COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT ON THE REVISION OF THE REGULATORY FRAMEWORK FOR MEDICAL DEVICES

Accompanying the documents

Proposals 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 and on in vitro diagnostic medical devices

Table of contents

1........... Problem definition. 4

1.1........ Problem MD-1: Scope - regulatory gaps or uncertainties. 4

1.1.1..... Products manufactured utilising non-viable cells or tissues of human origin. 4

1.1.2..... Implantable or other invasive products without a medical purpose. 5

1.1.3..... Reprocessing of single-use medical devices. 6

1.2........ Problem MD-2: Adaptation of legal requirements to technological, scientific and regulatory developments  7

1.3........ Problem MD-3: Clinical evaluation and clinical investigations, in particular those carried out in more than one Member State. 7

2........... Objectives. 9

3........... Policy options. 10

3.1........ Policy options regarding objective MD-1: Covering legal gaps and loopholes. 10

3.1.1..... Products manufactured utilising non-viable human cells and tissues. 10

3.1.1.1.. Policy option MD-1A: Regulate products manufactured utilising non-viable human cells and tissues as medicinal products. 10

3.1.1.2.. Policy option MD-1B: Regulate products manufactured utilising non-viable human cells and tissues as medical devices. 10

3.1.2..... Implantable or other invasive products without a medical purpose. 10

3.1.2.1.. Policy option MD-1C: Regulation of certain implantable or other invasive products without a medical purpose within the MDD.. 10

3.1.2.2.. Policy option MD-1D: Regulation of certain implantable or other invasive products without a medical purpose outside the legislation on medical devices. 11

3.1.3..... Reprocessing of single-use medical devices. 11

3.1.3.1.. Policy option MD-1E: Prohibition of the reprocessing of single-use medical devices. 11

3.1.3.2.. Policy option MD-1F: Harmonized regulation of the reprocessing of single-use medical devices  11

3.1.3.3.. Policy option MD-1G: Minimum criteria for the reprocessing of single-use medical devices. 11

3.2........ Policy options regarding objective MD-2: Appropriate legal requirements taking into account technological, scientific and regulatory developments. 12

3.2.1..... Policy option MD-2A: No legislative action. 12

3.2.2..... Policy option MD-2B: Review of the classification rules and essential requirements regarding specific devices or technologies. 12

3.3........ Policy options regarding objective MD-3: Enhanced legal certainty and coordination in the field of clinical evaluation and investigations, in particular those conducted in more than one Member State. 12

3.3.1..... Policy option MD-3A: Introduction of the term "sponsor" for clinical investigations and further clarification of key provisions in the field of clinical evaluation and investigations. 12

3.3.2..... Policy options MD-3B – MD-3C: Assessment of multi-national investigations. 13

3.3.2.1.. Policy option MD-3B: Coordinated assessment of multi-national investigations by the Member States where the investigation is performed. 13

3.3.2.2.. Policy option MD-3C: Voluntary cooperation among the  Member States where the clinical investigation is performed. 13

4........... Analysis of impact and comparison of the policy options. 13

4.1........ Impact of policy options MD-1A and MD-1B: (products manufactured utilising non-viable human cells and tissues) 13

4.2........ Impact of the policy options MD-1C and MD-1D (implantable or other invasive products without a medical purpose) 15

4.3........ Impact of the policy options MD-1E and MD-1G (reprocessing of single-use medical devices) 17

4.4........ Impact of the policy options MD-2A and MD-2B (appropriate legal requirements taking into account technological, scientific and regulatory developments) 21

4.5........ Impact of the policy options MD-3A to MD-3C (clinical investigations and evaluation) 22

5........... Overview of preferred options. 24

6........... Monitoring and evaluation. 25

6.1........ Scope. 25

6.1.1..... Products manufactured utilising non-viable cells or tissues of human origin. 25

6.1.2..... Implantable or other invasive products without a medical purpose. 25

6.1.3..... Reprocessing of single-use medical devices. 25

6.2........ Review of the classification rules and essential requirements regarding specific devices or technologies  25

6.3........ Coordinated analysis of clinical investigations conducted in more than one Member State. 25

1.           Problem definition

1.1.        Problem MD-1: Scope - regulatory gaps or uncertainties

1.1.1.     Products manufactured utilising non-viable cells or tissues of human origin

At the occasion of the adoption of the IVDD, the legislator in recital (35) called for the adoption of legislation on medical devices manufactured using substances of human origin[1]. So far, this mandate has only been partly fulfilled. Firstly, Directives 2000/70/EC and 2001/104/EC subjected medical devices incorporating a medicinal substance derived from human blood or plasma to the AIMDD and the MDD. Secondly, Regulation (EC) No 1394/2007 concerning advanced therapy medicinal products (ATMP Regulation)[2] covers medical devices which are combined with viable human or animal cells or tissues or with non-viable human or animal cells or tissues which are liable to act upon the human body with action that can be considered as primary to that of the medical device. Directive 2004/23/EC concerning human tissues and cells[3] appears to cover appropriately non-viable human tissues and cells that are not substantially manipulated[4] and products derived from such tissues and cells. It applies to the "donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications and of manufactured products derived from human tissues and cells intended for human applications" unless such manufactured products are covered by other directives. Recital (6) of Directive 2004/23/EC states that tissues and cells to be used for industrially manufactured products, including medical devices, should be covered by that directive only as far as donation, procurement and testing of the tissues and cells are concerned.

Except for medical devices incorporating a medicinal substance derived from human blood or plasma, devices incorporating or derived from human tissues or cells are currently exempted from the AIMDD and MDD[5]. This means that certain products which are manufactured utilising non-viable human[6] cells or tissues, other than those that have undergone only non-substantial modification, and which do not act principally by metabolic, immunological or pharmacological means fall into a regulatory gap at Union level as far as Directive 2004/23/EC is not applicable. They are regulated under different systems in the Member States or are not specifically regulated at all which has been identified by manufacturers as a significant obstacle for the development of tissue-engineered devices in Europe[7]. The Council, in its Conclusions on innovation in the medical device sector, invited the Commission to consider "how to address the regulatory gaps in the system, for instance in relation to medical devices manufactured utilising non-viable human cells and tissues"[8].

When Directive 2007/47/EC was adopted, the Commission committed to consider proposals for the appropriate regulation to cover any regulatory gap which might remain at EU level after the adoption of the ATMP Regulation.

1.1.2.     Implantable or other invasive products without a medical purpose

It is currently not clear whether implantable or other invasive products for which the manufacturer does not claim a medical purpose, but e.g. an aesthetic or cosmetic purpose, are covered by the AIMDD or MDD or not. Some argue that the third indent of the ‘medical device’ definition in Article 1(2)(a) of the MDD covers any device which pursues the purpose of "investigation, replacement or modification of the anatomy or of a physiological process", regardless of whether the manufacturer attributes to it a medical or a non-medical (e.g. aesthetic) purpose. However, according to the prevailing interpretation of the Commission, Member States and stakeholders, a device falls within the definition of a medical device when it pursues a medical purpose[9]. The question is currently pending before the European Court of Justice for a preliminary ruling[10].

Typical invasive "aesthetic products" (e.g. non-corrective contact lenses; wrinkle fillers; implants for augmentation of specific body parts such as breast, lips, gluteus, calf, pectoral etc.) belong to the same type of products than those with a medical purpose, have similar risk features than their related medical devices and are often used in a medical environment (aesthetic or plastic surgery). The use of implantable or other invasive products for aesthetic or other non-medical purposes is constantly growing and concerns were voiced by Members of the European Parliament[11], competent authorities and stakeholders[12] regarding the regulatory control of such products.

Assuming that products without a medical purpose are not covered by the MDD, Directive 2001/95/EC on general product safety (GPSD)[13] is applicable to the extent that the products are intended or likely to be used by consumers. The GPSD, however, only sets general requirements and does not make provision for a pre-market assessment.

