|
8.4. |
The devices intended to be sterilised shall be manufactured in appropriately controlled (e.g. environmental) conditions. |
|
8.5. |
Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the device indicated by the manufacturer and, if the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer. |
|
8.6. |
The labelling of the devices shall distinguish between identical or similar products placed on the market in both sterile and non-sterile condition. |
9. Devices incorporating materials of biological origin
|
9.1. |
Where the devices include tissues, cells and substances originating from animals, the processing, preservation, testing and handling of tissues, cells and substances of such origin shall be carried out so as to provide optimal safety for user, professional or lay, or other person. In particular, safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process. This may not apply to certain devices if the activity of the virus and other transmissible agent are integral to the intended purpose of the device or when such elimination or inactivation process would compromise the performance of the device. |
|
9.2. |
Where the devices include human tissues, cells or substances, the selection of sources, donors and/or substances of human origin, the processing, preservation, testing and handling of tissues, cells and substances of such origin shall be carried out so as to provide optimal safety for user, professional or lay, or other person. In particular, safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process. This may not apply to certain devices if the activity of the virus and other transmissible agent are integral to the intended purpose of the device or when such elimination or inactivation process would compromise the performance of the device. |
|
9.3. |
Where the devices include cells or substances of microbial origin, the processing, preservation, testing and handling of cells and substances shall be carried out so as to provide optimal safety for user, professional or lay, or other person. In particular, safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process. This may not apply to certain devices if the activity of the virus and other transmissible agent are integral to the intended purpose of the device or when such elimination or inactivation process would compromise the performance of the device. |
10. Interaction of devices with their environment
|
10.1. |
If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system, shall be safe and shall not impair the specified performances of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use. Connections which the user has to handle shall be designed and constructed in such a way as to minimise all possible risks from incorrect connection. |
|
10.2. |
The devices shall be designed and manufactured in such a way as to remove or reduce as far as possible and appropriate:
|
|
10.3. |
The devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention shall be paid to devices whose intended purpose includes exposure to or use in association with flammable substances or substances which could cause combustion. |
|
10.4. |
The devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance, where such is necessary to achieve the performances intended, can be done safely. |
|
10.5. |
The devices that are intended to be operated together with other devices or products shall be designed and manufactured in such as way that the interoperability is reliable and safe. |
|
10.6. |
The devices shall be designed and manufactured in such a way as to facilitate the safe disposal of the device and/or of any waste substances by the user, professional or lay, or other person. |
|
10.7. |
The measuring, monitoring or display scale (including colour change and other visual indicators) shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose of the device. |
11. Devices with a measuring function
|
11.1. |
The devices having a primary analytical measuring function shall be designed and manufactured in such a way as to provide sufficient accuracy, precision and stability of measurement within appropriate accuracy limits, taking into account the intended purpose of the device and of available and appropriate reference measurement procedures and materials. The accuracy limits shall be specified by the manufacturer. |
|
11.2. |
The measurements made by devices with a measuring function and expressed in legal units shall conform to the provisions of Council Directive 80/181/EEC (3). |
12. Protection against radiation
|
12.1. |
The devices shall be designed, manufactured and packaged in such a way that exposure of user, professional or lay, or other persons to the emitted radiation (intended, unintended, stray or scattered) is reduced as far as possible. |
|
12.2. |
When the devices are intended to emit potentially hazardous, visible and/or invisible radiation, they shall as far as possible be:
|
|
12.3. |
The operating instructions for devices emitting radiation shall give detailed information as to the nature of the emitted radiation, means of protecting the user, and on ways of avoiding misuse and of eliminating the risks inherent in installation. |
13. Software incorporated in devices and standalone software
|
13.1. |
The devices that incorporate electronic programmable systems, including software, or standalone software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance according to the intended purpose. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible and appropriate consequent risks. |
|
13.2. |
For the devices that incorporate software or for standalone software that are devices in themselves, the software shall be developed and manufactured according to the state of the art taking into account the principles of development life cycle, risk management, verification and validation. |
|
13.3. |
Software referred to in this Section that are intended to be used in combination with mobile computing platforms shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards to level of light or noise). |
14. Devices connected to or equipped with an energy source
|
14.1. |
For the devices connected to or equipped with an energy source, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible and appropriate consequent risks. |
|
14.2. |
The devices where the safety of the patient depends on an internal power supply in the device shall be equipped with a means of determining the state of the power supply. |
|
14.3. |
The devices shall be designed and manufactured in such a way as to reduce as far as possible the risks of creating electromagnetic interference which could impair the operation of this or other devices or equipment in the intended environment. |
|
14.4. |
The devices shall be designed and manufactured in such a way as to provide an adequate level of intrinsic immunity to electromagnetic disturbance to enable them to operate as intended. |
|
14.5. |
The devices shall be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks to the user, professional or lay, or other person both during normal use of the device and in the event of a single fault condition in the device, provided the device is installed and maintained as indicated by the manufacturer. |
15. Protection against mechanical and thermal risks
|
15.1. |
The devices shall be designed and manufactured in such a way as to protect the user, professional or lay, or other person against mechanical risks. |
|
15.2. |
The devices shall be sufficiently stable under the foreseen operating conditions. They shall be suitable to withstand stresses inherent in the foreseen working environment, and to retain this resistance during the expected lifetime of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer. |
|
15.3. |
Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means shall be incorporated. Any guards or other means included with the device to provide protection, in particular against moving parts, shall be secure and shall not interfere with access for the normal operation of the device, or restrict routine maintenance of the device as intended by the manufacturer. |
|
15.4. |
The devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance. |
|
15.5. |
The devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance. |
|
15.6. |
Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user, professional or lay, or other person has to handle shall be designed and constructed in such a way as to minimise all possible risks. |
|
15.7. |
Errors likely to be made when fitting or refitting, or connecting or reconnecting, certain parts before or during use which could be a source of risk must be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings. The same information must be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk. |
|
15.8. |
Accessible parts of the devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use. |
16. Protection against the risks posed by devices intended by the manufacturer for self-testing or near-patient testing
|
16.1. |
The devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to the intended user and the influence resulting from variation that can be reasonably anticipated in the intended user's technique and environment. The information and instructions provided by the manufacturer shall be easy for the intended user to understand and apply. |
|
16.2. |
The devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way as to
|
|
16.3. |
The devices intended for self-testing and near-patient testing shall, where reasonably possible, include a procedure by which the intended user can: [Am. 204]
|
III. REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE
17. Label and instructions for use
17.1. General requirements regarding the information supplied by the manufacturer
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and communicate safety and performance related information to the user, professional or lay, or other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and must be made available on the manufacturer's website taking into account the following: [Am. 206]
|
(i) |
The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams. Some devices may include separate information for the professional user and the lay person. |
|
(ii) |
The information required on the label, shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices. Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided. |
|
(iii) |
In duly justified and exceptional cases instructions for use may not be needed or may be abbreviated if the device can be used safely and as intended by the manufacturer without any such instructions for use. |
|
(iv) |
Labels shall be provided in a human-readable format but may be supplemented by machine-readable forms, such as radio-frequency identification (RFID) or bar codes. |
|
(v) |
When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing. |
|
(vi) |
Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contraindications, precautions or warnings in the information supplied by the manufacturer. [Am. 207] |
|
(vii) |
Where appropriate, this information should take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CTS. In areas for which no standards or CTS exist, the symbols and colours shall be described in the documentation supplied with the device. |
|
(viii) |
In the case of devices containing a substance or a mixture which may be considered as being dangerous, taking account of the nature and quantity of its constituents and the form under which they are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where there is insufficient space to put all the information on the device itself or on its label, the relevant hazard pictograms shall be put on the label and the other information required by that Regulation shall be given in the instructions for use. |
|
(ix) |
The provisions of Regulation (EC) No 1907/2006 on the safety data sheet shall apply, unless all relevant information as appropriate is already made available by the instructions for use. |
17.2. Information on the label
The label shall bear the following particulars:
|
(i) |
The name or trade name of the device; |
|
(ii) |
The details strictly necessary for the user to identify the device and, where it is not obvious for the user, the intended purpose of the device; |
|
(iii) |
The name, registered trade name or registered trade mark of the manufacturer and the address of his registered place of business at which he can be contacted and his location be established; |
|
(iv) |
For imported devices, the name, registered trade name or registered trade mark of the authorised representative established within the Union and the address of his registered place of business at which he can be contacted and his location be established; |
|
(v) |
An indication that the device is for in vitro diagnostic use; |
|
(vi) |
The batch code/lot number or the serial number of the device preceded by the word LOT or SERIAL NUMBER or an equivalent symbol, as appropriate; |
|
(vii) |
Where applicable, the unique device identification (UDI); |
|
(viii) |
An unambiguous indication of the date until when the device may be used safely, without degradation of performance, expressed at least as the year, the month and, where relevant, the day, in that order; |
|
(ix) |
Where there is no indication of the date until when it may be used safely, the year of manufacture. This year of manufacture may be included as part of the batch or serial number, provided the date is clearly identifiable; |
|
(x) |
Where relevant, an indication of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of these, or other terms which accurately reflect the contents of the package; |
|
(xi) |
An indication of any special storage and/or handling condition that applies; |
|
(xii) |
Where appropriate, an indication of the sterile state of the device and the sterilisation method, or a statement indicating any special microbiological state or state of cleanliness; |
|
(xiii) |
Warnings or precautions to be taken that need to be brought to the immediate attention of the user, professional or lay, or other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use; |
|
(xiv) |
Where applicable, any particular operating instructions; |
|
(xv) |
If the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union; [Am. 208] |
|
(xvi) |
If the device is intended for self-testing or near-patient testing, an indication of that fact; |
|
(xvii) |
If the device is for performance evaluation only, an indication of that fact; |
|
(xviii) |
Where device kits include individual reagents and articles that may be made available as separate devices, each of these devices shall comply with the labelling requirements contained in this Section; |
|
(xix) |
Wherever reasonable and practicable, the devices and separate components shall be identified, where appropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. |
17.3. Information in the instructions for use
|
17.3.1. |
The instructions for use shall contain the following particulars:
|
|
17.3.2. |
In addition, the instructions for use for devices intended for self-testing or near-patient testing shall comply with the following principles:
|
(1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
(2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
ANNEX II
TECHNICAL DOCUMENTATION
The technical documentation and, if applicable, the summary technical documentation (STED) to be drawn up by the manufacturer shall include in particular the following elements:
1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
1.1. Device description and specification
|
(a) |
product or trade name and a general description of the device, including its intended purpose; |
|
(b) |
the UDI device identifier as referred to in item (i) of point (a) of Article 22(1) attributed by the manufacturer to the device in question, as soon as identification of this device shall be based on a UDI system, or otherwise clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability; |
|
(c) |
the intended purpose of the device which may include:
|
|
(d) |
the description of the principle of the assay method or instrument principles of operation; |
|
(e) |
the risk class of the device and the applicable classification rule according to Annex VII; |
|
(f) |
the description of the components and where appropriate, the description of the reactive ingredients of relevant components (such as antibodies, antigens, nucleic acid primers); and where applicable: |
|
(g) |
the description of the specimen collection and transport materials provided with the device or descriptions of specifications recommended for use; |
|
(h) |
for instruments of automated assays: the description of the appropriate assay characteristics or dedicated assays; |
|
(i) |
for automated assays: a description of the appropriate instrumentation characteristics or dedicated instrumentation; |
|
(j) |
a description of any software to be used with the device; |
|
(k) |
a description or complete list of the various configurations/variants of the device that will be made available; |
|
(l) |
a description of the accessories, other in vitro diagnostic medical devices and other products, which are intended to be used in combination with the device. |
1.2. Reference to previous and similar generations of the device
|
(a) |
an overview of the manufacturer’s previous generation(s) of the device, if such exist; |
|
(b) |
an overview of the manufacturer’s similar devices available on the EU or international markets, if such exist. |
2. INFORMATION SUPPLIED BY THE MANUFACTURER
|
(a) |
a complete set of
|
|
(b) |
a list of the language variants for the Member States where the device is envisaged to be marketed. |
3. DESIGN AND MANUFACTURING INFORMATION
3.1. Design information
Information to allow a general understanding of the design stages applied to the device.
This shall include:
|
(a) |
the description of the critical ingredients of the device such as antibodies, antigens, enzymes and nucleic acid primers provided or recommended for use with the device; |
|
(b) |
for instruments, the description of major subsystems, analytical technology (e.g. operating principles, control mechanisms), dedicated computer hardware and software; |
|
(c) |
for instruments and software, the overview of the entire system; |
|
(d) |
for standalone software, the description of the data interpretation methodology (i.e. algorithm); |
|
(e) |
for devices intended for self-testing or near-patient testing devices the description of the design aspects that make them suitable for self-testing or near-patient testing. |
3.2. Manufacturing information
|
(a) |
Information to allow a general understanding of the manufacturing processes such as production, assembly, final product testing, and packaging of the finished device. More detailed information needs to be provided for the audit of the quality management system or other applicable conformity assessment procedures; |
|
(b) |
identification of all sites, including suppliers and sub-contractors, where critical manufacturing activities are performed. [Am. 265] |
4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
The documentation shall contain information regarding the solutions adopted to meet the general safety and performance requirements laid down in Annex I. This information may take the form of a checklist identifying:
|
(a) |
the general safety and performance requirements that apply to the device and why others do not apply; |
|
(b) |
the method(s) used to demonstrate conformity with each applicable general safety and performance requirement; |
|
(c) |
the harmonised standards or CTS applied or other method(s) employed; |
|
(d) |
the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CTS or other method employed to demonstrate conformity with the general safety and performance requirements. This information shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation. |
5. RISK/BENEFIT ANALYSIS AND RISK MANAGEMENT
The documentation shall contain a summary of
|
(a) |
the risk/benefit analysis referred to in Section 1 and 5 of Annex I; and |
|
(b) |
the solutions adopted and the results of the risk management referred to in Section 2 of Annex I. |
6. PRODUCT VERIFICATION AND VALIDATION
The documentation shall contain the results of verification and validation testing and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.
This includes:
6.1 Information on analytical performance
|
6.1.1 |
Specimen type This section shall describe the different specimen types that can be used, including their stability (e.g. storage and where applicable transport conditions) and storage conditions (e.g. duration, temperature limits and freeze/thaw cycles). |
|
6.1.2 |
Analytical performance characteristics |
|
6.1.2.1 |
Accuracy of measurement
|
|
6.1.2.2 |
Analytical sensitivity This section shall include information about the study design and results. It shall provide a description of specimen type and preparation including matrix, analyte levels, and how levels were established. The number of replicates tested at each concentration shall also be provided as well as a description of the calculation used to determine assay sensitivity. |
|
6.1.2.3 |
Analytical specificity This section shall describe interference and cross reactivity studies to determine the analytical specificity in the presence of other substances/agents in the specimen. Information shall be provided on the evaluation of potentially interfering and cross reacting substances/agents on the assay, on the substance/agent type and concentration tested, specimen type, analyte test concentration, and results. Interferents and cross reacting substances/agents, which vary greatly depending on the assay type and design, could derive from exogenous or endogenous sources such as:
|
|
6.1.2.4 |
Metrological traceability of calibrator and control material values |
|
6.1.2.5 |
Measuring range of the assay This section shall include information on the measuring range (linear and non-linear measuring systems) including the limit of detection and describe information on how these were established. This information shall include a description of specimen type, number of specimen, number of replicates, and preparation including information on matrix, analyte levels and how levels were established. If applicable, a description of high dose hook effect and the data supporting the mitigation (e.g. dilution) steps shall be added. |
|
6.1.2.6 |
Definition of assay cut-off This section shall provide a summary of analytical data with a description of the study design including methods for determining the assay cut-off, including:
|
6.2 Information on clinical performance
Where applicable, the documentation shall contain data on the clinical performance of the device.
The clinical evidence report referred to in Section 3 of Annex XII shall be included and/or fully referenced in the technical documentation. [Am. 215]
6.3 Stability (excluding specimen stability)
This section shall describe claimed shelf life, in use stability and shipping stability studies.
|
6.3.1 |
Claimed shelf life This section shall provide information on stability testing studies to support the claimed shelf life. Testing shall be performed on at least three different lots manufactured under conditions that are essentially equivalent to routine production conditions (these lots do not need to be consecutive lots). Accelerated studies or extrapolated data from real time data are acceptable for initial shelf life claim but need to be followed up with real time stability studies. Such detailed information shall describe:
|
|
6.3.2 |
In-use stability This section shall provide information on in-use stability studies for one lot reflecting actual routine use of the device (real or simulated). This may include open vial stability and/or, for automated instruments, on board stability. In the case of automated instrumentation if calibration stability is claimed, supporting data shall be included. Such detailed information shall describe:
|
|
6.3.3 |
Shipping stability This section shall provide information on shipping stability studies for one lot to evaluate the tolerance of products to the anticipated shipping conditions. Shipping studies can be done under real and/or simulated conditions and shall include variable shipping conditions such as extreme heat and/or cold. Such information shall describe:
|
6.4 Software verification and validation
The documentation shall contain evidence of the validation of the software, as used in the finished device. This information shall typically include the summary results of all verification, validation and testing performed in-house and as applicable in an actual user environment prior to final release. It shall also address all of the different hardware configurations and, where applicable, operating systems identified in the labelling.
6.5 Additional information in specific cases
|
(a) |
In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with respect to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues. |
|
(b) |
In the case of devices containing tissues, cells and substances of animal, human or microbial origin, information on the origin of such material and on the conditions in which it was collected. |
|
(c) |
In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications. |
|
(d) |
If the device is to be connected to other equipment in order to operate as intended, a description of this combination including proof that it conforms to the general safety and performance requirements when connected to any such equipment having regard to the characteristics specified by the manufacturer. |
ANNEX III
EU DECLARATION OF CONFORMITY
|
1. |
Name, registered trade name or registered trade mark of the manufacturer and, if applicable, his authorised representative, and the address of their registered place of business where they can be contacted and their location be established; |
|
2. |
A statement that the declaration of conformity is issued under the sole responsibility of the manufacturer; |
|
3. |
The UDI device identifier as referred to in item (i) of point (a) of Article 22(1) as soon as identification of the device that is covered by the declaration shall be based on a UDI system; |
|
4. |
Product or trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device that is covered by the declaration (it may include a photograph, where appropriate). Except for the product or trade name, the information allowing identification and traceability may be provided by the device identifier referred to in point 3; |
|
5. |
Risk class of the device in accordance with the rules set out in Annex VII; |
|
6. |
A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with other relevant Union legislation that make provision for the issuing of a declaration of conformity; |
|
7. |
References to the relevant harmonised standards or CTS used in relation to which conformity is declared; [Am. 266] |
|
8. |
Where applicable, name and identification number of the notified body, description of the conformity assessment procedure performed and identification of the certificate(s) issued; |
|
9. |
Where applicable, additional information; |
|
10. |
Place and date of issue, name and function of the person who signs as well as indication for and on behalf of whom he/she signs, signature. |
ANNEX IV
CE MARKING OF CONFORMITY
|
1. |
The CE marking shall consist of the initials ‘CE’ taking the following form:
|
|
2. |
If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected. |
|
3. |
The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices. |
ANNEX V
INFORMATION TO BE SUBMITTED WITH THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLE 23
AND
DATA ELEMENTS OF THE UDI DEVICE IDENTIFIER IN ACCORDANCE WITH ARTICLE 22
Part A
Information to be submitted with the registration of devices in accordance with Article 23
Manufacturers or, when applicable, authorised representatives, and, when applicable, importers shall submit the following information:
|
1. |
economic operator's role (manufacturer, authorised representative, or importer), |
|
2. |
name, address and contact details of the economic operator, |
|
3. |
where submission of information is completed by another person on behalf of any of the economic operators mentioned under point 1, the name, address and contact details of this person, |
|
4. |
UDI device identifier, or where identification of the device is not yet based on a UDI system, the data elements laid down in points 5 to 18 of Part B of this Annex, |
|
5. |
type, number and expiry date of certificate and name or identification number of the notified body that has issued the certificate (and link to the information on the certificate entered by the notified body in the electronic system on certificates), |
|
6. |
Member State where the device shall or has been placed on the market in the Union, |
|
7. |
in case of devices classified as classes B, C or D: Member States where the device is or shall be made available, |
|
8. |
in case of imported device: country of origin, |
|
9. |
presence of tissues, cells or substances of human origin (y/n), |
|
10. |
presence of tissues, cells or substances of animal origin (y/n), |
|
11. |
presence of cells or substances of microbial origin (y/n), |
|
12. |
risk class of the device according to the rules set out in Annex VII, |
|
13. |
where applicable, single identification number of the interventional clinical performance study and other clinical performance study involving risks for the subjects of the study conducted in relation to the device (or link to the clinical performance study registration in the electronic system regarding clinical performance studies), |
|
14. |
in case of devices designed and manufactured by another legal or natural person as referred in Article 8(10), the name, address and contact details of that legal or natural person, |
|
15. |
in case of devices classified as class C or D, the summary of safety and performance, and the full dataset collected during the clinical study and the post-market clinical follow-up, [Am. 216] |
|
16. |
status of the device (on the market, no longer manufactured, withdrawn from the market, recalled), |
|
17. |
indication when the device is a ‘new’ device. A device shall be considered as ‘new’ if:
|
|
18. |
Indication if the device is intended for self-testing or near-patient testing. |
|
18a. |
Full technical documentation and the clinical performance report. [Am. 217] |
Part B
Data elements of the UDI device identifier in accordance with Article 22
The UDI device identifier shall provide access to the following information related to the manufacturer and the device model:
|
1. |
quantity per package configuration, |
|
2. |
if applicable, alternative or additional identifier(s), |
|
3. |
the way how the device production is controlled (expiration date or manufacturing date, lot or batch number, serialisation number), |
|
4. |
if applicable, the ‘unit of use’ device identifier (when a UDI is not assigned to the device at the level of its ‘unit of use’, a ‘unit of use’ device identifier shall be assigned to associate the use of a device with a patient), |
|
5. |
name and address of the manufacturer (as indicated on the label), |
|
6. |
if applicable, name and address of the authorised representative (as indicated on the label), |
|
7. |
Global Medical Device Nomenclature (GMDN) code or internationally recognised nomenclature code, |
|
8. |
if applicable, trade/brand name, |
|
9. |
if applicable, device model, reference, or catalogue number, |
|
10. |
additional product description (optional), |
|
11. |
if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use), |
|
12. |
if applicable, additional trade names of the device, |
|
13. |
labelled as single use device (y/n), |
|
14. |
if applicable, restricted number of reuses, |
|
15. |
device packaged sterile (y/n), |
|
16. |
need for sterilisation before use (y/n), |
|
17. |
URL for additional information, e.g. electronic instructions for use (optional), |
|
18. |
if applicable, critical warnings or contraindications. |
ANNEX VI
MINIMUM REQUIREMENTS TO BE MET BY NOTIFIED BODIES
1. ORGANISATIONAL AND GENERAL REQUIREMENTS
1.1. Legal status and organisational structure
|
1.1.1. |
A notified body shall be established under the national law of a Member State, or under the law of a third country with which the Union has concluded an agreement in this respect, and shall have full documentation of its legal personality and status. This shall include information about ownership and the legal or natural persons exercising control over the notified body. |
|
1.1.2. |
If the notified body is a legal entity that is part of a larger organisation, the activities of this organisation as well as its organisational structure and governance, and the relationship with the notified body shall be clearly documented. |
|
1.1.3. |
If the notified body wholly or partly owns legal entities established in a Member State or in a third country, the activities and responsibilities of those entities, as well as their legal and operational relationships with the notified body, shall be clearly defined and documented. |
|
1.1.4. |
The organisational structure, distribution of responsibilities and operation of the notified body shall be such that it assures confidence in the performance and results of the conformity assessment activities conducted. The organisational structure and the functions, responsibilities and authority of its top-level management and of other personnel with influence upon the performance and results of the conformity assessment activities shall be clearly documented. This information shall be made publicly available. |
1.2. Independence and impartiality
|
1.2.1. |
The notified body shall be a third-party body that is independent of the manufacturer of the product in relation to which it performs conformity assessment activities. The notified body shall also be independent of any other economic operator having an interest in the product as well as of any competitor of the manufacturer. This does not preclude the notified body from performing conformity assessment activities for different economic operators producing different or similar products. |
|
1.2.2. |
The notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities. The notified body shall have procedures in place that effectively ensure identification, investigation and resolution of any case in which a conflict of interests may arise, including involvement in consultancy services in the field of in vitro diagnostic medical devices prior to taking up employment with the notified body. |
|
1.2.3. |
The notified body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not
The notified body shall make publicly available the declarations of interest of its top-level management and the personnel responsible for carrying out the conformity assessment tasks. The national authority shall verify the compliance of the notified body with the provisions under this point and shall report to the Commission twice a year in full transparency. |
|
1.2.4. |
The impartiality of the notified bodies, of their top level management and , of the assessment personnel and subcontractors shall be guaranteed. The remuneration of the top level management and, assessment personnel and subcontractors of a notified body shall not depend on the results of the assessments. |
|
1.2.5. |
If a notified body is owned by a public entity or institution, independence and absence of any conflict of interests shall be ensured and documented between, on the one hand, the national authority responsible for notified bodies and/or competent authority and, on the other hand, the notified body. |
|
1.2.6. |
The notified body shall ensure and document that the activities of its subsidiaries or subcontractors, or of any associated body, do not affect its independence, impartiality or objectivity of its conformity assessment activities. The notified body shall provide evidence to the national authority of compliance with this point. |
|
1.2.7. |
The notified body shall operate in accordance with a set of consistent, fair and reasonable terms and conditions, taking into account the interests of small and medium-sized enterprises as defined by Recommendation 2003/361/EC. |
|
1.2.8. |
The requirements of this section in no way preclude exchanges of technical information and regulatory guidance between a notified body and a manufacturer seeking their conformity assessment. |
1.3. Confidentiality
The personnel of a notified body shall observe professional secrecy with regard to information obtained in carrying out their tasks under this Regulation, only in justified cases and except in relation to the national authorities responsible for notified bodies, competent authorities or the Commission. Proprietary rights shall be protected. To this end, the notified body shall have documented procedures in place.
Where information and data are requested from the notified body by public or healthcare professionals and where such a request is declined, the notified body shall justify the reasons for non-disclosure and shall make publicly available its justification.
1.4. Liability
The notified body shall take out appropriate liability insurance that corresponds to the conformity assessment activities for which it is notified, including the possible suspension, restriction or withdrawal of certificates, and the geographic scope of its activities, unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.
1.5. Financial requirements
The notified body , including its subsidiaries, shall have at its disposal the financial resources required to conduct its conformity assessment activities and related business operations. It shall document and provide evidence of its financial capacity and its sustainable economic viability, taking into account specific circumstances during an initial start-up phase.
1.6. Participation in coordination activities
|
1.6.1. |
The notified body shall participate in, or ensure that its assessment personnel including subcontractors, is informed of and trained on the relevant standardisation activities and the activities of the notified body coordination group and that its assessment and decision making personnel are informed of all relevant legislation, standards , guidance and best practice documents adopted in the framework of this Regulation. The notified body shall keep a record of the actions it takes to inform its personnel. [Am. 218] |
|
1.6.2. |
The notified body shall adhere to a code of conduct, addressing among other things, ethical business practices for notified bodies in the field of in vitro diagnostic medical devices that is accepted by the national authorities responsible for notified bodies. The code of conduct shall provide for a mechanism of monitoring and verification of its implementation by notified bodies. |
2. QUALITY MANAGEMENT REQUIREMENTS
|
2.1. |
The notified body shall establish, document, implement, maintain and operate a quality management system that is appropriate to the nature, area and scale of its conformity assessment activities and capable of supporting and demonstrating the consistent achievement of the requirements of this Regulation. |
|
2.2. |
The quality management system of the notified body and its subcontractors shall at least address the following:
|
3. RESOURCE REQUIREMENTS
3.1. General
|
3.1.1. |
A notified body and its subcontractors shall be capable of carrying out all the tasks assigned to it by this Regulation with the highest degree of professional integrity and the requisite technical competence in the specific field, whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility. In accordance with Article 35, this requirement shall be monitored to ensure that it is of the requisite quality. In particular, it shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical , scientific and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified. This presupposes the permanent availability within its organisation of sufficient scientific personnel who possess experience , a university degree and the knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Regulation and, in particular, those set out in Annex I. Permanent ‘in-house’ staff shall be used. However, in accordance with Article 30, notified bodies may hire external experts on an ad hoc and temporary basis provided they can make publicly available the list of those experts, as well as their declarations of interest and the specific tasks for which they are responsible. Notified bodies shall conduct unannounced inspections at least once a year of all premises at which the medical devices coming within their remit are manufactured. The notified body responsible for carrying out the assessment tasks shall notify the other Member States of the findings of the annual inspections carried out. Those findings shall be set out in a report. It shall also forward a record of the annual inspections carried out to the relevant national authority responsible. |
|
3.1.2. |
At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a notified body shall have within its organisation the necessary administrative, technical and scientific personnel with medical, technical and where needed pharmacological knowledge and sufficient and appropriate experience relating to in vitro diagnostic medical devices and the corresponding technologies to perform the conformity assessment tasks, including the assessment of clinical data or the evaluation of an assessment made by a subcontractor . |
|
3.1.3. |
The notified body shall clearly document the extent and the limits of the duties, responsibilities and authorities in relation of the personnel, including any subcontractors, subsidiaries and external experts , involved in conformity assessment activities and inform the personnel concerned about it. |
|
3.1.3a. |
The notified body shall make available the list of its personnel involved in conformity assessment activities and their expertise to the Commission and, upon request, to other parties. That list shall be kept up to date. [Am. 220] |
3.2. Qualification criteria in relation to personnel
|
3.2.1. |
The MDCG shall establish and document the principles of high level competence and qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities (knowledge, experience and other competence required) and the required training (initial and ongoing training). The qualification criteria shall address the various functions within the conformity assessment process (e.g. auditing, product evaluation/testing, design dossier/file review, decision-making) as well as the devices, technologies and areas covered by the scope of designation. |
|
3.2.2. |
The qualification criteria shall refer to the scope of the notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 31, providing sufficient level of detail for the required qualification within the subdivisions of the scope description. Specific qualification criteria shall be defined for the assessment of biocompatibility aspects, safety, clinical evaluation and the different types of sterilisation processes. |
|
3.2.3. |
The personnel responsible for authorising other personnel to perform specific conformity assessment activities and the personnel with overall responsibility for the final review and decision-making on certification shall be employed by the notified body itself and shall not be subcontracted. This personnel altogether shall have proven knowledge and experience in the following:
|
|
3.2.4. |
Clinical experts: notified bodies shall have available personnel with clinical expertise in clinical investigation design, medical statistics, clinical patient management, good clinical practice in the field of clinical investigations. Permanent ‘in-house’ staff shall be used. However, in accordance with Article 28, notified bodies may hire external experts on an ad hoc and temporary basis provided they can make publicly available the list of those experts, as well as the specific tasks for which they are responsible. This personnel shall be integrated in the notified body's decision-making process in a steady way in order to:
|
|
3.2.5. |
Product assessors: the personnel responsible for carrying out product related review reviews (e.g. design dossier review, technical documentation review or type examination including aspects such as clinical evaluation, sterilisation, software validation) shall have the following proven qualification specialist qualifications which should include :
|
|
3.2.6. |
Auditor: The personnel responsible for carrying out audits of the manufacturer's quality management assurance system shall have the following proven qualification specialist qualifications, which should include :
|
3.3. Documentation of qualification, training and authorisation of personnel
|
3.3.1. |
The notified body shall have a process in place to fully document the qualification of each personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2. Where in exceptional circumstances the fulfilment of the qualification criteria set out in Section 3.2 cannot be fully demonstrated, the notified body shall appropriately justify the authorisation of this personnel to carry out specific conformity assessment activities. |
|
3.3.2. |
For its personnel referred to in Sections 3.2.3 to 3.2.6, the notified body shall establish and maintain up to date:
|
3.4. Subcontractors and external experts
|
3.4.1. |
Without prejudice to the limitations emanating from Section 3.2., the notified bodies may subcontract clearly defined parts of the conformity assessment activities in particular where clinical expertise is limited . The subcontracting of the auditing of quality management systems or of product related reviews as a whole is not allowed. |
|
3.4.2. |
Where a notified body subcontracts conformity assessment activities either to an organisation or an individual, it shall have a policy describing the conditions under which subcontracting may take place. Any subcontracting or consultation of external experts shall be properly documented , be publicly available and be subject to a written agreement covering, among others, confidentiality and conflict of interests. |
|
3.4.3. |
Where subcontractors or external experts are used in the context of the conformity assessment, the notified body shall have adequate own competence in each product area , each treatment or medical speciality for which it is designated to lead the conformity assessment, to verify the appropriateness and validity of expert opinions and make the decision on the certification. |
|
3.4.4. |
The notified body shall establish procedures for assessing and monitoring the competence of all subcontractors and external experts used. |
|
3.4.4a. |
The policy and procedures under points 3.4.2 and 3.4.4 shall be communicated to the national authority before any subcontracting takes place. [Am. 222] |
3.5. Monitoring of competences and training
|
3.5.1. |
The notified body shall appropriately monitor the satisfactory performance of the conformity assessment activities by its personnel. |
|
3.5.2. |
It shall review the competence of its personnel and identify training needs and ensure that necessary measures are taken accordingly, in order to maintain the required level of qualification and knowledge. [Am. 223] |
3.5a. Additional requirements for special notified bodies
3.5a.1. Clinical Experts for special notified bodies
Notified bodies shall have available personnel with expertise in clinical investigation design, medical statistics, clinical patient management, good clinical practice in the field of clinical investigations and pharmacology. Permanent ‘in-house’ staff shall be used. However, in accordance with Article 30, notified bodies may hire external experts on an ad hoc and temporary basis provided they can make publicly available the list of those experts, as well as the specific tasks for which they are responsible. That personnel shall be integrated in the notified body's decision-making process in a steady way in order to:
|
— |
identify when specialist input is required for the assessment of the clinical investigation plans and the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts; |
|
— |
appropriately train external clinical experts in the relevant requirements of this Regulation, delegated and/or implementing acts, harmonised standards, CTS and guidance documents and ensure that the external clinical experts are fully aware of the context and implication of their assessment and advice provided; |
|
— |
be able to discuss the rationale of the planned study design, the clinical investigation plans and the selection of the control intervention with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation; |
|
— |
be able to scientifically challenge the clinical investigation plans and the clinical data presented, and the results of the external clinical experts' assessment of the manufacturer's clinical evaluation; |
|
— |
be able to ascertain the comparability and consistency of the clinical assessments conducted by clinical experts; |
|
— |
be able to make an objective clinical judgement about the assessment of the manufacturer's clinical evaluation and make a recommendation to the notified body's decision maker; |
|
— |
have an understanding of active substances; |
|
— |
ensure independence and objectivity and disclose potential conflicts of interest. [Am. 224] |
3.5a.2. Product specialists for special notified bodies
The personnel responsible for carrying out product related reviews (e.g. design dossier review, technical documentation review or type examination) for devices referred to in Article 41a shall have the following proven product specialist qualifications:
|
— |
meet the requirement for product assessors; |
|
— |
have an advanced academic degree in a field relevant to medical devices, or alternatively have six years of relevant experience in in vitro diagnostic medical devices or related sectors; |
|
— |
have an ability to identify key risks of products within the specialist’s product categories without prior reference to manufacturer’s specifications or risk analyses; |
|
— |
have an ability to assess the essential requirements in the absence of harmonised or established national standards; |
|
— |
the professional experience should be gained in the first product category their qualification is based on, relevant to the product category of designation of the notified body, providing sufficient knowledge and experience to thoroughly analyse the design, the validation and verification testing and the clinical use, with a sound understanding of the design, manufacture, testing, clinical use and risks associated with such a device; |
|
— |
missing professional experience for further product categories closely related to the first product category, may be substituted by internal product specific training programmes; |
|
— |
for product specialists with qualifications in specific technology, professional experience should be gained in the specific technology area, relevant to the scope of designation of the notified body. |
For each designated product category, the special notified body shall have a minimum of two product specialists of which at least one in-house, to review devices referred to in Article 41a(1). For those devices, product specialists shall be available in-house for the designated technology fields covered by the scope of notification. [Am. 267]
3.5a.3. Training for product specialists
Product specialists shall receive a minimum of 36 hours of training in in vitro diagnostic medical devices, in vitro diagnostic medical device regulations, and assessment and certification principles, including training in the verification of manufactured product.
The notified body shall ensure that in order for a product specialist to be qualified, he or she obtains adequate training in the relevant procedures of the notified body’s quality management system and is taken through a training plan consisting of sufficient design dossier reviews witnessed, performed under supervision and peer reviewed before doing a qualifying full independent review.
For each product category for which qualification is sought, the notified body must show evidence of appropriate knowledge in the product category. A minimum of five design dossiers (at least two of them initial applications or significant extensions of certification) shall be conducted for the first product category. For subsequent qualification in additional product categories evidence of adequate product knowledge and experience needs to be demonstrated. [Am. 226]
3.5a.4. Maintenance qualification for product specialists
Qualifications of product specialists shall be reviewed on an annual basis; a minimum of four design dossier reviews, independent of the number of product categories qualified for shall be demonstrated as a four-year rolling average. Reviews of significant changes to the approved design (not full design examinations) shall count for 50 %, as shall reviews supervised.
On an ongoing basis, the product specialist shall be required to show evidence of state-of-the-art product knowledge, review experience in each product category for which qualification exists. Annual training with regard to latest status of Regulations, harmonized standards, relevant guidance documents, clinical evaluation, performance evaluation, CTS requirements must be demonstrated.
If the requirements for renewal of qualification are not met, the qualification shall be suspended. Then the first upcoming design dossier review shall be done under supervision, and re-qualification confirmed based on the outcome of that review. [Am. 227]
4. PROCESS REQUIREMENTS
|
4.1. |
The notified body's decision-making process shall be transparent and clearly documented and its outcome publicly available , including the process for the issue, suspension, reinstatement, withdrawal or refusal of conformity assessment certificates, their modification or restriction and the issue of supplements. |
|
4.2. |
The notified body shall have in place a documented process for the conduct of the conformity assessment procedures for which it is designated taking into account their respective specificities, including legally required consultations, in respect of the different categories of devices covered by the scope of notification, ensuring transparency and the ability of reproduction of those procedures. |
|
4.3. |
The notified body shall have in place documented procedures that are publicly available covering at least:
|
4a. A RECOMMENDED DURATION FOR CONFORMITY ASSESSMENTS CONDUCTED BY NOTIFIED BODIES
|
4.1. |
Notified bodies shall identify the audit duration for the stage 1 and stage 2 initial audits, and surveillance audits for each applicant and certified client. |
|
4.2. |
An audit duration shall be based, inter alia, on the effective number of personnel of the organisation, the complexity of the processes within the organisation, the nature and the characteristics of the medical devices included in the scope of the audit and the different technologies that are employed to manufacture and control the medical devices. The audit duration may be adjusted based on any significant factors that uniquely apply to the organisation to be audited. The notified body shall ensure that any variation in audit duration does not compromise the effectiveness of audits. |
|
4.3. |
The duration of any scheduled on site audit shall not be less than one auditor/day. |
|
4.4. |
Certification of multiple sites under one quality assurance system shall not be based on a sampling system. [Am. 229] |
ANNEX VII
CLASSIFICATION CRITERIA
1. IMPLEMENTING RULES FOR THE CLASSIFICATION RULES
|
1.1. |
Application of the classification rules shall be governed by the intended purpose , novelty, complexity and inherent risk of the devices. [Am. 230] |
|
1.2. |
If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. |
|
1.3. |
Accessories are classified in their own right separately from the device with which they are used. |
|
1.4. |
Standalone software, which drives a device or influences the use of a device, falls automatically in the same class as the device. If standalone software is independent of any other device, it is classified in its own right. |
|
1.5. |
Calibrators intended to be used with a device shall be classified in the same class as the device. |
|
1.6. |
Standalone control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes shall be classified in the same class as the device. |
|
1.7. |
The manufacturer shall take into consideration all the rules in order to establish the proper classification for the device. |
|
1.8. |
Where a device has multiple intended purposes stated by the manufacturer, which place the device into more than one class, it shall be classified in the higher class. |
|
1.9. |
If several classification rules apply to the same device the rule resulting in the higher classification shall apply. |
2. CLASSIFICATION RULES
2.1. Rule 1
Devices intended for the following purposes are classified as class D:
|
— |
Devices intended to be used to detect the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion or transplantation. |
|
— |
Devices intended to be used to detect the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or currently undefined risk of propagation. |
This rule applies to first line assays, confirmatory assays and supplemental assays.
2.2. Rule 2
Devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation, are classified as class C, except when intended to determine any of the following markers:
|
— |
ABO system [A (ABO1), B (ABO2), AB (ABO3)]; |
|
— |
Rhesus system [RH1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e)]; |
|
— |
Kell system [Kel1 (K)]; |
|
— |
Kidd system [JK1 (Jka), JK2 (Jkb)]; |
|
— |
Duffy system [FY1 (Fya), FY2 (Fyb)] |
in which case they are classified as class D.
2.3. Rule 3
Devices are classified as class C if they are intended for:
|
(a) |
detecting the presence of, or exposure to, a sexually transmitted agent; |
|
(b) |
detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation; |
|
(c) |
detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual or foetus or embryo being tested, or to the individual's offspring; [Am. 231] |
|
(d) |
pre-natal screening of women in order to determine their immune status towards transmissible agents; |
|
(e) |
determining infective disease status or immune status, if there is a risk that an erroneous result would lead to a patient management decision resulting in an imminent life-threatening situation for the patient or for the patient's offspring; |
|
(f) |
selection of patients, i.e.
|
|
(g) |
human genetic testing; |
|
(h) |
monitoring of levels of medicinal products, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient or for the patient's offspring; |
|
(i) |
management of patients suffering from a life-threatening infectious disease; |
|
(j) |
screening for congenital disorders in the foetus or embryo . [Am. 233] |
2.4. Rule 4
|
(a) |
Devices intended for self-testing are classified as class C, except those devices from which the result is not determining a medically critical status, or is preliminary and requires follow-up with the appropriate laboratory test in which case they are Class B. |
|
(b) |
Devices intended for blood gases and blood glucose determinations for near-patient testing are class C. Other devices that are intended for near-patient testing shall be classified in their own right. |
2.5. Rule 5
The following devices are classified as class A:
|
(a) |
reagents or other articles which possess specific characteristics, intended by the manufacturer to make them suitable for in vitro diagnostic procedures related to a specific examination; |
|
(b) |
instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures; |
|
(c) |
specimen receptacles. |
2.6. Rule 6
Devices not covered by the above-mentioned classification rules are classified as class B.
2.7. Rule 7
Devices which are controls without a quantitative or qualitative assigned value are classified as class B.
ANNEX VIII
CONFORMITY ASSESSMENT BASED ON FULL QUALITY ASSURANCE AND DESIGN EXAMINATION
Chapter I: Full Quality Assurance System
|
1. |
The manufacturer shall ensure application of the quality management system approved for the design, manufacture and final inspection of the devices concerned, as specified in Section 3, and is subject to audit as laid down in Sections 3.3 and 3.4 and to the surveillance as specified in Section 4. |
|
2. |
The manufacturer who fulfils the obligations imposed by Section 1 shall draw up and keep an EU declaration of conformity in accordance with Article 15 and Annex III for the device model covered by the conformity assessment procedure. By issuing a declaration of conformity, the manufacturer ensures and declares that the devices concerned meet the provisions of this Regulation which apply to them. |
3. Quality management system
|
3.1. |
The manufacturer shall lodge an application for assessment of his quality management system with a notified body. The application shall include:
|
|
3.2. |
Application of the quality management system shall ensure that the devices conform to the provisions of this Regulation which apply to them at every stage, from design to final inspection. All the elements, requirements and provisions adopted by the manufacturer for his quality management system shall be documented in a systematic and orderly manner in the form of written policies and procedures, such as quality programmes, quality plans, quality manuals and quality records. Moreover, the documentation to be submitted for the assessment of the quality management system shall include an adequate description of, in particular:
In addition, the manufacturer shall grant the notified body access to the technical documentation referred to in Annex II. |
|
3.3. |
Audit
|
|
3.4. |
The manufacturer shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system or the product-range covered. The notified body shall assess the changes proposed and verify whether after these changes the quality management system still meets the requirements referred to in Section 3.2. It shall notify the manufacturer of its decision which shall contain the conclusions of the audit and a reasoned assessment. The approval of any substantial change to the quality management system or the product-range covered shall take the form of a supplement to the EU full quality assurance certificate. |
4. Surveillance assessment applicable to devices classified as class C and D
|
4.1. |
The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality management system. |
|
4.2. |
The manufacturer shall authorise the notified body to carry out all the necessary audits, including inspections, and supply it with all relevant information, in particular:
|
|
4.3. |
The notified body shall periodically, at least every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality management system and the post-market surveillance plan, and shall supply the manufacturer with an assessment report. This shall include inspections on the premises of the manufacturer and, if appropriate, of the manufacturer’s suppliers and/or subcontractors. At the time of such inspections, the notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. |
|
4.4. |
The notified body shall randomly perform for each manufacturer and generic device group unannounced factory inspections to the manufacturer at the relevant manufacturing sites and, if appropriate, of the manufacturer's suppliers and/or subcontractors which may be combined with the periodic surveillance assessment referred to in Section 4.3. or be performed in addition to this surveillance assessment. The notified body shall establish a plan for the unannounced inspections which shall not be disclosed to the manufacturer. At the time of such inspections, the notified body shall carry out tests or ask to carry them out in order to check that the quality management system is working properly. It shall provide the manufacturer with an inspection report and with a test report. The notified body shall carry out such inspections at least once every three years. [Am. 236] Within the context of such unannounced inspections, the notified body shall check an adequate sample from the production or the manufacturing process to verify that the manufactured device is in conformity with the technical documentation and/or design dossier. Prior to the unannounced inspection, the notified body shall specify the relevant sampling criteria and testing procedure. Instead of, or in addition to, the sampling from the production, the notified body shall take samples of devices from the market to verify that the manufactured device is in conformity with the technical documentation and/or design dossier. Prior to the sampling, the notified body shall specify the relevant sampling criteria and testing procedure. The notified body shall provide the manufacturer with an inspection report which shall include, if applicable, the result of the sample check. |
|
4.5. |
In the case of devices classified as class C, the surveillance assessment shall also include the assessment of the design documentation within the technical documentation of the device(s) concerned on the basis of further representative sample(s) chosen in accordance with the rationale documented by the notified body in accordance with point (c) of Section 3.3. |
|
4.6. |
The notified body shall ensure that the composition of the assessment team assures experience with the technology concerned, continuous objectivity and neutrality; this shall include a rotation of the members of the assessment team at appropriate intervals. As a general rule, a lead auditor shall not lead and attend an audit for more than three consecutive years in respect to the same manufacturer. |
|
4.7. |
If the notified body establishes a divergence between the sample taken from the production or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose restrictions on it. |
Chapter II: Design dossier examination
5. Examination of the design of the device and batch verification applicable to devices in class D
|
5.1. |
In addition to the obligation imposed by Section 3, the manufacturer of devices classified as class D shall lodge with the notified body referred to in Section 3.1 an application for the examination of the design dossier relating to the device which he plans to manufacture and which falls into the device category covered by the quality management system referred to in Section 3. |
|
5.2. |
The application shall describe the design, manufacture and performances of the device in question. It shall include the technical documentation as referred to in Annex II; where the technical documentation is voluminous and/or held in different locations, the manufacturer shall submit a summary technical documentation (STED) and grant access to the full technical documentation upon request. In the case of devices for self-testing or near-patient testing, the application shall also include the aspects referred to in Section 6.1, point b). |
|
5.3. |
The notified body shall examine the application employing staff with proven knowledge and experience regarding the technology concerned. The notified body shall ensure that the manufacturer’s application adequately describes the design, manufacture and performance of the device, allowing assessment of whether the product conforms with the requirements set out in this Regulation. The notified body shall comment on the conformity of the following:
The notified body may require the application to be completed by further tests or other evidence to allow assessment of conformity with the requirements of this Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests. |
|
5.4. |
Before issuing an EU design-examination certificate, the notified body shall request a reference laboratory, where designated in accordance with Article 78, to verify compliance of the device with the CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The reference laboratory shall provide a scientific opinion within 30 days. The scientific opinion of the reference laboratory and any possible updates shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision. The notified body shall not deliver the certificate if the scientific opinion is unfavourable. |
|
5.5. |
The notified body shall provide the manufacturer with an EU design-examination report. If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU design-examination certificate. The certificate shall contain the conclusions of the examination, the conditions of validity, the data needed for identification of the approved design, where appropriate, a description of the intended purpose of the device. |
|
5.6. |
Changes to the approved design shall receive further approval from the notified body which issued the EU design-examination certificate, wherever the changes could affect conformity with the general safety and performance requirements of this Regulation or with the conditions prescribed for use of the device. The applicant shall inform the notified body which issued the EU design-examination certificate of any planned changes to the approved design. The notified body shall examine the planned changes, notify the manufacturer of its decision and provide him with a supplement to the EU design-examination report. Where the changes could affect compliance with the CTS or with other solutions chosen by the manufacturer which were approved through the EU design-examination certificate, the notified body shall consult the reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CTS or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent are maintained. The reference laboratory shall provide a scientific opinion within 30 days. The approval of any change to the approved design shall take the form of a supplement to the EU design-examination certificate. |
|
5.7. |
To verify conformity of manufactured devices classified as class D, the manufacturer shall carry out tests on the manufactured devices or each batch of devices. After the conclusion of the controls and tests he shall forward to the notified body without delay the relevant reports on these tests. Furthermore, the manufacturer shall make the samples of manufactured devices or batches of devices available to the notified body in accordance with pre-agreed conditions and modalities which shall include that the notified body or the manufacturer, in regular intervals, shall send samples of the manufactured devices or batches of devices to a reference laboratory, where designated in accordance with Article 78, to carry out appropriate tests. The reference laboratory shall inform the notified body about its findings. [Am. 238] |
|
5.8. |
The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed time-frame, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates. |
6. Examination of the design of specific types of devices
|
6.1. |
Examination of the design of devices for self-testing and near-patient testing classified as class A, B or C and of devices for near patient testing classified as class C [Am. 239]
|
|
6.2. |
Examination of the design of companion diagnostics
|
Chapter III: Administrative provisions
|
7. |
The manufacturer or his authorised representative shall, for a period ending at least five years after the last device has been placed on the market, keep at the disposal of the competent authorities:
|
|
8. |
Each Member State shall make provision that this documentation is kept at the disposal of the competent authorities for the period indicated in the first sentence of the preceding paragraph in case the manufacturer, or his authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of this period. |
ANNEX IX
CONFORMITY ASSESSMENT BASED ON TYPE EXAMINATION
|
1. |
EU type-examination is the procedure whereby a notified body ascertains and certifies that a representative sample of the production covered fulfils the relevant provisions of this Regulation. |
2. Application
The application shall include:
|
— |
the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of the authorised representative, |
|
— |
the technical documentation referred to in Annex II needed to assess the conformity of the representative sample of the production in question, hereinafter referred to as the ‘type’, with the requirements of this Regulation; where the technical documentation is voluminous and/or held in different locations, the manufacturer shall submit a summary technical documentation (STED) and grant access to the full technical documentation upon request. The applicant shall make a ‘type’ available to the notified body. The notified body may request other samples as necessary, |
|
— |
in the case of devices for self-testing or near-patient testing, test reports, including results of studies carried out with intended users, and data showing the handling suitability of the device in view of its intended purpose for self-testing or near patient-testing, |
|
— |
a written declaration that no application has been lodged with any other notified body for the same type, or information about any previous application for the same type that has been refused by another notified body. |
3. Assessment
The notified body shall:
|
3.1. |
examine and assess the technical documentation and verify that the type has been manufactured in conformity with that documentation; it shall also record the items designed in conformity with the applicable specifications of the standards referred to in Article 6 or CTS, as well as the items not designed on the basis of the relevant provisions of the abovementioned standards; |
|
3.2. |
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether the solutions adopted by the manufacturer meet the general safety and performance requirements of this Regulation if the standards referred to in Article 6 or CTS have not been applied; if the device is to be connected to other equipment in order to operate as intended, proof shall be provided that it conforms to the general safety and performance requirements when connected to any such equipment having the characteristics specified by the manufacturer; |
|
3.3. |
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether, if the manufacturer has chosen to apply the relevant standards, these have actually been applied; |
|
3.4. |
agree with the applicant on the place where the necessary assessments and tests will be carried out; |
|
3.5. |
in the case of devices classified as class D, or for companion diagnostics, request a reference laboratory, where designated in accordance with Article 78, to verify compliance of the device with the CTS or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The reference laboratory shall provide a scientific opinion within 30 days. The scientific opinion of the reference laboratory and any possible update shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision. The notified body shall not deliver the certificate if the scientific opinion is unfavourable; [Am. 242] |
|
3.6. |
For companion diagnostic intended to be used to assess the patient eligibility to a treatment with a specific medicinal product, seek the opinion, on the basis of the draft summary of safety and performance and the draft instructions for use, of a one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC (hereinafter referred to as ‘medicinal products competent authority’) or the European Medicines Agency (hereinafter referred to as ‘EMA’) on the suitability of the device in relation to the medicinal product concerned. Where the medicinal product falls exclusively within the scope of the Annex of Regulation (EC) No 726/2004, the notified body shall consult the EMA. The medicinal products authority or the European Medicines Agency shall deliver its opinion, if any, within 60 days upon receipt of the valid documentation. This 60-day period may be extended only once for a further 60 days on scientifically valid grounds. The opinion of the medicinal products authority or of the EMA and any possible update shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the opinion, if any, expressed by the medicinal products competent authority concerned or the EMA when making its decision. It shall convey its final decision to the medicinal products competent authority concerned or to the EMA. [Am. 243] |
4. Certificate
If the type conforms to the provisions of this Regulation, the notified body shall issue an EU type-examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the assessment, the conditions of validity and the data needed for identification of the type approved. The relevant parts of the documentation shall be annexed to the certificate and a copy kept by the notified body.