Assuming that products which pursue the purpose of investigation, replacement or modification of the anatomy or of a physiological process are covered by the MDD, even without a medical purpose, there would still remain a considerable grey area as regards for example non-corrective contact lenses because they would most likely not be considered as modifying the anatomy or a physiological process. 

1.1.3.     Reprocessing of single-use medical devices

The reprocessing of a medical device includes steps needed to allow its safe reuse such as routine maintenance, disassembly, cleaning, disinfection and/or sterilization. It is a common practice for reusable devices (e.g. surgical instruments) but it is also carried out regarding devices for single use (e.g. angioplasty catheters). Only the latter practice is subject to discussion in this impact assessment.

The concept of single use device (SUD)[14] was introduced in the MDD by Directive 2007/47/EC. The regulation is currently limited to information requirements on the label and in the instructions for use[15]. Few Member States (e.g. Germany) allow the reprocessing of SUD and have developed guidelines[16], other Member States prohibit (e.g. France) or discourage (e.g. UK) SUD reprocessing whilst most Member States do not have specific regulations on this issue. At international level, the regulatory approaches differ as well. Whilst in Japan the reprocessing of SUD is prohibited, around 10 third party reprocessors are established in the US where the reprocessing of some SUD is performed and where, according to FDA regulations, reprocessors of SUD are considered as manufacturers[17].

The reprocessing is either done 'in house' by the users (e.g. hospitals) or by an external reprocessing company. According to information provided by the reprocessing industry, 50-60 external reprocessing companies are established in Europe, but only four of them (all established in Germany) carry out reprocessing of SUD. Even for the European market leader, it appears to remain a limited part of their business.

Article 12a of the MDD, introduced by Directive 2007/47/EC, required the Commission to submit a report to the European Parliament and to the Council on the issue of reprocessing of medical devices and to submit any proposal it would deem appropriate in the light of the findings of this report in order to ensure a high level of health protection in relation to this practice. Based on a Scientific Opinion of the SCENIHR[18], the Commission submitted the report in August 2010[19] in which it described the public health aspects as well as ethical, environmental and economic aspects in relation to reprocessing of SUD. In terms of public health and patient safety, the risks are especially related to remaining pathogenic micro-organisms, persistence of chemical substances used during reprocessing and alteration of performance of the device.

1.2.        Problem MD-2: Adaptation of legal requirements to technological, scientific and regulatory developments

All in all, the MDD appropriately captures new technologies. In particular, the essential requirements and the classification rules usually are sufficiently flexible to apply also to innovative devices. Several amendments were introduced in the essential requirements and classification rules by Directive 2007/47/EC which became applicable in March 2010. Some aspects, however, which are related to the appropriate risk-assessment regarding devices using material or technologies with a potentially increased risk were not yet sufficiently mature at the moment of this latest revision or have come to light subsequently due to post-market experience.

Examples: Medical devices with nanomaterial; ingested devices; assisted reproductive technologies; agents for organ conservation; apheresis systems; products incorporating living microorganisms.

In the absence of specific classification rules and essential requirements, the existing provisions are interpreted and implemented in different ways by the Member States leading to different levels of protection of public health and patient safety as well as to obstacles to the free movement of products.      

Nanomaterial is used in medical devices still to a limited extent but their use is expected to grow. Examples for nanotechnology in medical devices are cancer therapy, joint or mesh implants, blood vessel prosthesis[20]. In some cases (e.g. cancer therapy) the nanomaterial is intended to be released in the body. The Commission's working group on New and Emerging Technologies in Medical Devices (N&ET) in July 2007 presented a report on nanotechnology and suggested, among others, a specific classification rule (class III) for medical devices which incorporate or consist of "free" nanomaterial. With a view to the potential increase of nanotechnology used in devices and the regulatory development in this field (e.g. Commission Recommendation 2011/696/EU on the definition of nanomaterial), appropriate regulation should be considered for this revision of the MDD.

1.3.        Problem MD-3: Clinical evaluation and clinical investigations, in particular those carried out in more than one Member State

As part of the essential requirements to be fulfilled according to the AIMDD and MDD, a medical device must not – subject to a risk/benefit analysis – compromise the safety of patients, users or other persons and it must achieve the (clinical) performance intended by the manufacturer. The manufacturer must demonstrate the conformity with the essential requirements on the basis of clinical data (clinical evaluation) which is laid down in Annex VII of the AIMDD and Annex X of the MDD. A clinical evaluation may be based either on relevant scientific literature or on results of a clinical investigation (or on both). The concept of 'performance'/'clinical performance', however, is not very clear and has prompted concerns that demonstration of the clinical benefit was not sufficiently required when demonstrating the intended performance.     

The EU regulation of clinical investigations regarding medical devices is not very extensive and consists only of Article 10, Annex 6 sections 2.2 and 3.2, and Annex 7, section 2 of the AIMDD and Article 15, Annex VIII sections 2.2 and 3.2, and Annex X, section 2 of the MDD. These provisions require manufacturers or authorised representatives to notify the competent authorities where the investigation shall be conducted 60 days before its start, to draw up a statement and documentation regarding procedural and safety requirements and to conduct the investigation in conformity with ethical considerations and according to a predefined methodology.

The absence of a full-fledged regulation of clinical investigations is not considered a problem and the issue of clinical investigation has not been mentioned in the questionnaire of the 2008 public consultation. But some responses to the public consultation raised concerns regarding the lack of harmonisation between national competent authorities regarding the approval of investigations. The Commission's Clinical Investigation and Evaluation (CIE) Working Group listed issues where legislative clarifications (e.g. introduction of the notion "sponsor") and a better coordination amongst Member States would improve the EU regulations in this field. Also the High Level Group on Administrative Burden suggested the introduction of a single approval procedure for clinical investigations in the field of medical devices carried out in more than one Member State[21].

The assessment of notifications of clinical investigations falls in the responsibility of every individual Member State. The competent authority assesses the technical and safety aspects whilst ethical aspects are assessed by ethics committees. Currently, the medical devices directives only make provision for an exchange of information between Member States when a clinical investigation is refused, halted, significantly modified or temporarily interrupted (Article 10(3) AIMDD and Article 15(6) MDD), but they do not require any coordination of the assessment by the competent authorities involved when a clinical investigation is conducted in more than one Member State.

According to surveys conducted in the framework of the CIE working group, an increase can be noted as regards pre-market clinical investigations notified to EU/EFTA national authorities. This increase may be linked to the reinforcement of the requirements regarding clinical evaluation and clinical investigations by Directive 2007/47/EC which came into application in 2010:

Year || 2008 || 2009 || 2010

Notifications of pre-market clinical investigations || ca. 529 || ca. 660 || ca. 719

These figures give an indication but are not exact since some national competent authorities did not provide data while other authorities counted pre-market clinical investigations and performance evaluations for IVD together. Data for 2008 suggest that roughly 30% of clinical investigations are conducted in more than one Member State. For 2009 and 2010, half of the national competent authorities have not provided data distinguishing between national and multi-national investigations. But according to those who did, the number of national and multi-national investigations is almost half/half[22]. It can be estimated that between 200 and 350 clinical investigations a year are conducted in more than one Member States. In terms of patients enrolled in multi-national investigations, it can be estimated that their number is higher than the number of patients enrolled in pure national investigations[23].

The overall approval (or non-objection) rate is high, either on initial assessment or after submission of supplementary information (the practice differs considerably between Member States). Data available for 2008 suggest that the rate of multi-national investigations which are approved only after supplementary information is relatively high (67%) compared to single country investigations which in their majority are approved on initial assessment. These figures suggest that multi-national clinical investigations tend to give rise to more queries for additional information than pure national investigations which need to be dealt with by the applicant.

The fact that manufacturers/sponsors must submit their documentation to each competent authority and are then subject to multiple queries for additional information increases their administrative costs. In addition, the assessments of the competent authorities concerned may lead to different outcomes as regards technical and safety aspects related to the same device intended for clinical investigation. This also means that patients participating in the same multi-national investigation are subject to different safety levels. Moreover, the revision of the AIMDD/MDD provides the opportunity to align the provisions regarding clinical investigations on medical devices, where appropriate, with the recently adopted Proposal for a Regulation on clinical trials on medicinal products for human use[24].