5. Changes to the type
|
5.1. |
The applicant shall inform the notified body which issued the EU type-examination certificate of any planned change to the approved type. |
|
5.2. |
Changes to the approved product shall receive further approval from the notified body which issued the EU type-examination certificate wherever the changes may affect conformity with the general safety and performance requirements or with the conditions prescribed for use of the product. The notified body shall examine the planned changes, notify the manufacturer of its decision and provide him with a supplement to the EU type-examination report. The approval of any change to the approved type shall take the form of a supplement to the initial EU type-examination certificate. |
|
5.3. |
Where the changes could affect compliance with the CTS or with other solutions chosen by the manufacturer which were approved through the EU type-examination certificate, the notified body shall consult the reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent are maintained. |
The reference laboratory shall provide a scientific opinion within 30 days.
|
5.4. |
Where the changes affect a companion diagnostic approved through the EU type-examination certificate with regard to its suitability in relation to a medicinal product, the notified body shall consult the medicinal products competent authority that was involved in the initial consultation or the EMA. The medicinal products competent authority or the EMA shall give its opinion, if any, within 30 days after receipt of the valid documentation regarding the changes. The approval of any change to the approved type shall take the form of a supplement to the initial EU type-examination certificate. [Am. 244] |
6. Administrative provisions
The manufacturer or his authorised representative shall, for a period ending at least five years, after the last device has been placed on the market, keep at the disposal of the competent authorities:
|
— |
the documentation referred to in the second indent of Section 2, |
|
— |
the changes referred to in Section 5, |
|
— |
copies of EU type-examination certificates and their additions. |
Section 8 of Annex VIII shall apply.
ANNEX X
CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE
|
1. |
The manufacturer shall ensure application of the quality management system approved for the manufacture of the devices concerned and carry out the final inspection, as specified in Section 3, and is subject to the surveillance referred to in Section 4. |
|
2. |
The manufacturer who fulfils the obligations imposed by Section 1 shall draw up and keep an EU declaration of conformity in accordance with Article 15 and Annex III for the device model covered by the conformity assessment procedure. By issuing an EU declaration of conformity, the manufacturer ensures and declares that the devices concerned conform to the type described in the EU type-examination certificate and meet the provisions of this Regulation which apply to them. |
3. Quality management system
|
3.1. |
The manufacturer shall lodge an application for assessment of his quality management system with a notified body. The application shall include:
|
|
3.2. |
Application of the quality management system shall ensure that the devices conform to the type described in the EU type-examination certificate and to the provisions of this Regulation which apply to them at every stage. All the elements, requirements and provisions adopted by the manufacturer for his quality management system shall be documented in a systematic and orderly manner in the form of written policies and procedures such as quality programmes, quality plans, quality manuals and quality records. It shall, in particular, include an adequate description of all elements listed in points (a), (b), (d) and (e) of Section 3.2 of Annex VIII. |
|
3.3. |
The provisions of points (a) and (b) of Section 3.3 of Annex VIII, apply. If the quality system ensures that the devices conform to the type described in the in the EU type-examination certificate and conforms to the relevant provisions of this Regulation, the notified body shall issue an EU quality assurance certificate. The decision shall be notified to the manufacturer. It shall contain the conclusions of the inspection and a reasoned assessment. |
|
3.4. |
The provisions of the Section 3.4 of Annex VIII apply. |
4. Surveillance
The provisions of Section 4.1, the first, second and fourth indents of Section 4.2, Section 4.3, Section 4.4, Section 4.6 and Section 4.7 of Annex VIII apply.
5. Verification of manufactured devices classified as class D
|
5.1. |
In the case of devices classified as class D, the manufacturer shall carry out tests on the manufactured devices or each batch of devices. After the conclusion of the controls and tests he shall forward to the notified body without delay the relevant reports on these tests. Furthermore, the manufacturer shall make the samples of manufactured devices or batches of devices available to the notified body in accordance with pre-agreed conditions and modalities which shall include that the notified body or the manufacturer, in regular intervals, shall send samples of the manufactured devices or batches of devices to a reference laboratory, where designated in accordance with Article 78, to carry out appropriate laboratory tests. The reference laboratory shall inform the notified body about its findings [Am. 245] |
|
5.2. |
The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed time-frame, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates. |
6. Administrative provisions
The manufacturer or his authorised representative shall, for a period ending at least five years after the last device has been placed on the market, keep at the disposal of the competent authorities:
|
— |
the declaration of conformity, |
|
— |
the documentation referred to in the fourth indent of Section 3.1 of Annex VIII, |
|
— |
the documentation referred to in the seventh indent of Section 3.1 of Annex VIII, including the EU type-examination certificate referred to in Annex IX, |
|
— |
the changes referred to in Section 3.4 of Annex VIII and |
|
— |
the decisions and reports from the notified body as referred to in Sections 3.3, 4.3 and 4.4 of Annex VIII. |
Section 8 of Annex VIII shall apply.
ANNEX XI
MINIMUM CONTENT OF CERTIFICATES ISSUED BY A NOTIFIED BODY
|
1. |
Name, address and identification number of the notified body; |
|
2. |
name and address of the manufacturer and, if applicable, of the authorised representative; |
|
3. |
unique number identifying the certificate; |
|
4. |
date of issue; |
|
5. |
date of expiry; |
|
6. |
data needed for the identification of the device(s) or categories of devices covered by the certificate, including the intended purpose of the device(s) and the GMDN code(s) or internationally recognised nomenclature code(s); |
|
7. |
if applicable, the manufacturing facilities covered by the certificate; |
|
8. |
reference to this Regulation and the relevant Annex according to which the conformity assessment has been carried out; |
|
9. |
examinations and tests performed, e.g. reference to relevant standards/test reports/audit report(s); |
|
10. |
if applicable, reference to the relevant parts of the technical documentation or other certificates required for the placing on the market of the device(s) covered; |
|
11. |
if applicable, information about the surveillance by the notified body; |
|
12. |
conclusions of the notified body's assessment, examination or inspection; |
|
13. |
conditions for or limitations to the validity of the certificate; |
|
14. |
legally binding signature of the notified body according to the applicable national law. |
ANNEX XII
CLINICAL EVIDENCE AND POST-MARKET FOLLOW-UP
Part A: Clinical evidence
The demonstration of conformity with the general safety and performance requirements set out in Annex I, under the normal conditions of use of the device, shall be based on clinical evidence.
The clinical evidence includes all the information supporting the scientific validity of the analyte, the analytical performance and, where applicable, the clinical performance of the device for its intended purpose as stated by the manufacturer.
1. SCIENTIFIC VALIDITY DETERMINATION AND PERFORMANCE EVALUATION
1.1. Scientific validity determination
|
1.1.1. |
The scientific validity refers to the association of the analyte to a clinical condition or a physiological state. |
|
1.1.2. |
The determination of the scientific validity may not be necessary where the association of the analyte to a clinical condition or a physiological state is well known, based on available information, such as peer reviewed literature, historical data and experience. |
|
1.1.3. |
For a new analyte and/or a new intended purpose, the scientific validity shall be demonstrated based on one or a combination of the following sources:
|
|
1.1.4. |
The information supporting the scientific validity of the analyte shall be summarised as part of the clinical evidence report. |
1.2. Performance evaluation
The performance evaluation of a device is the process by which generated data are assessed and analysed to demonstrate the analytical performance, and where applicable the clinical performance of that device for its intended purpose as stated by the manufacturer.
Interventional performance studies and other clinical performance studies involving risks for the subjects of the studies shall only be performed once the analytical performance of the device has been established and determined to be acceptable.
1.2.1. Analytical performance
|
1.2.1.1 |
The analytical performance characteristics are described in point (a) of Section 6(1) of Annex I. |
|
1.2.1.2 |
As a general rule, the analytical performance shall always be demonstrated on the basis of analytical performance studies. |
|
1.2.1.3 |
For novel devices, it may not be possible to demonstrate trueness since suitable higher order reference materials or a suitable comparative method may not be available. If there are no comparative methods, different approaches may be used (e.g. comparison to some other well-documented method, comparison to the composite reference method). In the absence of such approaches, a clinical performance study comparing test performance to the current clinical standard practice would be needed. |
|
1.2.1.4 |
The analytical performance data full dataset shall accompany the clinical evidence report and may be summarised as part of the clinical evidence report it . [Am. 246] |
1.2.2. Clinical performance
|
1.2.2.1 |
The clinical performance characteristics are described in point (b) of Section 6(1) of Annex I. |
|
1.2.2.2 |
Clinical performance data may not be required for established and standardised devices and for devices classified as class A according to the rules set out in Annex VII. |
|
1.2.2.3 |
Clinical performance of a device shall be demonstrated based on one or a combination of the following sources
|
|
1.2.2.4 |
Clinical performance studies shall be performed unless it is duly justified to rely on other sources of clinical performance data. |
|
1.2.2.5 |
The clinical performance data full dataset shall accompany the clinical evidence report and may be summarised as part of the clinical evidence report it . [Am. 247] |
|
1.2.2.6 |
When the clinical performance evaluation includes a clinical performance study, the level of detail of the clinical performance study report referred to in Section 2.3.3 of this Annex will vary based on the risk class of the device determined according to the rules set out in Annex VII:
|
2. CLINICAL PERFORMANCE STUDIES
2.1. Purpose of clinical performance studies
The purpose of clinical performance studies is to establish or confirm aspects of device performance which cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing. This information is used to demonstrate compliance with the relevant general safety and performance requirements with respect to clinical performance. When clinical performance studies are conducted, the data obtained shall be used in the performance evaluation process and be part of the clinical evidence for the device.
2.2. Ethical considerations for clinical performance studies
Every step in the clinical performance study, from first consideration of the need and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, as for example those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964 and last amended by the 59th World Medical Association General Assembly in Seoul, Korea, in 2008. Conformity with the above principles shall be granted after an examination by the ethics committee concerned. [Am. 250]
2.3. Methods for clinical performance studies
2.3.1. Clinical performance study design type
Clinical performance studies shall be designed in such a way as to maximize the relevance of the data while minimising potential biases. The design of the study shall provide the data necessary to address the clinical performance of the device.
2.3.2. Clinical performance study protocol
Clinical performance studies shall be performed on the basis of an appropriate ‘clinical performance study protocol’.
The clinical performance study protocol shall set out how the study is intended to be conducted. It shall contain information about the study design such as the purpose, objectives, study population, description of test method(s) and interpretation of results, site training and monitoring, specimen type, specimen collection, preparation, handling and storage, inclusion and exclusion criteria, limitations, warning and precautions, data collection/management, data analysis, required materials, number of study sites and if applicable, clinical endpoints/outcomes, and requirements for patient follow-up.
In addition, the clinical performance study protocol shall identify the key factors which may impact the completeness and significance of results, such as intended participant follow-up procedures, decision algorithms, discrepancy resolution process, masking/blinding, approaches to statistical analyses, and methods for recording endpoints/outcomes and, where appropriate, communication of test results.
2.3.3. Clinical performance study report
A ‘clinical performance study report’, signed by a medical practitioner or any other authorised person responsible, shall contain documented information on the clinical performance study protocol, results and conclusions of the clinical performance study, including negative findings. The results and conclusions shall be transparent, free of bias and clinically relevant. The report shall contain sufficient information to enable it to be understood by an independent party without reference to other documents. The report shall also include as appropriate any protocol amendments or deviations, and data exclusions with the appropriate rationale. The report shall be accompanied by the clinical evidence report as described in point 3.1 and be accessible through the electronic system referred to in Article 51. [Am. 251]
3. CLINICAL EVIDENCE REPORT
|
3.1 |
The clinical evidence report shall contain the scientific validity data, the analytical performance data and, where applicable, the clinical performance data. If the analytical performance data is determined to be sufficient to declare conformity with the general safety and performance requirements set out to in Annex I without the need for clinical performance data, a rationale should be documented and included in the clinical evidence report. |
|
3.2 |
The clinical evidence report shall in particular outline:
|
|
3.3 |
The clinical evidence data and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer's post-market surveillance plan referred to in Article 8(5) which shall include a plan for the device post-market follow-up in accordance with Part B of this Annex. The clinical evidence data and its subsequent updates through post-market follow-up shall be accessible through the electronic systems referred to in Articles 51 and 60. [Am. 252] |
Part B: Post-market follow-up
|
1. |
Manufacturers shall put in place procedures to enable them to collect and evaluate information relating to the scientific validity, as well as the analytical and clinical performance of their devices on the basis of data obtained from post-market follow-up. |
|
2. |
Where such information becomes available to the manufacturer, an appropriate risk assessment shall be conducted and the clinical evidence report shall be amended accordingly. |
|
3. |
Where changes to devices are necessary, the conclusion of the post market follow-up shall be taken into account for the clinical evidence referred to in Part A of this Annex and for the risk assessment referred to in Section 2 of Annex I. If necessary, the clinical evidence or risk management shall be updated and/or corrective actions be implemented. |
|
4. |
Any new intended purpose of a device shall be supported by an updated clinical evidence report. |
ANNEX XIII
INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER CLINICAL PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES
I. Documentation regarding the application for interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies
For devices for performance evaluation intended to be used in the context of interventional clinical performance studies or other clinical performance studies involving risks for the subjects of the studies the sponsor shall draw up and submit the application in accordance with Article 49 accompanied by the documentation as laid down below:
1. Application form
The application form shall be duly filled out containing the following information:
|
1.1. |
Name, address and contact details of the sponsor and, if applicable, name, address and contact details of his contact person established in the Union. |
|
1.2. |
If different from the above, name, address and contact details of the manufacturer of the device intended for performance evaluation and, if applicable, of his authorised representative. |
|
1.3. |
Title of the clinical performance study. |
|
1.4. |
Single identification number in accordance with Article 49(1). |
|
1.5. |
Status of the clinical performance study (e.g. first submission, resubmission, significant amendment). |
|
1.6. |
If resubmission with regard to same device, previous date(s) and reference number(s) of earlier submission(s) or in the case of significant amendment, reference to the original submission. |
|
1.7. |
If parallel submission for a clinical trial on a medicinal product in accordance with Regulation (EU) No [Ref. of future Regulation on clinical trials], reference to the official registration number of the clinical trial. |
|
1.8. |
Identification of the Member States, EFTA countries, Turkey and third countries in which the clinical performance study shall be conducted as part of a multicentre/multinational study at the time of application. |
|
1.9. |
Brief description of the device for performance evaluation (e.g. name, GMDN code or internationally recognised nomenclature code, intended purpose, risk class and applicable classification rule according to Annex VII). |
|
1.10 |
Summary of the clinical performance study protocol. |
|
1.11. |
If applicable, information regarding a comparator. |
2. Investigator's Brochure
The investigator's brochure (IB) shall contain the information on the device for performance evaluation that is relevant for the study and available at the time of application. It shall be clearly identified and contain in particular the following information:
|
2.1. |
Identification and description of the device, including information on the intended purpose, the risk classification and applicable classification rule according to Annex VII, design and manufacturing of the device and reference to previous and similar generations of the device. |
|
2.2. |
Manufacturer's instructions for installation, and use, including storage and handling requirements, as well as the label and instructions for use to the extent that this information is available. |
|
2.3. |
Pre-clinical testing and experimental data. |
|
2.4. |
Existing clinical data, in particular the following:
|
|
2.5. |
Summary of the risk/benefit analysis and the risk management, including information regarding known or foreseeable risks and warnings. |
|
2.6. |
In the case of devices that include tissues, cells and substances of human, animal or microbial origins detailed information on the tissues, cells and substances, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to the tissues, cells and substances. |
|
2.7. |
Reference to harmonised or other internationally recognised standards complied with in full or in part. |
|
2.8. |
A clause that any updates to the IB or any other relevant information that is newly available shall be brought to the attention of the investigators. |
|
3. |
Clinical performance study protocol, as referred to in Section 2.3.2 of Annex XII. |
4. Other information
|
4.1. |
A signed statement by the natural or legal person responsible for the manufacture of the device for performance evaluation that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical performance study and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the subject. This statement may be supported by an attestation issued by a notified body. |
|
4.2. |
Where applicable according to national law, a copy of the opinion(s) of the ethics committee(s) concerned as soon as available. |
|
4.3. |
Proof of insurance cover or indemnification of subjects in case of injury, according to the national law |
|
4.4. |
Documents and procedures to be used to obtain informed consent. |
|
4.5 |
Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data, in particular:
|
Ia. Incapacitated subjects and minors
1. Incapacitated subjects
In the case of incapacitated subjects who have not given, or who have not refused to give, informed consent before the onset of their incapacity, interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies may be conducted only where, in addition to the general conditions, all of the following conditions are met:
|
— |
the informed consent of the legal representative has been obtained; consent shall represent the subject’s presumed will and may be revoked at any time, without detriment to the subject; |
|
— |
the incapacitated subject has received adequate information in relation to his or her capacity for understanding regarding the study and its risks and benefits from the investigator or his/her representative, in accordance with the national law of the Member State concerned; |
|
— |
the explicit wish of an incapacitated subject, who is capable of forming an opinion and assessing this information, to refuse participation in, or to be withdrawn from, the clinical performance study at any time without giving a reason and with no liability or prejudice whatsoever being incurred by the subject or their legal representative as a result, shall be followed by the investigator; |
|
— |
no incentives or financial inducements are given except compensation for participation in the clinical performance study; |
|
— |
such research is essential to validate data obtained in a clinical performance study on persons able to give informed consent or by other research methods; |
|
— |
such research relates directly to a medical condition from which the person concerned suffers; |
|
— |
the clinical performance study has been designed to minimise pain, discomfort, fear, and any other foreseeable risk in relation to the disease and the developmental stage and both the risk threshold and the degree of distress are specially defined and constantly observed; |
|
— |
the research is necessary to promote the health of the population concerned by the clinical performance study and cannot instead be performed on capacitated subjects; |
|
— |
there are grounds for expecting that participation in the clinical performance study will produce a benefit for the incapacitated subject outweighing the risks or will produce only a minimal risk; |
|
— |
an ethics committee, with expertise regarding the relevant disease and the patient population concerned, or that has taken advice on clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol; |
The test subject shall as far as possible take part in the consent procedure. [Am. 253]
2. Minors
An interventional clinical performance study and other clinical performance studies involving risks for the minor may be conducted only where, in addition to the general conditions, all of the following conditions are met:
|
— |
the written informed consent of the legal representative or representatives has been obtained, whereby consent shall represent the minor’s presumed will; |
|
— |
the informed and express consent of the minor has been obtained, where the minor is able to give consent according to national law; |
|
— |
the minor has received all relevant information in a way adapted to his or her age and maturity, from a medical doctor (either the investigator or member of the study team) trained or experienced in working with children, regarding the study, the risks and the benefits; |
|
— |
without prejudice to the second indent, the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical performance study at any time, is duly taken into consideration by the investigator; |
|
— |
no incentives or financial inducements are given except payment for participation in the clinical performance study; |
|
— |
such research either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors; |
|
— |
the clinical performance study has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage, and both the risk threshold and the degree of distress are specially defined and constantly observed; |
|
— |
there are grounds to expect that some direct benefit for the category of patients concerned by the study may be obtained from the clinical performance study; |
|
— |
the corresponding scientific guidelines of the Agency have been followed; |
|
— |
the interests of the patient shall always prevail over those of science and society; |
|
— |
the clinical performance study does not replicate other studies based on the same hypothesis and age-appropriate technology is used; |
|
— |
an ethics committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol. |
The minor shall take part in the consent procedure in a manner adapted to his or her age and maturity. Minors who are able to give consent according to national law shall also give their informed and express consent to participate in the study.
If during a clinical performance study the minor reaches the age of majority as defined in the national law of the Member State concerned, his/her express informed consent shall be obtained before the study may continue. [Am. 254]
II. Other sponsor's obligations
|
1. |
The sponsor shall undertake to keep available for the competent national authorities any documentation necessary to provide evidence for the documentation referred to in Chapter I of this Annex. If the sponsor is not the natural or legal person responsible for the manufacture of the device intended for performance evaluation, this obligation may be fulfilled by that person on behalf of the sponsor. |
|
2. |
The reportable events shall be provided by the investigator(s) in timely conditions. |
|
3. |
The documentation mentioned in this Annex shall be kept for a period of time of at least five years after the clinical performance study with the device in question has ended, or, when the device is subsequently placed on the market, at least five years after the last device has been placed on the market. Each Member State shall make provision that this documentation is kept at the disposal of the competent authorities for the period indicated in the preceding paragraph in case the sponsor, or his contact person, established within its territory goes bankrupt or ceases its activity prior to the end of this period. |
ANNEX XIV
CORRELATION TABLE
|
Directive 98/79/EC |
This Regulation |
|
Article 1(1) |
Article 1(1) |
|
Article 1(2) |
Article 2 |
|
Article 1(3) |
Number (36) of Article 2 |
|
Article 1(4) |
— |
|
Article 1(5) |
Article 4(4) and (5) |
|
Article 1(6) |
Article 1(6) |
|
Article 1(7) |
Article 1(4) |
|
Article 2 |
Article 4(1) |
|
Article 3 |
Article 4(2) |
|
Article 4(1) |
Article 20 |
|
Article 4(2) |
Article 17(1) |
|
Article 4(3) |
Article 17(3) |
|
Article 4(4) |
Article 8(7) |
|
Article 4(5) |
Article 16(6) |
|
Article 5(1) |
Article 6(1) |
|
Article 5(2) |
— |
|
Article 5(3) |
Article 7 |
|
Article 6 |
— |
|
Article 7 |
Article 84 |
|
Article 8 |
Articles 67 to 70 |
|
Article 9(1) 1st subparagraph |
Article 40(5) 1st subparagraph |
|
Article 9(1) 2nd subparagraph |
Article 40(3) 2nd subparagraph and (4) 2nd subparagraph |
|
Article 9(2) |
Article 40(2) |
|
Article 9(3) |
Article 40(3) |
|
Article 9(4) |
Article 40(7) |
|
Article 9(5) |
— |
|
Article 9(6) |
Article 9(3) |
|
Article 9(7) |
Article 8(4) |
|
Article 9(8) |
Article 41(1) |
|
Article 9(9) |
Article 41(3) |
|
Article 9(10) |
Article 43(2) |
|
Article 9(11) |
Article 40(8) |
|
Article 9(12) |
Article 45(1) |
|
Article 9(13) |
Article 5(2) |
|
Article 10 |
Article 23 |
|
Article 11(1) |
Numbers (43) and (44) of Article 2, Article 59(1) and Article 61(1) |
|
Article 11(2) |
Article 59(3) and Article 61(1) 2nd subparagraph |
|
Article 11(3) |
Article 61(2) and (3) |
|
Article 11(4) |
— |
|
Article 11(5) |
Article 61(3) and Article 64 |
|
Article 12 |
Article 25 |
|
Article 13 |
Article 72 |
|
Article 14(1)(a) |
Article 39(4) |
|
Article 14(1)(b) |
— |
|
Article 14(2) |
— |
|
Article 14(3) |
— |
|
Article 15(1) |
Article 31 and Article 32 |
|
Article 15(2) |
Article 27 |
|
Article 15(3) |
Article 33(1) and Article 34(2) |
|
Article 15(4) |
— |
|
Article 15(5) |
Article 43(4) |
|
Article 15(6) |
Article 43 (3) |
|
Article 15(7) |
Articles 29(2) and Article 33(1) |
|
Article 16 |
Article 16 |
|
Article 17 |
Article 71 |
|
Article 18 |
Article 73 |
|
Article 19 |
Article 80 |
|
Article 20 |
Article 75 |
|
Article 21 |
— |
|
Article 22 |
— |
|
Article 23 |
Article 90 |
|
Article 24 |
— |
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/362 |
P7_TA(2014)0268
European environmental economic accounts ***I
European Parliament legislative resolution of 2 April 2014 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 691/2011 on European environmental economic accounts (COM(2013)0247 — C7-0120/2013 — 2013/0130(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/17)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2013)0247), |
|
— |
having regard to Article 294(2) and Article 338(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0120/2013), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the undertaking given by the Council representative by letter of 12 February 2014 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on the Environment, Public Health and Food Safety (A7-0420/2013), |
|
1. |
Adopts its position at first reading hereinafter set out; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
P7_TC1-COD(2013)0130
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council amending Regulation (EU) No 691/2011 on European environmental economic accounts
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 538/2014.)
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/363 |
P7_TA(2014)0269
European Year for Development (2015) ***I
European Parliament legislative resolution of 2 April 2014 on the proposal for a decision of the European Parliament and of the Council on the European Year of Development (2015) (COM(2013)0509 — C7-0229/2013 — 2013/0238(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/18)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2013)0509), |
|
— |
having regard to Article 294(2), Article 209 and Article 210(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0229/2013), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
Having regard to the opinion of the European Economic and Social Committee of 10 December 2013 (1). |
|
— |
having regard to the undertaking given by the Council representative by letter of 20 February 2014 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Development and the opinion of the Committee on Women's Rights and Gender Equality (A7-0384/2013), |
|
1. |
Adopts its position at first reading hereinafter set out; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) Not yet published in the Official Journal.
P7_TC1-COD(2013)0238
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Decision No …/2014/EU of the European Parliament and of the Council on the European Year for Development (2015)
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Decision No 472/2014/EU.)
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/364 |
P7_TA(2014)0270
Space surveillance and tracking support framework ***I
European Parliament legislative resolution of 2 April 2014 on the proposal for a decision of the European Parliament and of the Council establishing a space surveillance and tracking support programme (COM(2013)0107 — C7-0061/2013 — 2013/0064(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/19)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2013)0107), |
|
— |
having regard to Article 294(2) and Article 189(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0061/2013), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the opinion of the European Economic and Social Committee of 10 July 2013, (1) |
|
— |
having regard to the undertaking given by the Council representative by letter of 5 February 2014 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Industry, Research and Energy and the opinions of the Committee of Foreign Affairs and the Committee on Budgets (A7-0030/2014), |
|
1. |
Adopts its position at first reading hereinafter set out; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 327, 12.11.2013, p. 38.
P7_TC1-COD(2013)0064
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Decision No …/2014/EU of the European Parliament and of the Council establishing a Framework for Space Surveillance and Tracking Support
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Decision No 541/2014/EU.)
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/365 |
P7_TA(2014)0271
Management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material ***I
European Parliament legislative resolution of 2 April 2014 on the proposal for a regulation of the European Parliament and of the Council laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005, Directive 2009/128/EC and Regulation (EC) No 1107/2009 and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC (COM(2013)0327 — C7-0167/2013 — 2013/0169(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/20)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2013)0327), |
|
— |
having regard to Article 294(2), Article 43(2) and Article 168(4)(b) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0167/2013), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the opinion of the European Economic and Social Committee of 16 October 2013 (1), |
|
— |
after consulting the Committee of the Regions, |
|
— |
having regard to the undertaking given by the Council representative by letter of 5 February 2014 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Agriculture and Rural Development and the opinions of the Committee on Budgets and the Committee on the Environment, Public Health and Food Safety (A7-0424/2013), |
|
1. |
Adopts its position at first reading hereinafter set out; |
|
2. |
Takes note of the Commission statement annexed to this resolution; |
|
3. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
4. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 67, 6.3.2014, p. 166.
P7_TC1-COD(2013)0169
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 652/2014.)
ANNEX TO THE LEGISLATIVE RESOLUTION
STATEMENT FROM THE COMMISSION
on the procedures for the approval of veterinary and phytosanitary programmes
In order to better inform the Member States, the Commission will arrange an annual meeting of the Standing Committee on Plants, Animals, Food and Feed which shall focus on the outcome of the evaluation procedure of programmes. That meeting will take place no later than 30 November of the year preceding the implementation of the programmes.
In connection with that meeting, the Commission will present the list of the programmes technically approved and proposed for co-financing. Both financial and technical details will be discussed with the national delegations, and their comments will be considered.
In addition, before taking its final decision thereon, the Commission will, during a meeting of the Standing Committee on Plants, Animals, Food and Feed in January, communicate to the Member States the final list of programmes selected for co-financing and the final amount allocated to each programme.
Preparatory work for the design of the work programme for the implementation of the measures referred to in Articles 9, 19 and 25 will be carried out with experts of Member States in early February of each year in order to give Member States the relevant information to establish the eradication and surveillance programmes.
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/368 |
P7_TA(2014)0272
Imports of timber ***I
European Parliament legislative resolution of 2 April 2014 on the proposal for a regulation of the European Parliament and of the Council amending Council Regulation (EC) No 2173/2005 on the establishment of a FLEGT licensing scheme for imports of timber into the European Community (COM(2013)0015 — C7-0021/2013 — 2013/0010(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/21)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2013)0015), |
|
— |
having regard to Article 294(2) and Article 207(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0021/2013), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the undertaking given by the Council representative by letter of 19 February 2014 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on International Trade and the opinion of the Committee on Development (A7-0429/2013), |
|
1. |
Adopts its position at first reading hereinafter set out; |
|
2. |
Takes note of the Commission statement annexed to this resolution; |
|
3. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
4. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
P7_TC1-COD(2013)0010
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council amending Council Regulation (EC) No 2173/2005 as regards the delegated and implementing powers to be conferred on the Commission
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 657/2014.)
ANNEX TO THE LEGISLATIVE RESOLUTION
Commission Statement on delegated acts
In the context of this Regulation, the Commission recalls the commitment it has taken in paragraph 15 of the Framework Agreement on relations between the European Parliament and the European Commission to provide to the Parliament full information and documentation on its meetings with national experts within the framework of its work on the preparation of delegated acts.
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/370 |
P7_TA(2014)0273
Clinical trials on medicinal products for human use ***I
European Parliament legislative resolution of 2 April 2014 on the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (COM(2012)0369 — C7-0194/2012 — 2012/0192(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/22)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2012)0369), |
|
— |
having regard to Article 294(2) and Articles 114 and 168(4) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0194/2012), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Polish Sejm, asserting that the draft legislative act does not comply with the principle of subsidiarity, |
|
— |
having regard to the opinion of the European Economic and Social Committee of 12 December 2012 (1), |
|
— |
after consulting the Committee of the Regions, |
|
— |
having regard to the undertaking given by the Council representative by letter of 20 December 2013 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy, the Committee on the Internal Market and Consumer Protection and the Committee on Civil Liberties, Justice and Home Affairs (A7-0208/2013), |
|
1. |
Adopts its position at first reading hereinafter set out; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 44, 15.2.2013, p. 99.
P7_TC1-COD(2012)0192
Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 536/2014.)
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/371 |
P7_TA(2014)0274
Community framework for the nuclear safety of nuclear installations *
European Parliament legislative resolution of 2 April 2014 on the proposal for a Council directive amending Directive 2009/71/Euratom establishing a Community framework for the nuclear safety of nuclear installations (COM(2013)0715 — C7-0385/2013 — 2013/0340(NLE))
(Consultation)
(2017/C 408/23)
The European Parliament,
|
— |
having regard to the Commission proposal to the Council (COM(2013)0715), |
|
— |
having regard to Articles 31 and 32 of the Euratom Treaty, pursuant to which the Council consulted Parliament (C7-0385/2013), |
|
— |
having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Industry, Research and Energy (A7-0252/2014), |
|
1. |
Approves the Commission proposal as amended; |
|
2. |
Calls on the Commission to alter its proposal accordingly, in accordance with Article 293(2) of the Treaty on the Functioning of the European Union and Article 106a of the Euratom Treaty; |
|
3. |
Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament; |
|
4. |
Asks the Council to consult Parliament again if it intends to substantially amend the Commission proposal; |
|
5. |
Instructs its President to forward its position to the Council and the Commission. |
Amendment 1
Proposal for a directive
Citation 4 a (new)
|
Text proposed by the Commission |
Amendment |
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Amendment 2
Proposal for a directive
Citation 4 b (new)
|
Text proposed by the Commission |
Amendment |
||
|
|
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Amendment 3
Proposal for a directive
Recital 6
|
Text proposed by the Commission |
Amendment |
||||
|
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Amendment 4
Proposal for a directive
Recital 7
|
Text proposed by the Commission |
Amendment |
||||
|
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Amendment 5
Proposal for a directive
Recital 15
|
Text proposed by the Commission |
Amendment |
||||
|
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Amendment 6
Proposal for a directive
Recital 22
|
Text proposed by the Commission |
Amendment |
||||
|
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Amendment 7
Proposal for a directive
Recital 23
|
Text proposed by the Commission |
Amendment |
||||
|
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Amendment 8
Proposal for a directive
Recital 24
|
Text proposed by the Commission |
Amendment |
||||
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Amendment 9
Proposal for a directive
Recital 25
|
Text proposed by the Commission |
Amendment |
||||
|
|
Amendment 10
Proposal for a directive
Recital 28
|
Text proposed by the Commission |
Amendment |
||||
|
|
Amendment 11
Proposal for a directive
Recital 29
|
Text proposed by the Commission |
Amendment |
||||
|
|
Amendment 12
Proposal for a directive
Recital 33
|
Text proposed by the Commission |
Amendment |
||||
|
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Amendment 13
Proposal for a directive
Recital 33 a (new)
|
Text proposed by the Commission |
Amendment |
||
|
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Amendment 14
Proposal for a directive
Recital 35
|
Text proposed by the Commission |
Amendment |
||||
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Amendment 15
Proposal for a directive
Recital 36
|
Text proposed by the Commission |
Amendment |
||||
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Amendment 16
Proposal for a directive
Recital 42 a (new)
|
Text proposed by the Commission |
Amendment |
||
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Amendment 17
Proposal for a directive
Article 1 — point 2
Directive 2009/71/Euratom
Article 1 — point c
|
Text proposed by the Commission |
Amendment |
||||
|
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Amendment 18
Proposal for a directive
Article 1 — point 2 a (new)
Directive 2009/71/EURATOM
Article 1 — point d (new)
|
Text proposed by the Commission |
Amendment |
||||
|
|
|
Amendment 19
Proposal for a directive
Article 1 — point 4
Directive 2009/71/Euratom
Article 3 — point 7
|
Text proposed by the Commission |
Amendment |
||
|
deleted |
Amendment 20
Proposal for a directive
Article 1 — point 4
Directive 2009/71/Euratom
Article 3 — point 7 a (new)
|
Text proposed by the Commission |
Amendment |
||
|
|
|
Amendment 21
Proposal for a directive
Article 1 — point 4
Directive 2009/71/Euratom
Article 3 — point 8
|
Text proposed by the Commission |
Amendment |
||||
|
|
Amendment 22
Proposal for a directive
Article 1 — point 4
Directive 2009/71/Euratom
Article 3 — point 8 a (new)
|
Text proposed by the Commission |
Amendment |
||
|
|
|
Amendment 23
Proposal for a directive
Article 1 — point 4
Directive 2009/71/Euratom
Article 3 — point 12
|
Text proposed by the Commission |
Amendment |
||||
|
|
||||
|
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(The amendment from ‘reasonably achievable’ to ‘reasonably practicable’ applies throughout the text. This will necessitate corresponding changes throughout.) |
Amendment 24
Proposal for a directive
Article 1 — point 4
Directive 2009/71/Euratom
Article 3 — point 13
|
Text proposed by the Commission |
Amendment |
||||
|
|
Amendment 25
Proposal for a directive
Article 1 — point 4
Directive 2009/71/Euratom
Article 3 — point 14
|
Text proposed by the Commission |
Amendment |
||||
|
|
Amendment 26
Proposal for a directive
Article 1 — point 4
Directive 2009/71/Euratom
Article 3 — point 15
|
Text proposed by the Commission |
Amendment |
||
|
deleted |
Amendment 27
Proposal for a directive
Article 1 — point 4
Directive 2009/71/Euratom
Article 3 — point 16 a (new)
|
Text proposed by the Commission |
Amendment |
||
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Amendment 28
Proposal for a directive
Article 1 — point 4
Directive 2009/71/Euratom
Article 3 — point 17 a (new)
|
Text proposed by the Commission |
Amendment |
||
|
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Amendment 29
Proposal for a directive
Article 1 — point 4
Directive 2009/71/Euratom
Article 3 — point 17 b (new)
|
Text proposed by the Commission |
Amendment |
||
|
|
|
Amendment 30
Proposal for a directive
Article 1 — point 6 — point a
Directive 2009/71/Euratom
Article 4 — paragraph 1
|
Text proposed by the Commission |
Amendment |
|
1. Member States shall establish and maintain a national legislative, regulatory and organisational framework (hereinafter referred to as the ‘national framework’) for nuclear safety of nuclear installations that allocates responsibilities and provides for coordination between relevant state bodies. The national framework shall provide in particular for: |
1. Member States shall establish and maintain a national legislative, regulatory , administrative and organisational framework (hereinafter referred to as the ‘national framework’) for nuclear safety of nuclear installations that allocates responsibilities and provides for coordination between relevant state bodies. The national framework shall provide in particular for: |
Amendment 31
Proposal for a directive
Article 1 — point 7
Directive 2009/71/Euratom
Article 5 — paragraph 2 — point a
|
Text proposed by the Commission |
Amendment |
||||
|
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Amendment 32
Proposal for a directive
Article 1 — point 7
Directive 2009/71/Euratom
Article 5 — paragraph 2 — point c
|
Text proposed by the Commission |
Amendment |
||||
|
|
Amendment 33
Proposal for a directive
Article 1 — point 7
Directive 2009/71/Euratom
Article 5 — paragraph 2 — point d
|
Text proposed by the Commission |
Amendment |
||||
|
|
Amendment 34
Proposal for a directive
Article 1 — point 7
Directive 2009/71/Euratom
Article 5 — paragraph 2 — point e
|
Text proposed by the Commission |
Amendment |
||||
|
|
Amendment 35
Proposal for a directive
Article 1 — point 7
Directive 2009/71/Euratom,
Article 5 — paragraph 3 a (new)
|
Text proposed by the Commission |
Amendment |
|
|
3a. Persons with executive responsibility within the competent regulatory authority shall be appointed according to clearly defined procedures and requirements for appointment. They may be relieved from office during their term especially if they do not comply with the requirements of independence set out in this Article or have been guilty of misconduct under national law. An appropriate cooling-off period for posts with a potential conflict of interest shall be defined. |
Amendment 36
Proposal for a directive
Article 1 — point 7
Directive 2009/71/Euratom
Article 5 — paragraph 3 — point e
|
Text proposed by the Commission |
Amendment |
||||
|
|
Amendment 37
Proposal for a directive
Article 1 — point 7
Directive 2009/71/Euratom
Article 5 — paragraph 3 — point f (new)
|
Text proposed by the Commission |
Amendment |
||
|
|
|
Amendment 64
Proposal for a directive
Article 1 — point 8 — point a
Directive 2009/71/Euratom
Article 6 — paragraph 1
|
Text proposed by the Commission |
Amendment |
|
1. Member States shall ensure that the national framework requires that the prime responsibility for the nuclear safety of a nuclear installation rests with the licence holder. This responsibility cannot be delegated. |
1. Member States shall ensure that the national framework requires that the sole responsibility for the nuclear safety of a nuclear installation rests with the licence holder. This responsibility cannot be delegated. Nuclear operators and waste licensees shall be fully insured and all insurance costs as well as liabilities and costs for damage caused to people and the environment in the case of accidents shall be fully covered by the operators and licensees. |
Amendment 65
Proposal for a directive
Article 1 — point 8 — point b
Directive 2009/71/Euratom
Article 6 — paragraph 2
|
Text proposed by the Commission |
Amendment |
|
2. Member States shall ensure that the national framework requires licence holders, under the supervision of the competent regulatory authority, to regularly assess and verify, and continuously improve, as far as reasonably achievable, the nuclear safety of their nuclear installations in a systematic and verifiable manner. |
2. Member States shall ensure that the national framework requires licence holders, under the supervision of the competent regulatory authority, to regularly assess and verify, and continuously improve, the nuclear safety of their nuclear installations in a systematic and verifiable manner. |
Amendment 38
Proposal for a directive
Article 1 — point 8 — point d
Directive 2009/71/Euratom
Article 6 — paragraph 4
|
Text proposed by the Commission |
Amendment |
|
4. Member States shall ensure that the national framework requires licence holders to establish and implement management systems which give due priority to nuclear safety and are regularly verified by the competent regulatory authority. |
4. Member States shall ensure that the national framework requires licence holders to establish and implement management systems which give due priority to nuclear safety , including promotion and enhancement of a nuclear safety culture, and are regularly verified by the competent regulatory authority. |
Amendment 39
Proposal for a directive
Article 1 — point 8 — point f
Directive 2009/71/Euratom
Article 6 — paragraph 5
|
Text proposed by the Commission |
Amendment |
|
5. Member States shall ensure that the national framework requires licence holders to provide for and maintain adequate financial and human resources, with appropriate qualifications, expertise and skills, to fulfil their obligations with respect to nuclear safety of a nuclear installation, laid down in paragraphs 1 to 4a of this Article and Articles 8a to 8d of this Directive. These obligations also extend to subcontracted workers. |
5. Member States shall ensure that the national framework requires licence holders to provide for and maintain adequate financial and human resources, with appropriate qualifications, expertise and skills, to fulfil their obligations with respect to nuclear safety of a nuclear installation, laid down in paragraphs 1 to 4a of this Article and Articles 8a to 8d of this Directive , including during and after its decommissioning . These obligations also extend to subcontracted workers. |
Amendment 40
Proposal for a directive
Article 1 — point 9
Directive 2009/71/Euratom
Article 7
|
Text proposed by the Commission |
Amendment |
|
Member States shall ensure that the national framework requires all parties to make arrangements for education, training and exercise for their staff having responsibilities relating to the nuclear safety of nuclear installations and to on-site emergency preparedness and response arrangements, in order to build up, maintain and to further develop up-to-date and mutually recognised expertise and skills in nuclear safety. |
Member States shall ensure that the national framework requires all parties to make arrangements for education, continuous training and exercise for their staff having responsibilities relating to the nuclear safety of nuclear installations and to on-site emergency preparedness and response arrangements, in order to build up, maintain and to further develop up-to-date and mutually recognised expertise and skills in nuclear safety. |
Amendment 41
Proposal for a directive
Article 1 — point 9
Directive 2009/71/Euratom
Article 8
|
Text proposed by the Commission |
Amendment |
|
Transparency |
Transparency |
|
1. Member States shall ensure that up to date and timely information in relation to nuclear safety of nuclear installations and related risks is made available to workers and the general public, with specific consideration to those living in the vicinity of a nuclear installation. |
1. Member States shall ensure that up to date information in relation to nuclear safety of nuclear installations and related risks is made available to workers and the general public without undue delay , with specific consideration to those living in the vicinity of a nuclear installation. A widespread and transparent communication process shall be ensured including, where appropriate, by regular information and consultation of citizens. |
|
The obligation established in the first subparagraph includes ensuring that the competent regulatory authority and the licence holders, within their fields of responsibility, develop, publish and implement a transparency strategy covering, inter alia, information on normal operating conditions of nuclear installations, non-mandatory consultation activities with the workers and the general public and communication in case of abnormal events and accidents. |
The obligation established in the first subparagraph includes ensuring that the competent regulatory authority and the licence holders, within their fields of responsibility, develop, publish and implement a transparency strategy covering, inter alia, information on normal operating conditions of nuclear installations, consultation activities with the workers, where appropriate, and the general public, and immediate communication in case of incidents and accidents. It shall also cover significant information such as siting, construction, extension, commissioning, operation, operation beyond design service life, final shutdown and decommissioning . |
|
2. Information shall be made available to the public in accordance with applicable Union and national legislation and international obligations, provided that this does not jeopardise other overriding interests, such as security, recognised in national legislation or international obligations. |
2. Information shall be made available to the public in accordance with applicable Union and national legislation and international obligations, provided that this does not jeopardise other overriding interests, such as security, recognised in national legislation or international obligations. |
|
3. Member States shall ensure that the public shall be given early and effective opportunities to participate in the licensing process of nuclear installations, in accordance with relevant Union and national legislation and international obligations. |
3. Member States shall ensure that the public shall be given early and effective opportunities to participate in the environmental impact assessment of nuclear installations, in accordance with relevant Union and national legislation and international obligations, in particular the Aarhus Convention . |
Amendment 42
Proposal for a directive
Article 1 — point 10
Directive 2009/71/Euratom
Article 8a
|
Text proposed by the Commission |
Amendment |
||||
|
Safety objective for nuclear installations |
Safety objective for nuclear installations |
||||
|
1. Member States shall ensure that the national framework requires that nuclear installations are designed, sited, constructed, commissioned, operated and decommissioned with the objective of avoiding potential radioactive releases by: |
1. Member States shall ensure that the national framework requires that nuclear installations are designed, sited, constructed, commissioned, operated and decommissioned with the objective of preventing accidents and radioactive releases and, should an accident occur, mitigating its effects and preventing radioactive releases and large, long-term, off-site contamination by: |
||||
|
|
||||
|
|
||||
|
2. Member States shall ensure that the national framework requires that the objective set out in paragraph 1 applies to existing nuclear installations to the extent reasonably achievable . |
2. Member States shall ensure that the national framework requires that the objective set out in paragraph 1 applies in full to nuclear installations for which a construction licence is granted for the first time after … (*1) and to existing nuclear installations to the extent reasonably practicable . |
Amendment 43
Proposal for a directive
Article 1 — point 10
Directive 2009/71/Euratom
Article 8b
|
Text proposed by the Commission |
Amendment |
||||||||
|
Implementation of the safety objective for nuclear installations |
Implementation of the safety objective for nuclear installations |
||||||||
|
In order to achieve the safety objective set out in Article 8a, Member States shall ensure that the national framework requires that nuclear installations are: |
In order to achieve the safety objective set out in Article 8a, Member States shall ensure that the national framework requires that nuclear installations are: |
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Amendment 44
Proposal for a directive
Article 1 — point 10
Directive 2009/71/Euratom
Article 8c
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Text proposed by the Commission |
Amendment |
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Methodology for siting, design, construction, commissioning, operation and decommissioning of nuclear installations |
Methodology for siting, design, construction, commissioning, operation and decommissioning of nuclear installations |
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1. Member States shall ensure that the national framework requires that the licence holder, under the supervision of the competent regulatory authority: |
1. Member States shall ensure that the national framework requires that the licence holder, under the supervision of the competent regulatory authority: |
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2. Member States shall ensure that the national framework requires that the granting or the review of a licence to construct and/or operate a nuclear installation should be based upon an appropriate site- and installation-specific safety assessment. |
2. Member States shall ensure that the national framework requires that the granting or the review of a licence to construct and/or operate a nuclear installation should be based upon an appropriate site- and installation-specific safety assessment including on-site inspections by the national authority . |
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3. Member States shall ensure that the national framework requires, for nuclear power plants and, if applicable, for research reactor facilities, for which a construction licence is sought for the first time, that the competent regulatory authority obliges the applicant to demonstrate that the design practically limits the effects of a reactor core damage to within the containment. |
3. Member States shall ensure that the national framework requires, for nuclear power plants and, if applicable, for research reactor facilities, for which a construction licence is sought for the first time, that the competent regulatory authority obliges the applicant to demonstrate that the design practically limits the effects of a reactor core damage to within the containment. |
Amendment 45
Proposal for a directive
Article 1 — point 10
Directive 2009/71/Euratom
Article 8d
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Text proposed by the Commission |
Amendment |
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On-site emergency preparedness and response |
On-site emergency preparedness and response |
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Member States shall ensure that the national framework requires that the licence holder, under the supervision of the competent regulatory authority: |
Member States shall ensure that the national framework requires that the licence holder, under the supervision of the competent regulatory authority: |
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Amendment 46
Proposal for a directive
Article 1 — point 11
Directive 2009/71/Euratom
Article 8e
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Text proposed by the Commission |
Amendment |
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Peer Reviews |
Peer Reviews |
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1. Member States shall at least every ten years arrange for periodic self-assessments of their national framework and competent regulatory authorities and invite an international peer review of relevant segments of their national framework and competent regulatory authorities with the aim of continuously improving nuclear safety. Outcomes of any peer review shall be reported to the Member States and the Commission, when available. |
1. Member States shall at least every eight years arrange for periodic self-assessments of their national framework and competent regulatory authorities and invite an international peer review of relevant segments of their national framework and competent regulatory authorities with the aim of continuously improving nuclear safety. Outcomes of any peer review shall be reported to the Member States and the Commission, when available. The European Parliament shall be regularly informed about the results of the peer reviews as well as about related measures and plans. |
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2. Member States, with the support of the competent regulatory authorities, shall periodically arrange, and at least every six years, a system of topical peer reviews and agree on a time-frame and the modalities for implementation. For this purpose Member States shall: |
2. Member States, with the support of the competent regulatory authorities, shall periodically arrange, and at least every six years, a system of topical peer reviews, and agree on a time-frame and the modalities for implementation. For this purpose Member States, in the framework of ENSREG, shall: |
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2a. The topic of the first topical peer review shall be decided not later than … (*2) . |
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3. Each Member State subject to the peer review referred to in paragraph 2 shall arrange for the planning and mode of implementation on its territory of relevant technical recommendations resulting from the peer-review process and shall inform the Commission thereof . |
3. Each Member State subject to peer reviews referred to in paragraph 2 shall report the outcomes to all Member States and the Commission and arrange for the planning and mode of implementation on its territory of relevant technical recommendations resulting from the peer-review process and publish an action plan reflecting the steps taken . |
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4. Should the Commission identify substantial deviations or delays in the implementation of the technical recommendations resulting from the peer review process, the Commission shall invite the competent regulatory authorities of Member States not concerned to organise and carry out a verification mission to get a full picture of the situation and inform the Member State concerned about possible measures to remedy any identified shortcomings. |
4. Should the Commission in close coordination with ENSREG identify substantial deviations or delays in the implementation of the technical recommendations resulting from the peer review process, the Commission shall invite the competent regulatory authorities of Member States not concerned to organise and carry out a verification mission to get a full picture of the situation and inform the Member State concerned about possible measures to remedy any identified shortcomings. |
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5. In case of an accident which leads to an early or large release or an abnormal event leading to situations that would require off-site emergency measures or protecting measures for the public, the Member State concerned shall invite within six months a peer review of the installation concerned in accordance with paragraph 2, and to which the Commission shall be invited to participate. |
5. In case of an accident or an incident leading to situations that would require off-site emergency measures or protecting measures for the public, the Member State concerned shall invite within six months a peer review of the installation concerned in accordance with paragraph 2. |
Amendment 47
Proposal for a directive
Article 1 — point 11
Directive 2009/71/Euratom
Article 8f
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Text proposed by the Commission |
Amendment |
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Based on the results of the peer reviews performed in accordance with Article 8e(2) and the resulting technical recommendations, in line with the principles of transparency and continuous improvement of nuclear safety, Member States shall, with the support of the competent regulatory authorities, jointly develop and establish guidelines on the specific topics referred to in Article 8e(2)(a). |
Based on the results of the peer reviews performed in accordance with Article 8e(2) and the resulting technical recommendations, in line with the principles of transparency and continuous improvement of nuclear safety, Member States shall, with the support of the competent regulatory authorities, jointly develop and establish guidelines on the specific topics referred to in Article 8e(2)(a). |
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The results of the topical peer reviews shall be used to foster discussions in the nuclear community which potentially could lead to the development of a set of harmonised Community nuclear safety criteria in the future. |
(33) OJ L 199, 2.8.2011, p. 48.
(33) OJ L 199, 2.8.2011, p. 48.
(33a) Texts adopted, P7_TA(2013)0089.
(34) Adopted by the Coreper on 25 April 2007 (doc. Ref. 8784/07) and the Economic and Financial Affairs Council on 8 May 2007.
(34) Adopted by the Coreper on 25 April 2007 (doc. Ref. 8784/07) and the Economic and Financial Affairs Council on 8 May 2007.
(42) OJ L 371, 30.12.1987, p. 76.
(43) OJ L 357, 7.12.1989, p. 31.
(42) OJ L 371, 30.12.1987, p. 76.
(43) OJ L 357, 7.12.1989, p. 31.
(*1) Date of entry into force of this Directive.
(*2) Three years after the entry into force of this Directive.
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30.11.2017 |
EN |
Official Journal of the European Union |
C 408/397 |
P7_TA(2014)0275
Common system of taxation applicable in the case of parent companies and subsidiaries of different Member States *
European Parliament legislative resolution of 2 April 2014 on the proposal for a Council directive amending Directive 2011/96/EU on the common system of taxation applicable in the case of parent companies and subsidiaries of different Member States (COM(2013)0814 — C7-0464/2013 — 2013/0400(CNS))
(Special legislative procedure — consultation)
(2017/C 408/24)
The European Parliament,
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having regard to the Commission proposal to the Council (COM(2013)0814), |
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having regard to Article 115 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C7-0464/2013), |
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having regard to Rule 55 of its Rules of Procedure, |
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having regard to the report of the Committee on Economic and Monetary Affairs and the opinion of the Committee on Legal Affairs (A7-0243/2014), |
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1. |
Approves the Commission proposal as amended; |
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2. |
Calls on the Commission to alter its proposal accordingly, in accordance with Article 293(2) of the Treaty on the Functioning of the European Union; |
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3. |
Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament; |
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4. |
Asks the Council to consult Parliament again if it intends to substantially amend the Commission proposal; |
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5. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
Amendment 1
Proposal for a directive
Recital - 1 (new)
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Text proposed by the Commission |
Amendment |
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Amendment 2
Proposal for a directive
Recital - 1 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 3
Proposal for a directive
Recital 2
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Text proposed by the Commission |
Amendment |
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Amendment 4
Proposal for a directive
Recital 4
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Text proposed by the Commission |
Amendment |
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Amendment 5
Proposal for a directive
Recital 5
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Text proposed by the Commission |
Amendment |
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Amendment 6
Proposal for a directive
Article 1 — point 1
Directive 2011/96/EU
Article 1 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. This Directive shall not preclude the application of domestic or agreement-based provisions required for the prevention of tax evasion. |
2. This Directive shall not preclude the application of domestic or agreement-based provisions required in order to prevent tax evasion or to permit the taxation of activities at the place of production or consumption, in so far as they are compatible with this Directive . |
Amendment 7
Proposal for a directive
Article 1 — point 2
Directive 2011/96/EU
Article 1a — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall withdraw the benefit of this directive in the case of an artificial arrangement or an artificial series of arrangements which has been put into place for the essential purpose of obtaining an improper tax advantage under this directive and which defeats the object, spirit and purpose of the tax provisions invoked. |
1. Member States shall withdraw the benefit of this directive in the case of an artificial arrangement or an artificial series of arrangements which has been put into place for the purpose of obtaining an improper tax advantage under this directive and which defeats the object, spirit and purpose of the tax provisions invoked. |
Amendment 8
Proposal for a directive
Article 1 — point 2
Directive 2011/96/EU
Article 1 a — paragraph 2 — subparagraph 2 — introductory part
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Text proposed by the Commission |
Amendment |
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In determining whether an arrangement or series of arrangements is artificial, Member States shall ascertain, in particular, whether they involve one or more of the following situations: |
In determining whether an arrangement or series of arrangements is artificial, Member States shall ascertain, in particular , but not exclusively , whether they involve one or more of the following situations: |
Amendment 9
Proposal for a directive
Article 1 — point 2 a (new)
Directive 2011/96/EU
Article 3 — paragraph 2 — point a
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Present text |
Amendment |
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2a. In Article 3(2), point (a) is replaced by the following: |
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Amendment 11
Proposal for a directive
Article 1 a (new)
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Text proposed by the Commission |
Amendment |
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Article 1a Review By 31 December 2016, the Commission shall report to the European Parliament and to the Council reviewing the operation of the amendments to Directive 2011/96/EU introduced by this Directive and in particular its effectiveness in preventing tax avoidance and abuse. That report shall be submitted together with a legislative proposal, if appropriate. |
Amendment 12
Proposal for a directive
Article 3
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Text proposed by the Commission |
Amendment |
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This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. |
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall be published in consolidated form with the Directive which it amends within three months of its publication. |
(1a) Council Directive 2011/96/EU of 30 November 2011 on the common system of taxation applicable in the case of parent companies and subsidiaries of different Member States (OJ L 345, 29.12.2011, p. 8).
Thursday 3 April 2014
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30.11.2017 |
EN |
Official Journal of the European Union |
C 408/402 |
P7_TA(2014)0277
Community regime for the control of exports, transfer, brokering and transit of dual-use items ***II
European Parliament legislative resolution of 3 April 2014 on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council amending Regulation (EC) No 428/2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items (18086/1/2013 — C7-0093/2014 — 2011/0310(COD))
(Ordinary legislative procedure: second reading)
(2017/C 408/25)
The European Parliament,
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having regard to the Council position at first reading (18086/1/2013 — C7-0093/2014), |
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having regard to its position at first reading (1) on the Commission proposal to Parliament and the Council (COM(2011)0704), |
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having regard to Article 294(7) of the Treaty on the Functioning of the European Union, |
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having regard to Rule 72 of its Rules of Procedure, |
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having regard to the recommendation for second reading of the Committee on International Trade (A7-0236/2014), |
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Approves the Council position at first reading; |
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Approves the joint statement by Parliament, the Council and the Commission annexed to this resolution; |
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3. |
Takes note of the Commission statements annexed to this resolution; |
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4. |
Notes that the act is adopted in accordance with the Council position; |
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5. |
Instructs its President to sign the act with the President of the Council, in accordance with Article 297(1) of the Treaty on the Functioning of the European Union; |
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6. |
Instructs its Secretary-General to sign the act, once it has been verified that all the procedures have been duly completed, and, in agreement with the Secretary-General of the Council, to arrange for its publication, together with all the statements annexed to this resolution, in the Official Journal of the European Union; |
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7. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 68 E, 7.3.2014, p. 112.
ANNEX TO THE LEGISLATIVE RESOLUTION
Joint Statement by the European Parliament, the Council and the Commission on the review of the dual-use export control system
The European Parliament, the Council and the Commission recognise the importance of continuously enhancing the effectiveness and coherence of the EU's strategic export controls regime, ensuring a high level of security and adequate transparency without impeding competiveness and legitimate trade in dual-use items.
The three institutions consider that modernisation and further convergence of the system is needed in order to keep up with new threats and rapid technological changes, to reduce distortions, create a genuine common market for dual-use items (uniform level playing field for exporters) and continue serving as an export control model for third countries.
To this end, it is essential to streamline the process for updating the control lists (Annexes to the Regulation); strengthen risk assessment and exchange of information, develop improved industry standards, and reduce disparities in implementation.
The European Parliament, the Council and the Commission acknowledge the issues regarding the export of certain information and communication technologies (ICT) that can be used in connection with human rights violations as well as to undermine the EU's security, particularly for technologies used for mass-surveillance, monitoring, tracking, tracing and censoring, as well as for software vulnerabilities.
Technical consultations have been initiated in this respect, including in the framework of EU Dual Use Peer Visit, the Dual Use Coordination Group, and the export control regimes, and actions continue to be taken to address situations of urgency through sanctions (pursuant to Article 215 TFEU), or national measures. Efforts will also be intensified to promote multilateral agreements in the context of export control regimes, and options will be explored, to address this issue in the context of the on-going review of EU dual-use export control policy, and the preparation of a Commission Communication. In this context the three institutions took note of the agreement on 4 December 2013 by the Participating States of the Wassenaar Arrangement to adopt controls on complex surveillance tools that enable unauthorised access to computer systems, and on IP-network surveillance systems.
The European Parliament, the Council and the Commission also commit to further development of existing ‘catch-all’ mechanism for dual-use items falling outside the Annex I of the Regulation, in order to further enhance the export control system and its application within the European single market.
Commission Statement on delegated acts
In the context of this Regulation, the Commission recalls the commitment it has taken in paragraph 15 of the Framework Agreement on relations between the European Parliament and the European Commission to provide to the Parliament full information and documentation on its meetings with national experts within the framework of its work on the preparation of delegated acts.
Commission Statement on updating the Regulation
In order to ensure a more integrated, efficient and coherent European approach to the movement (exports, transfer, brokering and transit) of strategic items, the Commission will put forward a new proposal for updating the Regulation as expeditiously as possible.
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30.11.2017 |
EN |
Official Journal of the European Union |
C 408/404 |
P7_TA(2014)0278
Greenhouse gas emission trading (international aviation emissions) ***I
European Parliament legislative resolution of 3 April 2014 on the proposal for a directive of the European Parliament and of the Council amending Directive 2003/87/EC establishing a scheme for greenhouse gas emission allowance trading within the Community, in view of the implementation by 2020 of an international agreement applying a single global market-based measure to international aviation emissions (COM(2013)0722 — C7-0374/2013 — 2013/0344(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/26)
The European Parliament,
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having regard to the Commission proposal to Parliament and the Council (COM(2013)0722), |
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— |
having regard to Article 294(2) and Article 192(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0374/2013), |
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having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
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having regard to the opinion of the European Economic and Social Committee of 22 January 2014 (1), |
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after consulting the Committee of the Regions, |
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having regard to the undertaking given by the Council representative by letter of 7 March 2014 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
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having regard to Rules 55 of its Rules of Procedure, |
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having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and of the Committee on Transport and Tourism (A7-0079/2014), |
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1. |
Adopts its position at first reading hereinafter set out; |
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2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
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3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) Not yet published in the Official Journal.
P7_TC1-COD(2013)0344
Position of the European Parliament adopted at first reading on 3 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council amending Directive 2003/87/EC establishing a scheme for greenhouse gas emission allowance trading within the Community, in view of the implementation by 2020 of an international agreement applying a single global market-based measure to international aviation emissions
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 421/2014.)
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30.11.2017 |
EN |
Official Journal of the European Union |
C 408/405 |
P7_TA(2014)0279
Interchange fees for card-based payment transactions ***I
Amendments adopted by the European Parliament on 3 April 2014 on the proposal for a regulation of the European Parliament and of the Council on interchange fees for card-based payment transactions (COM(2013)0550 — C7-0241/2013 — 2013/0265(COD)) (1)
(Ordinary legislative procedure: first reading)
(2017/C 408/27)
Amendment 1
Proposal for a regulation
Recital 7
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Text proposed by the Commission |
Amendment |
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Amendment 2
Proposal for a regulation
Recital 8
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Text proposed by the Commission |
Amendment |
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Amendment 3
Proposal for a regulation
Recital 9
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Text proposed by the Commission |
Amendment |
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Amendment 4
Proposal for a regulation
Recital 10
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Text proposed by the Commission |
Amendment |
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Amendment 5
Proposal for a regulation
Recital 11
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Text proposed by the Commission |
Amendment |
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Amendment 6
Proposal for a regulation
Recital 15
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Text proposed by the Commission |
Amendment |
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Amendment 7
Proposal for a regulation
Recital 16
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Text proposed by the Commission |
Amendment |
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Amendment 8
Proposal for a regulation
Recital 17
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Text proposed by the Commission |
Amendment |
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Amendment 9
Proposal for a regulation
Recital 18
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Text proposed by the Commission |
Amendment |
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Amendment 10
Proposal for a regulation
Recital 18 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 11
Proposal for a regulation
Recital 19 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 12
Proposal for a regulation
Recital 22
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Text proposed by the Commission |
Amendment |
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Amendment 13
Proposal for a regulation
Recital 23
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Text proposed by the Commission |
Amendment |
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Amendment 14
Proposal for a regulation
Recital 30
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Text proposed by the Commission |
Amendment |
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Amendment 15
Proposal for a regulation
Recital 30 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 16
Proposal for a regulation
Recital 31
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Text proposed by the Commission |
Amendment |
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Amendment 17
Proposal for a regulation
Article 1 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. This Regulation lays down uniform technical and business requirements for payment card transactions carried out within the Union, where both the payer's payment service provider and the payee's payment service provider are established therein. |
1. This Regulation lays down uniform technical and business requirements for card-based payment transactions carried out within the Union, where both the payer's payment service provider and the payee's payment service provider are established therein. |
Amendment 18
Proposal for a regulation
Article 1 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. This Regulation does not apply to payment instruments that can be used only within a limited network designed to address precise needs through payment instruments only to be used in a limited way, because they allow the specific instrument holder to acquire goods or services only in the premises of the issuer, within a limited network of service providers under a direct commercial agreement with a professional issuer, or because they can be used only to acquire a limited range of goods or services. |
2. This Regulation does not apply to payment instruments that can be used only within a limited network designed to address precise needs through payment instruments only to be used in a limited way, because they allow the specific instrument holder to acquire goods or services only in the premises of the issuer, within a limited network of service providers under a direct commercial agreement with a professional issuer, or because they can be used only to acquire a very narrow range of goods or services. |
Amendment 19
Proposal for a regulation
Article 1 — paragraph 3 — point a
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Text proposed by the Commission |
Amendment |
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deleted |
Amendment 20
Proposal for a regulation
Article 1 — paragraph 3 — point b
|
Text proposed by the Commission |
Amendment |
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Amendment 21
Proposal for a regulation
Article 1 — paragraph 3 — point c
|
Text proposed by the Commission |
Amendment |
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Amendment 22
Proposal for a regulation
Article 1 — paragraph 4 a (new)
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Text proposed by the Commission |
Amendment |
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4a. Articles 6 and 7 shall not apply to domestic debit card schemes that operate with an average interchange fee or net compensation model which is verifiably below the threshold value in Articles 3 and 4. |
Amendment 23
Proposal for a regulation
Article 2 — point 4
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Text proposed by the Commission |
Amendment |
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Amendment 24
Proposal for a regulation
Article 2 — point 5
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Text proposed by the Commission |
Amendment |
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Amendment 25
Proposal for a regulation
Article 2 — point 8
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Text proposed by the Commission |
Amendment |
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Amendment 26
Proposal for a regulation
Article 2 — point 12 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 27
Proposal for a regulation
Article 2 — point 13
|
Text proposed by the Commission |
Amendment |
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Amendment 28
Proposal for a regulation
Article 2 — point 15
|
Text proposed by the Commission |
Amendment |
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Amendment 29
Proposal for a regulation
Article 3 — title
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Text proposed by the Commission |
Amendment |
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Interchange fees for cross-border consumer debit or credit card transactions |
Interchange fees for consumer debit or credit card based payment transactions |
Amendment 30
Proposal for a regulation
Article 3 — paragraph 1
|
Text proposed by the Commission |
Amendment |
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1. With effect from two months after the entry into force of this Regulation , payment services providers shall not offer or request for cross-border debit card transactions a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of more than 0,2 % of the value of the transaction. |
1. With effect from … (*1), payment services providers shall not offer or request for debit transactions by card a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of more than the lower amount of 7 eurocents or 0,2 % of the value of the transaction. |
Amendment 31
Proposal for a regulation
Article 3 — paragraph 2
|
Text proposed by the Commission |
Amendment |
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2. With effect from two months after the entry into force of this Regulation , payment services providers shall not offer or request for cross-border credit card transactions a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of more than 0,3 % of the value of the transaction. |
2. With effect from … (*2), payment services providers shall not offer or request for credit transactions by card a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of more than 0,3 % of the value of the transaction. |
Amendment 32
Proposal for a regulation
Article 3 — paragraph 2 a (new)
|
Text proposed by the Commission |
Amendment |
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2a. Member States may maintain or introduce lower caps or measures of equivalent object or effect through national legislation. |
Amendment 33
Proposal for a regulation
Article 4
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Text proposed by the Commission |
Amendment |
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Article 4 |
deleted |
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Interchange fees for all consumer debit or credit card transactions |
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1. With effect from two years after the entry into force of this Regulation, payment service providers shall not offer or request a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of more than 0,2 % of the value of the transaction for any debit card based transactions. |
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2. With effect from two years after the entry into force of this Regulation, payment service providers shall not offer or request a per transaction interchange fee or other agreed remuneration with an equivalent object or effect of more than 0,3 % of the value of the transaction for any credit card based transactions. |
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Amendment 34
Proposal for a regulation
Article 5
|
Text proposed by the Commission |
Amendment |
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For the purposes of the application of the caps referred to in Article 3 and Article 4 , any net compensation received by an issuing bank from a payment card scheme in relation to payment transactions or related activities shall be treated as part of the interchange fee. |
For the purposes of the application of the caps referred to in Article 3, any net compensation received by an issuing payment service provider in relation to payment transactions shall be treated as part of the interchange fee. |
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Competent authorities shall prevent any attempts by the payment service providers to circumvent this Regulation, including the issuance of payment cards in third countries. |
Amendment 35
Proposal for a regulation
Article 6 — paragraph 4 a (new)
|
Text proposed by the Commission |
Amendment |
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4a. Any restriction of the provision of payment-related services in payment card schemes rules shall be prohibited, unless it is non-discriminatory and objectively necessary to operate the payment scheme. |
Amendment 36
Proposal for a regulation
Article 6 a (new)
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Text proposed by the Commission |
Amendment |
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Article 6a |
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Cross-border transactions |
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For cross-border transactions, the interchange fee applicable shall be that of the country of the acquirer. |
Amendment 37
Proposal for a regulation
Article 7 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Payment card schemes shall allow for the possibility that authorisation and clearing messages of single card transactions be separated and processed by different processing entities. |
2. Payment card schemes and issuers shall allow for the possibility that authorisation and clearing messages of single card transactions be separated and processed by different processing entities. Scheme rules and rules in licensing agreements or other contracts leading to a restriction on the freedom to choose a processor shall be prohibited. |
Amendment 38
Proposal for a regulation
Article 7 — paragraph 4
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Text proposed by the Commission |
Amendment |
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4. Processing entities within the Union shall ensure that their system is technically interoperable with other systems of processing entities within the Union through the use of standards developed by international or European standardisation bodies. In addition, processing entities shall not adopt or apply business rules that restrict interoperability with other processing entities within the Union. |
4. By … (*3) processing entities within the Union shall ensure that their system is technically interoperable with other systems of processing entities within the Union through the use of standards developed by international or European standardisation bodies. In addition, processing entities shall not adopt or apply business rules that restrict interoperability with other processing entities within the Union. |
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4a. In order to ensure consistent harmonisation of this Article, EBA shall, after consulting an advisory panel as referred to in Article 41 of Regulation (EU) No 1093/2010, develop draft regulatory technical standards establishing requirements to be complied with by payment systems, payment schemes and processing entities to ensure a fully open and competitive card processing market. |
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EBA shall submit those draft regulatory technical standards to the Commission by … (*4) |
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Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010. |
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The requirements referred to in the first subparagraph shall enter into force by … (*5) and shall be updated on a regular basis as appropriate. |
Amendment 39
Proposal for a regulation
Article 7 — paragraph 4 b (new)
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Text proposed by the Commission |
Amendment |
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4b. Member States may exempt newly established card-based payment schemes from applying this Article for a limited period of time by way of derogation from Articles 1 to 4b after consulting the Commission. |
Amendment 40
Proposal for a regulation
Article 8 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Any schemes rules and rules in licensing agreements that hinder or prevent an issuer from co-badging two or more different brands of payment instruments on a card, telecommunication, digital or IT device shall be prohibited. |
1. Any schemes rules and rules in licensing agreements or measures of equivalent effect that hinder or prevent an issuer from co-badging two or more different brands of payment instruments on a card, telecommunication, digital or IT device shall be prohibited. |
Amendment 41
Proposal for a regulation
Article 8 — paragraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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1a. When entering into a contractual agreement with a payment services provider, the consumer may decide to have two or more different brands of payment instruments on a payment card, telecommunication, digital or IT device. In good time before the contract is signed, the payment service provider shall provide the consumer with clear and objective information on all the payment brands available and their characteristics, including their functionality, cost and security. |
Amendment 42
Proposal for a regulation
Article 8 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Any difference in treatment of issuers or acquirers in schemes rules and rules in licensing agreements concerning co-badging on a card, telecommunication, digital or IT device shall be objectively justified and non-discriminatory. |
2. Any difference in treatment of issuers or acquirers in schemes rules and rules in licensing agreements concerning co-badging or equivalent co-residing of different brands or applications on a card, telecommunication, digital or IT device shall be objectively justified and non-discriminatory. |
Amendment 43
Proposal for a regulation
Article 8 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. Payment card schemes shall not impose reporting requirements, obligations to pay fees or other obligations with the same object or effect on card issuing and acquiring payment services providers for transactions carried out with any device on which their brand is present in relation to transactions for which their scheme is not used. |
3. Payment card schemes shall not impose reporting requirements, obligations to pay fees or similar obligations with the same object or effect on card issuing and acquiring payment services providers for transactions carried out with any device on which their brand is present in relation to transactions for which their scheme is not used. |
Amendment 44
Proposal for a regulation
Article 8 — paragraph 4
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Text proposed by the Commission |
Amendment |
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4. Any routing principles aimed at directing transactions through a specific channel or process and other technical and security standards and requirements with respect to the handling of more than one payment card brand on a card, telecommunication, digital or IT device shall be non-discriminatory and shall be applied in a non-discriminatory manner. |
4. Any routing principles or equivalent measures aimed at directing transactions through a specific channel or process and other technical and security standards and requirements with respect to the handling of more than one payment card brand or equivalent on a card, telecommunication, digital or IT device shall be non-discriminatory and shall be applied in a non-discriminatory manner. |
Amendment 45
Proposal for a regulation
Article 8 — paragraph 6
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Text proposed by the Commission |
Amendment |
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6. Payment card schemes, issuers, acquirers and payment card handling infrastructure providers shall not insert automatic mechanisms, software or devices on the payment instrument or at equipment applied at the point of sale which limit the choice of application by the payer when using a co-badged payment instrument. |
6. Payment card schemes, issuers, acquirers and payment card handling infrastructure providers shall not insert automatic mechanisms, software or devices on the payment instrument or on equipment applied at the point of sale which limit the choice of application by the payer and the payee when using a co-badged payment instrument. Payees shall retain the option of installing automatic mechanisms in the equipment used at the point of sale which make a priority selection of a particular brand or application. However, payees shall not prevent the payer, for the categories of cards or related payment instruments accepted by the payee, from overriding an automatic priority selection made by the payee in its equipment . |
Amendment 46
Proposal for a regulation
Article 9 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Acquirers shall offer and charge payees individually specified merchant service charges for different categories and different brands of payment cards unless merchants request in writing acquiring payment services providers to charge blended merchant services charges. |
1. Acquirers shall offer and charge payees individually specified merchant service charges for different categories and different brands of payment cards with different interchange fee levels unless merchants request in writing acquiring payment services providers to charge blended merchant services charges. |
Amendment 47
Proposal for a regulation
Article 10 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Payment schemes and payment service providers shall not apply any rule that may oblige payees accepting cards and other payment instruments issued by one issuing payment service provider within the framework of a payment instruments scheme to also accept other payment instruments of the same brand and/or category issued by other issuing payment service providers within the framework of the same scheme, except if they are subject to the same regulated interchange fee. |
1. Payment schemes and payment service providers shall not apply any rule that may oblige payees accepting cards and other payment instruments issued by one issuing payment service provider within the framework of a payment instruments scheme to also accept other payment instruments of the same brand and/or category issued by other issuing payment service providers within the framework of the same scheme, except if they are subject to the same interchange fee which, moreover, complies with the caps set under this Regulation . |
Amendment 48
Proposal for a regulation
Article 10 — paragraph 4
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Text proposed by the Commission |
Amendment |
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4. Issuing payment service providers shall ensure that their payment instruments are visibly and electronically identifiable, enabling payees to identify unequivocally which brands and categories of prepaid, debit, credit or commercial cards or card based payments based on these are chosen by the payer. |
4. By … (*6) , issuing payment service providers shall ensure that their payment instruments are electronically identifiable, and, in the case of their newly issued card-based payment instruments, also visibly identifiable , enabling payees and payers to identify unequivocally which brands and categories of prepaid, debit, credit or commercial cards or card based payments based on these are chosen by the payer. |
Amendment 49
Proposal for a regulation
Article 11 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. Paragraphs 1 and 2 are without prejudice to the rules on charges, reductions or other steering set out in Article 55 of the proposal COM (2013)547 and in Article 19 of Directive 2011/83/EU (22). |
3. Paragraphs 1 and 2 of this Article are without prejudice to the rules on charges, reductions or other steering set out in Article 55 of Directive 2014/…/EU [PSD and in Article 19 of Directi (22). |
Amendment 50
Proposal for a regulation
Article 12 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. When entering into a contractual agreement with a payment services provider, the consumer shall also be provided with clear and objective periodical information about the payment characteristics and payment fees applied to payment transactions. |
Amendment 51
Proposal for a regulation
Article 14 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall lay down rules on the sanctions applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are applied. Such sanctions shall be effective, proportionate and dissuasive. |
1. Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are applied. EBA may issue guidelines in accordance with Article 16 of Regulation (EU) No 1093/2010 in order to ensure that those penalties are effective, proportionate and dissuasive. |
Amendment 52
Proposal for a regulation
Article 15 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall establish adequate and effective out-of-court complaint and redress procedures for the settlement of disputes arising under this Regulation between payees and their payment service providers. For those purposes, Member States shall designate existing bodies, where appropriate, or establish new bodies. |
1. Member States shall establish independent, adequate and effective out-of-court complaint and redress procedures for the settlement of disputes arising under this Regulation between payees and their payment service providers. For those purposes, Member States shall designate existing bodies, where appropriate, or establish new bodies. Payment service providers shall adhere to at least one alternative dispute resolution body. |
Amendment 53
Proposal for a regulation
Article 15 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Member States shall notify the Commission of those bodies by two years after the entry into force of this Regulation . They shall notify the Commission without delay of any subsequent change concerning those bodies. |
2. Member States shall notify the Commission of those bodies by … (*7). They shall notify the Commission without delay of any subsequent change concerning those bodies. |
Amendment 54
Proposal for a regulation
Article 15 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. Member States shall ensure that payment service providers participate in complaints procedures pursuant to paragraph 1. |
Amendment 55
Proposal for a regulation
Article 16 — paragraph 1
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Text proposed by the Commission |
Amendment |
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Four years after the entry into force of this Regulation , the Commission shall present to the European Parliament and to the Council a report on the application of this Regulation. The Commission's report shall look in particular at the appropriateness of the levels of interchange fees and at steering mechanisms such as charges, taking into account the use and cost of the various means of payments and the level of entry of new players and new technology on the market. |
By … (*8), the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation. The Commission's report shall look in particular at the appropriateness of the levels of interchange fees and at steering mechanisms such as charges, taking into account the use and cost of the various means of payments and the level of entry of new players, new technology and innovative business models on the market. The assessment should, in particular, consider: |
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The report by the Commission shall, if appropriate, be accompanied by a legislative proposal that may include a proposed amendment of the maximum cap for interchange fees. |
(1) The matter was referred back to the committee responsible for reconsideration pursuant to Rule 57(2), second subparagraph (A7-0167/2014).
(21) Italy, Hungary, Poland and the United Kingdom.
(21) Italy, Hungary, Poland and the United Kingdom.
(1a) Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).
(*1) One year after the date of entry into force of this Regulation.
(*2) One year after the date of entry into force of this Regulation.
(*3) One year after the date of entry into force of this Regulation.
(*4) Date…
(*5) Two years after the date of entry into force of this Regulation.
(*6) One year after the date of entry into force of this Regulation .
(22) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights…
(22) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights , amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council.
(*7) Two months after the date of entry into force of this Regulation.
(*8) Two years after the date of entry into force of this Regulation.
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30.11.2017 |
EN |
Official Journal of the European Union |
C 408/429 |
P7_TA(2014)0280
Payment services in the internal market ***I
Amendments adopted by the European Parliament on 3 April 2014 on the proposal for a directive of the European Parliament and of the Council on payment services in the internal market and amending Directives 2002/65/EC, 2013/36/EU and 2009/110/EC and repealing Directive 2007/64/EC (COM(2013)0547 — C7-0230/2013 — 2013/0264(COD)) (1)
(Ordinary legislative procedure: first reading)
(2017/C 408/28)
Amendment 1
Proposal for a directive
Recital 2
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Text proposed by the Commission |
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Amendment 2
Proposal for a directive
Recital 3
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Text proposed by the Commission |
Amendment |
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Amendment 3
Proposal for a directive
Recital 4
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Text proposed by the Commission |
Amendment |
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Amendment 4
Proposal for a directive
Recital 5
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Text proposed by the Commission |
Amendment |
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Amendment 5
Proposal for a directive
Recital 5 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 6
Proposal for a directive
Recital 6
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Text proposed by the Commission |
Amendment |
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Amendment 7
Proposal for a directive
Recital 7
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Text proposed by the Commission |
Amendment |
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Amendment 8
Proposal for a directive
Recital 7 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 9
Proposal for a directive
Recital 8
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Text proposed by the Commission |
Amendment |
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Amendment 10
Proposal for a directive
Recital 9
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Text proposed by the Commission |
Amendment |
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Amendment 11
Proposal for a directive
Recital 10
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Text proposed by the Commission |
Amendment |
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Amendment 12
Proposal for a directive
Recital 12
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Text proposed by the Commission |
Amendment |
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Amendment 13
Proposal for a directive
Recital 13
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Text proposed by the Commission |
Amendment |
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Amendment 14
Proposal for a directive
Recital 13 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 15
Proposal for a directive
Recital 15
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Text proposed by the Commission |
Amendment |
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Amendment 16
Proposal for a directive
Recital 18
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Text proposed by the Commission |
Amendment |
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Amendment 17
Proposal for a directive
Recital 19
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Text proposed by the Commission |
Amendment |
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Amendment 18
Proposal for a directive
Recital 19 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 19
Proposal for a directive
Recital 27
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Text proposed by the Commission |
Amendment |
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Amendment 20
Proposal for a directive
Recital 29
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Text proposed by the Commission |
Amendment |
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Amendment 21
Proposal for a directive
Recital 30
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Text proposed by the Commission |
Amendment |
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Amendment 22
Proposal for a directive
Recital 32
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Text proposed by the Commission |
Amendment |
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Amendment 23
Proposal for a directive
Recital 34
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Text proposed by the Commission |
Amendment |
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Amendment 24
Proposal for a directive
Recital 41
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Text proposed by the Commission |
Amendment |
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Amendment 25
Proposal for a directive
Recital 43
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Text proposed by the Commission |
Amendment |
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Amendment 26
Proposal for a directive
Recital 46
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Text proposed by the Commission |
Amendment |
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Amendment 27
Proposal for a directive
Recital 49
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Text proposed by the Commission |
Amendment |
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Amendment 28
Proposal for a directive
Recital 51
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Text proposed by the Commission |
Amendment |
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Amendment 29
Proposal for a directive
Recital 51 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 30
Proposal for a directive
Recital 54
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Text proposed by the Commission |
Amendment |
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Amendment 31
Proposal for a directive
Recital 57
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Text proposed by the Commission |
Amendment |
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Amendment 32
Proposal for a directive
Recital 63
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Text proposed by the Commission |
Amendment |
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Amendment 33
Proposal for a directive
Recital 66
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Text proposed by the Commission |
Amendment |
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Amendment 34
Proposal for a directive
Recital 68
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Text proposed by the Commission |
Amendment |
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Amendment 35
Proposal for a directive
Recital 71
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Text proposed by the Commission |
Amendment |
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Amendment 36
Proposal for a directive
Recital 72 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 37
Proposal for a directive
Recital 74
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Text proposed by the Commission |
Amendment |
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Amendment 38
Proposal for a directive
Recital 74 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 39
Proposal for a directive
Recital 80
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Text proposed by the Commission |
Amendment |
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Amendment 40
Proposal for a directive
Recital 80 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 41
Proposal for a directive
Recital 83 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 42
Proposal for a directive
Article 2 — paragraph 1 — subparagraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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The Commission shall review the application of this paragraph. By … (*1) , it shall, on the basis of that review, present a legislative proposal, if appropriate, extend the application of provisions of Title IV other than Article 78 to payment transactions where only one of the payment service providers is located within the Union in respect of those parts of the payments transaction which are carried out in the Union where technically feasible. |
Amendment 43
Proposal for a directive
Article 3 — point d
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Text proposed by the Commission |
Amendment |
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Amendment 44
Proposal for a directive
Article 3 — point j
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Text proposed by the Commission |
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Amendment 45
Proposal for a directive
Article 3 — point k
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Text proposed by the Commission |
Amendment |
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Amendment 46
Proposal for a directive
Article 3 — point k a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 47
Proposal for a directive
Article 3 — point l
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Text proposed by the Commission |
Amendment |
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Amendment 48
Proposal for a directive
Article 4 — point 12
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Text proposed by the Commission |
Amendment |
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Amendment 49
Proposal for a directive
Article 4 — point 18
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Text proposed by the Commission |
Amendment |
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Amendment 50
Proposal for a directive
Article 4 — point 21
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Text proposed by the Commission |
Amendment |
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Amendment 51
Proposal for a directive
Article 4 — point 22
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Text proposed by the Commission |
Amendment |
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Amendment 52
Proposal for a directive
Article 4 — point 26
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Text proposed by the Commission |
Amendment |
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Amendment 53
Proposal for a directive
Article 4 — point 32
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Text proposed by the Commission |
Amendment |
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Amendment 54
Proposal for a directive
Article 4 — point 33
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Text proposed by the Commission |
Amendment |
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Amendment 55
Proposal for a directive
Article 4 — point 38 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 56
Proposal for a directive
Article 4 — point 38 b (new)
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Text proposed by the Commission |
Amendment |
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Amendment 57
Proposal for a directive
Article 4 — point 38 c (new)
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Text proposed by the Commission |
Amendment |
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Amendment 58
Proposal for a directive
Article 4 — point 38 d (new)
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Text proposed by the Commission |
Amendment |
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Amendment 59
Proposal for a directive
Article 4 — point 38 e (new)
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Text proposed by the Commission |
Amendment |
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Amendment 60
Proposal for a directive
Article 5 — paragraph 1 — point g
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Text proposed by the Commission |
Amendment |
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Amendment 61
Proposal for a directive
Article 5 — paragraph 1 — point k
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Text proposed by the Commission |
Amendment |
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Amendment 62
Proposal for a directive
Article 5 — paragraph 3 a — subparagraph 1 (new)
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Text proposed by the Commission |
Amendment |
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3a. EBA shall, after consulting an advisory panel set up in accordance with Article 41 of Regulation (EU) No 1093/2010, which represents all stakeholders, including those operating outside the banking industry, develop draft regulatory technical standards specifying the information to be provided to the competent authorities in the application for the authorisation of payment institutions, including the requirements laid down in points (a), (b), (c), (e) and (g) to (j) of paragraph 1. |
Amendment 63
Proposal for a directive
Article 5 — paragraph 3 a — subparagraph 2 (new)
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Text proposed by the Commission |
Amendment |
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EBA shall submit those draft regulatory technical standards to the Commission by … |
Amendment 64
Proposal for a directive
Article 5 — paragraph 3 a — subparagraph 3 (new)
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Text proposed by the Commission |
Amendment |
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The Commission shall adopt the draft regulatory standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010. |
Amendment 65
Proposal for a directive
Article 9 — paragraph 1 — introductory part
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Text proposed by the Commission |
Amendment |
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1. The Member States or competent authorities shall require a payment institution which provides any payment services and, insofar as it at the same time is engaged in other business activities referred to in Article 17(1)(c) to safeguard all funds which have been received from the payment service users or through another payment service provider for the execution of payment transactions, in either of the following ways: |
1. The Member States or competent authorities shall require a payment institution which provides any payment service listed in Annex I or carries out a business activity referred to in Article 17(1)(c) to safeguard all funds which have been received from the payment service users or through another payment service provider for the execution of payment transactions, in either of the following ways: |
Amendment 66
Proposal for a directive
Article 9 — paragraph 1 — point a
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Text proposed by the Commission |
Amendment |
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Amendment 67
Proposal for a directive
Article 10 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. A payment institution which under the national law of its home Member State is required to have a registered office, shall have its head office in the same Member State as its registered office. |
3. A payment institution which under the national law of its home Member State is required to have a registered office, shall have its head office in the same Member State as its registered office and in which it actually carries out its business activities . |
Amendment 68
Proposal for a directive
Article 12 — paragraph 1 — introductory part
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Text proposed by the Commission |
Amendment |
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1. The competent authorities may withdraw an authorisation issued to a payment institution only where the institution falls within the following cases: |
1. The competent authorities may withdraw an authorisation issued to a payment institution only where the institution falls within any of the following cases: |
Amendment 69
Proposal for a directive
Article 12 — paragraph 1 — point d
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Text proposed by the Commission |
Amendment |
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Amendment 70
Proposal for a directive
Article 13 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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The register shall also identify and give reasons for each withdrawal of authorisation by the competent authorities. |
Amendment 71
Proposal for a directive
Article 14 — paragraph 4 — subparagraph 1
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Text proposed by the Commission |
Amendment |
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4. EBA shall develop draft regulatory technical standards setting technical requirements regarding access to the information contained in the public registers referred to in Article 13 at the Union level. EBA shall submit those draft regulatory technical standards to the Commission by […within two years of the date of entry into force of this Directive] . |
4. EBA shall develop draft regulatory technical standards setting technical requirements regarding access to the information contained in the public registers referred to in Article 13 at the Union level after consulting the advisory panel referred to in Article 5(3a) . |
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EBA shall submit those draft regulatory technical standards to the Commission by … (*2). |
Amendment 72
Proposal for a directive
Article 17 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. When payment institutions engage in the provision of one or more of the payment services, they may hold only payment accounts used exclusively for payment transactions. Member States shall ensure that access to those payment accounts is proportionate. |
2. When payment institutions engage in the provision of one or more of the payment services, they may hold payment accounts used exclusively for payment transactions. Member States shall ensure that payment institutions are granted access to credit institutions' payment and deposit account services, on an objective, non-discriminatory and proportionate basis. Such access shall be extensive enough to allow payment institutions to provide payment services in an unobstructed and efficient manner. |
Amendment 73
Proposal for a directive
Article 21 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. Where there is more than one competent authority for matters covered by this Title on its territory, Member States shall ensure that those authorities cooperate closely so that they can discharge their respective duties effectively. The same applies in cases where the authorities competent for matters covered by this Title are not the competent authorities responsible for the supervision of credit institutions. |
3. Where the authority competent for matters covered by this Title is not the competent authority responsible for the supervision of credit institutions Member States shall ensure that those authorities cooperate closely so that they can discharge their respective duties effectively. |
Amendment 74
Proposal for a directive
Article 22 — paragraph 1 — subparagraph 2 — point a
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Text proposed by the Commission |
Amendment |
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Amendment 75
Proposal for a directive
Article 22 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. Any request for information or documents made by competent authorities of the Member States shall be made on the basis of a decision that specifies its legal basis, the purpose of the request, details of the information or documents required, the time by which they are required and the period for which the information or documents are to be retained. |
Amendment 76
Proposal for a directive
Article 25 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. The competent authorities of the different Member States shall cooperate with each other and, where appropriate, with the European Central Bank and the national central banks of the Member States, EBA and other relevant competent authorities designated under Union or national legislation applicable to payment service providers. |
1. The competent authorities of the different Member States shall cooperate with each other and, where appropriate, with the European Central Bank and the national central banks of the Member States, EBA and other relevant competent authorities designated under Union or national legislation applicable to payment service providers. Where those authorities are processing personal data, they should specify for which precise purpose and mention the appropriate legal basis in Union law. |
Amendment 77
Proposal for a directive
Article 25 — paragraph 2 — point d a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 78
Proposal for a directive
Article 25 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. EBA shall have the mandate to start and promote binding mediation to settle disputes between competent authorities arising out of the exchange of information. |
Amendment 79
Proposal for a directive
Article 26 — paragraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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1a. Member States shall not impose any additional requirements on a Union payment institution wishing to provide payment services in a host Member State which are not applicable to payment institutions authorised by the host Member State. |
Amendment 80
Proposal for a directive
Article 26 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. The competent authorities shall provide each other with all essential and/or relevant information, in particular in the case of infringements or suspected infringements by an agent, a branch or an entity to which activities are outsourced. In this regard, the competent authorities shall communicate, upon request, all relevant information and, on their own initiative, all essential information. |
3. The competent authorities shall provide each other with all essential and/or relevant information, in particular in the case of infringements or suspected infringements by an agent, a branch or an entity to which activities are outsourced. In this regard, the competent authorities shall communicate, upon request, all relevant information and, on their own initiative, all essential information. In the case of retention of personal data, the storage of personal data by competent authorities shall not exceed ten years. In any event, the storage of personal data shall comply with Directive 95/46/EC. |
Amendment 81
Proposal for a directive
Article 26 — paragraph 5
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Text proposed by the Commission |
Amendment |
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5. EBA shall issue guidelines addressed to competent authorities in accordance with Article 16 of Regulation (EU) No 1093/2010 on the elements to be taken into consideration when deciding whether the activity the payment institution notified intends to provide in another Member State under paragraph 1 of this Article would amount to the exercise of the right of establishment or freedom to provide services. Those guidelines shall be issued by […within two years of the date of entry into force of this Directive] . |
5. EBA shall issue guidelines addressed to competent authorities in accordance with Article 16 of Regulation (EU) No 1093/2010 on the elements to be taken into consideration when deciding whether the activity the payment institution notified intends to provide in another Member State under paragraph 1 of this Article would amount to the exercise of the right of establishment or freedom to provide services. Those guidelines shall be issued by … (*3). |
Amendment 82
Proposal for a directive
Article 27 — paragraph 1 — point a
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Text proposed by the Commission |
Amendment |
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Amendment 83
Proposal for a directive
Article 31 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. Member States shall ensure that individuals are provided with appropriate information about the processing of personal data in accordance with national provisions transposing Articles 10 and 11 of Directive 95/46/EC and with Article 11 of Regulation (EC) No 45/2001. |
Amendment 84
Proposal for a directive
Article 33 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. Where the payment service provider may impose charges for information in accordance with paragraph 2, they shall be appropriate and in line with the payment service provider’s actual costs. |
3. Where the payment service provider may impose charges for information in accordance with paragraph 2, they shall be reasonable and in line with the payment service provider’s actual costs. |
Amendment 85
Proposal for a directive
Article 33 — paragraph 3 a (new)
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Text proposed by the Commission |
Amendment |
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3a. Member States shall ensure that consumers who switch their payment account, upon request can receive the transactions carried out on the former payment account recorded on a durable medium from the transferring payment service provider for a reasonable fee. |
Amendment 86
Proposal for a directive
Article 34
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Text proposed by the Commission |
Amendment |
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Member States may stipulate that the burden of proof shall lie with the payment service provider to prove that it has complied with the information requirements set out in this Title. |
Member States shall stipulate that the burden of proof shall lie with the payment service provider to prove that it has complied with the information requirements set out in this Title. |
Amendment 87
Proposal for a directive
Article 37 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall require that before the payment service user is bound by any single payment service contract or offer, the payment service provider, in an easily accessible manner, makes available to the payment service user the information and conditions specified in Article 38. At the payment service user's request, the payment service provider shall provide the information and conditions on paper or on another durable medium. The information and conditions shall be given in easily understandable words and in a clear and comprehensible form, in an official language of the Member State where the payment service is offered or in any other language agreed between the parties. |
1. Member States shall require that before the payment service user is bound by any single payment service contract or offer, the payment service provider, in an easily accessible manner, makes available to the payment service user the information and conditions specified in Article 38 with regard to its own services . At the payment service user's request, the payment service provider shall provide the information and conditions on paper or on another durable medium. The information and conditions shall be given in easily understandable words and in a clear and comprehensible form, in an official language of the Member State where the payment service is offered or in any other language agreed between the parties. |
Amendment 88
Proposal for a directive
Article 37 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. Member States shall require that, where a payment order is initiated by a third-party payment service provider, it makes available to the payment service user the information and conditions referred to in Article 38. The information and conditions shall be given in a clear and understandable form and in an official language of the Member State where the payment service is offered or in any other language agreed between the parties. |
Amendment 89
Proposal for a directive
Article 38 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Member States shall ensure that for payment initiation services, the third party payment service provider shall provide the payer with information about the service offered and contact information to the third party payment service provider. |
2. Member States shall ensure that for payment initiation services, the third party payment service provider shall , prior to initiation, provide the payer with the following clear and comprehensive information: |
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Amendment 90
Proposal for a directive
Article 39 — introductory part
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Text proposed by the Commission |
Amendment |
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Where a third party payment service provider, at the request of the payer, initiates a payment order, it shall provide or make available to the payer and, where applicable, the payee, immediately after initiation, the following data: |
Where a third party payment service provider, at the request of the payer, initiates a payment order, it shall provide to the payer and, where applicable, the payee, immediately after initiation, the following data in a clear and non-ambiguous manner : |
Amendment 91
Proposal for a directive
Article 39 — point a
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Text proposed by the Commission |
Amendment |
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Amendment 92
Proposal for a directive
Article 39 — paragraph 1 — point d
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Text proposed by the Commission |
Amendment |
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Amendment 93
Proposal for a directive
Article 39 — paragraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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This Article is without prejudice to the data protection obligations applicable to the third-party payment service provider and the payee. |
Amendment 94
Proposal for a directive
Article 41 — introductory part
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Text proposed by the Commission |
Amendment |
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Immediately after receipt of the payment order, the payer's payment service provider shall provide or make available to the payer, in the same way as provided for in Article 37(1), the following data: |
Immediately after receipt of the payment order, the account servicing payment service provider shall provide or make available to the payer, in the same way as provided for in Article 37(1), the following data with regard to its own services : |
Amendment 95
Proposal for a directive
Article 42 — introductory part
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Text proposed by the Commission |
Amendment |
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Immediately after the execution of the payment transaction, the payee's payment service provider shall provide or make available to the payee, in the same way as provided for in Article 37(1), all of the following data: |
Immediately after the execution of the payment transaction, the payee's payment service provider shall provide or make available to the payee, in the same way as provided for in Article 37(1), all of the following data with regard to its own services if they are available to him in person : |
Amendment 96
Proposal for a directive
Article 44 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall require that, in good time before the payment service user is bound by any framework contract or offer, the payment service provider provide the payment service user on paper or on another durable medium with the information and conditions specified in Article 45. The information and conditions shall be given in easily understandable words and in a clear and comprehensible form, in an official language of the Member State where the payment service is offered or in any other language agreed between the parties. |
1. Member States shall require that, in good time before the payment service user is bound by any framework contract or offer, the payment service provider make available or, on the request of the payment service user, provide the payment service user on paper or on another durable medium with the information and conditions specified in Article 45. The information and conditions shall be given in easily understandable words and in a clear and comprehensible form, in an official language of the Member State where the payment service is offered or in any other language agreed between the parties. |
Amendment 97
Proposal for a directive
Article 45 — point 2 — point a
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Text proposed by the Commission |
Amendment |
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Amendment 98
Proposal for a directive
Article 45 — point 2 — point c
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Text proposed by the Commission |
Amendment |
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Amendment 99
Proposal for a directive
Article 45 point 6 — point a
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Text proposed by the Commission |
Amendment |
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Amendment 100
Proposal for a directive
Article 47 — paragraph 1 — subparagraph 1
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Text proposed by the Commission |
Amendment |
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1. Any changes in the framework contract as well as the information and conditions specified in Article 45, shall be proposed by the payment service provider in the same way as provided for in Article 44(1) and no later than two months before their proposed date of application. |
1. Any changes in the framework contract which are not clearly and unambiguously more favourable to payment service users as well as the information and conditions specified in Article 45, shall be proposed by the payment service provider in the same way as provided for in Article 44(1) no later than two months before their proposed date of application. |
Amendment 101
Proposal for a directive
Article 47 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Changes in the interest or exchange rates may be applied immediately and without notice, provided that such a right is agreed upon in the framework contract and that the changes are based on the reference interest or exchange rates agreed on in accordance with points (b) and (c) of Article 45(3). The payment service user shall be informed of any change in the interest rate at the earliest opportunity in the same way as provided for in Article 44(1), unless the parties have agreed on a specific frequency or manner in which the information is to be provided or made available. However, changes in interest or exchange rates which are more favourable to the payment service users, may be applied without notice. |