2.           Objectives

The overall objectives pursued by the revision of the regulatory framework for medical devices as set out in the main part of this impact assessment (section 3.1.) are also the guiding principles for the specific issues of the MDD. These general objectives can be further detailed by the specific objectives set out below. Each of them contributes to the achievement of the overall objectives.

Ø Objective MD-1: Covering of legal gaps and loopholes

Ø Objective MD-2: Appropriate legal requirements taking into account technological, scientific and regulatory developments

Ø Objective MD-3: Enhanced legal certainty and coordination in the field of clinical evaluation and investigations, in particular those conducted in more than one Member State

3.           Policy options

3.1.        Policy options regarding objective MD-1: Covering legal gaps and loopholes

3.1.1.     Products manufactured utilising non-viable human cells and tissues

To cover the regulatory gap regarding products manufactured utilising non-viable human cells and tissues, other than those that have undergone only non-substantial manipulation, basically two options need to be assessed: to regulate these products as medicinal products or as medical devices. The "no EU action" needs to be discarded since it would not change anything to the current unsatisfactory situation. 

3.1.1.1.  Policy option MD-1A: Regulate products manufactured utilising non-viable human cells and tissues as medicinal products

This option would subject products which are manufactured utilising non-viable human cells and tissues to the medicinal products legislation and would thus require the extension of the scope of Regulation (EC) No 1394/2007 concerning advanced therapy medicinal products.

3.1.1.2.  Policy option MD-1B: Regulate products manufactured utilising non-viable human cells and tissues as medical devices

This option would subject products which are manufactured utilising non-viable human cells and tissues (and which are not covered by the ATMP Regulation) to the legislation on medical devices. It would require the adoption of specific requirements regarding the safety of the products (especially regarding the risk of transmissible infectious agents) and their traceability. In addition, a consultation procedure allowing competent authorities to verify the safety of the processed human tissues/cells could be envisaged, as well as a consultation EMA Committee of Advanced Therapies (CAT) in order to ensure consistency as regards the possible borderline cases between ATMP and medical devices which could arise due to questions concerning the principal mode of action of the product manufactured utilising human tissues or cells or the status as viable or non-viable of these tissues or cells. 

3.1.2.     Implantable or other invasive products without a medical purpose

For products with aesthetic or other non-medical purposes, the pivotal question is whether to regulate them within the medical devices legislation or not. Two options are to be considered: one would lead to the application of the medical devices legislation and the other option would require the adoption of a separate legislation. The option to apply the Cosmetics Regulation to this kind of products was discarded from the beginning because Regulation (EC) No 1223/2009 on cosmetic products clearly states that it only applies to products which come into contact with the surface of the skin, excluding all ingested, inhaled, injected and implanted products from its scope[25].

3.1.2.1.  Policy option MD-1C: Regulation of certain implantable or other invasive products without a medical purpose within the MDD 

This option would subject implantable or other invasive products, for which the manufacturer does not claim a medical purpose, to the medical devices legislation provided that they belong to a type of products which also exist as a medical device (e.g. body implants, fillers, contact lenses). A positive list would be established and the European Commission would be empowered to manage it. Such a condition would be necessary to avoid an unreasonable broadening of the scope of the medical device legislation to products such as ear-rings or body piercings.

3.1.2.2.  Policy option MD-1D: Regulation of certain implantable or other invasive products without a medical purpose outside the legislation on medical devices

This option would keep the scope of the medical devices legislation limited to devices with a medical purpose. It would require the adoption of a separate legislation either in the context of the General Product Safety Directive or a 'standalone' regulation which would set the safety requirements for these products (possibly in analogy to those applicable to similar medical devices).

3.1.3.     Reprocessing of single-use medical devices

Based on the findings of the 2010 Commission's report on the reprocessing of medical devices, and with a view to the mandate given to the Commission by Article 12a MDD to submit a proposal deemed appropriate to ensure a high level of health protection, the "no action" needs to be discarded because it would not address the safety concerns identified. Three policy options are reasonably to be considered: the ban on reprocessing of SUD, a harmonized regulation of reprocessing of SUD or some minimum criteria to be respected by Member States that allow the reprocessing of SUD.  

3.1.3.1.  Policy option MD-1E: Prohibition of the reprocessing of single-use medical devices

The extreme option would be to ban the practice of reprocessing of SUD and their use in the EU, as it is for example the case in France and in Japan. 

3.1.3.2.  Policy option MD-1F: Harmonized regulation of the reprocessing of single-use medical devices

This option would require the reprocessors of CE marked SUD, be they the users (e.g. hospitals) or external reprocessing companies, to fulfil the same requirements as manufacturers of medical devices and indicate the fact that a device has been reprocessed on the label. Reprocessed SUD would bear the CE marking and would therefore benefit from the principle of free movement of goods. The reprocessing would be limited to CE marked SUD only. The reprocessing of SUD intended for critical use (i.e. intended for surgically invasive medical procedures)[26] would be prohibited due to the risk of infection which may be caused by persistent pathogenic micro-organisms. In addition, Member States would be given the right to ban the reprocessing of SUD and the use of reprocessed SUD on their territory, thus restricting the free movement of reprocessed SUD.  

3.1.3.3.  Policy option MD-1G: Minimum criteria for the reprocessing of single-use medical devices

This policy option would leave it to Member States to ban or to allow the reprocessing of SUD. Should they allow it, they would need to limit the reprocessing to SUD put into service within their territory, to require that reprocessors, be they the users (e.g. hospitals) or external reprocessing companies, fulfill the same requirements as manufacturers of medical devices and reprocessors would have to indicate on the label that the device has been reprocessed. There would be no CE marking of reprocessed SUD and therefore no free movement within the EU.

3.2.        Policy options regarding objective MD-2: Appropriate legal requirements taking into account technological, scientific and regulatory developments

3.2.1.     Policy option MD-2A: No legislative action

This policy option would maintain the status quo and not review the classification rules and essential requirements in order to take account of technological, scientific and regulatory developments. The issues would rather be addressed by legally non-binding guidance.

3.2.2.     Policy option MD-2B: Review of the classification rules and essential requirements regarding specific devices or technologies

This policy option would review and adapt, where necessary, the classification rules of the MDD on the basis of discussions which take place in the MDEG Borderline and Classification Working Group and in light of the requests formally submitted to the Commission by Member States in accordance with the MDD.

With regard to nanomaterial, it would incorporate a specific classification rule for medical devices which incorporate or consist of "free" nanomaterial as recommended by the Commission's N&ET Working Group and require manufacturers to provide appropriate information and to take the specific hazards related to the use of nanomaterial duly into account in the context of risk-analysis and risk-management. A definition would be provided on the basis of the Commission Recommendation 2011/696/EU on the definition on nanomaterial. 

3.3.        Policy options regarding objective MD-3: Enhanced legal certainty and coordination in the field of clinical evaluation and investigations, in particular those conducted in more than one Member State

A full-fledged regulation of clinical investigations similar to the legislation applicable to clinical trials for medicinal products (Directive 2001/20/EC), as well as the possibility of an approval of clinical investigations by an EU body, have been discarded from the beginning because it would not be proportionate to introduce such requirements at EU level for the huge variety of medical devices. However, where appropriate, care should be taken that the Proposal for a Regulation on clinical trials on medicinal products for human use is taken into account also for the rules on clinical investigations on medical devices in order to avoid unjustified discrepancies between two closely related regulatory frameworks.

3.3.1.     Policy option MD-3A: Introduction of the term "sponsor" for clinical investigations and further clarification of key provisions in the field of clinical evaluation and investigations

Instead of capturing only clinical investigations carried out by the manufacturer or its authorised representative as currently foreseen by the AIMDD and MDD, this option would introduce the term "sponsor" to cover also clinical investigations for regulatory purposes that are conducted under the responsibility of another person than the manufacturer. This would bring the EU legislation in line with practice in the Member States[27] and at international level. Other key concepts in the field of clinical evaluation and investigations, such as clinical performance, the reporting of serious adverse events and the relationship between clinical investigations and post-market clinical follow-up and other post-market safety issues, would also be further clarified.