2. Changes in the interest or exchange rates may be applied immediately and without notice, provided that such a right is agreed upon in the framework contract and that the changes in the interest or exchange rates are based on the reference interest or exchange rates agreed on in accordance with points (b) and (c) of Article 45(3). The payment service user shall be informed of any change in the interest rate at the earliest opportunity in the same way as provided for in Article 44(1), unless the parties have agreed on a specific frequency or manner in which the information is to be provided or made available. However, changes in interest or exchange rates which are more favourable to the payment service users, and changes to the framework contract which are clearly and unambiguously more favourable to payment service users, may be applied without notice. |
Amendment 102
Proposal for a directive
Article 48 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Termination of a framework contract concluded for a fixed period exceeding 12 months or for an indefinite period shall be free of charge for the payment service user after the expiry of 12 months . In all other cases charges for the termination shall be appropriate and in line with costs. |
2. Termination of a framework contract shall be free of charge for the payment service user. |
Amendment 103
Proposal for a directive
Article 50 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. A framework contract may include a condition that the information referred to in paragraph 1 is to be provided or made available periodically at least once a month and in an agreed manner which allows the payer to store and reproduce information unchanged. |
2. A framework contract shall include a condition that the information referred to in paragraph 1 is to be provided or made available periodically at least once a month , free of charge and in an agreed manner which allows the payer to store and reproduce information unchanged. |
Amendment 104
Proposal for a directive
Article 50 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. However, Member States may require payment service providers to provide information on paper once a month free of charge. |
3. However, Member States may require payment service providers to provide information on paper or another durable medium once a month free of charge. |
Amendment 105
Proposal for a directive
Article 51 — paragraph 1 — point a
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Text proposed by the Commission |
Amendment |
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Amendment 106
Proposal for a directive
Article 51 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. However, Member States may require payment service providers to provide information on paper once a month free of charge. |
3. However, Member States may require payment service providers to provide information on paper or another durable medium once a month free of charge. |
Amendment 107
Proposal for a directive
Article 52 — paragraph 2 — subparagraph 1
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Text proposed by the Commission |
Amendment |
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2. Where a currency conversion service is offered prior to the initiation of the payment transaction and where that currency conversion service is offered at the point of sale or by the payee, the party offering the currency conversion service to the payer shall disclose to the payer all charges as well as the exchange rate to be used for converting the payment transaction. |
2. Where a currency conversion service is offered prior to the initiation of the payment transaction and where that currency conversion service is offered at an ATM, the point of sale or by the payee, the party offering the currency conversion service to the payer shall disclose to the payer all charges as well as the exchange rate to be used for converting the payment transaction. |
Amendment 108
Proposal for a directive
Article 53 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Where, for the use of a given payment instrument, a payment service provider or a third party requests a charge, he shall inform the payment service user thereof prior to the initiation of the payment transaction. |
deleted |
Amendment 109
Proposal for a directive
Article 53 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. Where a payment service provider is entitled to pass on third party costs to the payer, the payer is not obliged to pay for them unless their full amount was made known prior to the initiation of the payment transaction. |
Amendment 110
Proposal for a directive
Article 55 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. The payment service provider may not charge the payment service user for fulfilment of its information obligations or corrective and preventive measures under this Title, unless otherwise specified in Articles 70(1), 71(5) and 79(2). Those charges shall be agreed between the payment service user and the payment service provider and shall be appropriate and in line with the payment service provider's actual costs. |
1. The payment service provider may not charge the payment service user for fulfilment of its information obligations or corrective and preventive measures under this Title, unless otherwise specified in Articles 70(1), 71(5) and 79(2). Those charges shall be agreed between the payment service user and the payment service provider and shall be appropriate and in line with the payment service provider's actual costs. Upon request, the payment service provider shall disclose the actual cost of the payment transaction. |
Amendment 111
Proposal for a directive
Article 55 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. The payment service provider shall not prevent the payee from requesting from the payer a charge, offering him a reduction or otherwise steering him towards the use of a given payment instrument. Any charges applied shall, however, not exceed the costs borne by the payee for the use the specific payment instrument. |
3. The payment service provider shall not prevent the payee from requesting from the payer a charge, offering him a reduction or otherwise steering him towards the use of a given payment instrument. Any charges applied shall, however, shall not exceed the direct costs borne by the payee for the use the specific payment instrument. |
Amendment 112
Proposal for a directive
Article 55 — paragraph 4 a (new)
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Text proposed by the Commission |
Amendment |
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4a. Notwithstanding paragraph 4, Member States may provide that the payee does not request any charge for the use of any payment instrument. |
Amendment 113
Proposal for a directive
Article 57 — paragraph 2 — subparagraph 1
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Text proposed by the Commission |
Amendment |
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2. Consent to execute a payment transaction or a series of payment transactions shall be given in the form agreed between the payer and the payment service provider. Consent may also be given directly or indirectly via the payee. Consent to execute a payment transaction shall also be considered given where the payer authorises a third party payment service provider to initiate the payment transaction with the account servicing payment service provider. |
2. Consent to execute a payment transaction or a series of payment transactions (including direct debit) shall be given in the form agreed between the payer and the payment service provider. Consent may also be given directly or indirectly via the payee. Consent to execute a payment transaction shall also be considered given where the payer authorises a third party payment service provider to initiate a payment transaction with an account servicing payment service provider servicing an account owned by the payer . |
Amendment 114
Proposal for a directive
Article 58 — title
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Text proposed by the Commission |
Amendment |
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Access to and use of payment account information by third party payment service provider |
Access to and use of payment account information by third party payment service provider and by third-party payment instrument issuers |
Amendment 115
Proposal for a directive
Article 58 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall ensure that a payer has the right to make use of a third party payment service provider to obtain payment services enabling access to payment accounts as referred to in point (7) of Annex I. |
1. Member States shall ensure that a payer , provided that the payer holds a payment account that can be accessed via online banking, has the right to make use of an authorised third party payment service provider, to obtain payment services enabling access to payment accounts as referred to in point (7) of Annex I. Member States shall ensure that a payer has the right to make use of an authorised third-party payment instrument issuer to obtain payment instrument enabling payment transactions. |
Amendment 116
Proposal for a directive
Article 58 — paragraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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1a. The account servicing payment service provider shall not deny access under this Article to the third-party payment service provider or to the third-party payment instrument issuer when it has been authorised to carry out a specific payment on behalf of the payer provided that the payer gives its consent in accordance with Article 57 in an express manner. |
Amendment 117
Proposal for a directive
Article 58 — paragraph 1 b (new)
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Text proposed by the Commission |
Amendment |
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1b. Payees who offer to payers the option of making use of third party payment service providers or third-party payment instrument issuers shall unambiguously provide to payers information about such third party payment service provider(s), including their registration number and the name of their responsible supervisory authority. |
Amendment 118
Proposal for a directive
Article 58 — paragraph 2 — introductory part
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Text proposed by the Commission |
Amendment |
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2. Where a third party payment service provider has been authorised by the payer to provide payment services under paragraph 1, he shall have the following obligations: |
2. Where a third party payment service provider has been authorised by the payer to provide payment services under paragraph 1, it shall have the following obligations: |
Amendment 119
Proposal for a directive
Article 58 — paragraph 2 — point a
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Text proposed by the Commission |
Amendment |
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Amendment 120
Proposal for a directive
Article 58 — paragraph 2 — point b
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Text proposed by the Commission |
Amendment |
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Amendment 121
Proposal for a directive
Article 58 — paragraph 2 — point c
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Text proposed by the Commission |
Amendment |
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Amendment 122
Proposal for a directive
Article 58 — paragraph 2 — point c a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 123
Proposal for a directive
Article 58 — paragraph 3 a (new)
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Text proposed by the Commission |
Amendment |
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3a. Where the payer has given consent to a third-party payment instrument issuer which has provided the payer with a payment instrument to obtain information on the availability of sufficient funds for a specified payment transaction on a specified payment account held by the payer, the account servicing payment service provider of the specified payment account shall provide such information to the third party payment instrument issuer immediately upon receipt of the payer's payment order. The information on the availability of sufficient funds should consist in a simple ‘yes’ or ‘no’ answer and not in a statement of the account balance, in accordance with Directive 95/46/EC. |
Amendment 124
Proposal for a directive
Article 58 — paragraph 4
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Text proposed by the Commission |
Amendment |
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4. Account servicing payment service providers shall treat payment orders transmitted through the services of a third party payment service provider without any discrimination for other than objective reasons in terms of timing and priority vis-à-vis payment orders transmitted directly by the payer himself. |
4. Account servicing payment service providers shall treat payment orders transmitted through the services of a third party payment service provider or by a third-party payment instrument issuer without any discrimination for other than objective reasons in particular in terms of timing and priority or charges vis-à-vis payment orders transmitted directly by the payer himself. |
Amendment 125
Proposal for a directive
Article 58 — paragraph 4 a (new)
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Text proposed by the Commission |
Amendment |
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4a. Third-party payment service providers shall not be required to enter into contractual relationships with account servicing payment service providers in the context of payment initiation or account information services. |
Amendment 126
Proposal for a directive
Article 58 — paragraph 4 b (new)
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Text proposed by the Commission |
Amendment |
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4b. Member States shall ensure that, once the common and secure open standards of communication have been established and are implemented by the account servicing payment service provider of the customer to third-party payment providers as under Article 94a, the payment service user may use the most secure, state of the art, technological solution in the initiation of e-payment transactions through third-party payment service providers. |
Amendment 127
Proposal for a directive
Article 59
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Text proposed by the Commission |
Amendment |
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Article 59 |
deleted |
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Access to and use of payment account information by third party payment instrument issuers |
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1. Member States shall ensure that a payer has the right to make use of a third party payment instrument issuer to obtain payment card services. |
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2. If the payer has given consent to a third party payment instrument issuer which has provided the payer with a payment instrument to obtain information on the availability of sufficient funds for a specified payment transaction on a specified payment account held by the payer, the account servicing payment service provider of the specified payment account shall provide such information to the third party payment instrument issuer immediately upon receipt of the payer's payment order. |
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3. Account servicing payment service providers shall treat payment orders transmitted through the services of a third party payment instrument issuer without any discrimination for other than objective reasons in terms of timing and priority in respect of payment orders transmitted directly by the payer personally. |
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Amendment 128
Proposal for a directive
Article 61 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. For the purposes of point (a) of paragraph 1, the payment service user shall, in particular, as soon as he in receipt of a payment instrument, take all reasonable steps to keep its personalised security features safe. The payment service users' obligations of care shall not inhibit the use of any payment instrument and services authorised under this Directive. |
2. For the purposes of point (a) of paragraph 1, the payment service user shall, in particular, as soon as he in receipt of a payment instrument, take all reasonable steps to keep its personalised security credentials safe. The payment service users' obligations of care shall not inhibit the use of any payment instrument and services authorised under this Directive. |
Amendment 129
Proposal for a directive
Article 62 — paragraph 1 — point a
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Text proposed by the Commission |
Amendment |
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Amendment 130
Proposal for a directive
Article 62 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. The payment service provider shall bear the risk of sending a payment instrument to the payer or of sending any personalised security features of it. |
2. The payment service provider shall bear the risk of sending a payment instrument to the payer or of sending any personalised security credentials of it. |
Amendment 131
Proposal for a directive
Article 63 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Where a third party payment service provider is involved, the payment service user shall also obtain rectification from the account servicing payment service provider pursuant to paragraph 1 of this Article, without prejudice to Articles 65(2) and 80(1). |
2. Where the payment service user has chosen to make use of a third party payment service provider the payment service user shall inform the latter and notify the account servicing payment service provider. The payment service user shall obtain rectification from the account servicing payment service provider pursuant to paragraph 1 of this Article without prejudice to Article 80(1). |
Amendment 132
Proposal for a directive
Article 63 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. The payment service user shall report to its account servicing payment service provider any incident known to them that affects the former in the context of its use of a third-party payment service provider or third-party payment instrument issuer. The account servicing payment service provider shall notify the national competent authorities of any incidents that occur. National competent authorities shall than follow the procedures established by EBA, in close cooperation with the ECB, as laid down in Article 85. |
Amendment 133
Proposal for a directive
Article 64 — paragraph 1 — subparagraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall require that, where a payment service user denies having authorised an executed payment transaction or claims that the payment transaction was not correctly executed, it is for the payment service provider and, if involved and as appropriate , the third party payment service provider, to prove that the payment transaction was authenticated, accurately recorded, entered in the accounts and not affected by a technical breakdown or some other deficiency. |
1. Member States shall require that, where a payment service user denies having authorised an executed payment transaction or claims that the payment transaction was not correctly executed, it is for the payment service provider and, if involved, the third party payment service provider, to prove that the payment transaction was authenticated, accurately recorded, entered in the accounts and not affected by a technical breakdown or some other deficiency. |
Amendment 134
Proposal for a directive
Article 64 — paragraph 1 — subparagraph 2
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Text proposed by the Commission |
Amendment |
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If the payment transaction has been initiated through a third party payment service provider, the burden shall be on the latter to prove that the payment transaction was not affected by a technical breakdown or other deficiencies linked to the payment service it is in charge of. |
If the payment service user initiates the payment transaction through a third party payment service provider, the burden shall be on the latter to prove that the payment transaction was authenticated, accurately recorded and not affected by a technical breakdown or other deficiencies linked to the payment service it is in charge of. |
Amendment 135
Proposal for a directive
Article 64 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Where a payment service user denies having authorised an executed payment transaction, the use of a payment instrument recorded by the payment service provider, including the third party payment service provider as appropriate, shall in itself not necessarily be sufficient to prove either that the payment transaction was authorised by the payer or that the payer acted fraudulently or failed with intent or gross negligence to fulfil one or more of the obligations under Article 61. |
2. Where a payment service user denies having authorised an executed payment transaction, the use of a payment instrument recorded by the payment service provider, including the third party payment service provider as appropriate, shall in itself not necessarily be sufficient to prove either that the payment transaction was authorised by the payer or that the payer acted fraudulently or failed with intent or gross negligence to fulfil one or more of the obligations under Article 61. In such a case mere assumptions without further supporting evidence beyond the recorded use of the payment instrument shall not be considered eligible proof against the payment user. Supporting evidence shall be given by the payment service provider, including the third-party provider as appropriate, to prove fraud or gross negligence on part of the payer. |
Amendment 136
Proposal for a directive
Article 65 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall ensure that, without prejudice to Article 63, in the case of an unauthorised payment transaction, the payer's payment service provider refunds to the payer immediately the amount of the unauthorised payment transaction and, where applicable, restores the debited payment account to the state in which it would have been had the unauthorised payment transaction not taken place. This shall also ensure that the credit value date for the payer's payment account shall be no later than the date the amount had been debited. |
1. Member States shall ensure that, without prejudice to Article 63, in the case of an unauthorised payment transaction, the payer's payment service provider refunds to the payer the amount of the unauthorised payment transaction within 24 hours of having noted or having been notified about the transaction, and, where applicable, restores the debited payment account to the state in which it would have been had the unauthorised payment transaction not taken place. This shall also ensure that the credit value date for the payer’s payment account shall be no later than the date the amount had been debited. |
Amendment 137
Proposal for a directive
Article 65 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Where a third party payment service provider is involved, the account servicing payment service provider shall refund the amount of the unauthorised payment transaction and, where applicable, restore the debited payment account to the state in which it would have been had the unauthorised payment transaction not taken place. Financial compensation to the account servicing payment service provider by the third party payment service provider may be applicable. |
2. Where a third party payment service provider is involved, the account servicing payment service provider shall refund the amount of the unauthorised payment transaction and, where applicable, restore the debited payment account to the state in which it would have been had the unauthorised payment transaction not taken place. If the third party payment service provider cannot demonstrate that it is not liable for the unauthorised payment transaction, it shall, within one business day, compensate the account servicing payment service provider for reasonable costs incurred as a result of the refund to the payer, including the amount of the unauthorised payment transaction. |
Amendment 138
Proposal for a directive
Article 66 — paragraph 1 — subparagraph 1
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Text proposed by the Commission |
Amendment |
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1. By way of derogation from Article 65 the payer may be obliged to bear the losses relating to any unauthorised payment transactions, up to a maximum of EUR 50, resulting from the use of a lost or stolen payment instrument or from the misappropriation of a payment instrument. |
1. By way of derogation from Article 65 the payer may be obliged to bear the losses relating to any unauthorised payment transactions, up to a maximum of EUR 50 or the equivalent in another national currency , resulting from the use of a lost or stolen payment instrument or from the misappropriation of a payment instrument. This shall not apply if the loss, theft or misappropriation of a payment instrument was not detectable to the payer prior to a payment. |
Amendment 139
Proposal for a directive
Article 66 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. EBA shall, in close cooperation with the ECB and after consulting the advisory panel referred to in Article 5(3a), issue guidelines addressed to payment service providers in accordance with Article 16 of Regulation (EU) No 1093/2010 on the interpretation and practical use of the concept of ‘gross negligence’ in this context. Those guidelines shall be issued by [insert date — twelve months from the date of entry into force of this Directive] and be updated on a regular basis as appropriate. |
Amendment 140
Proposal for a directive
Article 66 — paragraph 2 b (new)
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Text proposed by the Commission |
Amendment |
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2b. In cases where the payer has neither acted fraudulently nor with intent failed to fulfil his obligations under Article 61, Member States may reduce the liability referred to in paragraph 1, taking into account, in particular, the nature of the personalised security features of the payment instrument and the circumstances under which it was lost, stolen or misappropriated. |
Amendment 141
Proposal for a directive
Article 66 — paragraph 2 c (new)
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Text proposed by the Commission |
Amendment |
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2c. The payer shall not bear any financial consequences resulting from use of a lost, stolen or misappropriated payment instrument if the resulting unauthorised payment was made possible by a method or a security breach, that had already been known and documented and the payment service provider failed to enhance security schemes to effectively block further attacks of that kind, except where the payer himself has acted fraudulently. |
Amendment 142
Proposal for a directive
Article 67 — paragraph 1 — subparagraph 2
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Text proposed by the Commission |
Amendment |
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At the payment service provider's request, the payer shall bear the burden to prove such conditions are met . |
At the payment service provider's request, the payer shall provide factual elements relating to such conditions. |
Amendment 143
Proposal for a directive
Article 67 — paragraph 1 — subparagraph 3
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Text proposed by the Commission |
Amendment |
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The refund shall consist of the full amount of the executed payment transaction. This includes that the credit value date for the payer's payment account is no later than the date the amount had been debited. |
deleted |
Amendment 144
Proposal for a directive
Article 67 — paragraph 1 subparagraph 4
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Text proposed by the Commission |
Amendment |
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For direct debits the payer has an unconditional right for refund within the time limits set in Article 68 , except where the payee has already fulfilled the contractual obligations and the services have already been received or the goods have already been consumed by the payer. At the payment service provider's request, the payee shall bear the burden to prove that the conditions referred to in the third subparagraph . |
Member States shall ensure that, in addition to the right referred to in paragraph 1, for direct debits the payer has an unconditional right for refund within the time limits set in Article 68. |
Amendment 145
Proposal for a directive
Article 67 — paragraph 3 a (new)
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Text proposed by the Commission |
Amendment |
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3a. The refund shall consist of the full amount of the executed payment transaction. The credit value date for the payer’s payment account shall be no later than the date the amount had been debited. Executing a refund of a payment itself shall not alter the underlying legal claim of the payee. |
Amendment 146
Proposal for a directive
Article 67 — paragraph 3 b (new)
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Text proposed by the Commission |
Amendment |
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3b. Member States may allow their payment service providers to offer more favourable refund rights in accordance with their direct debit schemes providing that they are more advantageous to the payer. |
Amendment 147
Proposal for a directive
Article 67 a (new)
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Text proposed by the Commission |
Amendment |
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Article 67 a |
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Payment transactions where the transaction amount is not known in advance |
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1. For payment transactions, where the transaction amount is not known at the moment of the purchase, Member States shall set the maximum amount of funds which may be blocked on the payer's payment account and maximum time limits for which the funds may be blocked by the payee. |
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2. The payee shall be required to inform the payer prior to the transaction if funds exceeding the amount of the purchase would be blocked on the payer's payment account. |
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3. If funds exceeding the amount of the purchase have been blocked on the payer's payment account, this information shall be provided to the payer by his payment services provider in the account statement. |
Amendment 148
Proposal for a directive
Article 68 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall ensure that the payer can request the refund referred to in Article 67 of an authorised payment transaction initiated by or through a payee for a period of eight weeks from the date on which the funds were debited. |
1. Member States shall ensure that the payer can request the refund referred to in Article 67 of an authorised payment transaction initiated by or through a payee for a period of at least eight weeks from the date on which the funds were debited. |
Amendment 149
Proposal for a directive
Article 69 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall ensure that the point in time of receipt is the time when the payment order initiated directly by the payer or on his behalf by a third party payment service provider or indirectly by or through a payee is received by the payer's payment service provider. If the point in time of receipt is not on a business day for the payer's payment service provider, the payment order shall be deemed to have been received on the following business day. The payment service provider may establish a cut-off time near the end of a business day beyond which any payment order received shall be deemed to have been received on the following business day. |
1. Member States shall ensure that the point in time of receipt is the time when the payment order initiated directly by the payer or on his behalf by a third party payment service provider or indirectly by or through a payee is received by the payer's payment service provider. The point in time of receipt cannot be later than the point in time of debiting the payer's account. If the point in time of receipt is not on a business day for the payer's payment service provider, the payment order shall be deemed to have been received on the following business day. The payment service provider may establish a cut-off time near the end of a business day beyond which any payment order received shall be deemed to have been received on the following business day. |
Amendment 150
Proposal for a directive
Article 70 — paragraph 1 — subparagraph 1
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Text proposed by the Commission |
Amendment |
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1. Where the payment service provider refuses to execute a payment order, the refusal and, if possible, the reasons for it and the procedure for correcting any factual mistakes that led to the refusal shall be notified to the payment service user, unless prohibited by other relevant Union or national legislation. |
1. Where the payment service provider including, where applicable, the third-party payment service provider refuses to execute a payment order or to initiate a payment transaction , the refusal and, if possible, the reasons for it and the procedure for correcting any factual mistakes that led to the refusal shall be notified to the payment service user, unless prohibited by other relevant Union or national legislation. |
Amendment 151
Proposal for a directive
Article 70 — paragraph 1 — subparagraph 3
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Text proposed by the Commission |
Amendment |
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The framework contract may include a condition that the payment service provider may charge for such a notification if the refusal is objectively justified . |
The payment service provider shall not charge the payment service user for such a notification. |
Amendment 152
Proposal for a directive
Article 73 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. This Section shall apply to other payment transactions, unless otherwise agreed between the payment service user and the payment service provider, with the exception of Article 78, which is not at the disposal of the parties. However, when the payment service user and the payment service provider agree on a longer period than those laid down in Article 74, for intra-Union payment transactions such period shall not exceed 4 business days following the point in time of receipt in accordance with Article 69. |
2. This Section shall apply to other payment transactions, unless otherwise agreed between the payment service user and the payment service provider, with the exception of Article 78, which is not at the disposal of the parties. However, when the payment service user and the payment service provider agree on a longer period than those laid down in Article 74, for intra-Union payment transactions such period shall not exceed 4 business days , or such time as permitted by other legal obligations covered by national and Union law, following the point in time of receipt in accordance with Article 69. |
Amendment 153
Proposal for a directive
Article 74 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall require the payer's payment service provider to ensure that, after the point in time of receipt in accordance with Article 69, the amount of the payment transaction is credited to the payee's payment service provider's account at the latest by the end of the next business day. These periods may be extended by a further business day for paper-initiated payment transactions. |
1. Member States shall require the payer's payment service provider to ensure that, after the point in time of receipt in accordance with Article 69, the amount of the payment transaction is credited to the payee's payment service provider's account at the latest by the end of the next business day. That period may be extended by a further business day for paper-initiated payment transactions. |
Amendment 154
Proposal for a directive
Article 79 — paragraph 5 a (new)
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Text proposed by the Commission |
Amendment |
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5a. Member States shall ensure that in case an attempt to recover the funds in accordance to paragraph 3 fails, the payment service provider of the wrongly addressed payee is obliged to provide all necessary information to the payer in order to contact the recipient of the funds and if necessary file a legal claim to re-collect them. |
Amendment 155
Proposal for a directive
Article 80 — paragraph 1 — subparagraph 3
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Text proposed by the Commission |
Amendment |
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Where the payer's payment service provider or a third party payment service provider is liable under the first or the second subparagraph, the relevant payment service provider shall without undue delay refund to the payer the amount of the non-executed or defective payment transaction, and, where applicable, restore the debited payment account to the state in which it would have been had the defective payment transaction not taken place. The credit value date for the payer's payment account shall be no later than the date the amount had been debited. |
Where the payer's payment service provider or a third party payment service provider is liable under the first or the second subparagraph, the relevant payment service provider shall without undue delay refund to the payer the amount of the non-executed or defective payment transaction, and, where applicable, restore the debited payment account to the state in which it would have been had the defective payment transaction not taken place. The credit value date for the payer's payment account shall be no later than the date the amount had been debited. Where this is no longer technically possible, the payer shall also be compensated for loss of interest . |
Amendment 156
Proposal for a directive
Article 80 — paragraph 1 — subparagraph 6
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Text proposed by the Commission |
Amendment |
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In the case of a non-executed or defectively executed payment transaction where the payment order is initiated by the payer, the payment service provider shall regardless of liability under this paragraph, on request, make immediate efforts to trace the payment transaction and notify the payer of the outcome. This shall be free of charge for the payer. |
In the case of a non-executed or defectively executed payment transaction where the payment order is initiated by the payer, the payer's payment service provider shall regardless of liability under this paragraph, on request, make immediate efforts to trace the payment transaction and notify the payer of the outcome. This shall be free of charge for the payer. |
Amendment 157
Proposal for a directive
Article 80 — paragraph 2 — subparagraph 1
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Text proposed by the Commission |
Amendment |
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2. Where a payment order is initiated by or through the payee, the payment service provider shall, without prejudice to Article 63, Article 79(2) and (3), and Article 83, be liable to the payee for correct transmission of the payment order to the payment service provider of the payer in accordance with Article 74(3). Where the payee's payment service provider is liable under this subparagraph, he shall immediately re-transmit the payment order in question to the payment service provider of the payer. In the case of a late transmission of the payment order, the amount shall be value dated on the payee's payment account no later than the date the amount should have been value dated in case of correct execution. |
2. Where a payment order is initiated by or through the payee, the payment service provider shall, without prejudice to Article 63, Article 79(2) and (3), and Article 83, be liable to the payee for correct transmission of the payment order to the payment service provider of the payer in accordance with Article 74(3). Where the payee's payment service provider is liable under this subparagraph, he shall immediately re-transmit the payment order in question to the payment service provider of the payer. In the case of a late transmission of the payment order, the amount shall be value dated on the payee's payment account no later than the date the amount should have been value dated in case of correct execution. Where this is no longer technically possible, the payer shall also be compensated for loss of interest . |
Amendment 158
Proposal for a directive
Article 80 — paragraph 2 — subparagraph 2
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Text proposed by the Commission |
Amendment |
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In addition, the payment service provider of the payee shall, without prejudice to Article 63, Article 79(2) and (3), and Article 83, be liable to the payee for handling the payment transaction in accordance with its obligations under Article 78. Where the payee's payment service provider is liable under this subparagraph, it shall ensure that the amount of the payment transaction is at the payee's disposal immediately after that amount is credited to the payee's payment service provider's account. The amount shall be value dated on the payee's payment account no later than the date the amount should have been value dated in case of correct execution. |
In addition, the payment service provider of the payee shall, without prejudice to Article 63, Article 79(2) and (3), and Article 83, be liable to the payee for handling the payment transaction in accordance with its obligations under Article 78. Where the payee's payment service provider is liable under this subparagraph, it shall ensure that the amount of the payment transaction is at the payee's disposal immediately after that amount is credited to the payee's payment service provider's account. The amount shall be value dated on the payee's payment account no later than the date the amount should have been value dated in case of correct execution. Where this is no longer technically possible, the payer shall also be compensated for loss of interest. |
Amendment 159
Proposal for a directive
Article 80 — paragraph 2 — subparagraph 3
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Text proposed by the Commission |
Amendment |
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In the case of a non-executed or defectively executed payment transaction for which the payee's payment service provider is not liable under the first and second subparagraphs, the payer's payment service provider shall be liable to the payer. Where the payer's payment service provider is so liable he shall, as appropriate and without undue delay, refund to the payer the amount of the non-executed or defective payment transaction and restore the debited payment account to the state in which it would have been had the defective payment transaction not taken place. The credit value date for the payer's payment account shall be no later than the date the amount had been debited. |
In the case of a non-executed or defectively executed payment transaction for which the payee's payment service provider is not liable under the first and second subparagraphs, the payer's payment service provider shall be liable to the payer. Where the payer's payment service provider is so liable he shall, as appropriate and without undue delay, refund to the payer the amount of the non-executed or defective payment transaction and restore the debited payment account to the state in which it would have been had the defective payment transaction not taken place. The credit value date for the payer's payment account shall be no later than the date the amount had been debited. Where this is no longer technically possible, the payer shall also be compensated for loss of interest. |
Amendment 160
Proposal for a directive
Article 80 — paragraph 2 — subparagraph 4
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Text proposed by the Commission |
Amendment |
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In the case of a late executed payment transaction, the payer may decide that the amount shall be value dated on the payee's payment account no later than the date the amount should have been value dated in case of correct execution. |
In the case of a late executed payment transaction, the payer may decide that the amount shall be value dated on the payee's payment account no later than the date the amount should have been value dated in case of correct execution. Where this is no longer technically possible, the payer shall also be compensated for loss of interest . |
Amendment 161
Proposal for a directive
Article 82 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Where the liability of a payment service provider under Article 80 is attributable to another payment service provider or to an intermediary, that payment service provider or intermediary shall compensate the first payment service provider for any losses incurred or sums paid under Article 80. This shall include compensation where any of the payment service providers fail to use strong customer authentication. |
1. Where the liability of a payment service provider under Articles 65 and 80 is attributable to another payment service provider or to an intermediary, that payment service provider or intermediary shall compensate the first payment service provider for any losses incurred or sums paid under Articles 65 and 80. This shall include compensation where any of the payment service providers fail to use strong customer authentication. |
Amendment 162
Proposal for a directive
Article 82 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. EBA shall have the mandate to start and promote binding mediation to settle disputes between competent authorities arising out of the exercise of the rights provided for in this Article. |
Amendment 163
Proposal for a directive
Article 84 — paragraph 1
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Text proposed by the Commission |
Amendment |
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Any processing of personal data for the purposes of this Directive shall be carried out in accordance with Directive 95/46/EC, the national rules which transpose Directive 95/46/EC and Regulation (EC) No 45/2001. |
1. Member States shall permit the processing of personal data by payment systems and payment service providers when this is necessary to safeguard the prevention, investigation and detection of payment fraud. The processing of such personal data shall be carried out in accordance with Directive 95/46/EC, the national rules which transpose Directive 95/46/EC and Regulation (EC) No 45/2001. |
Amendment 164
Proposal for a directive
Article 84 — paragraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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1a. When processing personal data for the purposes of this Directive, the principles of necessity, proportionality, purpose limitation and proportionate data retention period shall be respected; |
Amendment 165
Proposal for a directive
Article 84 — paragraph 1 b (new)
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Text proposed by the Commission |
Amendment |
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1b. In particular, any provider, agent, user processing personal data should only access, process and retain personal data that are necessary for the performance of its payments services. |
Amendment 166
Proposal for a directive
Article 84 — paragraph 1 c (new)
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Text proposed by the Commission |
Amendment |
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1c. Privacy by design/privacy by default shall be embedded in all data processing systems developed and used within the framework of this Directive; |
Amendment 167
Proposal for a directive
Article 84 — paragraph 1 d (new)
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Text proposed by the Commission |
Amendment |
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1d. The documents referred to in Article 5(j) shall, inter alia, also specify the measures aimed to respect the principles of security and confidentiality and to implement the principle of privacy by design and privacy by default. |
Amendment 168
Proposal for a directive
Article 84 — paragraph 1 e (new)
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Text proposed by the Commission |
Amendment |
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1e. The development of standards and ensuring interoperability for the purposes of this Directive shall be based on privacy impact assessment, which shall allow for identifying which are the risks associated to each of the technical options available and which are the remedies that could be put in place to minimise data protection threats. |
Amendment 169
Proposal for a directive
Article 85 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Payment service providers are subject to Directive [NIS Directive] [OP please insert number of Directive once adopted] and notably to the risk management and incident reporting requirements in Articles 14 and 15 therein . |
1. Payment service providers shall establish a framework with appropriate mitigation measures and control mechanisms to manage the operational risks, including security risks, relating to the payment services they provide. As part of that framework payment service providers shall establish and maintain effective incident management procedures, including the detection and classification of major incidents. |
Amendment 170
Proposal for a directive
Article 85 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. The authority designated under Article 6(1) of Directive [NIS Directive] [OP please insert number of Directive once adopted] shall without undue delay inform the competent authority in the home Member State and EBA of the notifications of NIS incidents received from payment services providers . |
2. Payment service providers shall without undue delay notify any major operational incident, including security incidents, to the competent authority in the home Member State of the payment service provider . |
Amendment 171
Proposal for a directive
Article 85 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. Upon the receipt of the notification, the competent authority in the home Member State shall, without undue delay, provide the relevant details of the incident to EBA. |
Amendment 172
Proposal for a directive
Article 85 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. Upon receipt of the notification , and where relevant, EBA shall notify the competent authorities in the other Member States. |
3. Upon receipt of the notification EBA shall , in cooperation with the competent authority in the home Member State, assess the relevance of the incident, and, based on that assessment, notify competent authorities in the other Member States. |
Amendment 173
Proposal for a directive
Article 85 — paragraph 3 a (new)
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Text proposed by the Commission |
Amendment |
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3a. The national competent authority shall act preventively, if necessary, and in order to protect the immediate safety of the financial system. |
Amendment 174
Proposal for a directive
Article 85 — paragraph 4
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Text proposed by the Commission |
Amendment |
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4. In addition to the provisions of Article 14(4) of Directive [NIS Directive] [OP please insert number of Directive once adopted], where the security incident has the potential of impacting the financial interests of the payment service users of the payment service provider, it shall without undue delay notify its payment service users of the incident and inform them of possible mitigation measures that they can take on their side to mitigate the adverse effects of the incident. |
4. Where the security incident has the potential of impacting the financial interests of the payment service users of the payment service provider, it shall without undue delay notify its payment service users of the incident and inform them of all available mitigation measures that they can take on their side to mitigate the adverse effects of the incident. |
Amendment 175
Proposal for a directive
Article 85 — paragraph 4 a (new)
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Text proposed by the Commission |
Amendment |
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4a. EBA shall, in close cooperation with the ECB and after consulting the advisory panel referred to in Article 5(3a), develop guidelines specifying the framework for the notification of major incidents referred in the above paragraphs. The guidelines shall specify the scope and treatment of information to be submitted, including the criteria of relevance of incidents and standard notification templates to ensure a consistent and efficient notification process. |
Amendment 176
Proposal for a directive
Article 85 — paragraph 4 b (new)
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Text proposed by the Commission |
Amendment |
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4b. Member States shall ensure that payment service providers regularly provide data on fraud related to different means of payment to national competent authorities and to EBA. |
Amendment 177
Proposal for a directive
Article 86 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall ensure that payment service providers provide to the authority designated under Article 6(1) of Directive [NIS Directive] [OP please insert number of Directive once adopted] on a yearly basis updated information of the assessment of the operational and security risks associated with the payment services they provide and on the adequacy of the mitigation measures and control mechanisms implemented in response to these risks. The authority designated under Article 6(1) of Directive [NIS Directive] [OP please insert number of Directive once adopted] shall without undue delay transmit a copy of this information to the competent authority in the home Member State. |
1. Member States shall ensure that payment service providers provide to the competent authority on a yearly basis updated and comprehensive information on the assessment of the operational and security risks associated with the payment services they provide and on the adequacy of the mitigation measures and control mechanisms implemented in response to these risks. |
Amendment 178
Proposal for a directive
Article 86 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Without prejudice to Articles 14 and 15 of Directive [NIS Directive] [OP please insert number of Directive once adopted], EBA shall, in close cooperation with the ECB, develop guidelines with regard to the establishment, implementation and monitoring of the security measures, including certification processes when relevant. It shall, inter alia, take into account the standards and/or specifications published by the Commission under Article 16(2) of Directive [NIS Directive] [OP please insert number of Directive once adopted]. |
2. EBA shall, in close cooperation with the ECB, develop implementing technical standards with regard to the establishment, implementation and monitoring of the security measures, including certification processes when relevant. It shall, inter alia, take into account the standards and/or specifications published by the Commission as well as the ECB Eurosystem's recommendations for the security of internet payments under the ‘SecuRePay’ forum . |
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EBA shall submit those draft implementing technical standards to the Commission by … |
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Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1093/2010. |
Amendment 179
Proposal for a directive
Article 86 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. EBA shall, in close cooperation with the ECB, review the guidelines on a regularly basis, but at least every two years. |
3. EBA shall, in close cooperation with the ECB, review the implementing technical standards referred to in paragraph 2 on a regularly basis, but at least every two years. |
Amendment 180
Proposal for a directive
Article 86 — paragraph 4
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Text proposed by the Commission |
Amendment |
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4. Without prejudice to Articles 14 and 15 of Directive [NIS Directive] [OP please insert number of Directive once adopted], EBA shall issue guidelines to facilitate payment service providers in qualifying major incidents and the circumstances under which a payment institution is required to notify a security incident. Those guidelines shall be issued by (insert date — two years of the date of entry into force of this Directive) . |
4. EBA shall coordinate the sharing of information in the area of operational and security risks associated with payment services with the competent authorities and the ECB . |
Amendment 181
Proposal for a directive
Article 87 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Where a payment service provider provides services referred to in point 7 of Annex I, it shall authenticate itself towards the account servicing payment service provider of the account owner. |
2. Where a payment service provider provides services referred to in point 7 of Annex I, it shall authenticate itself towards the account servicing payment service provider of the account owner in accordance with the common and secure open standards of communication as defined under Article 94a . |
Amendment 182
Proposal for a directive
Article 87 — paragraph 3
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Text proposed by the Commission |
Amendment |
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3. EBA shall, in close cooperation with the ECB, issue guidelines addressed to payment service providers as set out in Article 1(1) of this Directive in accordance with Article 16 of Regulation (EU) No 1093/2010 on state of the art customer authentication and any exemption to the use of strong customer authentication. Those guidelines shall be issued by (insert date — two years from the date of entry into force of this Directive) and be updated on a regular basis as appropriate. |
3. EBA shall, in close cooperation with the ECB and after consulting the EDPS and the advisory panel referred to in Article 5(3a) , issue guidelines addressed to payment service providers as set out in Article 1(1) of this Directive in accordance with Article 16 of Regulation (EU) No 1093/2010 on how third-party payment service providers are to be authenticate themselves towards account servicing payment service providers, on state of the art customer authentication and on any exemption to the use of strong customer authentication. Those guidelines shall enter into force before … (*4) and be updated on a regular basis as appropriate. |
Amendment 183
Proposal for a directive
Article 88 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall ensure that procedures are set up which allow payment service users and other interested parties, including consumer associations, to submit complaints to the competent authorities with regard to payment service providers' alleged infringements of this Directive. |
1. Member States shall ensure that procedures are set up which allow payment service users and other interested parties, including consumer associations, to submit complaints to the competent authorities or alternative dispute resolution (ADR) authorities with regard to payment service providers' alleged infringements of this Directive. |
Amendment 184
Proposal for a directive
Article 89 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall designate competent authorities to ensure and monitor effective compliance with this Directive. Those competent authorities shall take all necessary measures to ensure such compliance. They shall be independent from payment service providers. They shall be competent authorities within the meaning of Article 4(2) of Regulation (EU) No 1039 /2010. |
1. Member States shall designate competent authorities to ensure and monitor effective compliance with this Directive. Those competent authorities shall take all necessary measures to ensure such compliance. They shall be independent from payment service providers. They shall be competent authorities as defined in Article 4(2) of Regulation (EU) No 1093 /2010. |
Amendment 185
Proposal for a directive
Article 89 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. The authorities referred to in paragraph 1 shall possess all the powers necessary for the performance of their duties. Where more than one competent authority is empowered to ensure and monitor effective compliance with this Directive, Member States shall ensure that those authorities collaborate closely so that they can discharge their respective duties effectively. |
2. The authorities referred to in paragraph 1 shall possess all the powers and resources necessary for the performance of their duties. |
Amendment 186
Proposal for a directive
Article 89 — paragraph 4 a (new)
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Text proposed by the Commission |
Amendment |
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4a. EBA shall, after consulting the ECB, issue guidelines addressed to the competent authorities in accordance with Article 16 of Regulation (EU) No 1093/2010, on the complaints procedures to be taken into consideration to ensure compliance with the relevant provisions under this Directive as set out under paragraph 1 above. Those guidelines shall be issued by … (*5) and shall be updated on a regular basis, as appropriate. |
Amendment 187
Proposal for a directive
Article 90 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall ensure that payment service providers put in place adequate and effective consumer complaint resolution procedures for the settlement of complaints of payment service users concerning the rights and obligations arising under this Directive. |
1. Member States shall ensure that payment service providers put in place and apply adequate and effective consumer complaint resolution procedures for the settlement of complaints of payment service users concerning the rights and obligations arising under this Directive , and shall monitor their performance in that regard . |
Amendment 188
Proposal for a directive
Article 90 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Member States shall require that payment service providers make every possible effort to reply, in writing, to the payment service users' complaints, addressing all points raised, within an adequate timeframe and at the latest within 15 business days. In exceptional situations, if the answer cannot be given within 15 business days for reasons beyond the control of the payment service provider, it shall be required to send a holding reply, clearly indicating the reasons for a delay in answering to the complaint and specifying the deadline by which the consumer will receive the final reply. That deadline may not, in any case, exceed another 30 business days. |
2. Member States shall require that payment service providers make every possible effort to reply, in writing, to the payment service users' complaints, addressing all points raised, within an adequate timeframe and at the latest within 15 business days. In exceptional situations, if the answer cannot be given within 15 business days for reasons beyond the control of the payment service provider, it shall be required to send a holding reply, clearly indicating the reasons for a delay in answering to the complaint and specifying the deadline by which the consumer will receive the final reply. That deadline may not, in any case, exceed another 15 business days. Where a Member State has more comprehensive complaint resolution procedures governed by the national competent authority the Member State's rules may be applied. |
Amendment 189
Proposal for a directive
Article 90 — paragraph 4
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Text proposed by the Commission |
Amendment |
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4. The information referred to in paragraph 2 shall be mentioned in an easily , directly, prominently and permanently accessible way on the website of the payment service provider , where one exists, in the general terms and conditions of the contract between the payment service provider and the payment service user and in invoices and receipts relating to such contracts . It shall specify how further information on the out-of-court redress entity concerned and on the conditions for using it can be accessed . |
4. The information referred to in paragraph 3 shall be mentioned in a clear, comprehensible and easily accessible way on the trader's website , where one exists and if applicable in the general terms and conditions of the contract of sales or service contracts between the trader and a consumer . |
Amendment 190
Proposal for a directive
Article 91 — paragraph 1
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Text proposed by the Commission |
Amendment |
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1. Member States shall ensure that adequate and effective out-of-court complaint and redress procedures for the settlement of disputes between payment service users and payment service providers concerning the rights and obligations arising under this Directive are established according to the relevant national and Union legislation, using existing bodies where appropriate. Member States shall ensure that such procedures are applicable to payment service providers and that they also cover the activities of appointed representatives. |
1. Member States shall ensure that adequate , independent, impartial, transparent and effective out-of-court complaint and redress procedures for the settlement of disputes between payment service users and payment service providers concerning the rights and obligations arising under this Directive are established according to the relevant national and Union legislation, using existing competent bodies where appropriate. Member States shall ensure that such procedures are applicable to and accessible by both users of payment services and payment service providers and that they also cover the activities of appointed representatives. |
Amendment 191
Proposal for a directive
Article 91 — paragraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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1a. Member States shall ensure that payment service providers adhere to one or more ADR bodies. |
Amendment 192
Proposal for a directive
Article 91 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Member States shall require the bodies referred to in paragraph 1 to cooperate for the resolution of cross-border disputes concerning the rights and obligations arising under this Directive. |
2. Member States shall require the bodies referred to in paragraph 1 to cooperate for the resolution of cross-border disputes concerning the rights and obligations arising under this Directive. Member States shall ensure that those bodies have sufficient capacity to engage in an adequate and efficient way in such cross-border cooperation. |
Amendment 193
Proposal for a directive
Article 92 — paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2а. EBA shall issue guidelines on the penalties referred to in paragraph 2 and shall ensure that they are effective, proportionate and dissuasive. |
Amendment 194
Proposal for a directive
Title 5
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Text proposed by the Commission |
Amendment |
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DELEGATED ACTS |
DELEGATED ACTS AND TECHNICAL STANDARDS |
Amendment 195
Proposal for a directive
Article 93 a (new)
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Text proposed by the Commission |
Amendment |
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Article 93a |
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Technical Standards |
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EBA shall develop draft regulatory technical standards to specify the conditions of application of the own funds requirements in Articles 7 and 8 and of the safeguarding requirements in Article 9. |
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EBA shall submit those draft regulatory technical standards to the Commission by … |
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Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010. |
Amendment 196
Proposal for a directive
Article 94 — paragraph 5
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Text proposed by the Commission |
Amendment |
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5. A delegated act adopted pursuant to Article 93 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. |
5. A delegated act adopted pursuant to Article 93 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. |
Amendment 197
Proposal for a directive
Article 94 a (new)
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Text proposed by the Commission |
Amendment |
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Article 94a |
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Common and secure open standards of communication |
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1. EBA shall, in close cooperation with the ECB and after consulting the advisory panel referred to in Article 5(3a),develop draft regulatory technical standards in the form of common and secure open standards of communication to establish how account servicing payment service providers and third-party payment service providers or third-party payment instrument issuers are to communicate with each other. |
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EBA shall submit those draft regulatory technical standards the Commission by … (*6) . |
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Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010. |
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2. The common and secure open standards of communication referred to in paragraph 1 shall include technical and functional specifications for the transmission of information and shall focus on optimising the security and the efficiency in the communication. |
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3. The common and secure open standards of communication shall in particular, on the basis of the provisions in Articles 58 and 87, specify how third-party payment service providers are to authenticate themselves towards account servicing payment service providers and how account servicing payment providers are to notify and inform third-party payment service providers. |
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4. EBA shall, in close cooperation with the ECB, ensure that the common and secure open standards of communication are developed after an appropriate consultation of all stakeholders in the payment services market including stakeholders operating outside the banking industry. |
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5. Member States shall ensure that the common and secure open standards of communication are used by the account servicing payment service providers, the third-party payment service providers and the third-party payment issuers. |
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6. The common and secure open standards of communication shall be subject to regular review in order to take account of innovation and technical developments. |
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7. This Article shall not preclude the application of other obligations laid down in this Directive. |
Amendment 198
Proposal for a directive
Article 94 b (new)
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Text proposed by the Commission |
Amendment |
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Article 94b |
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1. EBA shall make available on its website a list of all the authorised payment services providers within the Union. |
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2. That list shall refer to all authorised payment services providers whose registration as being revoked and the reasons therefor. |
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3. All payment service providers shall offer direct links on their websites to the website of the home competent authority that lists all the authorised payment services providers. |
Amendment 199
Proposal for a directive
Article 94 c (new)
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Text proposed by the Commission |
Amendment |
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Article 94c |
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Obligation to inform consumers of their rights |
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1. By … (*7) , the Commission shall, following a public consultation on a draft, produce a user friendly electronic leaflet listing, in a clear and easily comprehensible manner, the rights of consumers under this Directive and related Union law. |
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2. The leaflet referred to in paragraph 1 shall be made available to all consumers in the Union and other interested parties on the websites of the Commission, EBA and national banking regulators and shall be easy to download and to transfer to other websites. The Commission shall inform Member States, payment service providers and consumer associations of the publication of the leaflet. |
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3. Payment service providers shall ensure that the leaflet in its original format is made available to all consumers, including non-customers, electronically on their websites and on paper at their branches, their agents and the entities to which their activities are outsourced. |
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At those branches, agents and entities, the following clearly legible notice containing the following text shall be displayed in a manner clearly visible to consumers: ‘Ask at the counter for the text stating your rights as a payment services user’. |
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On their websites, the following clearly visible notice shall be displayed: ‘Click here for your rights as a payment services user’. Payment service providers shall also ensure that such information is easily accessible by its clients at all times via their online accounts, when available. |
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4. The leaflet shall, in particular, be distributed electronically or on paper when the client enters into any type of contract or, for clients who are existing clients at the date of publication of the leaflet, by notifying them within one year of publication by the Commission of the leaflet. |
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5. All payment service providers shall offer direct links on their websites to the website of the competent authority that lists all the certified payment services providers. |
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6. Payment service providers shall not charge their clients for providing information under this Article. |
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7. In respect of blind and partially sighted persons, the provisions of this Article shall be applied using appropriate alternative means. |
Amendment 200
Proposal for a directive
Article 95 — paragraph 2
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Text proposed by the Commission |
Amendment |
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2. Where a Member State makes use of any of the options referred to in paragraph 1, it shall inform the Commission thereof as well as of any subsequent changes. The Commission shall make the information public on a web-site or other easily accessible means. |
2. Where a Member State makes use of any of the options referred to in paragraph 1, it shall inform the Commission thereof as well as of any subsequent changes. The Commission shall make the information public on a web-site or other easily accessible means and shall simultaneously advise the European Parliament thereof . |
Amendment 201
Proposal for a directive
Article 96 — paragraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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By … (*8) , the Commission shall present a report, if appropriate accompanied by a legislative proposal, on the impact of including three-party schemes in the scope of the provisions regarding access to payment systems, having regard in particular to the level of competition and the market share of the card schemes. |
(1) The matter was referred back to the committee responsible for reconsideration pursuant to Rule 57(2), second subparagraph (A7-0169/2014).