3.3.2.     Policy options MD-3B – MD-3C: Assessment of multi-national investigations

3.3.2.1.  Policy option MD-3B: Coordinated assessment of multi-national investigations by the Member States where the investigation is performed

This policy option would offer to sponsors of multi-national investigations the possibility to submit the application to the Member States concerned simultaneously by means of a single submission. The technical assessment of the application, other than intrinsically national, local or ethical aspects, by the Member States concerned would be coordinated at EU level with one coordinating Member State in the lead (Coordinated Assessment Procedure). Every Member States would remain competent for the final decision regarding the clinical investigation conducted on its territory.

3.3.2.2.  Policy option MD-3C: Voluntary cooperation among the  Member States where the clinical investigation is performed

This policy option would make provision for facilitating a voluntary cooperation of Member States regarding a sponsor's applications for clinical investigations to be conducted in more than one Member State.

4.           Analysis of impact and comparison of the policy options

4.1.        Impact of policy options MD-1A and MD-1B: (products manufactured utilising non-viable human cells and tissues)

According to policy option MD-1A products manufactured utilising non-viable human cells and tissues, other than those which have undergone only non-substantial modification, which do not principally act by pharmacological, immunological or metabolic means would be submitted to the legislation concerning medicinal products and in particular to the one applicable to ATMP. To the contrary, policy option MD-1B would submit them to the medical devices legislation.

Public health protection and patient safety should be given highest priority when deciding about the appropriate regulatory framework for these products. Provided that appropriate essential requirements are introduced in the MDD addressing possible risks of infection and microbial contamination emanating from non-viable human cells or tissues and that only Notified Bodies with sufficient competence and expertise in the field of tissue engineered products will be able to perform the conformity assessment (see objective 1 of the main part of this impact assessment and the corresponding policy options), public health and patient safety would be protected under the medical devices legislation at a high level which can be considered equivalent to the one assured by a centralised marketing authorisation under the pharmaceuticals legislation. As additional safeguard, a mandatory consultation by Notified Bodies of national authorities that are competent in the field of safety and quality of human tissues and cells in accordance with Directive 2004/23/EC would assure an appropriate evaluation of cell- and tissue-specific risks, notably that the donation, procurement and testing of the cells or tissues have been in line with that directive. Simultaneously, the EMA Committee of Advanced Therapies should be consulted to ensure consistency as regards the possible borderline cases between ATMP and MD.    

The economic impact would mainly consist in the time and costs for the manufacturer to bring products manufactured utilising non-viable human tissues or cells onto the market and to comply with the legal requirements in the post-market phase. The length of the approval procedure has both economic impacts on the manufacturers and social impacts, in particular as regards the availability of new and innovative products for patients and users and the attractiveness of Europe as location for innovation.

The main part of this impact assessment (section 4.2) contains a comparison of the typical costs and timelines for approval under the regulations, on the one hand, for medicinal products and, on the other hand, for medical devices. It shows that

· the R&D costs to bring a new medicinal product to the market are significantly higher (€1bn) than the costs to bring a significantly new medical device to the market (€10m);

· the costs for a central marketing authorisation of a medicinal product are significantly higher (€349,500; for SMEs: €263,640) than the costs for a pre-market conformity assessment of a class III medical device (€10,000-€30,000);

· the timeline for the pre-market evaluation is longer for a medicinal product (210 days, without clock-stop) than for a class III medical device (70-105 days, without possible consultation of a regulatory authority).

Comparison of options MD-1A and MD-1B

Options MD-1A and MD-1B can be considered equal in terms of the level of protection of public health and patient safety provided that accompanying measures (additional essential requirements, appropriately qualified Notified Bodies and consultation of competent authorities) are taken. Both would also contribute to reduce the fragmentation of the internal market.

The economic impact of policy option MD-1A is clearly higher compared to option MD-1B. The high costs related to the marketing authorisation under the EU medicinal products legislation (EMA fees, technical requirements and time) has often been criticised and was also mentioned in many responses to the 2008 public consultation. Option MD-1B can thus be considered as the option which would put fewer burdens on economic operators and which would be more supportive for innovation. Moreover, it would be consistent if devices manufactured utilising non-viable human cells or tissues were regulated within the same piece of legislation as devices manufactured utilising non-viable animal cells or tissues which are already covered by the AIMDD and the MDD.      

Finally, the outcome of the negotiations on the ATMP Regulation and the exclusion from its scope of products which contain or consist of non-viable human cells or tissues and which do not principally act by pharmacological, immunological or metabolic action[28] would support the choice to include these products within the scope of the medical devices legislation.

With a view to the above, option MD-1B is the preferred option and should be retained.

4.2.        Impact of the policy options MD-1C and MD-1D (implantable or other invasive products without a medical purpose)

According to policy option MD-1C, products without a medical purpose which are injected or implanted in the human body, or which are otherwise invasive, and which belong to the same category of products that fall within the definition of a medical devices, would be submitted to the requirements of the medical device legislation, provided they are included in a 'positive list'.

With the suggested two-step-approach, the incorporation of a general provision regarding implantable or other invasive non-medical products in the medical device legislation would not have any immediate impact on these products. Only the inclusion in a 'positive list' would trigger the application of the legal requirements regarding a given type of products. This would have the advantage that the concrete impacts on specified products could be assessed once a type of product should be added to the positive list. 

Nonetheless, in general terms the expected impacts can already be determined.

For a large part of the products concerned which can be used both for reconstructive (i.e. medical) and aesthetic purposes (e.g. breast implants, wrinkle fillers) nothing will change since most manufacturers of those devices, which are used 'off label' for cosmetic purposes, do claim an intended medical purpose and therefore have to comply with the medical device legislation[29]. Nevertheless, individual cases often cause lengthy discussions with regulatory authorities. The positive impacts of option MD-1C would therefore be that the current situation is legally clarified to the benefit of the internal market and that a loophole would be plugged for those manufacturers who avoid a medical claim.

For other products, option MD-1C would mean a change of the regulatory status. The most common examples are non-corrective contact lenses without medical purpose. Even though some coloured non-corrective contact lenses may also be used as medical prosthesis in case of corneal problems, the vast majority of decorative lenses are used only temporarily to change the eye colour or simply "for fun"[30]. The use of sub-standard contact lenses can lead to corneal ulcers, corneal abrasion, vision impairment and in the worst case blindness[31].

For the manufacturers which produce both corrective and non-corrective contact lenses, the economic impact related to option MD-1C would be negligible since their quality management system anyway must comply with the requirements of the medical device legislation. Manufacturers of only non-corrective contact lenses would have, among others, to draw up a technical documentation (incl. clinical evaluation), be subject to a conformity assessment procedure by a Notified Body and set up a system to respond to incidents (vigilance) which would lead to additional costs. In the case of responsible manufacturers which already today apply an internal quality management system and follow-up of incidents, the additional costs would be limited to the involvement of a Notified Body. Manufacturers which place decorative contact lenses on the market without prior internal quality control and incident follow-up would have to adapt or lose Europe as a market place which would be a desired consequence of this policy option and increase consumer safety.

The enforcement of the requirements applicable to corrective contact lenses, including the control of the quality management of the manufacturer, would enhance the protection of the health of consumers compared to which the additional costs are to be considered low. The same considerations would apply to other aesthetic implantable or injectable devices which can cause infections, allergies, wounds, or skin damages[32].

Option MD-1C would also be in tune with regulations of major trading partners. In the US and Japan, the medical devices regulations explicitly cover contact lenses which include non-corrective ones and the US FDA approved cosmetic wrinkle fillers under their medical device regulations.

The application of the medical device legislation to implantable or other invasive products without a medical purpose may force some products out of the market in case that the manufacturer cannot demonstrate conformity with the essential requirements based on clinical data. In particular, those manufacturers who cannot rely on clinical data obtained for medical devices of the same category would, for ethical reasons, unlikely be allowed to conduct a clinical investigation with a product that does not have a medical purpose. Such effect, however, would ensure that only those non-medical products would be allowed on the EU market for which the manufacturer can prove the same level of safety and performance as for a similar medical device for which the demonstration of the conformity with the essential requirements by means of clinical data is required by law. 

Policy option MD-1D, on the contrary, would seek a solution outside the medical devices legislation and would require the adoption of a 'standalone' legislation. It can be assumed that, if adopted, such legislation would achieve an equivalent level of health protection as the medical device legislation and contribute to the good functioning of the internal market. An argument in favour of a separate legislation for aesthetic implants and other invasive products is to maintain the medical device legislation limited to products which have a medical purpose and which inherently are subject to a risk/benefit analysis. It would also be easier to extend the scope of such a 'standalone' legislation to other aesthetic products which have no similarities to medical devices. 

The negative impact of a separate legislation would be that manufacturers which produce same or similar products with and without a medical purpose (e.g. corrective and non-corrective contact lenses without medical purpose) would be subject to two different product-related legislations which, in particular for SME, would be more burdensome and increase compliance costs. Moreover, it would not appear logical to submit products which have the same features and the same risk profile to different requirements. In addition, experiences gained under one legislation (e.g. vigilance reporting) could not be easily taken into account for regulatory purposes for products subject to another legislation.

Comparison of policy options MD-1C and MD-1D

Due to the above demonstrated advantages, in particular in terms of consistency and competitiveness, of a regulation of certain implantable and other invasive products without a medical purpose within the medical devices legislation, policy option MD-1C is the preferred option and should be retained.

4.3.        Impact of the policy options MD-1E and MD-1G (reprocessing of single-use medical devices)

Despite the 2010 Commission report, no definitive information on the size of the market of reprocessed SUD is available[33]. It is in particular impossible to gather meaningful data regarding 'in house' reprocessing of SUD by the users due to legal uncertainty and liability aspects. Most of the data available concern Germany since it has the most developed regulatory framework for the reprocessing of SUD. According to those data, mainly invasive and complex SUD used in interventional cardiology (e.g. catheters) are reprocessed by external reprocessing companies.

According to data provided by the European market leader of external reprocessing companies, it reprocesses around 230,000 SUD a year, practically all of them being invasive devices, and employs 140 staff in the field of SUD reprocessing. 

Economic considerations are the main drivers for reprocessing of SUD. They need to be compared to the social implications of this practice (safety and ethical aspects). Environmental aspects (e.g. reduction of medical waste) should also be considered.

Economic aspects:

Increasing resource constraints require cost-containment in healthcare. The reprocessing of SUD is seen as a possibility of dividing purchasing costs for expensive SUD over multiple patients. According to a cost-effectiveness analysis provided to the Commission by the reprocessing industry, the German reprocessing companies set the prices for reprocessing at between 15% and 50% of the prices for new devices, depending on the product type[34]. The before-mentioned analysis in respect to the German market estimates potential cost-savings for cooled and non-cooled high-frequency (HF) ablation catheters used in cardiology at around 23mio.€ in Germany and extrapolates this data to 83mio.€ for Europe. This study is based on the assumption that ablation catheters are reprocessed 4 times and that 70% of the devices are reprocessable.

However, the overall cost-effectiveness of SUD reprocessing, when taking into account all costs linked to the reprocessing process, including validation processes and liability costs in case of failure of a reprocessed SUD, is disputed. It appears that the calculation of the costs is often not well described and it is not clear if costs for the validation of the feasibility of reprocessing of a given SUD as well as the reprocessing process to ensure an acceptable level of safety of a reprocessed SUD are taken into account (e.g. functionality and biocontamination aspects). Other important elements such as the cost of potential adverse events for patients, costs of the facilities, consumption of water or energy do not seem to be taken into account either. The cost-effectiveness may also vary considerably depending on the number of SUD reprocessed per year (scale effect) and the existence of a quality management system.

The cost-effectiveness analysis for the German market does not seem to take into account the validation process regarding the number of possible reuses. The assumption of four reprocessing cycles is an estimate based on the common clinical practice, but there is no scientific evidence that this number might be achieved for all HF ablation catheters and that the reprocessed SUD achieves the same level of safety and performances as the new device. In addition, there is no indication that the reprocessing costs might be extrapolated to the whole Union.

A study performed in Belgium[35] points out that the cost of reprocessed SUD angiography catheters may be higher than the cost of new products when the same level of safety and quality is ensured, i.e. when the reprocessor needs to demonstrate that the requirements of Directive 93/42/EEC are fulfilled. This study underlines that without scale benefits and taking into account the cost of an estimate rate of adverse events, the reprocessing costs are generally higher than or equivalent to the purchase of new SUD.

The need of scale effect to achieve cost-effectiveness is also one of the main conclusions of another study[36] which states that cost saving depends on the number of devices used per year in a cardiological department as well as the development of prices for new devices. For a hospital with a median number of 600 angioplasties and 200 electrophysiological studies per year, the study calculates cost-savings of 12% for percutaneous coronary angioplasty (PTCA) catheters and 33% to 41% for electrophysiology and ablation (EP) catheters. But this study is not based on real costs but on a mathematical model. 

An additional economic argument brought forward in favour of SUD reprocessing is the competitive pressure on original SUD manufacturers and its impact on prices for new devices. On the other hand, a broader use of the reprocessing practice would lead to a decrease of the sales volumes of original devices and therefore to a potential increase of their prices.

Finally, an independent scientific literature review on the economic analysis of SUD reprocessing published in 2008[37] comes to the conclusion that the evidence on the cost-effectiveness of this practice is considered inconclusive and not established.

Public health and safety considerations:

The number of documented incidents regarding reprocessed SUD is very small although it cannot be excluded that the reporting of incidents clearly linked to a reprocessed SUD is incomplete due to lack of knowledge about the fact that the device was reprocessed or due to liability aspects. In the US, available data did not show evidence of a significantly increased risk to patients exposed to reprocessed SUD[38]. This may be due to the requirements imposed by US FDA regulation on the reprocessing of SUD but there may also be a “grey” area where an incident cannot be clearly established or linked to the reprocessed SUD.

The scientific opinion issued by SCENIHR in 2010 on the safety of reprocessed single-use devices[39] describes biological risks for patients exposed to reprocessed SUD especially linked to viruses and non-conventional transmissible agents (prions). It also refers to publications which indicated that SUD having undergone reprocessing do not meet the same quality standards as new devices delivered by the original manufacturer since reprocessed SUD may exhibit contaminations by proteins and viral nucleic acids. A specific hazard, as highlighted in the SCENIHR opinion, is the possible contamination with agents causing transmissible spongiform encephalopathies (TSEs) such as variant Creutzfeldt-Jakob disease (vCJD). Medical devices may become contaminated with prions after contact with infected tissues and/or blood. Prions are particularly resistant to commonly used physical and chemical methods of cleaning, disinfection and/or sterilization and only relatively aggressive cleaning methods, not compatible with the commonly used materials for SUD, can ensure their inactivation.

Other major hazards described by SCENIHR are the persistence of chemical substances (e.g. ethylene oxide and its potentially toxic reaction products) used during the reprocessing process and the alterations in the performance and functionality of the SUD due to the reprocessing process. It is clear that not all SUD can be reprocessed due to their characteristics or their complexity. According to data provided by a reprocessing company[40], among 9,770 highly complex single-use medical devices assessed for their suitability to reprocessing, 6,030 (62%) were not reprocessable and among those, around 50% are not suitable for reprocessing for technical reasons. A validation process is therefore needed in order to ensure that the reprocessing of the SUD does not endanger the patient's safety.