(24) COM(2012) 941 final.
(24) COM(2012)0941.
(25) Directive XXXX/XX/EU of the European Parliament and of the Council of [date] concerning measures to ensure a high common level of network and information security across the Union (OJ L x, p x).
(25) Directive XXXX/XX/EU of the European Parliament and of the Council of [date] concerning measures to ensure a high common level of network and information security across the Union (OJ L x, p x).
(1a) Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).
(26) Regulation (EU) No [XX/XX/XX/] of the European Parliament and of the Council [date] on interchange fees for card-based payment transactions (OJ L x, p. x).
(26) Regulation (EU) No [XX/XX/XX/] of the European Parliament and of the Council [date] on interchange fees for card-based payment transactions (OJ L x, p. x).
(37) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(38) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.01.2001, p. 1).
(37) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(38) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.01.2001, p. 1).
(40) Regulation (EC) No 593/2008 of the European parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (ROME I) (OJ L 177, 4.7.2008, p. 6).
(40) Regulation (EC) No 593/2008 of the European parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (ROME I) (OJ L 177, 4.7.2008, p. 6).
(*1) Two years after the date of entry into force of this Directive.
(45) Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (OJ L 309, 25.11.2005, p. 15)
(46) Regulation (EC) No 1781/2006 of the European Parliament and of the Council of 15 November 2006 on information on the payer accompanying transfers of funds (OJ L 345, 8.12.2006, p. 1).
(45) Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (OJ L 309, 25.11.2005, p. 15)
(46) Regulation (EC) No 1781/2006 of the European Parliament and of the Council of 15 November 2006 on information on the payer accompanying transfers of funds (OJ L 345, 8.12.2006, p. 1).
(*2) Two years after the date of entry into force of this Directive.
(*3) 12 months after the date of entry into force of this Directive.
(*4) Date of transposition of this Directive (two years after the date of adoption of this Directive)
(*5) Two years after the date of entry into force of this Directive.
(*6) 12 months after the date of entry into force of this Directive.
(*7) Two years after the entry into force of this Directive.
(*8) Two years after the date of entry into force of this Directive.
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/512 |
P7_TA(2014)0281
European single market for electronic communications ***I
European Parliament legislative resolution of 3 April 2014 on the proposal for a regulation of the European Parliament and of the Council laying down measures concerning the European single market for electronic communications and to achieve a Connected Continent, and amending Directives 2002/20/EC, 2002/21/EC, 2002/22/EC, and Regulations (EC) No 1211/2009 and (EU) No 531/2012 (COM(2013)0627 — C7-0267/2013 — 2013/0309(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/29)
The European Parliament,
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having regard to the Commission proposal to Parliament and the Council (COM(2013)0627), |
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— |
having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0267/2013), |
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having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
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— |
having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Irish House of Representatives and the Irish Senate, the Maltese Parliament, the Austrian Federal Council and the Swedish Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity, |
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having regard to the opinion of the European Economic and Social Committee of 21 January 2014 (1), |
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having regard to the opinion of the Committee of the Regions of 31 January 2014 (2), |
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having regard to Rule 55 of its Rules of Procedure, |
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having regard to the report of the Committee on Industry, Research and Energy and the opinions of the Committee on the Internal Market and Consumer Protection, the Committee on Regional Development, the Committee on Culture and Education, the Committee on Legal Affairs and the Committee on Civil Liberties, Justice and Home Affairs (A7-0190/2014), |
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1. |
Adopts its position at first reading hereinafter set out; |
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2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
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3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 177, 11.6.2014, p. 64.
(2) OJ C 126, 26.4.2014, p. 53.
P7_TC1-COD(2013)0309
Position of the European Parliament adopted at first reading on 3 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council laying down measures concerning the European single market for electronic communications and to achieve a Connected Continent, and amending Directives 2002/20/EC, 2002/21/EC and 2002/22/EC, Regulations (EC) No 1211/2009 and (EU) No 531/2012 and Decision No 243/2012/EU [Am. 1]
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national Parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
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(1) |
Europe has to tap all sources of growth to exit the crisis, create jobs and regain its competitiveness. Restoring growth and job creation in the Union is the aim of the Europe 2020 Strategy. Furthermore, the Digital Sphere has become a part of the public space where new forms of cross-border trade are established, and business opportunities for European companies in the global digital economy are being created along with innovative market development and social and cultural interaction. The 2013 Spring European Council stressed the importance of the digital single market for growth and called for concrete measures, in order to establish a single market in information and communications technology (ICT) as early as possible. In line with the objectives of the Europe 2020 Strategy and with this call, this regulation aims at establishing contributing to the establishment of a single market for electronic communications by completing and adapting the existing Union Regulatory Framework for Electronic Communications (Directives 2002/19/EC (4), 2002/20/EC (5), 2002/21/EC (6), 2002/22/EC (7), 2002/58/EC (8) of the European Parliament and of the Council, Commission Directive 2002/77/EC (9), as well as Regulations (EC) No 1211/2009 (10), (EU) No 531/2012 (11) of the European Parliament and of the Council and Decision No 243/2012/EU of the European Parliament and of the Council (12)) in certain respects, and by defining the overall content, aim and timing of the next review of that framework . [Am. 2] |
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(2) |
The Digital Agenda for Europe (DAE), one of the flagship initiatives of Europe 2020 Strategy, has already recognised the role of ICT and network connectivity as an indispensable basis for the development of our economy and society. For Europe to reap the benefits of digital transformation, the Union needs a dynamic single market in electronic communications for all sectors and across all of Europe. Such a truly single communications market will be the backbone of an innovative and ‘smart’ digital economy and a foundation of the digital single market where online services can freely flow across borders within a single, open, standardised and interoperable framework . [Am. 3] |
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(3) |
In a seamless single market in electronic communications, The freedom to provide electronic communications networks and services to every customer in the Union and the right of each user to choose the best offer available on the market should be ensured and should not be hindered by the fragmentation of markets along national borders. The current regulatory framework for electronic communications , while recognising and allowing for objectively different conditions in the Member States, does not fully address such fragmentation, with due to other causes, with diverging national, rather than Union-wide implementation of the general authorisation regimes, regime , national spectrum assignment schemes, differences of access products available for electronic communications providers in different and different sets of sector-specific consumer rules applicable. For example, while Directive 2002/20/EC (Authorisation Directive)limits the type of information which may be required, 12 Member States, and different sets of sector-specific consumer rules applicable. The Union rules in many cases merely define a baseline, and are often implemented in diverging ways demand additional detail such as a categorisation of the intended types of activities, the geographical scope of the activity, the targeted market, the company structure, including names of shareholders and of shareholders of shareholders, Chamber of Commerce certification and a criminal records of the representative of the undertaking. Additional requirements such as these underline the importance of a firm policy by the Member States Commission regarding infringement procedures . [Am. 4] |
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(4) |
A truly single market for electronic communications should promote competition, coordination, investment, innovation and more capacity in new and enhanced networks and services by fostering market integration and cross-border service offerings , and should reduce to a minimum unnecessary regulatory burdens on undertakings . It should thus help to achieve , and even surpass, the ambitious high-speed broadband targets set out in the DAE and facilitate the emergence of services and applications that are able to exploit open data and formats in an interoperable, standardised and safe way, ensuring that they are available at the same functional and non-functional levels throughout the Union . The growing availability of digital infrastructures and services should in turn increase consumer choice, quality of service and diversity of content, and contribute to territorial and social cohesion, as well as facilitating mobility across the Union. [Am. 5] |
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(4a) |
As the European Parliament’s Directorate-General for Internal Policies (Policy Department B — Structural and Cohesion Policies) stresses in its 2013 study entitled ‘Internet, Digital Agenda and Economic Development of European Regions’ (‘the study’), a favourable regional context in terms of acceptance and receptiveness of ICT and information society development is an important or even decisive factor as this is the privileged place where demand for ICT development can emerge. [Am. 6] |
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(4b) |
As the study notes, the regional level is pertinent for identifying the opportunities offered by the Information Society and for carrying out plans and programmes in support of it. The study also points out that the interplay between the different levels of governance yields great potential for growth. Top-down initiatives and bottom-up projects should be combined, or at least developed in parallel, in order to attain the objective of creating a common digital market. [Am. 7] |
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(4c) |
If a European single market for electronic communications is to be established and territorial and social cohesion are to be strengthened, investment priority (2)(a) laid down in Article 5 of Regulation (EU) No 1301/2013 of the European Parliament and of the Council (13) should be implemented with a view to improving broadband access and high-speed networks and supporting the use of new technologies and networks in the digital economy and all European regions should be put in a position to make investments in this area, as specified in Article 4 of that Regulation. [Am. 8] |
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(4d) |
Investment in the latest infrastructure, which is essential if people in the Union are to be in a position to take advantage of new, innovative services must not be restricted to central or densely populated areas where it is certain to yield a return. Such investment must also be made at the same time in outlying and outermost regions, which are less densely populated and less developed, so that these regions do not fall even further behind. [Am. 9] |
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(5) |
The benefits arising from a single market for electronic communications should extend to the wider digital ecosystem that includes Union equipment manufacturers, content and application and software providers and the wider economy, covering sectors such as education, banking, automotive, logistics, retail, energy , medicine, mobility and transport, and the intelligent management of emergencies and natural disasters, which rely on connectivity and broadband to enhance their productivity , quality and end-user provision through, for example, ubiquitous cloud applications, advanced analysis of big data from communications networks, connected and interoperable objects and possibilities for integrated cross-border service provision for different parts of the company. , against a background of open-standard system interoperability and open data . Citizens, public administrations and the health sector should also benefit from a wider availability of e-government and e-health services. The offer of cultural and educational content and services, and cultural diversity in general, may be also enhanced in a single market for electronic communications. The provision of connectivity communications through electronic communications networks and services is of such importance to the wider economy and society and to the smart cities of the future that unjustified sector-specific burdens, whether regulatory or otherwise, should be avoided. [Am. 10] |
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(6) |
This Regulation aims at moving further towards the completion of the single electronic communications market through action on three broad, inter-related axes. First, it should secure affirm the freedom to provide electronic communications services across borders and networks in different Member States, building on the concept of a single EU authorisation which puts in place the conditions for ensuring greater consistency and predictability in the content and implementation of sector-specific regulation throughout the Union by harmonising and simplifying the application of the general authorisation scheme . Second, it is necessary to enable access on much more convergent terms and conditions to essential inputs for the cross-border provision of electronic communications networks and services, not only address the conditions and procedures for granting spectrum licenses for wireless broadband communications, for which both licensed and as well as the use of unlicensed spectrum is key, but also for fixed line connectivity. Third, in the interests of aligning business conditions and building the digital confidence of citizens, this Regulation should harmonise address rules on the protection of end-users, especially consumers. This includes rules on non-discrimination, contractual information, termination of contracts and switching, in addition to rules on access to online content, applications and services and on traffic management and shared, common standards on user privacy and data protection and security, which not only protect end-users but simultaneously guarantee the continued functioning of the Internet ecosystem as an engine of innovation. In addition, further reforms in the field of roaming should give end-users the confidence to stay connected when they travel in the Union, and should become over time a driver of convergent pricing and other conditions without being subject to additional charges over and above the tariffs which they pay in the Union Member State where their contract was concluded . [Am. 11] |
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(7) |
This Regulation should therefore complement supplement the existing Union regulatory framework and the applicable national legislations adopted in conformity with Union law, by introducing certain targeted measures establishing specific rights and obligations for both electronic communications providers and end-users, by making consequential amendments to the existing Directives and to Regulation (EU) No 531/2012 in order to secure greater convergence as well as some substantive changes consistent with a more competitive Single Market. [Am. 12] |
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(8) |
The measures provided in this Regulation respect the principle of technological neutrality, that is to say they neither impose nor discriminate in favour of the use of a particular type of technology. |
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(9) |
The provision of cross-border electronic communications is still subject to greater burdens than those confined to the national borders. In particular, cross-border providers still need to notify and pay fees in individual host Member States. Holders of a single EU A certain degree of harmonisation of the general authorisation should be subject to a single notification system in the Member State of their main establishment (home Member State), which will reduce the administrative burden for cross-border operators. The single EU authorisation should apply to any undertaking that provides or intends , involving the Body of European Regulators for Electronic Communications (BEREC) as the recipient of notifications, should further ensure the practical effectiveness of the freedom to provide electronic communications services and networks in more than one Member State, thereby entitling it to enjoy the rights attached to the freedom to provide electronic communications services and networks in accordance with this Regulation in any Member State. A single EU authorisation defining the legal framework applicable to electronic communications operators providing services across Member States on the basis of a general authorisation in the home Member State should ensure the effectiveness of the freedom to provide electronic communications services and networks in the whole Union the whole Union. Furthermore, notification is not mandatory in order to benefit from the general authorisation scheme and not all Member States require it. As a notification requirement imposes an administrative burden on the operator, Member States requiring notification should show that it is justified, in line with Union policy on abolishing unnecessary regulatory burdens. The Commission should be required to evaluate such requirements and, where appropriate, be empowered to request their removal. [Am. 13] |
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(10) |
The provision of electronic communications services or networks across borders may take different forms, depending on several factors such as the kind of network or services provided, the extent of the physical infrastructure needed or the number of subscribers in the different Member States. The intention to provide electronic communications services cross-border or to operate an electronic communications network in more than one Member State may be demonstrated by activities such as negotiation of agreements on access to networks in a given Member State or marketing via an internet site in the language of the targeted Member State. [Am. 14] |
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(11) |
Irrespective of how the provider chooses to operate electronic communications networks or provide electronic communications services across borders, the regulatory regime applicable to a European electronic communications provider should be neutral vis-à-vis the commercial choices which underlie the organisation of functions and activities across Member States. Therefore, regardless of the corporate structure of the undertaking, the home Member State of a European electronic communications provider should be considered to be the Member State where the strategic decisions concerning the provision of electronic communications networks or services are taken. [Am. 15] |
|
(12) |
The single EU authorisation should be based on the general authorisation in the home Member State. It should not be made subject to conditions which are already applicable by virtue of other existing national law which is not specific to the electronic communications sector. In addition, the provisions of this Regulation and Regulation (EU) No 531/2012 should also apply to European electronic communications providers. [Am. 16] |
|
(13) |
Most sector-specific conditions, for example concerning access to or security and integrity of networks or access to emergency services, are strongly linked to the place where such network is located or the service is provided. Consequently a European electronic communications provider may be subject to conditions applicable in the Member States where it operates, to the extent that this Regulation does not provide otherwise. [Am. 17] |
|
(14) |
Where Member States require contribution from the sector in order to finance universal service obligations and to the administrative costs of the national regulatory authorities, the criteria and procedures for apportioning contributions should be proportionate and non-discriminatory with regard to European electronic communications providers, so as not to hinder cross-border market entry, in particular of new entrants and smaller operators; individual undertakings’ contributions should therefore take into account the contributor’s market share in terms of turnover realised in the relevant Member State and should be subject to the application of a de minimis threshold. |
|
(15) |
It is necessary to ensure that in similar circumstances there is no discrimination in the treatment of any European electronic communications provider by different Member States and that consistent regulatory practices are applied in the single market, in particular as regards measures falling within the scope of Articles 15 or 16 of Directive 2002/21/EC, or Articles 5 or 8 of Directive 2002/19/EC. European electronic communications providers should therefore have a right to equal treatment by the different Member States in objectively equivalent situations in order to enable more integrated multi-territorial operations. Furthermore, there should be s pecific procedures at Union level for the review of draft decisions on remedies within the meaning of Article 7a of Directive 2002/21/EC in such cases, in order to avoid unjustified divergences in obligations applicable to European electronic communications providers in different Member States. The principle of equal treatment is a general principle of European Union law enshrined in Articles 20 and 21 of the Charter of Fundamental Rights of the European Union. According to settled case-law, that principle requires that comparable situations must not be treated differently and that different situations must not be treated in the same way unless such treatment is objectively justified. It is necessary to ensure that in similar circumstances there is no discrimination in the treatment of any electronic communications provider by different Member States and that consistent regulatory practices are applied in the single market, in particular as regards measures falling within the scope of Articles 15 or 16 of Directive 2002/21/EC, or Articles 5 or 8 of Directive 2002/19/EC. [Am. 18] |
|
(16) |
An allocation of regulatory and supervisory competences should be established between the home and any host Member State of European electronic communications providers with a view to reducing the barriers to entry while ensuring that the applicable conditions for the provision of electronic communications services and networks by these providers are properly enforced. Therefore, while each national regulatory authority should supervise compliance with the conditions applicable in its territory in accordance with Union legislation, including by means of sanctions and interim measures, only the national regulatory authority in the home Member State should be entitled to suspend or withdraw the rights of a European electronic communications provider to provide electronic communications networks and services in the whole Union or part thereof. [Am. 19] |
|
(17) |
Radio spectrum is a public good and an essential finite resource vital for the achievement of a wide range of social, cultural and economic values for the internal market for mobile, wireless broadband, broadcasting and satellite communications in the Union. Radio spectrum policy in the Union should contribute to the freedom of expression, including the freedom of opinion and the freedom to receive and disseminate information and ideas, irrespective of borders, as well as freedom and plurality of the media. Development of wireless broadband communications contributes to the implementation of the Digital Agenda for Europe and in particular to the aim of securing access to broadband at a speed of no less than 30 Mbps by 2020 for all Union citizens and of providing the Union with the highest possible broadband speed and capacity. However, while some regions of the Union has fallen behind other major global regions — North America, Africa and parts of Asia — in terms of the roll-out and penetration of the latest generation of are far advanced, both with respect to the policy goals of the Digital Agenda for Europe and globally, others have been lagging behind. In particular, this is partly due to the fragmentation of the Union process for making available spectrum particularly suitable for high speed wireless broadband technologies that are necessary to achieve access, which jeopardises the achievement of those policy goals for the Union as a whole. The piecemeal process of authorising and making available the 800 MHz band for wireless broadband communications, with over half of the Member States seeking having been granted a derogation by the Commission or otherwise failing to do so by the deadline laid down in Decision No 243/2012/EU, testifies to the urgency of action even within the term of the current Radio Spectrum Policy Programme. It also indicates a need for improvement in the Commission's exercise of its powers, of crucial importance for the loyal implementation of Union measures and sincere cooperation between Member States. Stringent efforts by the Commission to enforce already adopted Union measures to harmonise the conditions of availability and efficient use of radio spectrum for wireless broadband communications pursuant to Decision 676/2002/EC of the European Parliament and of the Council (14) have not been sufficient to address should, by themselves, contribute substantially to addressing this problem. [Am. 20] |
|
(17a) |
Trading and leasing of spectrum harmonised for wireless broadband communications increases flexibility and leads to more efficient allocation of spectrum resources. It should therefore be further facilitated and stimulated, including by ensuring that all rights of use, including those already granted, are of a sufficiently long duration. [Am. 21] |
|
(18) |
The application of various national policies creates inconsistencies and fragmentation of the internal market which hamper the roll-out of Union-wide services and the completion of the internal market for wireless broadband communications. It could in particular create unequal conditions for access to such services, hamper competition between undertakings established in different Member States and stifle investments in more advanced networks and technologies and the emergence of innovative services, thereby depriving citizens and businesses of ubiquitous integrated high-quality services and wireless broadband operators of increased efficiency gains from large-scale more integrated operations. Therefore, action at Union level regarding certain aspects of radio spectrum assignment should accompany the development of wide integrated coverage of advanced wireless broadband communications services throughout the Union. At the same time, sufficient flexibility is needed to accommodate specific national requirements and Member States should retain the right to adopt measures to organise their radio spectrum for purposes of public order, public security purposes and defence and defence, safeguarding and promoting general interest objectives such as linguistic and cultural diversity and media pluralism . [Am. 22] |
|
(19) |
Electronic communications services providers, including mobile operators or consortia of such operators, should be able to collectively should be able to collectively organise the efficient , technologically modern, advanced and affordable coverage of a vast part of the Union's territory to the long-term benefit of end users, and therefore use radio spectrum across several Member States with similar conditions, procedures, costs, timing, duration in harmonised bands, and with complementary radio spectrum packages, such as a combination of lower and higher frequencies for coverage of densely and less densely populated areas. Initiatives in favour of greater coordination and consistency would also enhance the predictability of the network investment environment. Such predictability would also be greatly favoured by a clear policy in favour of long-term duration of rights of use related to radio spectrum, without prejudice to the indefinite character of such rights in some Member States, and linked in its turn to clear improved conditions for the transfer, lease or sharing of part of all of the radio spectrum subject to such an individual right of use. [Am. 23] |
|
(20) |
Coordination and consistency of rights of use for radio spectrum should be improved, at least for the bands which have been harmonised for wireless fixed, nomadic and mobile broadband communications. This includes the bands identified at ITU level for International Mobile Telecommunications (IMT) Advanced systems, as well as bands used for radio local area networks (RLAN) such as 2,4 GHz and 5 GHz. It should also extend to bands that may be harmonised in the future for wireless broadband communications, as envisaged in Article 3(b) of the RSPP and in the RSPG Opinion on ‘Strategic challenges facing Europe in addressing the growing radio spectrum demand for wireless broadband’ adopted on 13 June 2013, such as, in the near future, the 700 MHz, 1.5 GHz and 3.8-4.2 GHz bands. Considering the significant societal, cultural, social and economic impact of decisions regarding spectrum, such decisions should take due account of the considerations mentioned in Article 8a of Directive 2002/21/EC and, where relevant , of the general-interest objectives mentioned in Article 9(4) of that Directive . [Am. 24] |
|
(21) |
Consistency between the different national radio spectrum assignment procedures would be favoured by more explicit provisions on the criteria relevant to the timing of authorisation procedures; the duration for which the rights of use are granted, fees and their payment modalities; capacity and coverage obligations; definition of the range of radio spectrum and spectrum blocks subject to a granting procedure; objective threshold requirements for the promotion of effective competition; conditions for the tradability of rights of use, including sharing conditions. |
|
(22) |
Limitation of the burden of fees to what is required by optimal radio spectrum management, with a balance between immediate payments and periodic fees, would encourage investment in infrastructure and technology roll-out, and pass-on of the attendant cost advantages to end users. |
|
(23) |
More synchronised radio spectrum assignments and consequential wireless broadband roll-out across the Union should support the achievement of scale effects in related industries such as for network equipment and terminal devices. Such industries could in turn take into account Union initiatives and policies regarding radio spectrum use, to a greater extent than has recently been the case. A harmonisation procedure for the timetables for assignment and minimum or common duration of rights of use in such bands should therefore be established. |
|
(24) |
As regards the other main substantive conditions which may be attached to rights of use of radio spectrum for wireless broadband, The convergent application by individual Member States of the regulatory principles and criteria set down in this Regulation the Union regulatory framework would be favoured by a coordination mechanism whereby the Commission and the competent authorities of the other Member States have an opportunity to comment in advance of the granting of rights of use by a given Member State and whereby the Commission has an opportunity, taking into account the views of the Member States, to forestall implementation of any proposal which appears to be non-compliant with Union law. [Am. 25] |
|
(25) |
Considering the massive growth in radio spectrum demand for wireless broadband, solutions for alternative spectrally efficient access to wireless broadband should be promoted. This encouraged and not prevented. This currently includes but is not restricted to the use of low-power wireless access systems with a small-area operating range such as so called ‘hotspots’ of radio local area networks (RLAN, also known as ‘Wi-Fi’), as well as networks of low-power small size cellular access points (also called femto-, pico- or metrocells). Dynamic spectrum access, including on a licence-exempt basis and other innovative technologies and uses of spectrum should be encouraged and made possible. [Am. 26] |
|
(26) |
Complementary wireless access systems such as RLAN, in particular publicly accessible RLAN access points, increasingly allow access to the internet for end users and allow mobile traffic off-loading by mobile operators, using harmonised radio spectrum resources without requiring an individual authorisation or right of use of the radio spectrum. |
|
(27) |
Most RLAN access points are so far used by private users as a local wireless extension of their fixed broadband connection. If end users, within the limits of their own internet subscription, choose to share access to their RLAN with others, the availability of a large number of such access points, particularly in densely populated areas, should maximise wireless data capacity through radio spectrum re-use and create a cost-effective complementary wireless broadband infrastructure accessible to other end users. Therefore, unnecessary restrictions for end users to share access to their own RLAN access points with other end users or to connect to such access points, should be removed or prevented. |
|
(28) |
In addition, unnecessary restrictions to the deployment and interlinkage of RLAN access points should also be removed. Public authorities or providers of public services increasingly use RLAN access points in their premises for their own purposes, for example for use by their personnel, to better facilitate cost-effective on-site access by citizens to e-Government services, or to support provision of smart public services with real-time information, such as for public transport or traffic management. Such bodies could also provide access to such access points for citizens in general as an ancillary service to services offered to the public on such premises, and should be enabled to do so in conformity with competition and public procurement rules. The making available of local access to electronic communications networks within or around a private property or a limited public area as an ancillary service to another activity that is not dependant on such an access, such as RLAN hotspots made available to customers of other commercial activities or to the general public in that area, should not qualify such a provider as an electronic communications provider. |
|
(29) |
Low power small-area wireless access points are very small and unobtrusive equipment similar to domestic Wi-Fi routers, for which technical characteristics should be specified at Union level for their deployment and use in different local contexts subject to general authorisation, without undue restrictions from individual planning or other permits. The proportionality of measures specifying the technical characteristics for such use to benefit from general authorisation should be ensured through characteristics which are significantly more restrictive than the applicable maximum thresholds in Union measures regarding parameters such as power output. |
|
(30) |
Member States should ensure that the management of radio spectrum at national level does not prevent other Member States from using the radio spectrum to which they are entitled, or from complying with their obligations as regards bands for which the use is harmonised at Union level. Building on the existing activities of the RSPG, a coordination mechanism is necessary to ensure that each Member State has equitable access to radio spectrum and that the outcomes of coordination are consistent and enforceable. [Am. 27] |
|
(31) |
Experience in the implementation of the Union's regulatory framework indicates that existing provisions requiring the consistent application of regulatory measures together with the goal of contributing to the development of the internal market have not created sufficient incentives to design access products on the basis of harmonised standards and processes, in particular in relation to fixed networks. When operating in different Member States, operators have difficulties in finding access inputs with the right quality and network and service interoperability levels, and when they are available, such inputs exhibit different technical features. This increases costs and constitutes an obstacle to the provision of services across national borders. [Am. 28] |
|
(32) |
The integration of the single market for electronic communications would be accelerated through establishment of a framework to define certain key European virtual products, which are particularly important for providers of electronic communication services to provide cross-border services and to adopt a pan-Union strategy in an increasingly all-IP environment, based on key parameters and minimum characteristics. [Am. 29] |
|
(33) |
The operational needs served by various virtual products should be addressed. European virtual broadband access products should be available in cases where an operator with significant market power has been required under the terms of the Framework Directive and the Access Directive to provide access on regulated terms at a specific access point in its network. First, efficient cross-border entry should be facilitated by harmonised products that enable initial provision by cross-border providers of services to their end customers without delay and with a predictable and sufficient quality, including services to business customers with multiple sites in different Member States, where this would be necessary and proportionate pursuant to market analysis. These harmonised products should be available for a sufficient period in order to allow access seekers and providers to plan medium and long term investments. [Am. 30] |
|
(34) |
Secondly, sophisticated virtual access products that require a higher level of investment by access seekers and allow them a greater level of control and differentiation, particularly by providing access at a more local level, are key to creating the conditions for sustainable competition across the internal market. Hence, these key wholesale access products to next-generation access (NGA) networks should also be harmonised to facilitate cross-border investment. Such virtual broadband access products should be designed to have equivalent functionalities to physical unbundling, in order to broaden the range of potential wholesale remedies available for consideration by national regulatory authorities under the proportionality assessment pursuant to Directive 2002/19/EC. [Am. 31] |
|
(35) |
Thirdly, it is also necessary to harmonise a wholesale access product for terminating segments of leased lines with enhanced interfaces, in order to enable cross-border provision of mission-critical connectivity services for the most demanding business users. [Am. 32] |
|
(35a) |
There is a need to harmonise the conditions for high-quality wholesale products used for the supply of business services to enable the provision of seamless services to cross-border and multi-national corporations across the European Union. Such harmonisation could play a significant role in terms of EU business competitiveness with regards to communications costs. [Am. 33] |
|
(36) |
In a context of progressive migration to ‘all IP networks’, the lack of availability of connectivity products based on the IP protocol for different classes of services with assured service quality that enable communication paths across network domains and across network borders, both within and between Member States, hinders the development of applications that rely on access to other networks, thus limiting technological innovation. Moreover, this situation prevents the diffusion on a wider scale of efficiencies which are associated with the management and provision of IP-based networks and connectivity products with an assured service quality level, in particular enhanced security, reliability and flexibility, cost-effectiveness and faster provisioning, which benefit network operators, service providers and end users. A harmonised approach to the design and availability of these products is therefore necessary, on reasonable terms including, where requested, the possibility of cross-supply by the electronic communications undertakings concerned. [Am. 34] |
|
(37) |
The establishment of European virtual broadband access products under this Regulation should be reflected in the assessment by national regulatory authorities of the most appropriate access remedies to the networks of operators designated as having significant market power, while avoiding over-regulation through the unnecessary multiplication of wholesale access products, whether imposed pursuant to market analysis or provided under other conditions. In particular, the introduction of the European virtual access products should not, in and of itself, lead to an increase in the number of regulated access products imposed on a given operator. Moreover, the need for national regulatory authorities, following the adoption of this Regulation, to assess whether a European virtual broadband access product should be imposed instead of existing wholesale access remedies, and to assess the appropriateness of imposing a European virtual broadband access product in the context of future market reviews where they find significant market power, should not affect their responsibility to identify the most appropriate and proportionate remedy to address the identified competition problem in accordance with Article 16 of Directive 2002/21/EC. [Am. 35] |
|
(38) |
In the interests of regulatory predictability, key elements of evolving decisional practice under the current legal framework which affect the conditions under which wholesale access products, including European virtual broadband access products, are made available for NGA networks, should also be reflected in the legislation. These should include provisions reflecting the importance, for the analysis of wholesale access markets and in particular of whether there is a need for price controls on such access to NGA networks, of the relationship between competitive constraints from alternative fixed and wireless infrastructures, effective guarantees of non-discriminatory access, and the existing level of competition in terms of price, choice and quality at retail level. The latter consideration ultimately determines the benefits to end users. For example, in the conduct of their case-by-case assessment pursuant to Article 16 of Directive 2002/21/EC and without prejudice to the assessment of significant market power and the application of EU competition rules, national regulatory authorities may consider that in the presence of two fixed NGA networks, market conditions are competitive enough to be able to drive network upgrades and to evolve towards the provision of ultra-fast services, which is one important parameter of retail competition. [Am. 36] |
|
(39) |
It is to be expected that intensified competition in a single market will lead to a reduction over time in sector-specific regulation based on market analysis. Indeed, one of the results of completing the Single Market should be a greater tendency towards effective competition on relevant markets, with ex post application of competition law increasingly being seen as sufficient to ensure market functioning. In order to ensure legal clarity and predictability of regulatory approaches across borders, clear and binding criteria should be provided on how to assess whether a given market still justifies the imposition of ex-ante regulatory obligations, by reference to the durability of bottlenecks and the prospects of competition, in particular infrastructure-based competition, and the conditions of competition at retail level on parameters such as price, choice and quality, which are ultimately what is relevant to end users and to the global competitiveness of the EU economy. This should underpin successive reviews of the list of markets susceptible to ex ante regulation and help national regulators to focus their efforts where competition is not yet effective and to do so in a convergent manner. The establishment of a true single market for electronic communications may in addition affect the geographical scope of markets, for the purposes of both sector-specific regulation based on competition principles and the application of competition law itself. |
|
(40) |
Disparities in the national implementation of sector-specific end-user protection rules create significant barriers to the single digital market, in particular in the form of increased compliance costs for providers of electronic communications to the public wishing to offer services across Member States. Moreover, fragmentation and uncertainty as to the level of protection granted in different Member States undermines end-users' trust and dissuades them from purchasing electronic communications services abroad. In order to achieve the Union's objective to remove barriers to the internal market it is necessary to replace existing, divergent national legal measures with a single and fully harmonised set of sector-specific rules which create a high common level of end-user protection. Such full harmonisation of the legal provisions should not prevent providers of electronic communications to the public from offering end-users contractual arrangements which go beyond that level of protection. [Am. 37] |
|
(41) |
As This Regulation harmonises only certain sector-specific rules, it should be without prejudice to the general consumer protection rules, as established by Union acts law and national legislation implementing them. [Am. 38] |
|
(42) |
Where the provisions in Chapters 4 and 5 of this Regulation refer to end-users, such provisions should apply not only to consumers but also to other categories of end-users, primarily micro enterprises. At their individual request, end-users other than consumers should be able to agree, by individual contract, to deviate from certain provisions. [Am. 39] |
|
(43) |
The completion of the single market for electronic communications also requires the removal of barriers for end-users to have access to electronic communications services across the Union. Public authorities should therefore not raise or maintain obstacles to the cross-border purchase of such services. Providers of electronic communications to the public should not deny or restrict access or discriminate against end-users on the basis of their nationality or Member State of residence. Differentiation should, however, be possible on the basis of objectively justifiable differences in costs, risks and market conditions such as demand variations and pricing by competitors. |
|
(44) |
Very significant price differences continue to prevail, both for fixed and mobile communications, between domestic voice and SMS communications and those terminating in another Member State. While there are substantial variations between countries, operators and tariff packages, and between mobile and fixed services, this continues to affect more vulnerable customer groups and to pose barriers to seamless communication within the Union. This occurs in spite of a very significant reduction, and convergence in absolute terms, of termination rates in the different Member States, and low prices on transit markets. Moreover, the transition to an ‘all-IP’ electronic communications environment should in due course bring additional cost reductions. Any significant retail tariff differences between domestic fixed long-distance communications which are communications other than those within one local area identified by a geographic area code in the national numbering plan, and fixed communications terminating in another Member State, should therefore be justified by reference to objective criteria. Retail tariffs for international mobile communications should not exceed the euro-voice and euro-SMS tariffs for regulated roaming calls and SMS messages, respectively, provided for in Regulation (EU) No 531/2012 unless justified by reference to objective criteria. Such criteria may include additional costs and a reasonable related margin. Other objective factors may include differences in related price elasticity and the easy availability to all end users of alternative tariffs from providers of electronic communications to the public which offer cross-border communications within the Union at little or no extra charge, or of information society services with comparable functionalities, provided that end users are actively informed of such alternatives by their providers. [Am. 40] |
|
(45) |
The internet has developed over the past decades as an open platform for innovation with low access barriers for end-users, content and application providers and internet service providers. The principle of ‘net neutrality’ in the open internet means that traffic should be treated equally, without discrimination, restriction or interference, independent of the sender, receiver, type, content, device, service or application. As stated by the European Parliament resolution of 17 November 2011 on the open internet and net neutrality in Europe (15) , the internet's open character has been a key driver of competitiveness, economic growth, social development and innovation — which has led to spectacular levels of development in online applications, content and services — and thus of growth in the offer of, and demand for, content and services, and has made it a vitally important accelerator in the free circulation of knowledge, ideas and information, including in countries where access to independent media is limited. The existing regulatory framework aims at promoting the ability of users to access and distribute information or run applications and services of their choice. Recently, however, the report of the BEREC on traffic management practices published in May 2012 and a study, commissioned by the Executive Agency for Consumers and Health and published in December 2012, on the functioning of the market of internet access and provision from a consumer perspective, showed that a significant number of users are affected by traffic management practices which block or slow down specific applications. These tendencies require clear rules at the Union level to maintain the open internet and to avoid fragmentation of the single market resulting from individual Member States' measures. [Am. 41] |
|
(46) |
The freedom of end-users to access and distribute information and lawful content, run applications and use services of their choice is subject to the respect of Union and compatible national law. This Regulation defines the limits for any restrictions to this freedom by providers of electronic communications to the public but is without prejudice to other Union legislation, including copyright rules and Directive 2000/31/EC. [Am. 42] |
|
(47) |
In an open internet, providers of electronic communications to the public internet access services should, within contractually agreed limits on data volumes and speeds for internet access services, not block, slow down, degrade or discriminate against specific content, applications or services or specific classes thereof except for a limited number of reasonable traffic management measures. Such measures should be technically necessary, transparent, proportionate and non-discriminatory. Reasonable traffic management encompasses prevention or impediment of serious crimes, including voluntary actions of providers to prevent access to and distribution of child pornography. Minimising the effects of network congestion should be considered reasonable provided that network congestion occurs only temporarily or in exceptional circumstances. Addressing network congestion should be allowed provided that network congestion occurs only temporarily or in exceptional circumstances. National Regulatory Authorities should be able to require that a provider demonstrates that equal treatment of traffic will be substantially less efficient . [Am. 43] |
|
(47a) |
This Regulation is without prejudice to Directive 2002/58/EC. [Am. 44] |
|
(48) |
Volume-based tariffs should be considered compatible with the principle of an open internet as long as they allow end-users to choose the tariff corresponding to their normal data consumption based on clear, transparent and explicit information about the conditions and implications of such choice. At the same time, such tariffs should enable providers of electronic communications to the public internet access services to better adapt network capacities to expected data volumes. It is essential that end-users are fully informed before agreeing to any data volume or speed limitations and the tariffs applicable, that they can continuously monitor their consumption and easily acquire extensions of the available data volumes if desired. [Am. 45] |
|
(49) |
There is also end- It should be possible to meet user demand for services and applications requiring an enhanced level of assured service quality offered by providers of electronic communications to the public or by content, applications or service providers. Such services may comprise inter alia broadcasting via Internet Protocol (IP-TV), video-conferencing and certain health applications. End-Users should therefore also be free to conclude agreements on the provision of specialised services with an enhanced quality of service with either providers of internet access services, providers of electronic communications to the public or providers of content, applications or services. Where such agreements are concluded with the provider of internet access, that provider should ensure that the enhanced quality service does not cause material detriment to the general quality of internet access. Furthermore, traffic management measures should not be applied in such a way as to discriminate between competing services. [Am. 46] |
|
(50) |
In addition, there is demand on the part of content, applications and services providers, for the provision of transmission services based on flexible quality parameters, including lower levels of priority for traffic which is not time-sensitive. The possibility for content, applications and service providers to negotiate such flexible quality of service levels with providers of electronic communications to the public is may also be necessary for the provision of specialised services and is expected to play an important role in the development of new certain services such as machine-to-machine (M2M) communications. At the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion. Providers of content, applications and services and providers of electronic communications to the public should therefore should therefore continue to be free to conclude specialised services agreements on defined levels of quality of service as long as such agreements do not substantially impair the general quality of internet access services service . [Am. 239] |
|
(51) |
National regulatory authorities play an essential role in ensuring that end-users are effectively able to exercise this freedom to avail of open internet access. To this end national regulatory authorities should have monitoring and reporting obligations, and ensure compliance of providers of internet access services, other providers of electronic communications to the public and other service providers and the availability of non-discriminatory internet access services of high quality which are not impaired by specialised services. In their assessment of a possible general impairment of internet access services, national regulatory authorities should take account of quality parameters such as timing and reliability parameters (latency, jitter, packet loss), levels and effects of congestion in the network, actual versus advertised speeds, performance of internet access services compared with specialised enhanced quality services, and quality as perceived by end-users. National regulatory authorities should establish complaint procedures providing effective, simple and readily available redress mechanisms for end users and be empowered to impose minimum quality of service requirements on all or individual providers of internet access services, other providers of electronic communications to the public and other service providers if this is necessary to prevent general impairment/degradation of the quality of service of internet access services. [Am. 240] |
|
(52) |
The measures to ensure better transparency and comparability of prices, tariffs, terms and conditions, and quality of service parameters including those specific to the provision of internet access services, should increase the ability of end-users to optimise their selection of providers and thus benefit fully from competition. Any voluntary certification scheme for interactive comparison websites, guides or similar tools should be independent from any provider of electronic communications, use plain and clear language, use complete and up-to-date information, have transparent methodology, be reliable and accessibility according to Web Content Accessibility Guidelines 2.0 and have an effective complaints handling procedure. [Am. 49] |
|
(53) |
End-users should be adequately informed of the price and the type of service offered before they purchase a service. This information should also be provided immediately prior to connection of the call when a call to a specific number or service is subject to particular pricing conditions, such as calls to premium rate services which are often subject to a special rate. Where such an obligation is disproportionate in view of the duration and cost of the tariff information for the service provider compared to the average call duration and the cost risk to which the end-user is exposed, national regulatory authorities may grant a derogation. End-users should also be informed if a free-phone number is subject to additional charges. [Am. 50] |
|
(54) |
Providers of electronic communications to the public should inform end-users adequately inter alia on their services and tariffs, quality of service parameters, access to emergency services and any limitation, and the choice of services and products designed for disabled consumers. In the case of tariff plans with a predefined volume of communications, providers of electronic communications to the public should also inform on the ability of consumers and other end-users so requesting to roll-over any unused volume of the previous billing period into the current billing period. This information should be provided in a clear and transparent manner and be specific to the Member States where the services are provided, and in the event of any change, be updated. Providers should be exempted from such information requirements as regards those offers which are individually negotiated. [Am. 51] |
|
(55) |
Availability of comparable information on products and services is paramount to the ability of end-users to make an independent evaluation of offers. Experience shows that availability of reliable and comparable information increases end-user confidence in the use of services and enhances the willingness to exercise their choice. |
|
(56) |
Contracts are an important means of giving end-users a high level of transparency of information and legal certainty. Providers of electronic communications to the public should give end-users clear and comprehensible information on all essential elements of the contract before the user is bound by the contract. The information should be mandatory and not be altered except by subsequent agreement of the end-user and the provider. The Commission and several national regulatory authorities recently found considerable discrepancies between the advertised speed of internet access services and the speed actually available to end-users. Providers of electronic communications to the public should therefore inform end-users, prior to the conclusion of the contract, of the speed and other quality of service parameters which they can realistically deliver at the end-user's main location. For fixed and mobile data links, normally available speed is the speed of a communications service that a consumer could expect to receive most of the time when accessing the service, regardless of the time of day. Normally available speed should be derived from estimated speed ranges, speed averages, peak-hour speed and minimal speed. The methodology should be established in BEREC guidelines and regularly reviewed and updated to reflect technology and infrastructure evolution. Member States should ensure that providers enable end-users to have access to comparable information on the coverage of the mobile networks, including different technologies in their Member State, prior to the conclusion of the contract, to enable those end-users to make informed purchasing decisions. [Am. 52] |
|
(57) |
With respect to terminal equipment, contracts should specify any restrictions imposed by the provider on the use of the equipment, for example by way of ‘SIM-locking’ mobile devices, and any charges due on termination of the contract prior to the agreed expiry date. No charges should be due after expiry of the agreed contract duration. Contracts should also specify the types of after-sales services, maintenance services and customer support services provided. Whenever possible, that information should also include technical information, provided on demand, concerning the proper functioning of the end-user's chosen terminal equipment. Provided that no technical incompatibility has been identified, that information should be provided free of charge. [Am. 53] |
|
(58) |
In order to avoid bill shocks end-, for all post-paid services, users should be able to define set a predefined maximum financial limit for the charges related to their usage of calls and internet access services. This facility should be available free of charge, with include an appropriate notification that can be consulted again subsequently, when the limit is being approached. Upon reaching the maximum limit, end-users should no longer receive or be charged for those services unless they specifically request the continued provision as agreed with the provider. [Am. 54] |
|
(58a) |
The processing of personal data referred to in Regulation of the European Parliament and of the Council laying down measures concerning the European Single Market for electronic communications and to achieve a Connected Continent should comply with Directive 95/46/EC of the European Parliament and of the Council (16) , which governs the processing of personal data carried out in the Member States pursuant to this Regulation and under the supervision of the Member States' competent authorities, in particular the independent public authorities designated by the Member States, and with Directive 2002/58/EC. [Am. 55] |
|
(58b) |
The processing of personal data referred to in Regulation of the European Parliament and of the Council laying down measures concerning the European Single Market for electronic communications and to achieve a Connected Continent should comply with Regulation (EC) No 45/2001 of the European Parliament and of the Council (17) . [Am. 56] |
|
(59) |
Experience from Member States and from a recent study commissioned by the Executive Agency for Consumers and Health has shown that long contract periods and automatic or tacit extensions of contracts constitute significant obstacles to changing a provider. It is thus desirable that end-users should be able to terminate, without incurring any costs, a contract six months after its conclusion. In such a case, end-users may be requested to compensate their providers for the residual value of subsidised terminal equipment or for the pro rata temporis value of any other promotions. Contracts which have been tacitly extended should be subject to termination with a one-month notice period. [Am. 57] |
|
(60) |
Any significant changes to the contractual conditions imposed by providers of electronic communications services to the public to the detriment of the end-user, for example in relation to charges, tariffs, data volume limitations, data speeds, coverage, or the processing of personal data, should be considered as giving rise to the right of the end-user to terminate the contract without incurring any costs. |
|
(61) |