For the above public health and safety considerations, reprocessing of SUD, if allowed, would need to be subject to a demonstration by the reprocessor that the benefit/risk ratio of the reprocessed SUD is the same than the one of a new SUD. In addition, ethical concerns also need to be taken into consideration with regard to information of the patient and of the healthcare professionals about the potentially increased risk linked with the use of a reprocessed SUD (e.g. patient's informed consent, information to healthcare professionals).

Environmental aspects:

Finally, the potential impact of SUD reprocessing on the environment should be considered. Mostly, the argument of medical waste reduction is brought forward in favor of reprocessing[41]. The reduction of waste, however, is only one (positive) environmental impact which may be reduced by (negative) impacts caused by transport, consumption of water, energy, disinfectants or chemicals (e.g. ethylene oxide[42]). To date, there does not seem to be a study available taking into account the global environmental impact of the SUD reprocessing practice. Results from a study comparing the environmental impact of single-use nappies versus reusable nappies, performed by the UK environmental agency, might however give some indications in that respect[43]. The conclusion of this study comparing disposable nappies, home laundered flat cloth nappies and commercially laundered prefolded cloth nappies delivered to the home was that no significant difference between the three practices as regards environmental impacts could be established.

Due to the inconclusiveness of a potential positive environmental impact of SUD reprocessing, environmental considerations should not play a determining factor in the assessment of the policy options which will be developed in the following paragraphs.

A ban on SUD reprocessing (policy option MD-1E) would be the safest option in terms of public health and patient safety because it would exclude all possible risks and hazards linked to the SUD reprocessing practice, including transmission of viruses and non-conventional transmissible agents (e.g. prions responsible for vCJD). On the other hand, a ban on the SUD reprocessing could lead to some pressure on some national healthcare budgets and might limit the access of patients to certain expensive interventional procedures in some Member States due to the prices of original medical devices. Limited availability of certain medical devices may therefore be a downside of a ban in terms of public health and patient safety.

As regards the economic impact, option MD-1E would have a negative economic impact since it would mean the end of the third party SUD reprocessing industry in Europe. It would also legally prohibit the 'in house' reprocessing of SUD by hospitals.  Benefits from a ban could possibly be drawn by the original SUD manufacturers since their sales volume would probably increase in some Member States.  

Policy option MD-1F (harmonized regulation of SUD reprocessing) would have some negative economic impact on the SUD reprocessors since they would likely need to enhance their validation process in order to meet regulatory requirements applicable to original equipment manufacturers and the additional labeling requirement to indicate that the device has been reprocessed. However, the association of US reprocessing companies claims that their members would already meet these requirements. This impact would be balanced with the potential that this option may provide in terms of further development of this activity across Europe by means of creating a single market for reprocessed SUD (except for SUD intended for critical use and for those Member States which would impose a ban of SUD reprocessing). This may also lead to the creation of jobs in the reprocessing industry, even though the number of new jobs is likely to be relatively low. A negative impact may also be a foreseeable decrease of the sales volumes for original SUD manufacturers, with some potential lose of jobs in the manufacturers' facilities.

The fact that reprocessors would be considered as manufacturers would ensure a high level of safety because any reprocessed SUD would need to have the same risk-benefit ratio as a new SUD. In addition, an acceptable level of protection of public health and patient safety against the potential risk of transmission of diseases (e.g. vCJD) would be ensured by means of a ban of the reprocessing of SUD intended for critical use. Individual Member States could prohibit the reprocessing of SUD and their use on their territory which would allow addressing specific situations that some Member States may have with regards to the reprocessing of SUD.

Policy option MD-1G (minimum requirements to be respected by Member States allowing SUD reprocessing) would have the smallest impact compared to the current situation. The economic impact on reprocessors might be caused by stricter validation processes in order to meet requirements applicable to original medical devices manufacturers and the additional labeling requirement to indicate that the device has been reprocessed. As stated above, the association of US reprocessing companies claims that their members would already meet these requirements. But reprocessors (except for those in larger Member States) would likely not be able to benefit from scale effects since they would only be allowed to reprocess SUD put into service in their own Member State and to put them back into the use cycle in that same Member State. 

In terms of public health and patient safety, by requiring reprocessors to meet the same requirements as manufacturer, this option would enhance the protection of patients in comparison with today's situation. This option would also address specific situations of Member States prompting them to ban SUD reprocessing and would contribute to address ethical concerns that some Member States may have with regard to the reprocessing of SUD.

Comparison of policy options MD-1E to MD-1G:

An EU-wide ban on SUD reprocessing (option MD-1E) would have the most far-reaching consequences as regards the impact on the (relatively small) reprocessing industry and on some national healthcare budgets. Whilst the ban could be justified invoking the precautionary principle, it may also have a negative impact on public health and patient safety by reducing access to expensive devices in some Member States. It therefore does not appear as the most appropriate option.

Option MD-1G could be considered as the smallest common denominator for EU legislation. It would enhance patient safety in comparison with today's situation. Option MD-1G would however ensure a lower level of public health protection than policy option MD-1F due to the possibility to reprocess also SUD intended for critical use. Finally, option MD-1G would not enable SUD reprocessors to reach large scale business activity and may prevent SUD reprocessing in smaller Member States where this practice would not be economically viable (no scale effect). This option therefore does not appear the most appropriate either.

A harmonized regulation of SUD reprocessing (option MD-1F) with the possibility for Member States to ban the practice appears the preferred option and should be retained. It would ensure a high level of public health protection and patient safety. At the same time, the SUD reprocessing industry would be able to develop economies of scale at high standards. This may ultimately also have a positive impact on some national healthcare budgets. Ethical aspects (information of the patient and of the healthcare professionals) would be addressed due to the labeling requirement. 

4.4.        Impact of the policy options MD-2A and MD-2B (appropriate legal requirements taking into account technological, scientific and regulatory developments)

Option MD-2A would not lead to any regulatory change regarding medical devices using material or technologies with an increased risk (e.g. medical devices with nanomaterial; ingested devices; assisted reproductive technologies; agents for organ conservation; apheresis systems; products incorporating living microorganisms). Legal uncertainty caused by different interpretations and implementation practices in the Member States and obstacles to the free movement of goods would continue to exist leading to different levels of protection of public health and patient safety. Manufacturers would not be obliged to take into account specific hazards emanating from a specific device type (e.g. ingestion of an absorbable substance). Especially in the field of nanotechnology, such approach would disregard scientific[44], political[45] and regulatory[46] developments of the last years which favour a proactive approach in this matter.

Option MD-2B, to the contrary, would make legislative adaptations to the current requirements in the field of classification and essential requirements where necessary. The number of products would be limited since they would mainly concern products which have traditionally not been considered as medical devices (e.g. some ingested products) or which have been emerging only recently. As regards devices using nanomaterial, specific essential requirements and a classification rule regarding devices using "free" nanomaterial[47] would ensure that the benefits and risks linked to the use of nanotechnology are appropriately addressed by the legislation and provide an appropriate basis for developing, if appropriate, additional specifications for the risk-assessment and risk-management to be followed by the manufacturers as scientific knowledge about nanotechnology evolves. The economic impact would be insignificant since devices currently using "free" nanomaterial are likely to fall within class III devices due to other product characteristics. Since nanotechnology usually is part of the specific performance of the medical device, the information is also already provided by the manufacturer. Option MD-2B would make the medical device legislation future-proof when other devices come to the market which use nanomaterial in a less transparent way or which otherwise would belong to a lower risk class. 

For the above reasons, option MD-2B is the preferred option and should be retained.

4.5.        Impact of the policy options MD-3A to MD-3C (clinical investigations and evaluation)

Option MD-3A would not have any negative impact because the vast majority of Member States already use the internationally defined term "sponsor"[48] instead of manufacturer/authorised representative and submit them to the legal requirements applicable to clinical investigations.

This option would therefore have the positive impact of harmonising the practice throughout the EU. It would also be a pre-condition for enhancing the cooperation between Member States as regards the technical assessment of applications for clinical investigations. Legal clarification of other concepts such as "serious adverse event" and "post-market clinical follow-up", currently further explained in guidance documents, will also have the positive impact of harmonising the practice throughout the EU.