Bundles comprising electronic communications and other services such as linear broadcasting have become increasingly widespread and are an important element of competition. Where divergent contractual rules on contract termination and switching apply to the different services composing such bundles, end-users are effectively prevented from switching to competitive offers for the entire bundle or parts of it. The provisions of this Regulation regarding contract termination and switching should, therefore, apply to all elements of such a bundle. |
|
(62) |
In order to take full advantage of the competitive environment, end-users should be able to make informed choices and switch providers when it is in their interests. End-users should therefore be able to switch without being hindered by legal, technical or procedural obstacles, including contractual conditions and charges. Number portability is a key facilitator of consumer choice and effective competition. It should be implemented within a minimum delay so that the number is effectively activated within one working day of concluding an agreement to port a number. Settlement of outstanding bills should not be a condition for execution of a porting request. |
|
(63) |
In order to support the provision of one-stop-shops and to facilitate a seamless switching experience for end-users, the switching process should be led by the receiving provider of electronic communications to the public. BEREC should be empowered to lay down guidelines setting out the respective responsibilities of the receiving and transferring provider in the switching and porting process, ensuring inter alia that the transferring provider of electronic communications to the public should does not delay or hamper the switching process. Automated processes should be used as widely , that the process is automated as much as possible and that a high level of protection of personal data is ensured. Those guidelines should be ensured also address the question of how to ensure continuity in the experience of end-users, including through identifiers, such as email addresses, through, for instance, the opportunity to opt for an email forwarding facility . Availability of transparent, accurate and timely information on switching should increase the end-users' confidence in switching and make them more willing to engage actively in the competitive process. [Am. 58] |
|
(64) |
Contracts with transferring providers of electronic communications to the public should be cancelled automatically after switching without any additional steps being required from end-users. In the case of pre-paid services any credit balance which has not been spent should be refunded to the switching consumer. [Am. 59] |
|
(65) |
End-users need to experience continuity when changing important identifiers such as email addresses. To this end, and to ensure that email communications are not lost, end-users should be given the opportunity to opt, free of charge, for an email forwarding facility offered by the transferring internet access service provider in cases where the end-user has an email address provided by the transferring provider. [Am. 60] |
|
(66) |
Competent national authorities may prescribe the global processes of porting numbers and switching, taking into account technological development and the need to ensure a swift, efficient and consumer-friendly switching process. Competent national authorities should be able to impose proportionate measures to protect end-users adequately throughout the switching process including appropriate sanctions that are necessary to minimise risks of abuse or delays and of end-users being switched to another provider without their consent. They should also be able to set an automatic compensation mechanism for end-users in such instances. |
|
(67) |
National regulatory authorities should be able to take effective action to monitor and secure compliance with the provisions of this Regulation, including the power to impose effective financial or administrative penalties in the event of any breach thereof. |
|
(68) |
In order to take account of market and technical developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of adapting the Annexes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. [Am. 61] |
|
(69) |
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the decision requiring Member States to adapt their plans for compliance with a common timetable for granting rights of use and allowing actual use. |
|
(70) |
The implementing powers relating to the harmonisation and coordination of authorisation of radio spectrum, characteristics of small-area wireless access points, coordination between Member States regarding allocation of radio spectrum, more detailed technical and methodological rules concerning European virtual access products and the safeguarding of internet access and of reasonable traffic management and quality of service, and fair use criteria should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (18). [Am. 62] |
|
(71) |
In order to ensure consistency between the objective and the measures needed to complete the single market for electronic communications pursuant to meet the objectives of this Regulation and some specific existing legislative provisions and to reflect key elements of evolving decisional practice, Directives 2002/21/EC, 2002/20/EC, 2002/22/EC, Regulations (EU) No 531/2012 and (EC) No 1211/2009, as well as Decision No 243/2012/EU, should be amended. This includes making provision for Directive 2002/21/EC and the related Directives to be read in conjunction with this Regulation, the introduction of strengthened powers of the Commission in order to ensure consistency of remedies imposed on European electronic communications providers having significant market power in the context of the European consultation mechanism harmonisation of the criteria adopted in assessing the definition and competitiveness of relevant markets, the adaptation of the notification system under Directive 2002/20/EC in view of the single EU authorisation as well as the repeal of provisions on minimum harmonisation of end-users rights provided in Directive 2002/22/EC made redundant by the full harmonisation provided in this Regulation. [Am. 63] |
|
(72) |
The mobile communications market remains fragmented in the Union, with no mobile network covering all Member States. As a consequence, in order to provide mobile communications services to their domestic customers travelling within the Union, roaming providers have to purchase wholesale roaming services from operators in a visited Member State. These wholesale charges constitute an important impediment to providing roaming services at price levels corresponding to domestic mobile services. Therefore further measures should be adopted to facilitate lowering these charges. Commercial or technical agreements among roaming providers which allow a virtual extension of their network coverage across the Union provide a means to internalise wholesale costs. To provide appropriate incentives, certain regulatory obligations laid down in Regulation (EU) No 531/2012 of the European Parliament and the Council (19) should be adapted. In particular, when roaming providers, through their own networks or through bilateral or multilateral roaming agreements ensure that all customers in the Union are offered by default roaming tariffs at the level of domestic tariffs, the obligation of domestic providers to enable their customers to access voice, SMS and data roaming services of any alternative roaming provider should not apply to such providers, subject to a transitional period where such access has already been granted. [Am. 64] |
|
(73) |
Bilateral or multilateral roaming agreements can allow a mobile operator to treat roaming by its domestic customers on the networks of partners as being to a significant degree equivalent to providing services to such customers on its own networks, with consequential effects on its retail pricing for such virtual on-net coverage across the Union. Such an arrangement at the wholesale level could allow the development of new roaming products and therefore increase choice and competition at retail level. [Am. 65] |
|
(74) |
The Digital Agenda for Europe and Regulation (EU) No 531/2012 establish the policy objective that the difference between roaming and domestic tariffs should approach zero. In practical terms, this requires that consumers falling into any of the broad observable categories of domestic consumption, identified by reference to a party's various domestic retail packages, should be in a position to confidently replicate the typical domestic consumption pattern associated with their respective domestic retail packages while periodically travelling within the Union, without additional costs to those incurred in a domestic setting. Such broad categories may be identified from current commercial practice by reference, for example, to the differentiation in domestic retail packages between pre-paid and post-paid customers; GSM-only packages (i.e. voice, SMS); packages adapted for different volumes of consumption; packages for business and consumer use respectively; retail packages with prices per unit consumed and those which provide ‘buckets’ of units (e.g. voice minutes, megabytes of data) for a standard fee, irrespective of actual consumption. The diversity of retail tariff plans and packages available to customers in domestic mobile markets across the Union accommodates varying user demands associated with a competitive market. That flexibility in domestic markets should also be reflected in the intra-Union roaming environment, while bearing in mind that the need of roaming providers for wholesale inputs from independent network operators in different Member States may still justify the imposition of limits by reference to reasonable use if domestic tariffs are applied to such roaming consumption. [Am. 66] |
|
(75) |
While it is in the first place for roaming providers to assess themselves the reasonable character of the volumes of roaming voice calls, SMS and data to be covered at domestic rates under their various retail packages, they may, notwithstanding the abolition of retail roaming charges by 15 December 2015, apply a ‘fair use clause’ to the consumption of regulated retail roaming services provided at the applicable domestic price level, by reference to fair use criteria. These criteria should be applied in such a way that consumers are in a position to confidently replicate the typical domestic consumption pattern associated with their respective domestic retail packages while periodically travelling within the Union. National regulatory authorities should supervise the application by roaming providers of such reasonable fair use limits and ensure that they are specifically defined by reference to detailed quantified information in the contracts in terms which are clear and transparent to customers. In so doing, national regulatory authorities should take utmost account of relevant guidance from BEREC , based on the results of a public consultation, for the application of fair use criteria in retail contracts provided by roaming providers . In its guidance, BEREC should identify various usage patterns substantiated by the underlying voice, data and SMS usage trends at the Union level, and the evolution of expectations as regards in particular wireless data consumption. The maximum eurotariff price caps should continue to serve as a safeguard limit for charges for consumption in excess of fair use limits until the expiry of Regulation (EU) No 531/2012. [Am. 67] |
|
(76) |
In addition, the significant reduction in mobile termination rates throughout the Union in the recent past should now allow the elimination of additional roaming charges for incoming calls. In order to provide clarity and legal certainty, the date of 15 December 2015 should be set for the final phasing out of retail roaming surcharges which began with Regulation (EC) No 717/2007 of the European Parliament and of the Council (20). In addition, the Commission should by 30 June 2015, in advance of that final abolition of retail surcharges, report on any necessary changes to the wholesale rates or wholesale market mechanisms, taking into account also mobile termination rates (MTR) applicable to roaming throughout the Union. [Am. 68] |
|
(77) |
In order to provide stability and strategic leadership to BEREC activities, BEREC Board of Regulators should be represented by a full-time Chairperson appointed by the Board of Regulators, on the basis of merit, skills, knowledge of electronic communication market participants and markets, and of experience relevant to supervision and regulation, following an open selection procedure organised and managed by the Board of Regulators assisted by the Commission. For the designation of the first Chairperson of the Board of Regulators, the Commission should, inter alia, draw up a shortlist of candidates on the basis of merit, skills, knowledge of electronic communication market participants and markets, and of experience relevant to supervision and regulation. For the subsequent designations, the opportunity of having a shortlist drawn up by the Commission should be reviewed in a report to be established pursuant to this Regulation. The Office of BEREC should therefore comprise the Chairperson of the Board of Regulators, a Management Committee and an Administrative Manager. [Am. 69] |
|
(78) |
Directives 2002/20/EC, 2002/21/EC and 2002/22/EC and Regulations (EC) No 1211/2009 and (EU) No 531/2012 , as well as Decision No 243/2012/EU, should therefore be amended accordingly. [Am. 70] |
|
(79) |
The Commission may always should seek BEREC's opinion in accordance with Regulation (EC) No 1211/2009, when it considers it necessary for the implementation of the provisions of this Regulation. [Am. 71] |
|
(79a) |
The regulatory framework for electronic communications should be reviewed as called for in the European Parliament resolution on Implementation report on the regulatory framework for electronic communications (21) . The review should be based on ex-post assessments of the impact of the framework since 2009, a full consultation and a thorough ex-ante assessment of expected impacts of the proposals emanating from the review. The proposals should be presented in sufficient time to enable the legislator to analyse and debate them properly. [Am. 72] |
|
(80) |
This Regulation respects fundamental rights and observes the rights and principles enshrined in the Charter of Fundamental Rights of the European Union, notably Article 8 (the protection of personal data), Article 11 (freedom of expression and information), Article 16 (freedom to conduct a business), Article 21 (non-discrimination) and Article 38 (consumer protection). |
|
(81) |
Since the objective of this Regulation, namely to establishes the regulatory principles and detailed rules necessary to complete a European single market for electronic communications, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, |
HAVE ADOPTED THIS REGULATION:
Chapter I
General provisions
Article 1
Objective and scope
1. This Regulation establishes the regulatory principles and detailed rules necessary to complete a European single market for electronic communications where: [Am. 73]
|
(a) |
providers of electronic communications services and networks have facilitate the practical exercise of the right, the ability and the incentive to develop, extend and of providers of electronic communications services and networks to operate their networks and to provide services irrespective of where the provider is established or its customers are situated in the Union through a harmonised and simplified notification system based on a harmonised template ; [Am. 74] |
|
(b) |
citizens and businesses have facilitate the practical exercise of the right and the possibility of citizens and businesses to access competitive, secure and reliable electronic communications services, irrespective of where they are provided from in the Union, with common rules to guarantee high standards of protection, privacy and security of their personal data, without being hampered by cross-border restrictions or unjustified additional costs and penalties .; [Am. 75] |
|
(ba) |
achieve a more coordinated Union framework for harmonised radio spectrum for wireless broadband communications services; [Am. 76] |
|
(bb) |
to address the phasing out of unjustified surcharges for roaming communications within the Union. [Am. 77] |
2. This Regulation establishes in particular regulatory principles pursuant to which the Commission, the Body of European Regulators for Electronic Communications (BEREC) and the national and regional competent authorities shall act, each within its own competences, in conjunction with the provisions of Directives 2002/19/EC, 2002/20/EC, 2002/21/EC and 2002/22/EC: [Am. 78]
|
(a) |
to secure simplified, predictable and convergent regulatory conditions regarding key administrative and commercial parameters, including as regards the proportionality of individual obligations which may be imposed pursuant to market analysis; [Am. 79] |
|
(b) |
to promote sustainable competition within the single market and the global competitiveness of the Union, and to reduce sector-specific market regulation accordingly as and when these objectives are achieved; [Am. 80] |
|
(c) |
to favour investment and innovation in new and enhanced high-capacity infrastructures which and to ensure that they reach throughout the Union and which can cater for evolving end-user demand , wherever end-users may be located in the Union ; [Am. 81] |
|
(d) |
to facilitate innovative and high-quality service provision; [Am. 82] |
|
(e) |
to ensure the availability and highly efficient use of radio spectrum, whether subject to general authorisation or to individual rights of use, for wireless broadband services in support of innovation, investment, jobs and end-user benefits; [Am. 83] |
|
(f) |
to serve the interests of citizens and end-users in connectivity by fostering the investment conditions for an increase in the choice and quality of network access and of service, and by facilitating mobility across the Union and both social and territorial inclusion. [Am. 84] |
3. In order to ensure implementation of the overarching regulatory principles set out in paragraph 2, this Regulation furthermore establishes the necessary detailed rules for:
|
(a) |
a single EU authorisation for European electronic communications providers; |
|
(b) |
further convergence of regulatory conditions as regards the necessity and proportionality of remedies imposed by national regulatory authorities on European electronic communications providers; |
|
(c) |
the harmonised provision at Union level of certain wholesale products for broadband under convergent regulatory conditions; |
|
(d) |
a coordinated European framework for the assignment of harmonised radio spectrum for wireless broadband communications services, thereby creating a European wireless space; |
|
(e) |
the harmonisation of rules related to rights of end-users and the promotion of effective competition in retail markets, thereby creating a European consumer space for electronic communications; |
|
(f) |
the phasing out of unjustified surcharges for intra-Union communications and roaming communications within the Union. [Am. 85] |
3a. The provisions of this Regulation shall be without prejudice to the Union acquis relating to data protection and Articles 7 and 8 of the Charter of Fundamental Rights of the European Union. [Am. 86]
Article 2
Definitions
For the purposes of this Regulation, the definitions set out in Directives 2002/19/EC, 2002/20/EC, 2002/21/EC, 2002/22/EC and 2002/77/EC shall apply.
The following definitions shall also apply:
|
(1) |
‘European electronic communications provider’ means an undertaking established in the Union providing or intending to provide electronic communications networks or services, whether directly or by means of one or more subsidiaries, directed to more than one Member State and which cannot be considered a subsidiary of another electronic communications provider; [Am. 87] |
|
(2) |
‘provider of electronic communications to the public’ means an undertaking providing public electronic communications networks or publicly available electronic communications services; |
|
(3) |
‘subsidiary’ means an undertaking in which another undertaking directly or indirectly:
|
|
(4) |
‘single EU authorisation’ means the legal framework applicable to a European electronic communications provider in the whole Union based on the general authorisation in the home Member State and in accordance with this Regulation; [Am. 89] |
|
(5) |
‘home Member State’ means the Member State where the European electronic communications provider has its main establishment; [Am. 90] |
|
(6) |
‘main establishment’ means the place of establishment in the Member State where the main decisions are taken as to the investments in and conduct of the provision of electronic communications services or networks in the Union; [Am. 91] |
|
(7) |
‘host Member State’ means any Member State different from the home Member State where a European electronic communications provider provides electronic communications networks or services; [Am. 92] |
|
(8) |
‘harmonised radio spectrum for wireless broadband communications’ means radio spectrum for which the conditions of availability and efficient , efficiency and primary use are harmonised at Union level, in particular pursuant to accordance with provisions laid down in Directive 2002/21/EC and Decision 676/2002/EC, and which serves for electronic communications services other than broadcasting; [Am. 93] |
|
(9) |
‘small-area wireless access point’ means a low power wireless network access equipment of small size operating within a small range , using licensed spectrum or a combination of licensed and license-exempt spectrum , which may or may not be part of a public terrestrial mobile communications network, and be equipped with one or more low visual impact antennas, which allows wireless access by the public to electronic communications networks regardless of the underlying network topology; [Am. 94] |
|
(10) |
‘radio local area network’ (RLAN) means a low power wireless access system, operating within a small range, with a low risk of interference to other such systems deployed in close proximity by other users, using on a non-exclusive license-exempt basis spectrum for which the conditions of availability and efficient use for this purpose are harmonised at Union level; [Am. 95] |
|
(11) |
‘virtual broadband access’ means a type of wholesale access to broadband networks that consists of a virtual access link to the customer premises over any access network architecture, excluding physical unbundling, together with a transmission service to a defined set of points of handover, and including specific network elements, specific network functionalities and ancillary IT systems; [Am. 96] |
|
(12) |
‘assured service quality (ASQ) connectivity product’ means a product that is made available at the internet protocol (IP) exchange, which enables customers to set up an IP communication link between a point of interconnection and one or several fixed network termination points, and enables defined levels of end to end network performance for the provision of specific services to end users on the basis of the delivery of a specified guaranteed quality of service, based on specified parameters; [Am. 97] |
|
(12a) |
‘net neutrality’ means the principle according to which all internet traffic is treated equally, without discrimination, restriction or interference, independently of its sender, recipient, type, content, device, service or application; [Ams 234 and 241] |
|
(13) |
‘long-distance communications’ means voice or messages services terminating outside the local exchange and regional charging areas as identified by a geographic area code in the national numbering plan; [Am. 98] |
|
(14) |
‘internet access service’ means a publicly available electronic communications service that provides connectivity to the internet in accordance with the principle of net neutrality, and thereby connectivity between virtually all end points of the internet, irrespective of the network technology or terminal equipment used; |
|
(15) |
‘specialised service’ means an electronic communications service or any other service that provides the capability to access specific content, applications or services, or a combination thereof, and whose technical characteristics are controlled from end-to-end or provides the capability to send or receive data to or from a determined number of parties or endpoints; optimised for specific content, applications or services, or a combination thereof, provided over logically distinct capacity, relying on strict admission control, offering functionality requiring enhanced quality from end to end, and that is not marketed or usable as a substitute for internet access service. [Ams 235 and 242] |
|
(16) |
‘receiving provider of electronic communications to the public’ means the provider of electronic communications to the public to which the telephone number or service is transferred; [Am. 101] |
|
(17) |
‘transferring provider of electronic communications to the public’ means the provider of electronic communications to the public from which a telephone number or service is transferred. [Am. 102] |
Chapter II
Single EU authorisation
Article 3
Freedom to provide electronic communications across the Union
1. A European Any electronic communications provider has the right to provide electronic communications networks and services in the whole Union and to exercise the rights linked to the provision of such networks and services in each Member State where it operates pursuant to a single EU authorisation which is subject only to the notification requirements provided in Article 4. [Am. 103]
2. The European electronic communications provider is subject to the rules and conditions applied in each Member State concerned in compliance with Union law unless otherwise provided in this Regulation and without prejudice to Regulation (EU) No 531/2012. [Am. 104]
3. By way of derogation from Article 12 of Directive 2002/20/EC, a European electronic communications provider may be subject to administrative charges applicable in the host Member State only if it has an annual turnover for electronic communications services in that Member State above 0,5 % of the total national electronic communications turnover. In levying these charges only the turnover for electronic communications services in the Member State concerned shall be taken into account. [Am. 105]
4. By way of derogation from Article 13(1)(b) of Directive 2002/22/EC a European electronic communications provider may be subject to the contributions imposed to share the net cost of universal service obligations in the host Member State only if it has an annual turnover for electronic communications services in that Member State above 3 % of the total national electronic communications turnover. In levying any such contribution only the turnover in the Member State concerned shall be taken into account. [Am. 106]
5. A European National regulatory authorities shall treat electronic communications provider shall be entitled to equal treatment by the national regulatory authorities of different providers equally in comparable situations, irrespective of their Member States in objectively equivalent situations State of establishment. [Am. 107]
6. In the event of a dispute between undertakings involving a European electronic communications provider regarding obligations applicable in accordance with Directives 2002/19/EC, 2002/20/EC, 2002/21/EC and 2002/22/EC, this Regulation or Regulation (EU) No 531/2012 in a host Member State, the European electronic communications provider may consult the national regulatory authority in the home Member State, which may deliver an opinion with a view to ensuring the development of consistent regulatory practices. The national regulatory authority in the host Member State shall take utmost account of the opinion issued by the national regulatory authority of the home Member State when deciding the dispute. [Am. 108]
7. European electronic communications providers who, at the date of entry into force of this Regulation, have the right to provide electronic communications networks and services in more than one Member State shall submit the notification provided for in Article 4 at the latest by 1 July 2016. [Am. 109]
Article 4
Notification procedure for European electronic communications providers
1. A European electronic communications provider shall submit a single notification in accordance with this Regulation to the national regulatory authority of the home Member State, before beginning activity in at least one Member State.
2. The notification shall contain a declaration of the provision or the intention to commence the provision of electronic communications networks and services and shall be accompanied by the following information only:
|
(a) |
the name of the provider, his legal status and form, registration number, where the provider is registered in trade or other similar public register, the geographical address of the main establishment, a contact person, a short description of the networks or services provided or intended to be provided, including identification of the home Member State; |
|
(b) |
the host Member State(s) where the services and the networks are provided or intended to be provided directly or by subsidiaries and, in the latter case, the name, his legal status and form, geographical address, registration number, where the provider is registered in trade or other similar public register in the host Member State, and contact point of any subsidiary concerned and the respective operating areas. Where a subsidiary is controlled jointly by two or more electronic communications providers with their main establishments in different Member States the subsidiary shall indicate the relevant home Member State among those of the parent companies for the purpose of this Regulation and shall be notified by the parent company of that home Member State accordingly. |
The notification shall be submitted in the language or languages applicable in the home Member State and in any host Member State.
3. Any change to the information submitted in accordance with paragraph 2 shall be made available to the national regulatory authority of the home Member State within one month following the change. In the event that the change to be notified concerns the intention to provide electronic communications networks or services in a host Member State that is not covered by a previous notification, the European electronic communications provider may begin activity in that host Member State upon notification.
4. Non-compliance with the notification requirement laid down in this Article shall constitute a breach of the common conditions applicable to the European electronic communications provider in the home Member State.
5. The national regulatory authority of the home Member State shall forward the information received in accordance with paragraph 2 and any change to that information in accordance with paragraph 3 to the national regulatory authorities of the concerned host Member States and to the BEREC Office within one week following reception of such information or any change.
The BEREC Office shall maintain a publicly accessible registry of notifications made in accordance with this Regulation.
6. At the request of a European electronic communications provider, the national regulatory authority of the home Member State shall issue a declaration in accordance with Article 9 of Directive 2002/20/EC, specifying that the undertaking in question is subject to the single EU authorisation.
7. In the event that one or more national regulatory authorities in different Member States consider that the identification of the home Member State in a notification made in accordance with paragraph 2 or any change to the provided information made available in accordance with paragraph 3 does not correspond or no longer corresponds to the main establishment of the undertaking pursuant to this Regulation, it shall refer the issue to the Commission, substantiating the grounds on which it bases its assessment. A copy of the referral shall be communicated to the BEREC Office for information. The Commission, having given the relevant European electronic communications provider and the national regulatory authority of the disputed home Member State the opportunity to express their views, shall issue a decision determining the home Member State of the undertaking in question pursuant to this Regulation within three months following the referral of the issue. [Am. 110]
Article 5
Compliance with the single EU authorisation
1. The national regulatory authority of each concerned Member State shall monitor and ensure, in accordance with its national legislation implementing the procedures provided for in Article 10 of Directive 2002/20/EC, that European electronic communications providers comply with the rules and conditions applicable in its territory in accordance with Article 3.
2. The national regulatory authority of a host Member State shall transmit to the national regulatory authority of the home Member State any relevant information concerning individual measures adopted in relation to a European electronic communications provider with a view to ensuring compliance with the rules and conditions applicable in its territory in accordance with Article 3. [Am. 111]
Article 6
Suspension and withdrawal of the rights to provide electronic communications of European electronic communications providers
1. Without prejudice to measures concerning suspension or withdrawal of rights of use for spectrum or numbers granted by any concerned Member State and interim measures adopted in accordance with paragraph 3, only the national regulatory authority of the home Member State may suspend or withdraw the rights of a European electronic communications provider to provide electronic communications networks and services in the whole Union or part thereof in accordance with national legislation implementing Article 10(5) of Directive 2002/20/EC.
2. In cases of serious or repeated breaches of the rules and conditions applicable in a host Member State in accordance with Article 3, where measures aimed at ensuring compliance taken by the national regulatory authority in the host Member State in accordance with Article 5 have failed, it shall inform the national regulatory authority in the home Member State and request that it adopts the measures provided for in paragraph 1.
3. Until a final decision on a request submitted in accordance with paragraph 2 is adopted by the national regulatory authority of the home Member State, the national regulatory authority of the host Member State may take urgent interim measures in accordance with national legislation implementing Article 10(6) of Directive 2002/20/EC where it has evidence of a breach of the rules and conditions applicable in its territory in accordance with Article 3. By way of derogation from the three months time-limit provided for in Article 10(6) of Directive 2002/20/EC, such interim measures may be valid until the national regulatory authority of the home Member State adopts a final decision.
The Commission, BEREC and the national regulatory authorities of the home Member State and other host Member States shall be informed of the interim measure adopted in due time.
4. Where the national regulatory authority of the home Member State considers taking a decision to suspend or withdraw rights of a European electronic communications provider in accordance with paragraph 1 either on its own initiative or at the request of the national regulatory authority of a host Member State, it shall notify its intention to the national regulatory authorities of any host Member State affected by such a decision. The national regulatory authority of a host Member State may deliver an opinion within one month.
5. Taking utmost account of any opinion of the national regulatory authority of the host Member States concerned, the national regulatory authority of the home Member State shall adopt a final decision and shall communicate it to the Commission, BEREC and the national regulatory authorities of the host Member States affected by such a decision within one week after its adoption.
6. Where the national regulatory authority of the home Member State has decided to suspend or withdraw rights of a European electronic communications provider in accordance with paragraph 1, the national regulatory authority of any host Member State concerned shall take appropriate measures to prevent the European electronic communications provider from further providing services or networks concerned by this decision within its territory. [Am. 112]
Article 7
Coordination of enforcement measures
1. When applying Article 6, the national regulatory authority of the home Member State shall take supervisory or enforcement measures related to an electronic communications service or network provided in another Member State or which has caused damage in another Member State with the same diligence as if the electronic communications service or network concerned was provided in the home Member State.
2. The Member States shall ensure that within their territories it is possible to serve the legal documents relating to measures taken in accordance with Articles 5 and 6. [Am. 113]
Chapter III
European inputs
Section 1 — Coordination of use of radio spectrum within the single market
Article 8
Scope of application and general provisions
1. This section shall apply to harmonised radio spectrum for wireless broadband communications in accordance with Directive 2002/21/EC, Decision No 676/2002/EC and Decision No 243/2012/EU . [Am. 114]
2. This section shall be without prejudice to the right of the Member States to benefit from fees imposed to ensure the optimal use of radio spectrum resources in accordance with Article 13 of Directive 2002/20/EC and to organise and use their radio spectrum for public order, public security and defence safeguarding general interest objectives such as cultural diversity and media pluralism . [Am. 115]
3. In the exercise of powers conferred in this section, the Commission shall take utmost account of any relevant opinion issued by the Radio Spectrum Policy Group (RSPG) established by Commission Decision 2002/622/EC (22) and of any regulatory best practice, report or advice issued by BEREC on matters within its competence . [Am. 116]
Article 8a
Harmonisation of certain aspects relating to transfer or lease of individual rights to use radio frequencies and their duration
1. Without prejudice to Directive 2002/21/EC or to the application of competition rules to undertakings, the following shall apply with respect to the transfer or lease of rights of use of spectrum, or parts thereof, identified in Article 6(8) of Decision No 243/2012/EU:
|
(a) |
Member States shall make current details of all such rights of use publicly available in a standardised electronic format; |
|
(b) |
Member States may not refuse to allow a transfer or lease to an existing holder of such rights of use; |
|
(c) |
in cases not covered by point (b), Member States may refuse a transfer only where it is found that there is a clear risk that the new holder would be unable to meet the existing conditions for the right of use; |
|
(d) |
in cases not covered by point (b), Member States may not refuse a lease where the transferor undertakes to remain liable for meeting the existing conditions for the right of use. |
2. Any administrative charge imposed on undertakings in connection with processing an application for the transfer or lease of spectrum shall, in total, cover only the administrative costs, including ancillary steps such as the issuance of a new right of use, incurred in processing the application. Any such charges shall be imposed in an objective, transparent and proportionate manner which minimises additional administrative costs and attendant charges. Article 12(2) of Directive 2002/20/EC shall apply to charges imposed under this paragraph.
3. All rights of use of spectrum shall be granted with a minimum duration of 25 years, and in any case for a duration appropriate to incentivise investment and competition and discourage the under-use or ‘hoarding’ of spectrum. Member States may grant rights of use of indefinite duration.
4. Member States may provide for proportionate and non-discriminatory withdrawal of rights, including those with a 25 year minimum duration, in order to ensure the efficient use of spectrum including, but not limited to, spectrum management purposes, national security, breach of licence, harmonised change of use of a band and non-payment of fees.
5. The duration of all existing rights of use of spectrum is hereby extended to 25 years from their date of grant, without prejudice to other conditions attached to the right of use and to rights of use of indefinite duration.
6. The introduction of minimum 25 year licence duration should not impede the ability of regulators to issue temporary licences and licences for secondary uses in a harmonised band. [Am. 117]
Article 9
Radio Spectrum use for wireless broadband communications: regulatory principles
1. Without prejudice to general interest objectives, the national competent authorities for radio spectrum shall contribute to the development of a wireless space where investment and competitive conditions for high-speed wireless broadband communications converge and which enables planning and provision of integrated , interoperable, open multi-territorial networks and services and economies of scale, thereby fostering innovation, economic growth and the long-term benefit of end users.
The national competent authorities shall refrain from applying procedures or imposing conditions for the use of radio spectrum which may unduly impede European electronic communications providers from providing integrated electronic communications networks and services in several Member States or throughout the Union. They shall ensure that the development of such a wireless space does not unduly impede, by creating interferences, the operation of existing services or applications in the concerned spectrum bands as well as in adjacent bands. [Am. 118]
2. The national competent authorities shall apply the least onerous authorisation system possible for allowing the use of radio spectrum, on the basis of objective, transparent, non-discriminatory and proportionate criteria, in such a way as to maximise flexibility and efficiency in radio spectrum use and to promote comparable conditions throughout the Union for integrated multi-territorial investments and operations by European electronic communications providers. [Am. 119]
3. When establishing authorisation conditions and procedures for the use of radio spectrum, national competent authorities shall have regard in particular to equal objective, transparent and non-discriminatory treatment between existing and potential operators and , as well as to collective, shared and unlicensed use of spectrum. National competent authorities shall also ensure the coexistence between European electronic communications providers and other undertakings existing and new radio spectrum users. To this end, they shall conduct a comprehensive impact assessment as well as consultations, which both shall involve all stakeholders . [Am. 120]
4. Without prejudice to paragraph 5, the national competent authorities shall take into account and, where necessary, shall reconcile the following regulatory principles when establishing authorisation conditions and procedures for rights of use for radio spectrum:
|
(a) |
maximisation of end user interest, including end users' interest in both efficient long-term investment and innovation in wireless networks and services and in effective competition; |
|
(b) |
ensuring the most efficient use and effective management of radio spectrum as well as availabity of unlicensed spectrum; |
|
(c) |
ensuring predictable and comparable conditions to enable the planning of long-term network investments and services on a multi-territorial basis and the achievement of scale economies; |
|
(d) |
ensuring the necessity and proportionality of the conditions imposed, including through an objective and transparent assessment of whether it is justified to impose additional conditions which could be in favour of or to the detriment of certain operators; |
|
(e) |
ensuring wide territorial coverage of high-speed wireless broadband networks and a high level of penetration and consumption of related services at the same time taking account of the public interest and the social, cultural and economic value of spectrum as a whole ; |
|
(ea) |
ensuring that any change in policy with regard to the efficient use of spectrum takes account of its impact on the public interest in terms of harmful interference and costs. [Am. 121] |
5. When considering whether to impose any of the specific conditions in respect of rights of use of radio spectrum referred to in Article 10, national competent authorities shall have particular regard to the criteria laid down in that Article.
5a. National competent authorities shall ensure that information is available on authorisation conditions and procedures for the use of radio spectrum, and allow stakeholders to present their views during the process. [Am. 122]
Article 10
Relevant criteria to be taken in account for use of radio spectrum
1. When determining the amount and type of radio spectrum to be assigned in a given procedure for granting rights of use for radio spectrum, the national competent authorities shall have regard to the following:
|
(a) |
the technical characteristics and the current and planned use of different available radio spectrum bands; [Am. 123] |
|
(b) |
the possible combination in a single procedure of complementary bands; and |
|
(c) |
the relevance of coherent portfolios of radio spectrum rights of use in different Member States to the provision of networks or services to the entire Union market or a significant part thereof. |
2. When determining whether to specify any minimum or maximum amount of radio spectrum, which would be defined in respect of a right of use in a given band or in a combination of complementary bands, national competent authorities shall ensure:
|
(a) |
the most efficient use of the radio spectrum in accordance with Article 9(4)(b), taking into account the characteristics and the current and planned use of the band or bands concerned; [Am. 124] |
|
(b) |
efficient network investment in accordance with Article 9(4)(a). |
This paragraph shall be without prejudice to the application of paragraph 5 as regards conditions defining maximum amounts of radio spectrum.
3. National competent authorities shall ensure that the fees for rights of use for radio spectrum of all types , if any:
|
(a) |
appropriately reflect the social , cultural and economic value of the radio spectrum, including beneficial externalities; |
|
(b) |
avoid under-utilisation and foster investment in the capacity, coverage and quality of networks and services; |
|
(c) |
avoid discrimination and ensure equality of opportunity between operators, including between existing and potential operators; |
|
(d) |
achieve an optimal distribution between immediate and, if any upfront and, preferably , periodic payments, having regard in particular to the need to incentivise rapid network roll-out and radio spectrum utilisation in accordance with Article 9(4)(b) and (e); |
|
(da) |
are paid not more than one year before operators can start using the radio spectrum. |
The technical and regulatory conditions attached to the rights of use for radio spectrum shall be defined and available to the operators and stakeholders prior the start of the auction process.
This paragraph shall be without prejudice to the application of paragraph 5 as regards any conditions resulting in differentiated fees between operators which are laid down with a view to promoting effective competition. [Am. 125]
4. National competent authorities may impose obligations to reach minimum territorial coverage only when they are necessary and proportionate, in accordance with Article 9(4)(d), to achieve specific objectives of general interest determined at national level. When imposing such obligations, the national competent authorities shall have regard to the following:
|
(a) |
any pre-existing coverage of the national territory by the relevant services, or by other electronic communications services; |
|
(b) |
the minimisation of the number of operators potentially subject to such obligations; |
|
(c) |
the possibility of burden sharing and reciprocity among various operators, including providers of other electronic communications services; |
|
(d) |
the investments required to achieve such coverage and the need to reflect these in the applicable fees; |
|
(e) |
the technical suitability of the relevant bands for efficient provision of wide territorial coverage. |
5. When determining whether to impose any of the measures to promote effective competition provided for in Article 5(2) of Decision No 243/2012/EU national competent authorities shall base their decision on an objective, prospective assessment of the following, taking into account market conditions and available benchmarks:
|
(a) |
whether or not effective competition is likely to be maintained or achieved in the absence of such measures; and |
|
(b) |
the likely effect of such temporary measures on existing and future investments by market operators. |
6. National competent authorities shall determine conditions under which undertakings may transfer or lease part or all of their individual rights to use radio spectrum to other undertakings, including the sharing of such radio spectrum. When determining those conditions, national competent authorities shall have regard to the following:
|
(a) |
optimisation of efficient radio spectrum use in accordance with Article 9(4)(b); |
|
(b) |
enabling the exploitation of beneficial sharing opportunities; |
|
(c) |
reconciliation of the interests of existing and potential right-holders; |
|
(d) |
creation of a better-functioning, more liquid market for access to radio spectrum. |
This paragraph shall be without prejudice to the application of competition rules to undertakings.
7. National competent authorities shall authorise the sharing of passive and active infrastructure and the joint roll-out of infrastructure for wireless broadband communications, taking into account:
|
(a) |
the state of infrastructure-based competition and any additional service-based competition; |
|
(b) |
the requirements of efficient radio spectrum use; |
|
(c) |
increased choice and a higher quality of service for end users; |
|
(d) |
technological innovation. |
This paragraph shall be without prejudice to the application of competition rules to undertakings.
Article 11
Additional provisions related to conditions for use of radio spectrum
1. Where the technical conditions for the availability and efficient use of harmonised radio spectrum for wireless broadband communications make it possible to use the relevant radio spectrum under a general authorisation regime, national competent authorities shall avoid imposing any additional condition and shall prevent any alternative use from impeding the effective application of such harmonised regime. This shall be without prejudice to the provisions of Article 2(8). [Am. 126]
2. National competent authorities shall establish authorisation conditions whereby an individual authorisation or right of use may be revoked or cancelled in case of persistent failure to use the relevant radio spectrum. The revocation or cancellation may be subject to appropriate compensation when the failure to use the radio spectrum is due to grounds beyond the control of the operator, and is objectively justified.
3. National competent authorities shall consider the need to establish, in conformity with competition rules, and with a view to the timely freeing up or sharing of sufficient harmonised radio spectrum in cost-efficient bands for high-capacity wireless broadband services:
|
(a) |
appropriate compensation or incentive payments to existing users or radio spectrum usage right holders, inter alia through incorporation in the bidding system or fixed amount for rights of use; or |
|
(b) |
incentive payments to be paid by existing users or radio spectrum usage right holders. |
4. The national competent authorities shall consider the need to fix appropriate minimum technology performance levels for different bands in accordance with Article 6(3) of Decision No 243/2012/EU with a view to improving spectral efficiency and without prejudice to measures adopted under Decision No 676/2002/EC.
When fixing those levels, they shall in particular:
|
(a) |
have regard to the cycles of technology development and of renewal of equipment, in particular terminal equipment; and |
|
(b) |
apply the principle of technology neutrality to achieve the specified performance level, in accordance with Article 9 of Directive 2002/21/EC. |
Article 12
Harmonisation of certain authorisation conditions relative to wireless broadband communications
1. Taking full account of Directive 2002/21/EC, in particular Articles 7, 8, 8a, 9 and 9a thereof, Decision No 676/2002/EC and Decision No 243/2012/EU, in particular Articles 2, 3, 5 and 6 thereof, national competent authorities shall establish timetables for the granting or reassignment of rights of use, or for the renewal of those rights under the terms of existing rights, which shall apply to radio spectrum harmonised for wireless broadband communications. [Am. 127]
The duration of the rights of use or the dates for subsequent renewal shall be set well in advance of the relevant procedure included in the timetable referred to in the first subparagraph. The timetables, durations and renewal cycles shall take account of the need for a predictable investment environment, the effective possibility to release any relevant new radio spectrum bands harmonised for wireless broadband communications and of the period for amortisation of related investments under competitive conditions. [Am. 128]
2. In order to ensure a coherent implementation of paragraph 1 throughout the Union and in particular to enable the synchronised availability of wireless services within the Union, the Commission may shall , by way of implementing acts to be adopted within one year from the date of entry into force of this Regulation :
|
(a) |
establish a common timetable for the Union as a whole, or timetables appropriate to the circumstances of different categories of Member States, the date or dates by which individual rights of use for a harmonised band, or a combination of complementary harmonised bands, shall be granted and actual use of the radio spectrum shall be allowed for exclusive or shared provision of wireless broadband communications throughout the Union; |
|
(b) |
determine a minimum duration that is no less than 25 years, for the rights granted in the harmonised bands , and in any case for a duration appropriate to incentivise investment, innovation and competition, and discourage the under-use or ‘hoarding’ of spectrum; or determine that the rights are to be granted for an indefinite duration ; |
|
(c) |
determine, in the case of rights which are not indefinite in character, a synchronised expiry or renewal date for the Union as a whole; |
|
(d) |
define the date of expiry of any existing rights of use of by which, in bands harmonised bands other than for wireless broadband communications, or, in the case of rights of indefinite duration, the date by which the right of use an existing right of use of spectrum shall be amended, in order to allow the provision of wireless broadband communications. |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(2) as well as without prejudice to the provisions set in article 9 (3) and (4) of Directive 2002/21/EC . [Am. 129]
3. Subject to Article 8a(4), the Commission may shall also adopt implementing acts within one year from the date of entry into force of this Regulation, harmonising the date of expiry or renewal of individual rights to use radio spectrum for wireless broadband in harmonised bands, which already exist at the date of adoption of such acts, with a view to synchronising throughout the Union the date for renewal or reassignment of rights of use for such bands, including possible synchronisation with the date of renewal or reassignment of other bands harmonised by implementing measures adopted in accordance with paragraph 2 or with this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(2).
Where implementing acts provided for in this paragraph define a harmonised date for renewal or reassignment of rights of use of radio spectrum which falls after the date of expiry or renewal of any existing individual rights of use of such radio spectrum in any of the Member States, the national competent authorities shall extend the existing duration of those rights until the harmonised date under the same previously applicable substantive authorisation of use shall be extended without prejudice to other conditions, including any applicable periodic fees attached to those rights .
Where the extension period granted in accordance with the second subparagraph is significant in comparison with the original duration of the rights of use, national competent authorities may subject the extension of rights to any adaptations of the previously applicable authorisation conditions which are necessary in the light of the changed circumstances, including the imposition of additional fees. These additional fees shall be based on an application pro rata temporis of any initial fee for the original rights of use which was expressly calculated by reference to the originally foreseen duration.
The implementing acts provided for in this paragraph shall not require the shortening of the duration of existing rights of use in any Member State except in accordance with Article 14(2) of Directive 2002/20/EC and shall not apply to existing rights of indefinite duration.
Where the Commission adopts an implementing act pursuant to paragraph 2, it may apply the provisions of this paragraph mutatis mutandis to any rights of use of the harmonised band concerned for wireless broadband.[Am. 130]
4. When adopting the implementing acts provided for in paragraphs 2 and 3, the Commission shall have regard to:
|
(a) |
the regulatory principles set out in Article 9; |
|
(b) |
objective variations across the Union in the needs for additional radio spectrum for wireless broadband provision, while taking into account common radio spectrum needs for integrated networks covering several Member States; |
|
(c) |
the predictability of operating conditions for existing radio spectrum users; |
|
(d) |
the take-up, development and investment cycles of successive generations of wireless broadband technologies; |
|
(e) |
end-user demand for high-capacity wireless broadband communications. |
In determining timetables for different categories of Member States which have not already granted individual rights of use and allowed actual use of the harmonised band in question, the Commission shall have due regard to any submissions made by Member States regarding the way radio spectrum rights have been historically granted, the grounds of restriction provided for in in Article 9(3) and (4) of Directive 2002/21/EC, the possible need to vacate the band in question, the effects on competition or geographical or technical constraints, taking into account the effect on the internal market. The Commission shall ensure that implementation is not unduly deferred and that any variation in timetables between Member States does not result in undue differences in the competitive or regulatory situations between Member States.
5. Paragraph 2 shall be without prejudice to the right of the Member States to grant rights of use for and to allow actual use of a harmonised band before the adoption of an implementing act in respect of that band, subject to compliance with the second subparagraph of this paragraph, or in advance of the harmonised date established by an implementing act for that band.
Where national competent authorities grant rights of use in a harmonised band before the adoption of an implementing act in respect of that band, they shall define the conditions of such grant, and in particular those relative to duration, in such a way that beneficiaries of the rights of use are made aware of the possibility that the Commission would will adopt implementing acts in accordance with paragraph 2 establishing a minimum duration of such rights or a synchronised expiry or renewal cycle for the Union as a whole. This subparagraph shall not apply to the grant of rights of indefinite duration. [Am. 131]
6. For the harmonised bands for which a common timetable for granting rights of use and allowing actual use has been established in an implementing act adopted in accordance with paragraph 2, national competent authorities shall provide timely and sufficiently detailed information to the Commission on their plans to ensure compliance. The Commission may shall adopt an implementing acts act defining the format and procedures for the provision of such information. Those within one year from the date of entry into force of this Regulation. That implementing acts act shall be adopted in accordance with the examination procedure referred to in Article 33(2). [Am. 132]
Where the Commission considers, upon reviewing such detailed plans provided by a Member State, that it is unlikely that the Member State in question will be able to comply with the timetable applicable to it, the Commission may adopt a decision by means of implementing act requiring that Member State to adapt its plans in an appropriate way to ensure such compliance.
Article 12a
Joint authorisation process to grant individual rights of use of radio spectrum
1. Two or several Member States may cooperate with each other, and with the Commission, in meeting their obligations under Article 6 and 7 of the Authorisation Directive with a view to establish a joint authorisation process to grant individual rights of use of radio spectrum, in line, where applicable, with any common timetable established in accordance with Article 12(2). The joint authorisation process shall meet the following criteria:
|
(a) |
the individual national authorisation processes shall be initiated and implemented by the national competent authorities according to a common schedule; |
|
(b) |
it shall provide where appropriate for common conditions and procedures for the selection and granting of individual rights among the Member States concerned; |
|
(c) |
it shall provide where appropriate for common or comparable conditions to be attached to the individual rights of use among the Member States concerned inter alia allowing operators to be granted consistent spectrum portfolios with regard to the spectrum blocks to be assigned. |
2. Where Member States intend to establish a joint authorisation process, the national competent authorities concerned shall simultaneously make their draft measures accessible to the Commission and the competent authorities. The Commission shall inform the other Member States.
3. A joint authorisation process shall be open at any time to other Member States. [Am. 133]
Article 13
Coordination of authorisation procedures and conditions for the use of radio spectrum for wireless broadband in the internal market
1. Where a national competent authority intends to subject the use of radio spectrum to a general authorisation or to grant individual rights of use of radio spectrum, or to amend rights and obligations in relation to the use of radio spectrum in accordance with Article 14 of Directive 2002/20/EC, it shall make accessible its draft measure, together with the reasoning thereof, simultaneously to the Commission and the competent authorities for radio spectrum of the other Member States, upon completion of the public consultation referred to in Article 6 of Directive 2002/21/EC, if applicable, and in any event only at a stage in its preparation which allows it to provide to the Commission and the competent authorities of the other Member States sufficient and stable information on all relevant matters.
The national competent authority shall provide information which shall include at least the following matters, where applicable:
|
(a) |
the type of authorisation process; |
|
(b) |
the timing of the authorisation process; |
|
(c) |
the duration of the rights of use , which shall be no less than 25 years, and in any case appropriate to incentivise investment and competition, and discourage the under-use or ‘hoarding’ of spectrum ; [Am. 134] |
|
(d) |
the type and amount of radio spectrum available, as a whole or to any given undertaking; |
|
(e) |
the amount and structure of any fees to be paid; |
|
(f) |
compensation or incentives regarding the vacation or sharing of radio spectrum by existing users; |
|
(g) |
coverage obligations; |
|
(h) |
wholesale access, national or regional roaming requirements; |
|
(i) |
the reservation of radio spectrum for certain types of operators, or the exclusion of certain types of operators; |
|
(j) |
conditions related to the assignment, reassignment, transfer or accumulation of rights of use; [Am. 135] |
|
(k) |
the possibility to use radio spectrum on a shared basis; |
|
(l) |
infrastructure sharing; |
|
(m) |
minimum technology performance levels; |
|
(n) |
restrictions applied in accordance with Articles 9(3) and 9(4) of Directive 2002/21/EC; |
|
(o) |
a revocation or withdrawal of one or several rights of use or an amendment of rights or conditions attached to such rights which cannot be considered as minor within the meaning of Article 14(1) of Directive 2002/20/EC. |
2. National competent authorities and the Commission may make comments to the competent authority concerned within a period of two months. The two-month period shall not be extended.