For these reasons, option MD-3A is necessary for any effective implementation of the requirements regarding clinical investigation and evaluation as it will ensure legal certainty and uniform application of the rules. It should therefore be retained in any case as condition sine qua non  complementary to any of the two alternative options regarding more coordination of the assessment procedure.

Options MD-3B and MD-3C concern the procedure and the question to which extent Member States should coordinate the assessment of aspects related to the safety of the investigational device. As it was stated in the problem description, no exact data exist as regards the number of multi-national clinical investigations, but the number can be estimated at around 200-350 a year which, in principle, would qualify for such a coordinated assessment.

Option MD-3B would bring most benefit for manufacturers (sponsors) who, by means of a single submission, could avoid multiple submissions and therefore reduce administrative burden. Industry, however, could not provide data as regards the costs caused by individual submissions and therefore, the administrative burden reduction cannot be quantified. Moreover, sponsors would benefit from consistency in the outcome of the technical assessment when this is coordinated. The option would nevertheless leave to the sponsor the choice between a single submission and multiple applications. This option would thus avoid to 'force' multi-national investigations into a coordination procedure where this might not be suitable due to the specific circumstances of the case. A coordinated procedure would also contribute to the objective that patients subject to the clinical investigation are protected at the same high level in all Member States where the investigation is conducted. Finally, a coordinated assessment procedure would not interfere in the Member States' ultimate responsibility for the approval of an investigation on their territory and thus respect the subsidiarity principle. Especially for smaller Member States, it would bring the benefit that resources could be shared and duplication of assessment of the same documentation by several authorities be avoided.

A coordinated assessment procedure, however, would have an impact on the EU budget because an EU body (Commission or an agency) would need to provide the administrative support to the national competent authorities in the coordination of the assessment. This would include the setting up of an IT infrastructure which would allow sponsors to file a single submission which is simultaneously forwarded to all Member States concerned and to facilitate the coordination between the national authorities where needed. In terms of human resources, 5 FTE at EU level would be required to implement option MD-3B. 

Option MD-3C would be less ambitious and leave the participation in a coordinated assessment to the willingness of each individual Member State. The costs at EU level would be the same for the IT infrastructure allowing for single submission and coordination between volunteering Member States. But since coordination would be voluntary, less human resources would likely be needed to facilitate the coordination, possibly only 1 FTE at EU level. 

The advantage of a voluntary coordination would be that only those Member States that are committed to take the coordinated assessment into account for the national approval of the clinical investigation would participate in such a process. This would likely enhance the effectiveness of the coordination when it takes place. The disadvantage, however, would be that participation in the coordination would be left to the willingness of the national competent authorities. The benefits for manufacturers (sponsors) of multi-national investigations would therefore be lower compared to the previous option. More importantly, the level of protection of patients participating in multi-national investigations would not be harmonised EU wide.

Comparison of policy options MD-3B to MD-3C:

Between policy options MD-3B and MD-3C, option MD-3B is the preferred one and should be retained. It would be an effective and efficient means to achieve an enhanced level of coordination as regards clinical investigations conducted in several Member States for the benefit of patients and sponsors. The benefits of option MD-3C would be uncertain because it would depend on the Member States' willingness to participate or not. Giving the sponsors the possibility to request coordination between the competent authorities involved appears to be the best solution, on the one hand, to achieve a positive impact of such coordination and, on the other hand, avoiding forcing such coordination where it would not fit due to the specificities of the investigation plan.

Since the Clinical Trials Directive in the field of pharmaceuticals is currently also being revised, the developments in that field are being followed to ensure consistency in the approach of both initiatives, unless differences are justified by the specificities of the sectors. 

5.           Overview of preferred options

The following policy options are the preferred ones for specific aspects related to the revision of the MDD:

Ø Option MD-1B: Regulation of products manufactured utilising non-viable human cells and tissues as medical devices

Ø Option MD-1C: Regulation of certain implantable or other invasive products without a medical purpose within the MDD

Ø Option MD-1F: Harmonized regulation of the reprocessing of single-use medical devices  

Ø Option MD-2B: Review of the classification rules and essential requirements regarding specific devices or technologies

Ø Option MD-3A: Introduction of the term "sponsor" for clinical investigations and further clarification of key provisions in the field of clinical evaluation and investigations

Ø Option MD-3B: Coordinated assessment of multi-national investigations by the Member States where the investigation is performed.

The policy options suggested for the extension of the scope of the MDD and its review on the basis of technological, scientific and regulatory developments would not lead to significant cost increases. On the other hand, filling the regulatory gaps regarding products manufactured utilising non-viable human cells and tissues, aesthetic products and reprocessing of single-use devices as well as introducing specific requirements for certain nanotechnology-based devices would address politically sensitive issues and eliminate uncertainties and divergences between the Member States.

As regards the suggestion to establish a coordinated assessment procedure for multi-national clinical investigations, it would be an important step towards a more harmonised implementation of the requirements and would reflect parallel regulatory developments with regard to clinical trials in the field of pharmaceuticals.

6.           Monitoring and evaluation

To monitor and evaluate the implementation of the future legislative act concerning medical devices (other than IVD) in respect to the specific issues discussed in this Annex 1, the following indicators can be taken into account:

6.1.        Scope

6.1.1.     Products manufactured utilising non-viable cells or tissues of human origin

The chosen policy option shall lead to the disappearance of the regulatory gap at EU level with regard to certain products manufactured utilising non-viable human tissues or cells and to a clear distinction between the application of Directive 2004/23/EC on tissues and cells, Regulation 1394/2007 on ATMP and the future medical device legislation. An indicator of success will be the creation of an internal market of these products in accordance with high safety standards.

6.1.2.     Implantable or other invasive products without a medical purpose

The chosen policy option shall lead to the disappearance of regulatory uncertainties with regard to the regulation of implantable or other invasive products without a medical purpose which are similar to medical devices. Its successful implementation should lead to the reduction of the number of such products available on the market that do not meet the safety and performance requirements set out in the medical device legislation.   

6.1.3.     Reprocessing of single-use medical devices

Harmonised requirements regarding the reprocessing of SUD (with the possibility for Member States to prohibit it) should lead to the development of a high quality and strictly regulated reprocessing sector in the EU in the field of single-use medical devices. Indicators to monitor the success of the chosen policy options are: the impact of an EU-wide regulation of SUD reprocessing on national healthcare budgets and the number of vigilance cases related to reprocessed SUD.

6.2.        Review of the classification rules and essential requirements regarding specific devices or technologies

The chosen policy option shall reduce the number of controversial cases as regards the appropriate classification of a given medical device and the essential requirements applicable to it.

6.3.        Coordinated analysis of clinical investigations conducted in more than one Member State    

Indicator of success of the chosen policy options in the field of clinical investigations and evaluation will be the number of sponsors' single submissions and the coordinated technical analysis of the safety aspects of the investigational device. Part of the evaluation of the success of this new procedure should be the benefits for national competent authorities in terms of work-sharing and the length of approval time of applications which went through a coordinated assessment procedure after single submission compared to those which are submitted individually in several Member States.

[1]               IVD manufactured from tissues, cells or substances of human origin are covered by the IVDD, see its recital (32).

[2]               Article 2(1)(d) of 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. 

[3]               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 cell, OJ L 102 of 7.4.2004, p.48.

[4]               Annex I of Regulation (EC) No 1394/2007 contains a non-exhaustive list of manipulation considered non-substantial.

[5]               See Article 1(6)(c) of Directive 90/385/EEC and Article 1(5)(f) of Directive 93/42/EEC

[6]               Medical devices which are manufactured utilising non-viable animal tissues which do not act principally by metabolic, immunological or pharmacological action, however, are covered by the medical device directives and specific requirements apply, e.g. Commission Directive 2003/32/EC introducing detailed specifications as regards the requirements laid down in Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin. 

[7]               See minutes of the MHRA Medical Device Technology Forum on tissue engineering, held on 27.11.2008, http://www.mhra.gov.uk/home/groups/clin/documents/websiteresources/con035987.pdf

[8]               Council Conclusions adopted on 6 June 2011, section 6, 13th indent.