When assessing the draft measure in accordance with this Article, the Commission shall have regard in particular to:
|
(a) |
the provisions of Directives 2002/20/EC and 2002/21/EC and Decision No. 243/2012/EU; |
|
(b) |
the regulatory principles set out in Article 9; |
|
(c) |
the relevant criteria for certain specific conditions set out in Article 10 and the additional provisions set out in Article 11; |
|
(d) |
any implementing act acts adopted in accordance with Article 12; [Am. 136] |
|
(e) |
coherence with recent, pending or planned procedures in other Member States, and possible effects on trade between Member States. |
If, within this period, the Commission notifies the competent authority that the draft measure would create a barrier to the internal market or that it has serious doubts as to its compatibility with Union law, the draft measure shall not be adopted for an additional period of two months. The Commission shall also inform the competent authorities of the other Member States of the position it has taken on the draft measure in such a case.
3. Within the additional two-month period referred to in paragraph 2, the Commission and the competent authority concerned shall cooperate closely to identify the most appropriate and effective measure in the light of the criteria referred to in paragraph 2, whilst taking due account of the views of market participants and the need to ensure the development of consistent regulatory practice.
4. At any stage during the procedure, the competent authority may amend or withdraw its draft measure taking utmost account of the Commission's notification referred to in paragraph 2.
5. Within the additional two-month period referred in paragraph 2, the Commission may:
|
(a) |
present a draft decision to the Communications Committee requiring the competent authority concerned to withdraw the draft measure. The draft decision shall be accompanied by a detailed and objective analysis of why the Commission considers that the draft measure should not be adopted as notified, together where necessary with specific proposals for amending the draft measure; or |
|
(b) |
take a decision changing its position in relation to the draft measure concerned. |
6. Where the Commission has not presented a draft decision referred to in paragraph 5(a) or takes a decision referred to in paragraph 5(b), the competent authority concerned may adopt the draft measure.
Where the Commission has presented a draft decision referred to in accordance with paragraph 5(a), the draft measure shall not be adopted by the competent authority for a period not exceeding six months from the notification sent to the competent authority pursuant to paragraph 2.
The Commission may decide to change its position in relation to the draft measure concerned at any stage of the procedure, including after the submission of a draft decision to the Communications Committee.
7. The Commission shall adopt any decision requiring the competent authority to withdraw its draft measure by means of implementing acts. Those implementing act shall be adopted in accordance with the examination procedure referred to in Article 33(2).
8. Where the Commission has adopted a decision in accordance with paragraph 7, the competent authority shall amend or withdraw the draft measure within six months of the date of notification of the Commission's decision. When the draft measure is amended, the competent authority shall undertake a public consultation where appropriate, and shall make the amended draft measure accessible to the Commission in accordance with paragraph 1.
9. The competent authority concerned shall take the utmost account of any comments of competent authorities of the other Member States and the Commission and may, except in cases covered by the third sub-paragraph of paragraph 2, by the second sub-paragraph of paragraph 6 and by paragraph 7, adopt the resulting draft measure and where it does so, shall communicate it to the Commission.
10. The competent authority shall inform the Commission of the results of the procedure to which its measure relates once that procedure has been concluded.
Article 14
Access to radio local area networks
1. National competent authorities shall allow the provision of access through radio local area networks to the network of a provider of electronic communications to the public as well as the use of the harmonised radio spectrum for such provision, subject only to general authorisation.
2. National competent authorities shall not prevent providers of electronic communications to the public from allowing access for the public to their networks, through radio local area networks, which may be located at an end user's premises, subject to compliance with the general authorisation conditions and the prior informed agreement of the end user.
3. Providers of electronic communications to the public shall not unilaterally restrict:
|
(a) |
the right of end users to accede to radio local area networks of their choice provided by third parties; |
|
(b) |
the right of end users to allow reciprocally or more generally access to the networks of such providers by other end users through radio local area networks, including on the basis of third-party initiatives which federate and make publicly accessible the radio local area networks of different end users. |
4. National competent authorities shall not restrict the right of end users to allow reciprocally or more generally access to their radio local area networks by other end users, including on the basis of third-party initiatives which federate and make publicly accessible the radio local area networks of different end users.
5. National competent authorities shall not restrict the provision of public access to radio local area networks:
|
(a) |
by public authorities on or in the immediate vicinity of premises occupied by such public authorities, when it is ancillary to the public services provided on such premises; |
|
(b) |
by initiatives of non-governmental organisations or public authorities to federate and make reciprocally or more generally accessible the radio local area networks of different end users, including, where applicable, the radio local area networks to which public access is provided in accordance with sub-point (a). |
6. An undertaking, public authority or other end user shall not be deemed to be a provider of electronic communications to the public solely by virtue of the provision of public access to radio local area networks, where such provision is not commercial in character, or is merely ancillary to another commercial activity or public service which is not dependent on the conveyance of signals on such networks.
Article 15
Deployment and operation of small-area wireless access points
1. National competent authorities shall allow the deployment, connection and operation of unobtrusive small-area wireless access points under the general authorisation regime and shall not unduly restrict that deployment, connection or operation through individual town planning permits or in any other way, whenever such use is in compliance with implementing measures adopted pursuant to paragraph 2.
This paragraph is without prejudice to the authorisation regime for the radio spectrum employed to operate small-area wireless access points.
2. For the purposes of the uniform implementation of the general authorisation regime for the deployment, connection and operation of small-area wireless access points pursuant to paragraph 1, the Commission may shall , by means of an implementing act to be adopted within one year from the date of entry into force of this Regulation , specify technical characteristics for the design, deployment and operation of small-area wireless access points, compliance with which shall ensure their unobtrusive character when in use in different local contexts. The Commission shall specify those technical characteristics by reference to the maximum size, power and electromagnetic characteristics, as well as the visual impact, of the deployed small-area wireless access points. Those technical characteristics for use of small-area wireless access points shall at a minimum comply with the requirements of Directive 2013/35/EU (23) and with the thresholds defined in Council Recommendation No 1999/519/EC (24). [Am. 137]
The technical characteristics specified in order for the deployment, connection and operation of small-area wireless access point to benefit from paragraph 1 shall be without prejudice to the essential requirements of Directive 1999/5/EC of the European Parliament and the Council relative to the placing on the market of such products (25). [Am. 138]
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(2).
Article 16
Radio spectrum coordination among Member States
1. Without prejudice to their obligations under relevant international agreements including ITU Radio Regulations, the national competent authorities shall ensure that the use of radio spectrum is organised on their territory, and shall in particular take all necessary radio spectrum allocation or assignment measures, in order that no other Member State is impeded from allowing on its territory the use of a specific harmonised band in accordance with Union legislation.
2. Member States shall cooperate with each other in the cross-border coordination of the use of radio spectrum in order to ensure compliance with paragraph 1 and to ensure that no Member State is denied equitable access to radio spectrum.
3. Any concerned Member State may invite the Radio Spectrum Policy Group to use its good offices to assist it and any other Member State in complying with this Article.
The Commission may adopt implementing measures to ensure that coordinated outcomes respect the requirement of equitable access to radio spectrum among the relevant Member States, to resolve any practical inconsistencies between distinct coordinated outcomes between different Member States, or to ensure the enforcement of coordinated solutions under Union law.Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(2). [Am. 139]
Section 2
European virtual access products
Article 17
European virtual broadband access product
1. The provision of a virtual broadband access product imposed in accordance with Article 8 and 12 of Directive 2002/19/EC shall be considered as the provision of a European virtual broadband access product if it is supplied in accordance with the minimum parameters listed in one of the Offers set out in Annex I and cumulatively meets the following substantive requirements:
|
(a) |
ability to be offered as a high quality product anywhere in the Union; |
|
(b) |
maximum degree of network and service interoperability and non-discriminatory network management between operators consistently with network topology; |
|
(c) |
capacity to serve end-users on competitive terms; |
|
(d) |
cost-effectiveness, taking into account the capacity to be implemented on existing and newly built networks and to co-exist with other access products that may be provided on the same network infrastructure; |
|
(e) |
operational effectiveness, in particular in respect of limiting to the extent possible implementation obstacles and deployment costs for virtual broadband access providers and virtual broadband access seekers; |
|
(f) |
respect of the rules on protection of privacy, personal data, security and integrity of networks and transparency in conformity with Union law. |
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 32 in order to adapt Annex I in light of market and technological developments, so as to continue to meet the substantive requirements listed in paragraph 1. [Am. 140]
Article 17a
Wholesale high-quality access products allowing the provision of business communications services
1. National Regulatory Authorities shall consider the proportionality of imposing on providers of electronic communications services designated in accordance with article 16 of Directive 2002/21/EC (Framework Directive) as having significant market power in a relevant market relating to the provision of wholesale high-quality electronic communications services an obligation to publish a wholesale reference offer taking into account the BEREC guidelines referred to in paragraph 2. This consideration should take place within one month after the publication of the BEREC guideline.
2. By 31 December 2015 BEREC shall, after consulting stakeholders and in cooperation with the Commission lay down guidelines specifying the elements to be included in the reference offer. The guidelines should cover terminating segments of leased lines as a minimum and may cover other business wholesale access products that BEREC deems appropriate taking into account retail and wholesale demand as well as regulatory best practices. NRAs may require additional elements to be included in the reference offer. BEREC shall review these guidelines regularly in light of market and technological developments . [Am. 141]
Article 18
Regulatory conditions related to European virtual broadband access product
1. A national regulatory authority which has previously imposed on an operator in accordance with Articles 8 and 12 of Directive 2002/19/EC any obligation to provide wholesale access to a next-generation network shall assess whether it would be appropriate and proportionate to impose instead an obligation to supply a European virtual broadband access product which provides at least equivalent functionalities to the currently imposed wholesale access product.
National regulatory authorities referred to in the first subparagraph shall conduct the requisite assessment of existing wholesale access remedies as soon as possible after the entry into force of this Regulation, irrespective of the timing of the analysis of relevant markets in accordance with Article 16(6) of Directive 2002/21/EC.
Where a national regulatory authority which has previously imposed an obligation to provide virtual broadband access considers, following its assessment pursuant to the first sub-paragraph, that a European virtual broadband access product is not appropriate in the specific circumstances, it shall provide a reasoned explanation in its draft measure in accordance with the procedure set out in Articles 6 and 7 of Directive 2002/21/EC.
2. Where a national regulatory authority intends to impose on an operator an obligation to provide wholesale access to a next-generation network in accordance with Articles 8 and 12 of Directive 2002/19/EC, it shall assess in particular, in addition to the factors set out in Article 12(2) of that Directive, the respective merits of imposing
|
(i) |
a passive wholesale input, such as physical unbundled access to the local loop or the sub-loop; |
|
(ii) |
a non-physical or virtual wholesale input offering equivalent functionalities, and in particular a European virtual broadband access product that satisfies the substantive requirements and parameters set out in Article 17(1) and in Annex I, point 1, of this Regulation. |
3. By way of derogation from Article 12(3) of Directive 2002/19/EC, where a national regulatory authority intends to impose on an operator an obligation to provide virtual broadband access in accordance with Articles 8 and 12 of that Directive, it shall impose an obligation to supply a European virtual broadband access product which has the most relevant functionalities to meet the regulatory need identified in its assessment. Where a national regulatory authority considers that a European virtual broadband access product would not be appropriate in the specific circumstances, it shall provide a reasoned explanation in its draft measure in accordance with the procedure set out in Articles 6 and 7 of Directive 2002/21/EC.
4. When assessing pursuant to paragraphs 1, 2 or 3 whether to impose a European virtual broadband access product instead of any other possible wholesale access product, the national regulatory authority shall have regard to the interest in convergent regulatory conditions throughout the Union for wholesale access remedies, the current and prospective state of infrastructure-based competition and the evolution of market conditions towards provision of competing next-generation networks, to investments made respectively by the operator designated as having significant market power and by access-seekers, and to the amortisation period for such investments.
The national regulatory authority shall set a transitional period for replacing an existing wholesale access product by a European virtual broadband access product if necessary.
5. By way of derogation from Article 9(3) of Directive 2002/19/EC, where an operator has obligations under Articles 8 and 12 of that Directive to provide a European virtual broadband access product, national regulatory authorities shall ensure the publication of a reference offer containing at least the elements set out in Annex I, point 1, point 2 or point 3, as the case may be.
6. By way of derogation from Article 16(3) of Directive 2002/21/EC, a national regulatory authority shall not impose a mandatory period of notice before withdrawing a previously imposed obligation to offer a European virtual broadband access product that satisfies the substantive requirements and parameters set out in Article 17(1) and in Annex I, point 2 of this Regulation, if the operator concerned voluntarily commits to make such product available at the request of third parties on fair and reasonable terms for a further period of three years.
7. Where a national regulatory authority is considering, in the context of an assessment pursuant to paragraphs 2 or 3, whether or not to impose or maintain price controls in accordance with Article 13 of Directive 2002/19/EC for wholesale access to next-generation networks, whether by means of one of the European virtual broadband access products or otherwise, it shall consider the state of competition in respect of the prices, choice and quality of products offered at retail level. It shall have regard to the effectiveness of protection against discrimination at wholesale level and to the state of infrastructure-based competition from other fixed line or wireless networks, giving due weight to the role of existing infrastructure-based competition between next-generation networks in driving further improvements in quality for end users, in order to determine whether price controls for wholesale access would not be necessary or proportionate in the specific case. [Am. 142]
Article 19
Assured service quality (ASQ) connectivity product
1. Any operator shall have the right to provide a European ASQ connectivity product as specified in paragraph 4.
2. Any operator shall meet any reasonable request to provide a European ASQ connectivity product as specified in paragraph 4 submitted in writing by an authorised provider of electronic communications services. Any refusal to provide a European ASQ product shall be based on objective criteria. The operator shall state the reasons for any refusal within one month from the written request.
It shall be deemed to be an objective ground of refusal that the party requesting the supply of a European ASQ connectivity product is unable or unwilling to make available, whether within the Union or in third countries, a European ASQ connectivity product to the requested party on reasonable terms, if the latter so requests.
3. Where the request is refused or agreement on specific terms and conditions, including price, has not been reached within two months from the written request, either party is entitled to refer the issue to the relevant national regulatory authority pursuant to Article 20 of Directive 2002/21/EC. In such a case, Article 3(6) of this Regulation may apply.
4. The provision of a connectivity product shall be considered as the provision of a European ASQ connectivity product if it is supplied in accordance with the minimum parameters listed in Annex II and cumulatively meets the following substantive requirements:
|
(a) |
ability to be offered as a high quality product anywhere in the Union; |
|
(b) |
enabling service providers to meet the needs of their end-users; |
|
(c) |
cost-effectiveness, taking into account existing solutions that may be provided on the same networks; |
|
(d) |
operational effectiveness, in particular in respect of limiting to the extent possible implementation obstacles and deployment costs for customers; and |
|
(e) |
ensuring that the rules on protection of privacy, personal data, security and integrity of networks and transparency in accordance with Union law are respected. |
5. The Commission shall be empowered to adopt delegated acts in accordance with Article 32 in order to adapt Annex II in light of market and technological developments, so as to continue to meet the substantive requirements listed in paragraph 4. [Am. 143]
Article 20
Measures relating to European access products
1. The Commission shall adopt by 1 January 2016 implementing acts laying down uniform technical and methodological rules for the implementation of a European virtual broadband access product within the meaning of Article 17 and of Annex I, point 1, in accordance with the criteria and parameters specified therein and in order to ensure the equivalence of the functionality of such a virtual wholesale access product to next-generation networks with that of a physical unbundled access product. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(2).
2. The Commission may adopt implementing acts laying down uniform technical and methodological rules for the implementation of one or more of the European access products within the meaning of Articles 17 and 19 and of Annex I, points 2 and 3, and Annex II, in accordance with the respective criteria and parameters specified therein. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(2). [Am. 144]
Chapter IV
Harmonised Users' rights of end-users to open internet access [Am. 146]
Article 21
Elimination of restrictions and discrimination
1. The freedom of end-users to use public electronic communications networks or publicly available electronic communications services provided by an undertaking established in another Member State shall not be restricted by public authorities.
2. Providers of electronic communications to the public shall not apply any discriminatory requirements or conditions of access or use to end-users based on the end-user's nationality or place of residence unless such differences are objectively justified.
3. Providers of electronic communications to the public shall not apply tariffs for intra-Union communications terminating in another Member State which are higher, unless objectively justified:
|
(a) |
as regards fixed communications, than tariffs for domestic long-distance communications; |
|
(b) |
as regards mobile communications, than the euro-tariffs for regulated voice and SMS roaming communications, respectively, established in Regulation (EU) No 531/2012. [Am. 145] |
Article 22
Cross-border dispute resolution
The out-of-court procedures set up in accordance with Article 34 (1) of Directive 2002/22/EC shall also apply to disputes related to contracts between consumers, and other end-users to the extent that such out-of-court procedures are available also for them, and providers of electronic communications to the public which are established in another Member State. For disputes within the scope of Directive 2013/11/EU (26) , the provisions of that Directive shall apply. [Am. 147]
Article 23
Freedom to provide and avail of open internet access, and reasonable traffic management [Am. 148]
1. End-users shall be free have the right to access and distribute information and content, run and provide applications and use services and use terminals of their choice via their internet access service , irrespective of the end-user’s or provider’s location or the location, origin or destination of the service, information or content, via their internet access service .
End-users shall be free to enter into agreements on data volumes and speeds with providers of internet access services and, in accordance with any such agreements relative to data volumes, to avail of any offers by providers of internet content, applications and services.
2. End-users shall also be free to agree with either providers of electronic communications to the public or with providers of content, applications and services on the provision of specialised services with an enhanced quality of service.
In order to enable the provision of specialised services to end-users, providers of content, applications and services and providers of electronic communications to the public shall be free to enter into agreements with each other to transmit the related data volumes or traffic as specialised services with a defined quality of service or dedicated capacity. The provision of specialised services shall not impair in a recurring or continuous manner the general quality of internet access services. Providers of internet access, of electronic communications to the public and providers of content, applications and services shall be free to offer specialised services to end-users. Such services shall only be offered if the network capacity is sufficient to provide them in addition to internet access services and they are not to the detriment of the availability or quality of internet access services. Providers of internet access to end-users shall not discriminate between functionally equivalent services and applications.
3. This Article is without prejudice to Union or national legislation related to the lawfulness of the information, content, application or services transmitted.
4. The exercise of the freedoms provided for in paragraphs 1 and 2 shall be facilitated by the provision of complete information in accordance with Article 25(1), Article 26 (2), and Article 27 (1) and (2).
End-users shall be provided with complete information in accordance with Article 20(2), Article 21(3) and Article 21a of Directive 2002/22/EC, including information on any traffic management measures applied that might affect access to and distribution of information, content, applications and services as specified in paragraphs 1 and 2 of this Article.
5. Within the limits of any contractually agreed Providers of internet access services and end-users may agree to set limits on data volumes or speeds for internet access services,. Providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking, slowing down, altering, degrading or discriminating against specific content, applications or services, or specific classes thereof, except in cases where it is necessary to apply reasonable traffic management measures. Reasonable Traffic management measures shall be transparent, non-discriminatory, proportionate and necessary to:
|
(a) |
implement a legislative provision or a court order, or prevent or impede serious crimes; |
|
(b) |
preserve the integrity and security of the network, services provided via this network, and the end-users' terminals; |
|
(c) |
prevent the transmission of unsolicited communications to end-users who have given their prior consent to such restrictive measures; |
|
(d) |
minimise prevent or mitigate the effects of temporary or and exceptional network congestion provided that equivalent types of traffic are treated equally. |
Reasonable Traffic management shall only entail processing of data that is necessary and proportionate to achieve the purposes set out in this paragraph measures shall not be maintained longer than necessary .
Without prejudice to Directive 95/46/EC, traffic management measures shall only entail such processing of personal data that is necessary and proportionate to achieve the purposes set out in this paragraph, and shall also be subject to Directive 2002/58/EC, in particular with respect to confidentiality of communications.
Providers of internet access services shall put in place appropriate, clear, open and efficient procedures aimed at addressing complaints alleging breaches of this Article. Such procedures shall be without prejudice to the end-users right to refer the matter to the national regulatory authority. [Ams 236 and 243]
Article 24
Safeguards for quality of service
1. National regulatory authorities shall closely monitor and ensure the effective ability of end-users to benefit from the freedoms provided for in In exercising their powers under Article 30a with respect to Article 23(1) and (2), compliance with Article 23 (5), and , national regulatory authorities shall closely monitor compliance with Article 23(5) and the continued availability of non-discriminatory internet access services at levels of quality that reflect advances in technology and that are not impaired by specialised services. They shall, in cooperation with other competent national authorities, also monitor the effects of specialised services on cultural diversity and innovation. National regulatory authorities shall report publish reports on an annual basis regarding their monitoring and findings, and provide those reports to the Commission and BEREC on their monitoring and findings. [Am. 153]
2. In order to prevent the general impairment of quality of service for internet access services or to safeguard the ability of end- users to access and distribute content or information or to run applications, services and software of their choice, national regulatory authorities shall have the power to impose minimum quality of service requirements, and where appropriate, other quality of service parameters, as defined by the national regulatory authorities on providers of electronic communications to the public.
National regulatory authorities shall, in good time before imposing any such requirements, provide the Commission with a summary of the grounds for action, the envisaged requirements and the proposed course of action. This information shall also be made available to BEREC. The Commission may, having examined such information, make comments or recommendations thereupon, in particular to ensure that the envisaged requirements do not adversely affect the functioning of the internal market. The envisaged requirements shall not be adopted during a period of two months from the receipt of complete information by the Commission unless otherwise agreed between the Commission and the national regulatory authority, or the Commission has informed the national regulatory authority of a shortened examination period, or the Commission has made comments or recommendations. National regulatory authorities shall take the utmost account of the Commission’s comments or recommendations and shall communicate the adopted requirements to the Commission and BEREC. [Am. 154]
3. Within six months of adoption of this regulation, BEREC shall, after consulting stakeholders and in close cooperation with the Commission may adopt implementing acts , lay down general guidelines defining uniform conditions for the implementation of the obligations of national competent authorities under this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(2) , including with respect to the application of traffic management measures and for monitoring of compliance . [Am. 155]
Article 24a
Review
The Commission shall, in close cooperation with BEREC, review the functioning of the provisions on specialised services and, after a public consultation, shall report and submit any appropriate proposals to the European Parliament and the Council by [insert date three years after the date of applicability of this regulation]. [Am. 156]
Article 25
Transparency and publication of information
1. Providers of electronic communications to the public shall, save for offers which are individually negotiated, publish transparent, comparable, adequate and up-to-date information on:
|
(a) |
their name, address and contact information; |
|
(b) |
for each tariff plan the services offered and the relevant quality of service parameters, the applicable prices (for consumers including taxes) and any applicable charges (access, usage, maintenance and any additional charges), as well as costs with respect to terminal equipment; |
|
(c) |
applicable tariffs regarding any number or service subject to particular pricing conditions; |
|
(d) |
the quality of their services, in accordance with implementing acts provided for in paragraph 2; |
|
(e) |
internet access services, where offered, specifying the following:
|
|
(f) |
measures taken to ensure equivalence in access for disabled end-users, including regularly updated information on details of products and services designed for them; |
|
(g) |
their standard contract terms and conditions, including any minimum contractual period, the conditions for and any charges due on early termination of a contract, the procedures and direct charges related to switching and portability of numbers and other identifiers, and compensation arrangements for delay or abuse of switching; |
|
(h) |
access to emergency services and caller location information for all services offered, any limitations on the provision of emergency services under Article 26 of Directive 2002/22/EC, and any changes thereto; |
|
(i) |
rights as regards universal service, including, where appropriate, the facilities and services mentioned in Annex I to Directive 2002/22/EC. |
The information shall be published in a clear, comprehensive and easily accessible form in the official language(s) of the Member State where the service is offered, and be updated regularly. The information shall, on request, be supplied to the relevant national regulatory authorities in advance of its publication. Any differentiation in the conditions applied to consumers and other end-users shall be made explicit.
2. The Commission may adopt implementing acts specifying the methods for measuring the speed of internet access services, the quality of service parameters and the methods for measuring them, and the content, form and manner of the information to be published, including possible quality certification mechanisms. The Commission may take into account the parameters, definitions and measurement methods set out in Annex III of the Directive 2002/22/EC .Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(2).
3. End-users shall have access to independent evaluation tools allowing them to compare the performance of electronic communications network access and services and the cost of alternative usage patterns. To this end Member States shall establish a voluntary certification scheme for interactive websites, guides or similar tools. Certification shall be granted on the basis of objective, transparent and proportionate requirements, in particular independence from any provider of electronic communications to the public, the use of plain language, the provision of complete and up-to-date information, and the operation of an effective complaints handling procedure. Where certified comparison facilities are not available on the market free of charge or at a reasonable price, national regulatory authorities or other competent national authorities shall make such facilities available themselves or through third parties in compliance with the certification requirements. The information published by providers of electronic communications to the public shall be accessible, free of charge, for the purposes of making available comparison facilities.
4. Upon request of the relevant public authorities, providers of electronic communications to the public shall distribute public interest information free of charge to end-users, where appropriate, by the same means as those ordinarily used by them in their communications with end-users. In such a case, that information shall be provided by the relevant public authorities to the providers of electronic communications to the public in a standardised format and may, inter alia, cover the following topics:
|
(a) |
the most common uses of electronic communications services to engage in unlawful activities or to disseminate harmful content, particularly where it may prejudice respect for the rights and freedoms of others, including infringements of data protection rights, copyright and related rights, and their legal consequences; and |
|
(b) |
the means of protection against risks to personal security and unlawful access to personal data when using electronic communications services. [Am. 157] |
Article 26
Information requirements for contracts
1. Before a contract on the provision of connection to a public electronic communications network or publicly available electronic communications services becomes binding providers of electronic communications to the public shall provide consumers, and other end-users unless they have explicitly agreed otherwise, at least the following information:
|
(a) |
the identity, address and contact information of the provider and, if different, the address and contact information for any complaints; |
|
(b) |
the main characteristics of the services provided, including in particular:
|
|
(c) |
details of prices and tariffs (for consumers including taxes and possibly due additional charges) and the means by which up-to-date information on all applicable tariffs and charges are made available; |
|
(d) |
payment methods offered and any cost differences due to the payment method, and available facilities to safeguard bill transparency and monitor the level of consumption; |
|
(e) |
the duration of the contract and the conditions for renewal and termination, including:
|
|
(f) |
any compensation and refund arrangements, including an explicit reference to statutory rights of the end-user, which apply if contracted service quality levels are not met; |
|
(g) |
where an obligation exists in accordance with Article 25 of Directive 2002/22/EC, the end-users' options as to whether or not to include their personal data in a directory, and the data concerned; |
|
(h) |
for disabled end-users, details of products and services designed for them; |
|
(i) |
the means of initiating procedures for the settlement of disputes, including cross-border disputes, in accordance with Article 34 of Directive 2002/22/EC and Article 22 of this Regulation; |
|
(j) |
the type of action that might be taken by the provider in reaction to security or integrity incidents or threats and vulnerabilities. |
2. In addition to paragraph 1, providers of electronic communications to the public shall provide end-users, unless otherwise agreed by an end-user who is not a consumer, at least the following information with respect to their internet access services:
|
(a) |
the level of applicable data volume limitations, if any; the prices for increasing the available data volume on an ad hoc or lasting basis; the data speed, and its cost, available after full consumption of the applicable data volume, if limited; and how end-users can at any moment monitor the current level of their consumption; |
|
(b) |
the actually available data speed for download and upload at the main location of the end-user, including actual speed ranges, speed averages and peak-hour speed, including the potential impact of allowing access to third parties through a radio local area network; |
|
(c) |
other quality of service parameters;; |
|
(d) |
information on any procedures put in place by the provider to measure and shape traffic so as to avoid congestion of a network, and information on how those procedures could impact on service quality and protection of personal data; |
|
(e) |
a clear and comprehensible explanation as to how any volume limitation, the actually available speed and other quality of service parameters, and the simultaneous use of specialised services with an enhanced quality of service, may practically impact the use of content, applications and services. |
3. The information referred to in paragraphs 1 and 2 shall be provided in a clear, comprehensive and easily accessible manner and in an official language of the end-user's Member State of residence, and shall be updated regularly. It shall form an integral part of the contract and shall not be altered unless the contracting parties expressly agree otherwise. The end-user shall receive a copy of the contract in writing.
4. The Commission may adopt implementing acts specifying the details of the information requirements listed in paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(2).
5. The contract shall also include, upon request by the relevant public authorities, any information provided by these authorities for this purpose on the use of electronic communications networks and services to engage in unlawful activities or to disseminate harmful content, and on the means of protection against risks to personal security and unlawful processing of personal data, referred to in Article 25(4) and relevant to the service provided. [Am. 158]
Article 27
Control of consumption
1. Providers of electronic communications to the public shall offer end-users the opportunity to opt, free of charge, for a facility which provides information on the accumulated consumption of different electronic communications services expressed in the currency in which the end-user is billed. Such a facility shall guarantee that, without the end-user's consent, the accumulated expenditure over a specified period of use does not exceed a specified financial limit set by the end-user.
2. Providers of electronic communications to the public shall ensure that an appropriate notification is sent to the end-user when the consumption of services has reached 80 % of the financial limit set in accordance with paragraph 1. The notification shall indicate the procedure to be followed to continue the provision of those services, including their cost. The provider shall cease to provide the specified services and to charge the end-user for it if the financial limit would otherwise be exceeded, unless and until the end-user requests the continued or renewed provision of those services. After having reached the financial limit end-users shall continue to be able to receive calls and SMS messages and access free-phone numbers and emergency services by dialling the European emergency number 112 free of charge until the end of the agreed billing period.
3. Providers of electronic communications to the public shall, immediately prior to connecting the call, enable end-users to access easily and without incurring any costs information on applicable tariffs regarding any number or service subject to particular pricing conditions unless the national regulatory authority has granted a prior derogation for reasons of proportionality. Any such information shall be provided in a comparable fashion for all such numbers or services.
4. Providers of electronic communications to the public shall offer end-users the opportunity to opt, free of charge for receiving itemised bills. [Am. 159]
Article 28
Contract termination
1. Contracts concluded between consumers and providers of electronic communications to the public shall not provide for a minimum duration that exceeds 24 months. Providers of electronic communications to the public shall offer end-users the possibility to conclude a contract with a maximum duration of 12 months.
2. Consumers, and other end-users unless they have otherwise agreed, shall have the right to terminate a contract with a one-month notice period, where six months or more have elapsed since conclusion of the contract. No compensation shall be due other than for the residual value of subsidised equipment bundled with the contract at the moment of the contract conclusion and a pro rata temporis reimbursement for any other promotional advantages marked as such at the moment of the contract conclusion. Any restriction on the usage of terminal equipment on other networks shall be lifted, free of charge, by the provider at the latest upon payment of such compensation.
3. Where the contracts or national law provide for contract periods to be extended tacitly, the provider of electronic communications to the public shall inform the end-user in due time so that the end-user has at least one month to oppose a tacit extension. If the end-user does not oppose, the contract shall be deemed to be a permanent contract which can be terminated by the end-user at any time with a one-month notice period and without incurring any costs.
4. End-users shall have the right to terminate their contract without incurring any costs upon notice of changes in the contractual conditions proposed by the provider of electronic communications to the public unless the proposed changes are exclusively to the benefit of the end-user. Providers shall give end-users adequate notice, not shorter than one month, of any such change, and shall inform them at the same time of their right to terminate their contract without incurring any costs if they do not accept the new conditions. Paragraph 2 shall apply mutatis mutandis .
5. Any significant and non-temporary discrepancy between the actual performance regarding speed or other quality parameters and the performance indicated by the provider of electronic communications to the public in accordance with Article 26 shall be considered as non-conformity of performance for the purpose of determining the end-user's remedies in accordance with national law.
6. A subscription to additional services provided by the same provider of electronic communications to the public shall not re-start the initial contract period unless the price of the additional service(s) significantly exceeds that of the initial services or the additional services are offered at a special promotional price linked to the renewal of the existing contract.
7. Providers of electronic communications to the public shall apply conditions and procedures for contract termination which do not raise obstacles to or disincentives against changing service provider. [Am. 160]
Article 29
Bundled offers
If a bundle of services offered to consumers comprises at least a connection to an electronic communications network or one electronic communications service, Articles 28 and 30 of this Regulation shall apply to all elements of the bundle. [Am. 161]
Chapter V
Facilitating change of providers
Article 30
Switching and portability of numbers
1. All end-users with numbers from a national telephone numbering plan who so request shall have the right to retain their number(s) independently of the provider of electronic communications to the public providing the service in accordance with Part C of Annex I to Directive 2002/22/EC, provided the provider is an electronic communications provider in the Member State to which the national numbering plan relates or is a European electronic communications provider which has notified to the competent regulatory authority of the home Member State the fact that it provides or intends to provide such services in the Member State to which the national numbering plan relates.
2. Pricing between providers of electronic communications to the public related to the provision of number portability shall be cost-oriented, and direct charges to end-users, if any, shall not act as a disincentive for end-users against changing provider.
3. Porting of numbers and their activation shall be carried out within the shortest possible time. For end-users who have concluded an agreement to port a number to a new provider that number shall be activated within one working day from the conclusion of such agreement. Loss of service during the process of porting, if any, shall not exceed one working day.
4. The receiving provider of electronic communications to the public shall lead the switching and porting process. End-users shall receive adequate information on switching before and during the switching process, and also immediately after it is concluded. End-users shall not be switched to another provider against their will.
5. The end-users’ contracts with transferring providers of electronic communications to the public shall be terminated automatically after conclusion of the switch. Transferring providers of electronic communications to the public shall refund any remaining credit to the consumers using pre-paid services.
6. Providers of electronic communications to the public which delay or abuse switching, including by not making available information necessary for porting in a timely manner, shall be obliged to compensate end-users who are exposed to such delay or abuse.
7. In the event that an end-user switching to a new provider of internet access services has an email address provided by the transferring provider, the latter shall, upon request by the end-user, forward to any email address indicated by the end-user, free of charge, all email communications addressed to the end-user’s previous email address for a period of 12 months. This email forwarding service shall include an automatic response message to all email senders alerting them about the end-user's new email address. The end-user shall have the option of requesting that the new email address should not be disclosed in the automatic response message.
Following the initial 12-month period, the transferring provider of electronic communications to the public shall give the end-user an option to extend the period for email forwarding, at a charge if required. The transferring provider of electronic communications to the public shall not allocate the end-users’ initial email address to another end-user before a period of two years following contract termination, and in any case during the period for which the email forwarding has been extended.
8. The competent national authorities may establish the global processes of switching and porting, including provision of appropriate sanctions on providers and compensations for end-users. They shall take into account necessary end-user protection throughout the switching process and the need to ensure efficiency of such process. [Am. 162]
Article 30a
Supervision and enforcement
1. National regulatory authorities shall have the necessary resources to monitor and supervise compliance with this Regulation within their territories.
2. National regulatory authorities shall make up-to-date information on the application of this Regulation publicly available in a manner that enables interested parties to have easy access to it.
3. National regulatory authorities shall have the power to require undertakings subject to obligations under this Regulation to supply all information relevant to the implementation and enforcement of this Regulation. Those undertakings shall provide such information promptly on request and in accordance with time limits and the level of detail required by the national regulatory authority.
4. National regulatory authorities may intervene on their own initiative in order to ensure compliance with this Regulation.
5. National regulatory authorities shall put in place appropriate, clear, open and efficient procedures to address complaints alleging breaches of Article 23. National regulatory authorities shall respond to complaints without undue delay.
6. Where a national regulatory authority finds that a breach of the obligations set out in this Regulation has occurred, it shall require the immediate cessation of such a breach. [Am. 163]
Chapter VI
Organisational and final provisions
Article 31
Penalties
Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 1 July 2016 at the latest and shall notify it without delay of any subsequent amendment affecting them.
With regard to European electronic communications providers, penalties shall be imposed in accordance with Chapter II regarding the respective competences of national regulatory authorities in the home and host Member States. [Am. 164]
Article 32
Delegation of powers
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Articles 17(2) and 19(5) shall be conferred on the Commission for an indeterminate period of time from the [date entry into force of the Regulation]
3. The delegation of power referred to in Articles 17(2) and 19(5) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Articles 17(2) and 19(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. [Am. 165]
Article 33
Committee procedure
1. The Commission shall be assisted by the Communications Committee established by Article 22(1) of Directive 2002/21/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Article 34
Amendments to Directive 2002/20/EC
|
(1) |
Article 3(2), the second subparagraph is deleted is amended as follows : [Am. 166]
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|
(2) |
In Article 10, the following new paragraph 6a is added : ‘6a. A national regulatory authority shall notify BEREC of any measures intended to be taken by it under paragraphs 5 and 6. Within two months from receipt of a notification, during which period the national regulatory authority may not adopt a final measure, BEREC shall adopt a reasoned opinion if it considers that the draft measure would create a barrier to the single market. BEREC shall forward any opinion to the national regulatory authority and the Commission. The national regulatory authority shall take the utmost account of any BEREC opinion and shall communicate any final measure to BEREC. BEREC shall update its register accordingly.’. [Am. 170] |
|
(3) |
In the Annex, the following part D is added:
|
Article 34a
Amendments to Decision No 243/2012/EU
In Article 6(8) of Decision No 243/2012/EU, the following subparagraph is added:
‘Member States shall allow the transfer or leasing of any additional harmonised bands on the same basis as those enumerated in the first subparagraph.’. [Am. 172]
Article 35
Amendments to Directive 2002/21/EC
Directive 2002/21/EC is amended as follows:
|
(1) |
In Article 1, the following paragraph 6 is added: ‘This Directive and the Specific Directives shall be interpreted and applied in conjunction with the provisions of Regulation No [XX/2014].’. [Am. 173] |
|
(1a) |
In Article 2, point g is amended as follows: ‘“national regulatory authority” means the body charged by a Member State with the regulatory tasks assigned in this Directive and the Specific Directives;’.[Am. 174] |
|
(1b) |
In Article 3, paragraph 3a is replaced by the following: ‘3a. Without prejudice to the provisions of paragraphs 4 and 5, each national regulatory authority shall be responsible at least for ex-ante market regulation under Articles 7, 7a, 15 and 16 of this Directive and Articles 9 to13b of Directive 2002/19/EC; for numbering, naming and addressing, co-location and sharing of network elements and associated facilities and for the resolution of disputes between undertakings in accordance with Articles 10, 12, 20 and 21 of this Directive and for affordability of tariffs, quality of service of designated undertakings, costing of universal service obligation, regulatory controls on retail services, contracts, transparency and publication of information, quality of service, ensuring equivalence in access and choice for disabled end-users, emergency services and the single European emergency call number, access to numbers and services, provision of additional facilities and facilitating change of provider under Articles 9, 11, 12, 17, 20, 20a, 21, 21a, 22, 23a, 26, 26a, 28, 29 and 30 of Directive 2002/22/EC, issues related to authorisation under Directive 2002/20/EC, as well as for Directive 2002/58/EC. Each national regulatory authority shall act independently and shall not seek or take instructions from any other body in relation to the exercise of these tasks assigned to them under national law implementing Community law. This shall not prevent supervision in accordance with national constitutional law. Only appeal bodies set up in accordance with Article 4 shall have the power to suspend or overturn decisions by the national regulatory authorities. Member States shall ensure that the head of a national regulatory authority, or where applicable, members of the collegiate body fulfilling that function within a national regulatory authority referred to in the first subparagraph or their replacements may be dismissed only if they no longer fulfil the conditions required for the performance of their duties which are laid down in advance in national law. The decision to dismiss the head of the national regulatory authority concerned, or where applicable members of the collegiate body fulfilling that function shall be made public at the time of dismissal. The dismissed head of the national regulatory authority, or where applicable, members of the collegiate body fulfilling that function shall receive a statement of reasons and shall have the right to request its publication, where this would not otherwise take place, in which case it shall be published. Member States shall ensure that national regulatory authorities referred to in the first subparagraph have separate annual budgets and that the budgets are sufficient for the performance of their tasks. The budgets and audited annual accounts shall be made public by each national regulatory authority. Each national regulatory authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities and shall have a number of competent personnel at its disposal for the proper performance of its tasks. Member States shall also ensure that national regulatory authorities have adequate financial and human resources to enable them to actively participate in and contribute to the Body of European Regulators for Electronic Communications (BEREC) (27). (27) Regulation (EC) No 1211/2009 of the European Parliament and of the Council of 25 November 2009 establishing the Body of European Regulators for Electronic Communications (BEREC) and the Office.’. [Am. 175]" |
|
(2) |
Article 7a is amended as follows:
|
|
(2a) |
In Article 8(4), point (g) is deleted. [Am. 180] |
|
(2b) |
In Article 9b(3), the first subparagraph is replaced by the following: ‘3. The Commission shall adopt appropriate implementing measures to facilitate the transfer or lease of rights to use radio frequencies between undertakings. Those measures shall be adopted by within 12 months following the date of application of Regulation […/…] (*2) . Those measures shall not cover frequencies which are used for broadcasting. (*2) Regulation (EU) No …/… of the European Parliament and of the Council of …. laying down measures concerning the European single market for electronic communications and amending Directives 2002/20/EC, 2002/21/EC and 2002/22/EC, Regulations (EC) No 1211/2009 and (EU) No 531/2012 and Decision 243/2012/EU (OJ L …,…, p.).’. [Am. 181]" |
|
(3) |
Article 15 is amended as follows:
|
|
(4) |
The first paragraph of Article 19 is amended as follows: ‘Without prejudice to Article 9 of this Directive and Articles 6 and 8 of Directive 2002/20/EC (Authorisation Directive), where the Commission finds that divergences in the implementation by the national regulatory authorities of the regulatory tasks specified in this Directive, and the Specific Directives and Regulation No […/2014] may create a barrier to the internal market, the Commission may shall , taking the utmost account of the opinion of BEREC, issue a recommendation or a decision on the harmonised application of the provisions in this Directive, the Specific Directives and Regulation No […/2014] in order to further the achievement of the objectives set out in Article 8.’. [Am. 182] |
Article 36
Amendments to Directive 2002/22/EC
1. With effect from 1 July 2016, Directive 2002/22/EC is amended as follows:
|
(1) |
In Article 1 (3), the first sentence is deleted. |
|
(1a) |
In the second subparagraph of Article 2, the following points are inserted:
|
|
(1b) |
The title of Article 20 is replaced by: ‘Information requirements for contracts’. [Am. 184] |
|
(1c) |
In Article 20, the following paragraph is inserted: 1. ‘-1a. Member States shall ensure that the information referred to in paragraphs 1 and 1a is provided prior to contract conclusion in a clear, comprehensive and easily accessible manner and without prejudice to the requirements set out in Directive 2011/83/EU (*3) regarding off-premises/distance contracts. The consumer and other end-user so requesting shall have access to a copy of the contract on a durable medium. Member States may maintain or introduce in their national law language requirements regarding the contractual information, so as to ensure that such information is easily understood by the consumer or other end-user so requesting. (*3) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).’. [Am. 185]" |
|
(1d) |
Article 20(1) is replaced by the following: 1. ‘1. Member States shall ensure that, when subscribing to services providing connection to a public communications network and/or publicly available electronic communications services, consumers, and other end-users so requesting, have a right to a contract with an undertaking or undertakings providing such connection and/or services. The contract shall specify at least the following information:
Member States may also require that the contract include any information which may be provided by the relevant public authorities for this purpose on the use of electronic communications networks and services to engage in unlawful activities or to disseminate harmful content, and on the means of protection against risks to personal security, privacy and personal data, referred to in Article 21(4) and relevant to the service provided.’. [Am. 186] |
|
(1e) |
In Article 20, the following paragraph is inserted: 1. ‘1a. In addition to the information referred to in paragraph 1, if the contract includes the provision of internet access services, that contract shall also include the following information:
|
|
(1f) |
Article 20 (2) is deleted. [Am. 188] |
|
(1 g) |
In Article 20, the following paragraph is added: ‘2a. Member States may maintain or introduce additional contractual information requirements in relation to contracts to which this Article applies.’. [Am. 189] |
|
(1h) |
In Article 20, the following paragraph is added: 1. ‘2b. BEREC shall issue guidelines for the establishment of standard contractual information templates containing the information required under paragraphs 1 and 1a of this Article. National regulatory authorities may specify additional requirements on the content, form and manner of the contractual information to be published, including in particular data delivery speeds, taking utmost account of the BEREC guidelines for the methods of measuring the speed and for the content, form and manner of the information to be published, as set out in Article 21(3a).’. [Am. 190] |
|
(1i) |
The following Article is inserted: ‘Article 20a Contract duration and termination 1. Member States shall ensure that the maximum duration of contracts concluded between consumers and providers of electronic communications to the public is 24 months. Providers of electronic communications to the public shall offer end-users the possibility of 12 month contracts. 2. The consumer shall have the right to withdraw from a distance or off premises contract within 14 days after its conclusion in accordance with Directive 2011/83/EU. 3. Where a contract or national law provides for contract periods with a fixed term (as opposed to a minimum term) to be automatically rolled over, the provider of electronic communications to the public shall inform the consumer in due time thereof so that the consumer has at least one month to oppose such automatic roll-over. If the consumer does not oppose such automatic roll-over, the contract shall be deemed to be a permanent rolling contract which can be terminated by the consumer, at any time with a one-month notice period and without incurring any costs except the cost of providing service during the notice period. 4. Member States shall ensure that consumers have the right to terminate their contract without incurring any costs upon receiving notice of changes in the contractual conditions proposed by the provider of electronic communications to the public unless the proposed changes are exclusively to the benefit of the end-user. Providers shall give consumers adequate notice, not less than one month, of any such change, and shall inform them at the same time of their right to terminate their contract without incurring any costs if they do not accept the new contractual conditions. Paragraph 2 shall apply mutatis mutandis. 5. Any significant discrepancy, continuous or regularly recurring, between the actual performance regarding speed or other quality of service parameters and the performance indicated by the provider of electronic communications to the public in accordance with Article 20 shall be deemed to constitute non-conformity of performance for the purposes of determining the remedies available to the consumer in accordance with national law. 6. Member States shall ensure that a subscription to additional services provided by the same provider of electronic communications to the public shall not re-start the initial contract period unless the additional services are offered at a special promotional price available only on the condition that the existing contract period is re-started. 7. Member States shall ensure that providers of electronic communications to the public apply conditions and procedures for contract termination which do not raise obstacles to or disincentives against changing service providers. 8. If a bundle of services offered to consumers comprises at least a connection to an electronic communications network or an electronic communications service, the provisions of this Article shall apply to all elements of the bundle. 9. Member States may maintain or introduce additional requirements to ensure a higher level of consumer protection in relation to contracts to which this Article applies.’. [Am. 191] |
|
(1j) |
Article 21 is replaced by the following: ‘Article 21 1. 1. Member States shall ensure that national regulatory authorities are able to oblige undertakings providing public electronic communications networks and/or publicly available electronic communications services to publish transparent, comparable, adequate and up-to-date information on applicable prices and tariffs, on any charges due on early termination of a contract and on standard terms and conditions in respect of access to, and use of, services provided by them to end-users in accordance with Annex II. Such information shall be published in a clear, comprehensive and easily accessible form and shall be updated regularly. Any differentiation in the conditions applied to consumers and other end-users so requesting shall be made explicit. National regulatory authorities may specify additional requirements regarding the form in which such information is to be published, which may in particular include the introduction of language requirements so as to ensure that such information is easily understood by consumers and other end-users so requesting. Member States shall ensure that providers of electronic communications to the public are obliged upon request to supply the information, to the relevant national regulatory authorities, in advance of its publication. 2. National regulatory authorities shall ensure that consumers and other end-users so requesting have access to independent evaluation tools to enable them to compare the performance of electronic communications network access and services and the cost of alternative usage patterns. Where such facilities are not available on the market free of charge or at a reasonable price, Member States shall ensure that national regulatory authorities are able to make such guides or techniques available themselves or through third party procurement. Third parties shall have a right to use, free of charge, the information published by undertakings providing electronic communications networks and/or publicly available electronic communications services for the purposes of selling or making available such independent evaluation tools. 2a. Member States shall ensure that national regulatory authorities, under guidance from BEREC and following consultation with relevant stakeholders, establish a voluntary certification scheme for interactive comparison websites, guides or similar tools, based on objective, transparent and proportionate requirements, including in particular independence from any provider of electronic communications to the public. 1. 3. Member States shall ensure that national regulatory authorities are able to oblige undertakings providing public electronic communications networks and/or publicly available electronic communications services to inter alia:
If deemed appropriate, national regulatory authorities may promote self- or co-regulatory measures prior to imposing any obligation. Member States may specify additional requirements on the content, form and manner of the information to be published, taking utmost account of the BEREC guidelines referred to in paragraph 3a of this Article. 3a. By … (*6) , BEREC, after consulting stakeholders and in close cooperation with the Commission, shall lay down general guidelines for the methods of measuring the speed, the quality of service parameters to be measured (inter alia average versus advertised speeds; quality as perceived by users), and the methods for measuring them over time, as well as the content, form and manner of the information to be published, including possible quality certification mechanisms, in order to ensure that end-users, including disabled end-users, have access to comprehensive, comparable, reliable and user-friendly information. Where appropriate, the parameters, definitions and measurement methods set out in Annex III may be used. 1. 4. Member States may require that the undertakings referred to in paragraph 3 distribute public interest information free of charge to end-users, where appropriate, by the same means as those ordinarily used by them in their communications with end-users. In such a case, that information shall be provided by the relevant public authorities to the providers of electronic communications to the public in a standardised format and may, inter alia, cover the following topics:
|
|
(1k) |
The following Article is inserted: ‘Article 21a Control of consumption 1. 1. Member States shall ensure that providers of electronic communications offer consumers and end-users the facility to monitor and control their usage of electronic communications services billed on time or volume consumption. This facility must include:
1. 2. BEREC shall lay down guidelines for the implementation of paragraph 1. After having reached the financial limit end-users shall continue to be able to receive calls and SMS messages and access free-phone numbers and emergency services by dialling the European emergency call number “112” free of charge until the end of the agreed billing period.’. [Am. 193] |
|
(2) |
Articles 20, 21, 22 and 30 are Article 22 is deleted. [Am. 194] |
|
(2a) |
Article 26 is replaced by the following: ‘1. Member States shall ensure that all end-users of the service referred to in paragraph 2, including users of public pay telephones are able to call the emergency services free of charge and without having to use any means of payment, by using the single European emergency call number “112” and any national emergency call number specified by Member States. 1a. Member States shall ensure that all users of private electronic communication networks are able to call the emergency services, or, where applicable, the internal emergency services, free of charge, by using the single European emergency call number “112” and any national emergency call number specified by the Member States. 2. Member States, in consultation with national regulatory authorities, emergency services and providers, shall ensure that undertakings providing end-users with an electronic communications service for originating national calls to a number or numbers in a national telephone numbering plan provide access to emergency services. 1. 3. Member States shall ensure that calls to the single European emergency call number “112” are appropriately answered and handled in the manner best suited to the national organisation of emergency systems. Such calls shall be answered and handled at least as expeditiously and effectively as calls to the national emergency number or numbers, where these continue to be in use. The Commission, in consultation with the relevant competent authorities, shall adopt a recommendation on performance indicators for Member States. The Commission shall submit to the European Parliament and the Council a report on the effectiveness of the implementation of the European emergency call number “112” and on the functioning of the performance indicators by the 31 December 2015 and every two years thereafter. 4. Member States shall ensure that access for disabled end-users to emergency services is equivalent to that enjoyed by other end-users. Measures taken to ensure that disabled end-users are able to access emergency services whilst travelling in other Member States shall be based to the greatest extent possible on European standards or specifications published in accordance with the provisions of Article 17 of Directive 2002/21/EC (Framework Directive), and they shall not prevent Member States from adopting additional requirements in order to pursue the objectives set out in this Article. 1. 5. Member States shall ensure that undertakings concerned make caller location information available free of charge to the authority handling emergency calls as soon as the call reaches that authority. This shall apply to all calls to the single European emergency call number “112”. Member States may extend this obligation to cover calls to national emergency numbers. The Commission shall ensure that competent regulatory authorities shall lay down criteria for the accuracy and reliability of the location information provided in accordance with paragraph 7 and taking utmost account of the BEREC guidelines. By… (*7) BEREC, after consulting relevant stakeholders and in close cooperation with the Commission, shall lay down guidelines for the criteria for the accuracy and reliability of the caller location information provided to emergency services. Those guidelines shall take into account the feasibility of using a mobile terminal equipped with a GNSS devices of mobile terminals in order to improve the accuracy and reliability of the caller location information of a “112” call. 6. Member States and the Commission shall ensure that citizens are adequately informed about the existence and use of the single European emergency call number “112”, in particular through initiatives specifically targeting persons travelling between Member States. The Commission shall support and complement Member States’ action. 7. In order to ensure the effective access to “112” services in the Member States, the Commission, having consulted BEREC, shall be empowered to adopt delegated acts in accordance with Article 37a concerning caller location criteria and key performance indicators on access to “112”. However, these measures shall be adopted without prejudice to, and shall have no impact on, the organisation of emergency services, which remains of the exclusive competence of Member States. 7a. The Commission shall maintain a database of E.164 numbers of European emergency services to ensure that they are able to contact each other from one Member State to another.’ [Am. 195] |
|
(2b) |
The following Article is inserted: ‘Article 26a Reverse EU “112” communication system No later than [1 year after the transposition deadline] the Commission shall submit a report to the European Parliament and the Council on the feasibility for setting up a Reverse EU “112” communication system using existing electronic communication networks, that covers the whole Union, is universal, multilingual, accessible, straightforward and effective in order to alert the public in the event of an imminent or developing disaster or major state of emergency. The Commission shall consult BEREC and civil defence services, and examine the standards and specifications necessary for the setting up of the system referred to in paragraph 1. While preparing that report the Commission shall take into account existing national and regional “112” systems and shall comply with the Union law on the protection of private data. Where appropriate, that report shall be accompanied by a legislative proposal.’. [Am. 196] |
|
(2c) |
Article 30 is replaced by the following: ‘1. Member States shall ensure that all subscribers with numbers from the national telephone numbering plan who so request can retain their number(s) independently of the provider of electronic communications to the public providing the service in accordance with the provisions of Part C of Annex I. 2. National regulatory authorities shall ensure that pricing between operators and/or service providers related to the provision of number portability is cost-oriented, and that direct charges to subscribers, if any, do not act as a disincentive for subscribers against changing service provider. 3. National regulatory authorities shall not impose retail tariffs for the porting of numbers in a manner that would distort competition, such as by setting specific or common retail tariffs. 1. 4. Porting of numbers and their subsequent activation shall be carried out within the shortest possible time. For end-users who have concluded an agreement to port a number to a new provider that number shall be activated within one working day. Without prejudice to the first subparagraph, competent national authorities may establish the global process of switching and porting of numbers taking into account the BEREC guidelines referred to in paragraph 4b. They shall take into account necessary end-user protection throughout the switching process, the need to ensure the efficiency of such a process for the end-user, the need to maintain continuity of service to the end-user and the need to ensure that switching processes are not harmful to competition. In any event, loss of service during the process of porting shall not exceed one working day. End-users shall not be switched to another provider against their will. Member States shall ensure that appropriate sanctions on undertakings are provided for, including an obligation to compensate subscribers in case of delay in porting, of not making available information necessary for porting in a timely manner, or abuse of porting by them or on their behalf. 4a. The receiving provider of electronic communications to the public shall lead the switching and porting process. End-users shall receive adequate information on switching before and during the switching process, and also immediately after it is concluded. 4b. BEREC shall lay down guidelines on all the modalities and procedures of the switching and porting process, in particular the respective responsibilities of the receiving and transferring provider in the process of switching and porting, information to be provided to consumers during that process, timely termination of an existing contract the refund of any pre-payments and effective e-mail forwarding services. 4c. If a bundle of services offered to consumers comprises at least a connection to an electronic communications network or an electronic communications service, the provisions of this Article shall apply to all elements of the bundle.’. [Am. 197] |
|
(2d) |
In Article 34 the following paragraph is added: ‘1a. The out-of-court procedures set up in accordance with paragraph 1 shall also apply to disputes related to contracts between consumers, and other end-users to the extent that such out-of-court procedures are available also for them, and providers of electronic communications to the public which are established in another Member State. In the case of disputes falling within the scope of Directive 2013/11/EU (*8) , the provisions of that Directive shall apply. (*8) Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (OJ L 165, 18.6.2013, p. 63).’. [Am. 198]" |
|
(2e) |
The following Article 37a is inserted: ‘Article 37a Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 26 shall be conferred on the Commission for an indeterminate period of time from … (*9). 3. The delegation of power referred to in Article 26 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.’. [Am. 199] |
|
(2f) |
In Annex II, point 1 is replaced by the following:
|
|
(2 g) |
In Annex II, point 2.2 is replaced by the following:
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|
(2h) |
In Annex II, the following point is inserted:
|
|
(2i) |
In Annex II, Point 2.5 is replaced by the following:
|
2. Member States shall maintain in force until 1 July 2016 all measures transposing the provisions referred to in paragraph 1.
Article 37
Amendments to Regulation (EU) No 531/2012
Regulation (EU) No 531/2012 is amended as follows:
|
(1) |
In Article 1(1), the following third subparagraph is inserted: ‘This Regulation shall apply to roaming services provided in the Union to end users whose domestic provider is a provider of electronic communications to the public in a Member State.’ [Am. 204] |
|
(2) |
In Article 2 (2), the following point (r) is inserted:
|
|
(3) |
In Article 4, the following paragraph 7 is added: ‘7. This Article shall not apply to roaming providers that provide regulated retail roaming services in accordance with Article 4a.’ [Am. 206] |
|
(4) |
The following Article 4a is inserted: ‘Article 4a 1. This Article shall apply to roaming providers which:
2. Paragraphs 1, 6 and 7 shall not preclude the limitation by a roaming provider of consumption of regulated retail roaming services at the applicable domestic service rate by reference to a reasonable use criterion. Any reasonable use criterion shall be applied in such a way that consumers availing of the roaming provider's various domestic retail packages are in a position to confidently replicate the typical domestic consumption pattern associated with their respective domestic retail packages while periodically travelling within the Union. A roaming provider availing of this possibility shall publish, in accordance with Article 25(1)(b) of Regulation XXX/2014, and include in its contracts, in accordance with Article 26(1)(b) and (c) of that Regulation, detailed quantified information on how the reasonable use criterion is applied, by reference to the main pricing, volume or other parameters of the retail package in question. By 31 December 2014, BEREC shall, after consulting stakeholders and in close cooperation with the Commission, lay down general guidelines for the application of reasonable use criteria in the retail contracts provided by roaming providers availing of this Article. BEREC shall develop such guidelines by reference to the overall objective set out in the first subparagraph, and shall have regard in particular to the evolution of pricing and consumption patterns in the Member States, to the degree of convergence of domestic price levels across the Union, to any observable effect of roaming at domestic service rates on the evolution of such rates, and to the evolution of wholesale roaming rates for unbalanced traffic between roaming providers. The competent national regulatory authority shall monitor and supervise the application of reasonable use criteria, taking utmost account of the BEREC general guidelines once they are adopted, and shall ensure that unreasonable terms are not applied. 3. Individual end-users served by a roaming provider availing of this Article may, upon their own request, make a deliberate and explicit choice to renounce the benefit of the application to regulated roaming services of the applicable domestic service rate under a given retail package in return for other advantages offered by that provider. The roaming provider shall remind those end users of the nature of the roaming advantages which would thereby be lost. National regulatory authorities shall monitor in particular whether roaming providers availing of this Article engage in business practices which would amount to circumvention of the default regime. 4. Regulated retail roaming charges laid down in Articles 8, 10 and 13 shall not apply to roaming services offered by a roaming provider availing of this Article to the extent that these are charged at the level of the applicable domestic service rate. Where a roaming provider availing of this Article applies charges which are different from the applicable domestic service rate for consumption of regulated roaming services going beyond reasonable use of such services in accordance with paragraph 2, or where an individual end user explicitly renounces the benefit of domestic service rates for regulated roaming services in accordance with paragraph 3, the charges for those regulated roaming services shall not exceed the retail roaming charges laid down in Articles 8, 10 and 13. 5. A roaming provider wishing to avail of this Article shall notify its own declaration and any bilateral or multilateral agreements by virtue of which it fulfills the conditions of paragraph 1, and any changes thereto, to the BEREC Office. The notifying roaming provider shall include in its notification proof of agreement to such notification by any contractual partners to notified bilateral or multilateral roaming agreements. 6. In the period from 1 July 2014 until 30 June 2016, this Article shall apply to roaming providers which do not fulfill the conditions set out in paragraph 1, when they respect the following conditions:
The roaming provider availing of this Article and any contractual partners within the meaning of point (b) may, as an alternative to the undertaking referred to in point (d), undertake, as from 1 July 2015, or as from the date of notification, whichever is the later, that any roaming surcharges applied in addition to the applicable domestic service rate in its various retail packages are, in aggregate, no more than 50 % of those applicable in those packages on 1 January 2015, irrespective of whether such surcharges are calculated on the basis of units such as voice minutes or megabytes, of periods such as days or weeks of roaming, or by any other means or combination thereof. Roaming providers invoking this point shall demonstrate compliance with the requirement of a 50 % reduction to the national regulatory authority and shall supply all necessary supporting evidence requested of them. Where the roaming provider availing of this Article notifies its own declaration and any relevant bilateral or multilateral roaming agreements to the BEREC Office pursuant to point (a) of the first subparagraph and thereby falls under this paragraph, the notifying roaming provider and any contractual partners within the meaning of point (b) shall each be bound to comply with their respective undertakings in accordance with points (c), (d) and (e) of the first subparagraph, including any alternative undertaking to that provided for in point (d) of that subparagraph, until at least 1 July 2018. 7. In the period from 1 July 2014 until 30 June 2016, this Article shall apply to roaming providers which do not fulfill the conditions set out in paragraph 1, when they respect the following conditions:
Where a roaming provider availing of this Article notifies its own declaration and any relevant bilateral or multilateral roaming agreements to the BEREC Office pursuant to point (a) of the first subparagraph and thereby falls under this paragraph, the notifying roaming provider and any contractual partners within the meaning of point (b) shall each be bound to comply with their respective undertakings to comply with the conditions of paragraph 1(a), until at least 1 July 2018. 8. Roaming providers shall negotiate in good faith the arrangements towards establishing bilateral or multilateral roaming agreements, on fair and reasonable terms having regard to the objective that such agreements with other roaming providers should allow the virtual extension of the home network coverage and the sustainable provision by each of the roaming providers availing of this Article of regulated retail roaming services at the same price level as their respective domestic mobile communications services. 9. By way of exception to paragraph 1, after 1 July 2016, this Article shall apply to roaming providers availing of this Article when those roaming providers demonstrate that they have sought in good faith to establish or extend a bilateral or multilateral roaming agreements on the basis of fair and reasonable terms in all Member States where they do not yet fulfill the requirements of 1 and have been unable to secure any bilateral or multilateral roaming agreement with a roaming provider in one or more Member States, provided they comply with the minimum coverage referred to in paragraph 6(b) and with all other relevant provisions of this Article. In those cases, roaming providers availing of this Article shall continue to seek to establish reasonable terms for conclusion of a roaming agreement with a roaming provider from any unrepresented Member State. 10. Where an alternative roaming provider has already been granted access to a domestic provider's customers pursuant to Article 4(1) and has already made the necessary investments to serve those customers, Article 4(7) shall not apply to such a domestic provider during a transitional period of three years. The transitional period is without prejudice to the need to respect any longer contractual period agreed with the alternative roaming provider. 11. This Article is without prejudice to the application of Union competition rules to bilateral and multilateral roaming agreements.’ [Am. 207] |
|
(4a) |
The following articles are inserted: ‘Article 6a Abolition of retail roaming charges With effect from 15 December 2015, roaming providers shall not levy any surcharge in comparison to the charges for mobile communications services at domestic level on roaming customers in any Member States for any regulated roaming call made or received, for any regulated roaming SMS/MMS message sent and for any regulated data roaming services used, nor any general charge to enable the terminal equipment or service to be used abroad. Article 6b Fair usage 1. By way of derogation from article 6a, and to prevent anomalous or abusive usage of retail roaming services, roaming providers may apply a “fair use clause” to the consumption of regulated retail roaming services provided at the applicable domestic price level, by reference to fair use criteria. These criteria shall be applied in such a way that consumers are in a position to confidently replicate the typical domestic consumption pattern associated with their respective domestic retail packages while periodically travelling within the Union. 2. In accordance with Article 20 of Directive 2002/22/EC, roaming providers shall publish and include in their contracts detailed quantified information on how any fair use criteria are applied, by reference to the main pricing, volume or other parameters of the retail package in question. 3. By 31 December 2014, BEREC shall, after consulting stakeholders and in close cooperation with the Commission, lay down general guidelines for the application of fair use criteria in retail contracts provided by roaming providers. BEREC shall have regard in particular to the evolution of pricing and consumption patterns in the Member States, to the degree of convergence of domestic price levels across the Union, to any observable effect of roaming at domestic service rates on the evolution of such rates, and to the evolution of effective wholesale roaming rates for unbalanced traffic between roaming providers. In addition, BEREC's guidelines may also have regard to relevant objective variations between Member States or between roaming providers in respect of factors such as domestic price levels, typical volumes included in retail packages or the average period during which customers travel within the Union. 4. In order to ensure consistent and simultaneous implementation across the Union of the application of the fair use criteria, the Commission shall, by means of implementing acts and based on the BEREC guidelines referred on paragraph 3, adopt, by 30 June 2015, detailed rules on the application of fair use criteria. 5. The competent national regulatory authority shall strictly monitor and supervise the application of fair use criteria as defined by the Commission implementing act referred on paragraph 4, taking utmost account of the BEREC general guidelines, of relevant objective factors specific to its Member State and of relevant objective variations between roaming providers, and shall ensure that unreasonable terms are not applied. 6. The retail charges for euro tariff services established by Articles 8, 10 and 13 of this Regulation apply for regulated roaming services in excess of any fair usage limit applied in accordance with Article 6b.’. [Am. 208] |
|
(5) |
In Article 8, paragraph 2 is amended as follows:
|
|
(5a) |
In Article 10, paragraph 2 is replaced by the following: ‘2. With effect from 1 July 2012, the retail charge (excluding VAT) for a euro-SMS tariff which a roaming provider may levy on its roaming customer for a regulated roaming SMS message sent by that roaming customer may vary for any regulated roaming SMS message but shall not exceed EUR 0,09. That maximum charge shall decrease to EUR 0,08 on 1 July 2013 and to EUR 0,06 on 1 July 2014. The maximum charges applicable as of 1 July 2014 shall expire 16 December 2015 save for regulated roaming SMS messages in excess of any fair use limit applied in accordance with Article 6b.’. [Am. 211] |
|
(5b) |
In Article 13, paragraph 2, the first subparagraph is replaced by the following: ‘2. With effect from 1 July 2012, the retail charge (excluding VAT) of a euro-data tariff which a roaming provider may levy on its roaming customer for the provision of a regulated data roaming service shall not exceed EUR 0,70 per megabyte used. The maximum retail charge for data used shall decrease to EUR 0,45 per megabyte used on 1 July 2013 and to EUR 0,20 per megabyte used on 1 July 2014. The maximum charges applicable as of 1 July 2014 shall expire 16 December 2015 save for regulated data roaming services in excess of any fair use limit applied in accordance with Article 6b.’. [Am. 212] |
|
(6) |
In Article 14, the following paragraph 1a is inserted: ‘1a. When the consumption of regulated retail roaming services at the applicable domestic service rate is limited by reference to a reasonable use criterion in accordance with Article 4a(2), roaming providers shall alert roaming customers when the consumption of roaming calls and SMS messages has reached the reasonable use limit and at the same time shall provide roaming customers with basic personalised pricing information on the roaming charges applicable to making a voice call or sending an SMS message outside the domestic service rate or package in accordance with the second, fourth and fifth sub-paragraphs of paragraph 1 of this Article.’ [Am. 213] |
|
(6a) |
Article 14 is deleted and replaced by the following with effect from 15 December 2015: ‘1. To alert roaming customers to the fact that they will be subject to roaming charges when making or receiving a call or when sending an SMS message, each roaming provider shall, except when the customer has notified the roaming provider that he does not require this service, provide the customer, automatically by means of a Message Service, without undue delay and free of charge, when he enters a Member State other than that of his domestic provider, with basic personalised pricing information on the roaming charges (including VAT) that apply to the making and receiving of calls and to the sending of SMS messages by that customer in the visited Member State. That basic personalised pricing information shall include the maximum charges (in the currency of the home bill provided by the customer's domestic provider) to which the customer may be subject under his tariff scheme for:
It shall also include the free-of-charge number referred to in paragraph 2 for obtaining more detailed information and information on the possibility of accessing emergency services by dialling the European emergency number 112 free of charge. On the occasion of each message, a customer shall have the opportunity to give notice to the roaming provider, free of charge and in an easy manner, that he does not require the automatic Message Service. A customer who has given notice that he does not require the automatic Message Service shall have the right at any time and free of charge to require the roaming provider to provide the service again. Roaming providers shall provide blind or partially-sighted customers with the basic personalised pricing information referred to in the first subparagraph automatically, by voice call, free of charge, if they so request. 2. In addition to paragraph 1, customers shall have the right to request and receive, free of charge, and irrespective of their location within the Union, more detailed personalised pricing information on the roaming charges that apply in the visited network to voice calls and SMS, and information on the transparency measures applicable by virtue of this Regulation, by means of a mobile voice call or by SMS. Such a request shall be to a free-of-charge number designated for this purpose by the roaming provider. Obligations provided for in paragraph 1 shall not apply to devices which do not support SMS functionality. 3. Roaming providers shall make available information to their customers on how to avoid inadvertent roaming in border regions. Roaming providers shall take reasonable steps to protect their customers from paying roaming charges for inadvertently accessed roaming services while situated in their home Member State. 4. The present article shall also apply to roaming calls and roaming SMS/MMS messages used by roaming customers travelling outside the Union and provided by a roaming provider. With effect from 15 December 2015, this article shall also apply in cases where the consumption of roaming calls and roaming SMS/MMS messages at the applicable domestic service rate is limited by reference to a fair use criterion in accordance with Article 6b and when the consumption has reached the fair use limit.’. [Am. 214] |
|
(7) |
In Article 15, the following paragraph 2a is inserted: ‘2a. When the consumption of regulated retail roaming services at the applicable domestic service rate is limited by reference to a reasonable use criterion in accordance with Article 4a(2), roaming providers shall alert roaming customers when the consumption of data roaming services has reached the reasonable use limit and at the same time shall provide roaming customers with basic personalised pricing information on the roaming charges applicable to data roaming outside the domestic service rate or package in accordance with paragraph 2 of this Article. Paragraph 3 of this Article shall apply to data roaming services consumed outside the applicable domestic service rates or packages referred to in Article 4a(2).’ [Am. 215] |
|
(7a) |
Article 15 is deleted and replaced by the following with effect from 15 December 2015: ‘Transparency and safeguard mechanisms for retail data roaming services 1. Roaming providers shall ensure that their roaming customers, both before and after the conclusion of a contract, are kept adequately informed of the charges which apply to their use of regulated data roaming services, in ways which facilitate customers' understanding of the financial consequences of such use and permit them to monitor and control their expenditure on regulated data roaming services in accordance with paragraphs 2 and 3. Where appropriate, roaming providers shall inform their customers, before the conclusion of a contract and on a regular basis thereafter, of the risk of automatic and uncontrolled data roaming connection and download. Furthermore, roaming providers shall notify to their customers, free of charge and in a clear and easily understandable manner, how to switch off these automatic data roaming connections in order to avoid uncontrolled consumption of data roaming services. 2. An automatic message from the roaming provider shall inform the roaming customer that the latter is roaming and provide basic personalised tariff information on the charges (in the currency of the home bill provided by the customer's domestic provider), expressed in price per megabyte, applicable to the provision of regulated data roaming services to that roaming customer in the Member State concerned, except where the customer has notified the roaming provider that he does not require that information. Such basic personalised tariff information shall be delivered to the roaming customer's mobile device, for example by an SMS message, an e-mail or a pop-up window on the mobile device, every time the roaming customer enters a Member State other than that of his domestic provider and initiates for the first time a data roaming service in that particular Member State. It shall be provided free of charge at the moment the roaming customer initiates a regulated data roaming service, by an appropriate means adapted to facilitate its receipt and easy comprehension. A customer who has notified his roaming provider that he does not require the automatic tariff information shall have the right at any time and free of charge to require the roaming provider to provide this service again. 3. Each roaming provider shall grant to all their roaming customers the opportunity to opt deliberately and free of charge for a facility which provides information on the accumulated consumption expressed in volume or in the currency in which the roaming customer is billed for regulated data roaming services and which guarantees that, without the customer's explicit consent, the accumulated expenditure for regulated data roaming services over a specified period of use, excluding MMS billed on a per-unit basis, does not exceed a specified financial limit. To this end, the roaming provider shall make available one or more maximum financial limits for specified periods of use, provided that the customer is informed in advance of the corresponding volume amounts. One of those limits (the default financial limit) shall be close to, but not exceed, EUR 50 of outstanding charges per monthly billing period (excluding VAT). Alternatively, the roaming provider may establish limits expressed in volume, provided that the customer is informed in advance of the corresponding financial amounts. One of those limits (the default volume limit) shall have a corresponding financial amount not exceeding EUR 50 of outstanding charges per monthly billing period (excluding VAT). In addition, the roaming provider may offer to its roaming customers other limits with different, that is, higher or lower, maximum monthly financial limits. The default limits referred to in the second and third subparagraphs shall be applicable to all customers who have not opted for another limit. Each roaming provider shall also ensure that an appropriate notification is sent to the roaming customer's mobile device, for example by an SMS message, an e-mail or a pop-up window on the computer, when the data roaming services have reached 80 % of the agreed financial or volume limit. Each customer shall have the right to require the roaming provider to stop sending such notifications and shall have the right, at any time and free of charge, to require the provider to provide the service again. When the financial or volume limit would otherwise be exceeded, a notification shall be sent to the roaming customer's mobile device. That notification shall indicate the procedure to be followed if the customer wishes to continue provision of those services and the cost associated with each additional unit to be consumed. If the roaming customer does not respond as prompted in the notification received, the roaming provider shall immediately cease to provide and to charge the roaming customer for regulated data roaming services, unless and until the roaming customer requests the continued or renewed provision of those services. Whenever a roaming customer requests to opt for or to remove a financial or volume limit facility, the change shall be made within one working day of receipt of the request, shall be free of charge, and shall not entail conditions or restrictions pertaining to other elements of the subscription. 4. Paragraphs 2 and 3 shall not apply to machine-to-machine devices that use mobile data communication. 5. Roaming providers shall take reasonable steps to protect their customers from paying roaming charges for inadvertently accessed roaming services while situated in their home Member State. This shall include informing customers on how to avoid inadvertent roaming in border regions. 6. This article shall apply in cases where the consumption of data roaming services at the applicable domestic service rate is limited by reference to a fair use criterion in accordance with Article 6b and when the consumption has reached the fair use limit. It shall also apply to data roaming services used by roaming customers travelling outside the Union and provided by a roaming provider. Where the customer opts for the facility referred to in the first subparagraph of paragraph 3, the requirements provided in paragraph 3 shall not apply if the visited network operator in the visited country outside the Union does not allow the roaming provider to monitor its customers’ usage on a real- time basis. In such a case the customer shall be notified by an SMS message when entering such a country, without undue delay and free of charge, that information on accumulated consumption and the guarantee not to exceed a specified financial limit are not available.’. [Am. 216] |
|
(8) |
Article 19 is amended as follows:
|
|
(8a) |
Article 19 is deleted and replaced by the following: ‘1. The Commission shall review the functioning of this Regulation and shall report to the European Parliament and the Council in accordance with paragraphs 2 to 6. 2. The Commission shall, by 30 June 2015, after a public consultation, report to the European Parliament and the Council on whether to change the duration or revise the level of maximum wholesale charges provided for in Articles 7, 9 and 12 or to provide for other arrangements to address wholesale market problems, including as regards mobile termination rates applicable to roaming. BEREC shall, by 31 December 2014, after a public consultation, lay down guidelines on measures to prevent anomalous or abusive usage for the purpose of Article 6a. 3. The Commission shall, by 30 June 2016, after a public consultation, report to the European Parliament and the Council on, inter alia:
The Commission shall examine, in particular, whether it is necessary to lay down additional technical and structural measures or to modify the structural measures. 4. If the report referred to in paragraph 2 shows that there is no level playing field between roaming providers and consequently that there is a need to change the duration or lower the level of maximum wholesale charges or to provide for other arrangements to address wholesale market problems, including by a significant reduction of the mobile termination rates applicable to roaming throughout the Union, the Commission shall, after consulting BEREC, make appropriate legislative proposals to the European Parliament and the Council to address this situation by 30 June 2015. If the report referred to in paragraph 3 shows that the structural measures provided for by this Regulation have not been sufficient to promote competition in the internal market for roaming services for the benefit of all European consumers, the Commission shall make appropriate proposals to the European Parliament and the Council to address this situation. With respect to both reports, proposals for any appropriate measures shall be presented simultaneously with the reports. 5. In addition, the Commission shall submit a report to the European Parliament and the Council every two years after the report referred to in paragraph 3. Each report shall include a summary of the monitoring of the provision of roaming services in the Union and an assessment of the progress towards achieving the objectives of this Regulation. 6. In order to assess the competitive developments in the Union-wide roaming markets, BEREC shall regularly collect data from national regulatory authorities on the development of retail and wholesale charges for voice, SMS and data roaming services. Those data shall be notified to the Commission at least twice a year. The Commission shall make them public. BEREC shall also annually collect information from national regulatory authorities on transparency and comparability of different tariffs offered by operators to their customers. The Commission shall make those data and findings public.’. [Am. 218] |
Article 38
Amendments to Regulation (EC) No 1211/2009
Regulation (EC) No 1211/2009 is amended as follows:
|
(1) |
In Article 1, paragraph 2 is replaced by the following: ‘2. BEREC shall act within the scope of Directive 2002/21/EC (Framework Directive) and Directives 2002/19/EC, 2002/20/EC, 2002/22/EC and 2002/58/EC (Specific Directives), and of Regulations (EU) No 531/2012 and No …/2014.’. |
|
(1a) |
In Article 3(1), the following points (ma) and (mb) are inserted:
|
|
(1b) |
In Article 3(1), the following point (na) is inserted:
|
|
(2) |
In Article 4, paragraphs 4 and 5 are deleted. [Am. 221] |
|
(3) |
The following Article 4a is inserted: ‘Article 4a Appointment and tasks of the Chairperson 1. The Board of Regulators shall be represented by a Chairperson, who shall be a full-time independent professional. The Chairperson shall be engaged as a temporary agent of the Office under Article 2(a) of the Conditions of Employment of Other servants. The Chairperson shall be responsible for preparing the work of the Board of Regulators and shall chair without the right to vote the meetings of the Board of Regulators and the Management Committee. Without prejudice to the role of the Board of Regulators in relation to the tasks of the Chairperson, the Chairperson shall neither seek nor accept any instruction from any government or NRA, from the Commission, or from any other public or private entity. 2. The Chairperson shall be appointed by the Board of Regulators on the basis of merit, skills, knowledge of electronic communication market participants and markets, and of experience relevant to supervision and regulation, following an open selection procedure. Before appointment, the candidate selected by the Board of Regulators may be invited to make a statement before the competent committee of the European Parliament and to answer questions put by its members. The appointment of the Chairperson is effective only after approval of the Management Committee. The Board of Regulators shall also elect, from among its members, a Vice-Chair who shall carry out the functions of the Chairperson in his absence. 3. The Chairperson’s term of office shall be 3 years and may be extended once. 4. In the course of the 9 months preceding the end of the 3-year term of office of the Chairperson, the Board of Regulators shall evaluate:
The Board of Regulators shall inform the European Parliament if it intends to extend the Chairperson's term of office. Within one month before any such extension, the Chairperson may be invited to make a statement before the competent committee of the Parliament and answer questions put by its members. 5. The Chairperson may be removed from office only upon a decision of the Board of Regulators acting on a proposal from the Commission and after approval of the Management Committee. The Chairperson shall not prevent the Board of Regulators and the Management Committee from discussing matters relating to the Chairperson, in particular the need for his removal, and shall not be involved in deliberations concerning such a matter.’ [Am. 222] |
|
(4) |
Article 6 is amended as follows:
|
|
(5) |
Article 7 is amended as follows:
|
|
(6) |
Article 8 paragraphs 2, 3, 4, are deleted and replaced as follows: ‘2. The Administrative Manager shall be engaged as a temporary agent of the Office under Article 2(a) of the Conditions of Employment of Other servants. 3. The Administrative Manager shall be appointed by the Management Committee from a list of candidates proposed by the Commission, following an open and transparent selection procedure. For the purpose of concluding the contract with the Administrative Manager, the Office shall be represented by the Chairperson of the Management Committee. Before appointment, the candidate selected by the Management Committee may be invited to make a statement before the competent committee of the European Parliament and to answer questions put by its members. 4. The term of office of the Administrative Manager shall be five years. By the end of that period, the Commission shall undertake an assessment that takes into account an evaluation of the Administrative Manager's performance and the Office's future tasks and challenges. 5. The Management Committee, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 4, may extend the term of office of the Administrative Manager once, for no more than five years. 6. The Management Committee shall inform the European Parliament if it intends to extend the Administrative Manager's term of office. Within one month before any such extension, the Administrative Manager may be invited to make a statement before the competent committee of the Parliament and answer questions put by its members. 7. An Administrative Manager whose term of office has been extended may not participate in another selection procedure for the same post at the end of the overall period. 8. The Administrative Manager may be removed from office only upon a decision of the Management Committee acting on a proposal from the Commission. 9. The Management Committee shall reach decisions on appointment, extension of the term of office or removal from office of the Administrative Manager on the basis of a two-thirds majority of its members with voting rights.’ [Am. 225] |
|
(7) |
In Article 9, paragraph 2 is amended as follows: ‘2. The Administrative Manager shall assist the Chairperson of the Board of Regulators with the preparation of the agenda of the Board of Regulators, the Management Committee and the Expert Working Groups. The Administrative Manager shall participate, without having the right to vote, in the work of the Board of Regulators and the Management Committee.’ [Am. 226] |
|
(8) |
Article 10 is amended as follows: ‘1. The Staff Regulations and the Conditions of Employment of Other Servants and the rules adopted by agreement between the institutions of the Union for giving effect to those Staff Regulations and the Conditions of Employment of Other Servants shall apply to the staff of the Office, including the Chairperson of the Board of Regulators and the Administrative Manager. 2. The Management Committee shall adopt appropriate implementing rules for giving effect to the Staff Regulations and the Conditions of Employment of Other Servants in accordance with Article 110 of the Staff Regulations. 3. The Management Committee shall, in accordance with paragraph 4, exercise with respect to the staff of the Office the powers conferred by the Staff Regulations on the Appointing Authority and by the Conditions of Employment of Other Servants on the Authority Empowered to Conclude a Contract of Employment (“the appointing authority powers”). 4. The Management Committee shall adopt, in accordance with Article 110 of the Staff Regulations, a decision based on Article 2.(1) of the Staff Regulations and on Article 6 of the Conditions of Employment of Other Servants, delegating relevant appointing authority powers to the Administrative Manager and defining the conditions under which this delegation of powers can be suspended. The Administrative Manager shall be authorised to sub-delegate those powers. Where exceptional circumstances so require, the Management Committee may by way of a decision temporarily suspend the delegation of the appointing authority powers to the Administrative Manager and those sub-delegated by the latter and exercise them itself or delegate them to one of its members or to a staff member other than the Administrative Manager.’ [Am. 227] |
|
(9) |
The following Article 10a is inserted: ‘Article 10a Seconded national experts and other staff 1. The Office may make use of Seconded national experts or other staff not employed by the Office. 2. The Management Committee shall adopt a decision laying down rules on the secondment of national experts to the Office.’ [Am. 228] |
Article 39
Review clause
The Commission shall submit reports on the perform a comprehensive evaluation and review of this Regulation the entire regulatory framework for electronic communications, and shall submit a report with appropriate proposals to the European Parliament and the Council at regular intervals. The first report shall be submitted no later than 1 July 2018. Subsequent reports shall be submitted every four years thereafter. The Commission shall, if necessary, submit appropriate proposals with a view to amending this Regulation, and aligning other legal instruments, taking account in particular of developments in information technology and of the state of progress in the information society. The reports shall be made public. by 30 June 2016 in order to allow sufficient time for the legislator to analyse and debate the proposals properly.
The review shall be based on a full public consultation as well as on ex-post assessments of the impact of the regulatory framework since 2009 and a thorough ex-ante assessment of the expected impact of the options emanating from the review .
The main goals of the review shall include:
|
(i) |
ensuring that substitutable services are subject to the same rules, taking into consideration the definition of electronic communications services in Article 2(c) of Directive 2002/21/EC, in order to achieve equivalent, coherent and consistent regulation of electronic communications services and services substitutable to them, including with respect to access, all aspects of consumer protection, including portability, as well as privacy and data protection; |
|
(ii) |
ensuring a high degree of consumer protection and more informed consumer choice through increased transparency and access to clear and comprehensive information, including on data delivery speeds and mobile network coverage; |
|
(iii) |
ensuring that users of digital services are able to control their digital life and data by removing obstacles to switching operating systems without losing their applications and data; |
|
(iv) |
further promoting effective and sustainable competition; |
|
(v) |
providing a stable and sustainable framework for investment; |
|
(vi) |
ensuring a harmonised, consistent and effective application; |
|
(vii) |
facilitating the development of pan-European providers and the provision of cross-border business services; |
|
(viii) |
ensuring that the regulatory framework is adequate for the digital age and delivers an internet ecosystem that supports the entire economy, and |
|
(ix) |
increasing user confidence in the internal market for electronic communications, including through measures to implement the future regulatory framework for the protection of personal data and measures to increase the security of electronic communications in the internal market. |
The review shall inter alia include:
|
(i) |
the universal service obligation, including a review of the need for an additional obligation to offer broadband internet access at a fair price; |
|
(ii) |
the competence of national regulatory authorities for all issues, including spectrum, that are addressed by the framework; the powers granted to the national regulatory authorities in the Member States and the scope of the requirement of independence of national regulatory authorities; |
|
(iii) |
cooperation between the national regulatory authorities and national competition authorities; |
|
(iv) |
the symmetric obligations relating to network access; |
|
(v) |
the rules on leverage effects and joint dominance; |
|
(vi) |
the market review processes; |
|
(vii) |
the impact of services that are substitutable to electronic communications services; including whether clarifications are needed regarding the reach of the regulatory framework's technological neutrality and regarding the dichotomy between services in the ‘information society’ bracket and those in the ‘electronic communications’ bracket; |
|
(viii) |
the necessity of abolishing redundant regulation; |
|
(ix) |
the lifting of regulation where a market analysis has shown the market concerned to be truly competitive and that ways and means exist for extended monitoring; |
|
(x) |
the experience with non-discrimination obligations and remedies; |
|
(xi) |
the effectiveness and functioning of the procedures established in Articles 7 and 7a of Directive 2002/21/EC; |
|
(xii) |
initiation of an Article 7/7a procedure in situations where phase II of the procedure is not triggered due to an NRA withdrawal of its draft measure or where an NRA does not propose a remedy to a problem recognised on a certain market; |
|
(xiii) |
the effectiveness and functioning of the procedure established in Article 19 of Directive 2002/21/EC; |
|
(xiv) |
transnational services and operators, taking into account the possibility for the Commission to identify transnational markets under Article 15(4) of Directive 2002/21/EC, and with a focus on the competitive provision of communications services to EU businesses and to the effective and consistent application of business grade remedies across the EU; |
|
(xv) |
identification of transnational markets, initially at least with respect to business services; enabling providers to notify BEREC of their intention to serve such markets, and supervision of providers serving such markets by BEREC; |
|
(xvi) |
the scope of BEREC's competencies; |
|
(xvii) |
a single Union authorisation and the supervisory structure for the framework as a whole; |
|
(xviii) |
active and passive inputs; |
|
(xix) |
the recommendation on relevant markets; |
|
(xx) |
the regulation of equipment, including bundling of equipment and operating systems; |
|
(xxi) |
the effectiveness of the implementation of the European emergency call number ‘112’, including in particular necessary measures to improve the accuracy and reliability of caller location criteria; |
|
(xxii) |
the feasibility of setting up a ‘reverse EU “112” communication system’; |
|
(xxiii) |
the impact of the internet having become a crucial infrastructure for conducting a wide array of economic and social activities. [Am. 229] |
Article 39a
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Articles 34, 35 and 36 by 12 months after the date of entry into force of this Regulation. They shall forthwith communicate to the Commission the text of those provisions.
2. When Member States adopt those provisions, they shall contain a reference to this Regulation or be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by Articles 34, 35 and 36. [Am. 230]
Article 40
Entry into force
1. This Regulation shall enter into force the twentieth day following that of its publication in the Official Journal of the European Union.
2. It shall apply from 1 July 2014.
However, Articles 21, 22, 23, 24, 25, 26, 27, 28, 29 and 30 shall apply from 1 July 2016. [Am. 231]
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at
For the European Parliament
The President
For the Council
The President
(1) OJ C 177, 11.6.2014, p. 64.
(2) OJ C 126, 26.4.2014, p. 53.
(3) Position of the European Parliament of 3 April 2014.
(4) Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities (Access Directive) (OJ L 108, 24.4.2002, p. 7).
(5) Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the authorisation of electronic communications networks and services (Authorisation Directive) (OJ L 108, 24.4.2002, p. 21).
(6) Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) (OJ L 108, 24.4.2002, p. 33).
(7) Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users' rights relating to electronic communications networks and services (Universal Service Directive) (OJ L 108, 24.4.2002, p. 51).
(8) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (E-Privacy Directive) (OJ L 201, 31.7.2002, p. 37).
(9) Commission Directive 2002/77/EC of 16 September 2002 on competition in the markets for electronic communications networks and service (OJ L 249, 17.9.2002, p. 21).
(10) Regulation (EC) No 1211/2009 of the European Parliament and of the Council of 25 November 2009 establishing the Body of European Regulators for Electronic Communications (BEREC) and the Office (OJ L 337, 18.12.2009, p. 1).
(11) Regulation (EU) No 531/2012 of the European Parliament and of the Council of 13 June 2012 on roaming on public mobile communications networks within the Union (OJ L 172, 30.6.2012, p. 10).
(12) Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 establishing a multiannual radio spectrum policy programme (OJ L 81, 21.3.2012, p. 7).
(13) Regulation (EU) No 1301/2013 of the European Parliament and of the Council of 17 December 2013 on the European Regional Development Fund and on specific provisions concerning the Investment for growth and jobs goal and repealing Regulation (EC) No 1080/2006 (OJ L 347, 20.12.2013, p. 289).
(14) Decision 676/2002/EC of the European Parliament and the Council of 7 March 2002 on a regulatory framework for radio spectrum policy in the European Community (Radio Spectrum Decision) (OJ L 108, 24.4.2002, p. 1).
(15) P7_TA(2011)0511 (OJ C 153 E, 31.5.2013, p. 128).
(16) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(17) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
(18) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(19) Regulation (EU) No 531/2012 of the European Parliament and the Council of 13 June 2012 on roaming on public mobile communications networks within the Union (OJ L 172, 30.6.2012, p. 10).
(20) Regulation (EC) No 717/2007 of the European Parliament and of the Council of 27 June 2007 on roaming on public mobile telephone networks within the Community and amending Directive 2002/21/EC (OJ L 171, 29.6.2007, p. 32)
(21) P7_TA(2013)0454.
(22) Commission Decision 2002/622/EC of 26 July 2002 establishing a Radio Spectrum Policy Group (OJ L 198, 27.7.2002, p. 49).
(23) Directive 2013/35/EU of the European Parliament and of the Council of 26 June 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) and repealing Directive 2004/40/EC (OJ L 179, 29.6.2013, p. 1).
(24) Recommendation 1999/519/EC of the Council of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz) (OJ L 199, 30.7.1999, p. 59).
(25) Directive 1999/5/EC of the European Parliament and the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (OJ L 91, 7.4.1999, p. 10).
(26) Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (OJ L 165, 18.6.2013, p. 63).
(*4) Number of this Regulation.
(*5) Number of this Regulation.
(*6) Date of application of this Regulation.
(*7) 6 months after the date of application of this Regulation.
(*9) Date of entry into force of this Regulation.
ANNEX I
MINIMUM PARAMETERS FOR OFFERS OF EUROPEAN VIRTUAL BROADBAND ACCESS PRODUCTS
|
1. |
OFFER 1 — Fixed network wholesale access product offered over next generation networks at Layer 2 of the International Standards Organisation seven layer model for communications protocols (‘Data Link Layer’), that offers equivalent functionalities to physical unbundling, with handover points at a level that is closer to the customer premises than the national or regional level. |
|
1.1 |
Network elements and related information:
|
|
1.2 |
Network functionalities:
|
|
1.3 |
Operational and business process:
|
|
1.4 |
Ancillary services and IT Systems:
|
|
2. |
OFFER 2: Fixed network wholesale access product offered at Layer 3 of the International Standards Organisation seven layer model for communications protocols (‘Network Layer’), at the IP level bit-stream level with handover points offering a higher degree of resource aggregation such as at national and/or regional level |
|
2.1 |
Network elements and related information:
|
|
2.2 |
Network functionalities:
Ability to support different quality of service levels (e.g. QoS 1, 2 and 3) with regard to:
|
|
2.3 |
Operational and business process:
|
|
2.4 |
Ancillary IT Systems:
Specifications for access to and use of ancillary IT systems for operational support systems, information systems and databases for pre-ordering, provisioning, ordering, maintenance and repair requests and billing, including their usage restrictions and procedures to access those services. |
|
3. |
OFFER 3: Wholesale terminating segments of leased lines with enhanced interface for the exclusive use of the access seeker providing permanent symmetric capacity without restriction as regards usage and with service level grade agreements, by means of a point-to-point connection and with Layer 2 of the International Standards Organisation (ISO) seven layer model for communications protocols (‘Data Link Layer’) network interfaces. |
|
3.1 |
Network elements and related information:
|
|
3.2 |
Network and product functionalities:
|
|
3.3 |
Operational and business process:
|
|
3.4 |
Service level agreements
|
|
3.5 |
Ancillary IT systems:
specifications for access to and use of ancillary IT systems for operational support systems, information systems and databases for pre-ordering, provisioning, ordering, maintenance and repair requests and billing, including their usage restrictions and procedures to access those services. [Am. 232] |
ANNEX II
MINIMUM PARAMETERS OF EUROPEAN ASQ CONNECTIVITY PRODUCTS
Network elements and related information
|
— |
A description of the connectivity product to be provided over a fixed network, including technical characteristics and adoption of any relevant standards. |
Network functionalities:
|
— |
connectivity agreement ensuring end-to-end Quality of Service, based on common specified parameters that enable the provision of at least the following classes of services:
|
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/595 |
P7_TA(2014)0282
Electronic identification and trust services for electronic transactions in the internal market ***I
European Parliament legislative resolution of 3 April 2014 on the proposal for a regulation of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market (COM(2012)0238 — C7-0133/2012 — 2012/0146(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/30)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2012)0238), |
|
— |
having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0133/2012), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the opinion of the European Economic and Social Committee of 18 September 2012 (1), |
|
— |
having regard to the undertaking given by the Council representative by letter of 28 February 2014 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Industry, Research and Energy and the opinions of the Committee on the Internal Market and Consumer Protection, the Committee on Legal Affairs and the Committee on Civil Liberties, Justice and Home Affairs (A7-0365/2013), |
|
1. |
Adopts its position at first reading hereinafter set out; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 351, 15.11.2012, p. 73.
P7_TC1-COD(2012)0146
Position of the European Parliament adopted at first reading on 3 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 910/2014.)
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/596 |
P7_TA(2014)0283
Statutory audit of public-interest entities ***I
European Parliament legislative resolution of 3 April 2014 on the proposal for a regulation of the European Parliament and of the Council on specific requirements regarding statutory audit of public-interest entities (COM(2011)0779 — C7-0470/2011 — 2011/0359(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/31)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2011)0779), |
|
— |
having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0470/2011), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Slovak Parliament and the Swedish Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity, |
|
— |
having regard to the opinion of the European Economic and Social Committee of 26 April 2012 (1), |
|
— |
having regard to the undertaking given by the Council representative by letter of 18 December 2013 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Legal Affairs and the opinions of the Committee on Industry, Research and Energy and the Committee on Economic and Monetary Affairs (A7-0177/2013), |
|
1. |
Adopts its position at first reading hereinafter set out; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 191, 29.6.2012, p. 61.
P7_TC1-COD(2011)0359
Position of the European Parliament adopted at first reading on 3 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council on specific requirements regarding statutory audit of public-interest entities and repealing Commission Decision 2005/909/EC
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 537/2014.)
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/597 |
P7_TA(2014)0284
Statutory audits of annual accounts and consolidated accounts ***I
European Parliament legislative resolution of 3 April 2014 on the proposal for a directive of the European Parliament and of the Council amending Directive 2006/43/EC on statutory audits of annual accounts and consolidated accounts (COM(2011)0778 — C7-0461/2011 — 2011/0389(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/32)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2011)0778), |
|
— |
having regard to Article 294(2) and Article 50 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0461/2011), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Swedish Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity, |
|
— |
having regard to the opinion of the European Economic and Social Committee of 26 April 2012 (1), |
|
— |
having regard to the undertaking given by the Council representative by letter of 18 December 2013 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on Legal Affairs and the opinions of the Committee on Industry, Research and Energy and the Committee on Economic and Monetary Affairs (A7-0171/2013), |
|
1. |
Adopts its position at first reading hereinafter set out; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
(1) OJ C 191, 29.6.2012, p. 61
P7_TC1-COD(2011)0389
Position of the European Parliament adopted at first reading on 3 April 2014 with a view to the adoption of Directive 2014/…/EU of the European Parliament and of the Council amending Directive 2006/43/EC on statutory audits of annual accounts and consolidated accounts
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive 2014/56/EU.)
|
30.11.2017 |
EN |
Official Journal of the European Union |
C 408/598 |
P7_TA(2014)0285
Reduction or elimination of customs duties on goods originating in Ukraine ***I
European Parliament legislative resolution of 3 April 2014 on the proposal for a regulation of the European Parliament and of the Council on the reduction or elimination of customs duties on goods originating in Ukraine (COM(2014)0166 — C7-0103/2014 — 2014/0090(COD))
(Ordinary legislative procedure: first reading)
(2017/C 408/33)
The European Parliament,
|
— |
having regard to the Commission proposal to Parliament and the Council (COM(2014)0166), |
|
— |
having regard to Article 294(2) and Article 207(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0103/2014), |
|
— |
having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to the undertaking given by the Council representative by letter of 27 March 2014 to approve Parliament's position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
|
— |
having regard to Rule 55 of its Rules of Procedure, |
|
— |
having regard to the report of the Committee on International Trade (A7-0238/2014), |
|
1. |
Adopts its position at first reading hereinafter set out; |
|
2. |
Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
|
3. |
Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
P7_TC1-COD(2014)0090
Position of the European Parliament adopted at first reading on 3 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council on the reduction or elimination of customs duties on goods originating in Ukraine
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) No 374/2014.)