[9]               MEDDEV 2.1/1 of April 1994: Definition of medical devices, accessory and manufacturer, http://ec.europa.eu/health/medical-devices/files/meddev/2_1-1___04-1994_en.pdf.

[10]             The German Federal Supreme Court (Bundesgerichtshof) has submitted this question to the ECJ for a preliminary ruling (BGH I ZR 53/09, Decision of 7 April 2011; ECJ C-219/11).

[11]             See written questions E-3878/10, E-1878/10, E-4071/09.

[12]             Clinica, August 2010 p. 26, "Aesthetic device scandal threatens to bring whole industry down with it"; Clinica, Sept/Oct. 2010, p. 12, "Aesthetic devices: Is specific EU legislation needed?"

[13]             Directive of the European Parliament and of the Council of 3 December 2001 on general product safety, OJ L 11 of 15.1.2002, p.4.

[14]             According to Article 1(2)(n) of Directive 93/42/EEC 'single use device' means "a device intended to be used once only for a single patient".

[15]             Annex I, sections 13.3(f) and 13.6(h) MDD. There it is also required that the manufacturer's indication of single use must be consistent across the EU.

[16]             Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention beim Robert-Koch-Institut und des Bundesinstituts für Arzneimittel und Medizinprodukte, "Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten", 1.11.2001, http://www.rki.de/cln_116/nn_201414/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Medpro__Rili,templateId=raw,property=publicationFile.pdf/Medpro_Rili.pdf

[17]             See Report of the United States Government Accountability Office (GOA), Reprocessed single-use medical devices, Jan. 2008, http://www.gao.gov/new.items/d08147.pdf.

[18]             SCENIHR, 15.4.2010, The Safety of Reprocessed Medical Devices Marketed for Single Use.

[19]             Report of 27 August 2010 on the issue of the reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC, COM(2010)433 final.

[20]             See AFSSAPS, Evaluation biologique des dispositifs médicaux contenant des nanomatériaux, 22.2.2011; BVMed, Nanotechnologien in der Medizintechnik, 27.4.2011; 4th European Conference for Clinical Nanomedicine (CLINAM 2011), www.clinam.org.

[21]             Opinion of 20 January 2009 (recommendation 18), http://ec.europa.eu/enterprise/policies/better-regulation/files/090114_finver_hlg_en.pdf. 

[22]             For 2009: 98 national CI and 104 multi-national CI; for 2010: 138 national CI and 127 multi-national CI. However, the two Member States with the highest number of CI notifications (DE, FR) did not distinguish between national and multi-national CI.  

[23]             For medicinal products, between 4,000 and 6,000 clinical trials are performed each year in the EU/EFTA. Even though it is not possible to extrapolate from data available for clinical trials for pharmaceuticals, the fact that around 25% of clinical trials for pharmaceuticals involve more than one EU/EFTA country which account for around 70% of trial subjects suggests that multi-national clinical investigations for medical devices are also larger and account for more patients subject to the investigations.  

[24]             COM(2012)369.

[25]             Article 2(2) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, OJ L 342 of 22.12.2009, p. 59.

[26]             The SCENIHR has  based its opinion on three categories of devices depending on risk: non-critical use, semi-critical use and critical use, see Scientific Opinion of the SCENHIR of 15 April 2010, http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_027.pdf and the Commission's report of 27 August 2010, COM(2010)443 final.

[27]             MEDDEV 2.7/2 (Guide for Competent Authorities in making an assessment of clinical investigation) and MEDDEV 2.7/3 (Clinical investigations: serious adverse event reporting) use already the term "sponsor".

[28]             See the last paragraph of Article 2(1)(b) of Regulation (EC) No 1394/2007.

[29]             See the announcement of the French Agency for Health Products AFSSAPS regarding 'produits injectables de comblement de rides' http://www.afssaps.fr/Dossiers-thematiques/Produits-injectables-de-comblement-des-rides/ 

[30]             See also US FDA's alert "Improper use of decorative contacts may haunt you" (Oct. 2009), http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048902.htm

[31]             According to a study in France, wearing cosmetic contact lenses increases 16.5. times the risk of developing microbial keratitis, Sauer A./Bourcier T., Microbial keratitis as a foreseeable complication of cosmetic contact lenses: a prospective study, in: Acta Ophtalmologica 2011, 1. According to the findings of the CLEER project, coloured contact lenses (plano and powered) resulted in statistically significantly more events than normal powered contact lenses, see Schweizer H., et al. The European Contact Lens Forum (ECLF) – The results of the CLEER-Project, in: Contact Lens & Anterior Eye (2011), doi:10.1016/j.clae.2011.02.013.

[32]             See also US FDA's alert "Wrinkle relief: injectable cosmetic fillers" (June 2008),  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049349.htm

[33]             Also the 2008 GOA report on reprocessing of SUD could not provide information about the size of the US reprocessed SUD market.

[34]             Von Eiff W., Reprocessing of single-use medical devices, Münster 17.2.2011.

[35]          Larmuseau D. et al., The impact of reprocessing single use devices in Belgium - An economic study, Erasmus MC University Medical Center, Institute for Medical Technology, Rotterdam, Netherlands, April 2008 (not published).

[36]             Tessarolo F. et al. Critical issues in reprocessing single-use medical devices for interventional cardiology.

[37]          Jacobs P. and al., Economic analysis of reprocessing single use medical devices: a systematic literature review, in: Infect Control Hosp Epidemiol 2008;29:297-301.

[38]             See the Jan. 2008 report of the United States Government Accountability Office (GOA) on Reprocessed single-use medical devices,

[39]             SCENIHR opinion "Safety of reprocessed medical devices marketed for single use" http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_027.pdf.

[40]             Matthias Tschoerner, Reprocessing in practice. Presentation given in vDSMH-EAMDR Forum on

“Reprocessing of highly complex medical devices”, 28. November 2008, Artemis Hotel, Amsterdam.

[41]             New York Times, 5.7.2010: "In a world of throwaways, making a dent in medical waste"; Kwakye G. et al., Green Surgical Practices for Health Care, in: Archives of Surgery, 146 (no. 2), Feb. 2011, p. 131. 

[42]             Classified as carcinogenic according to WHO.

[43]             Environmental agency, Life Cycle Assessment of Disposable and Reusable Nappies in the UK. www.environment-agency.gov.uk.

[44]             SCENIHR, "Scientific basis for the definition of the term 'nanomaterial'", 8.12.2010; JRC, "Considerations on a definition of nanomaterials for regulatory purposes", June 2010.

[45]             Draft Commission Recommendation on the definition of the terms "particulate nanomaterial" and "nano-constituent material", not yet adopted.

[46]             Regulation 1223/2009 on cosmetic products was the first product legislation containing provisions regarding nanomaterial.

[47]             Medical devices incorporating or consisting of nanomaterial unless it is encapsulated or bound in such a manner that it cannot be released to the patient’s organs, tissues, cells or molecules should be classified in class III.

[48]             ISO 14155:2011: Clinical investigation of medical devices for human beings – Good clinical practice.

COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT ON THE REVISION OF THE REGULATORY FRAMEWORK FOR MEDICAL DEVICES

Accompanying the documents

Proposals 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 and on in vitro diagnostic medical devices

Table of contents

1........... Problem definition. 6

1.1........ Problem IVD-1: Scope – regulatory gaps or uncertainties. 6

1.1.1..... "In-house" tests. 6

1.1.2..... Genetic tests. 6

1.1.3..... Companion diagnostics in personalized medicines. 6

1.2........ Problem IVD-2: Classification of IVDs and their appropriate conformity assessment, including batch release verification. 7

1.3........ Problem IVD-3: Unclear legal requirements and need for their adaptation to technological progress  7

1.3.1..... Clinical evidence. 7

1.3.2..... IVDs intended for point-of-care or near-patient testing. 8

1.3.3..... Alignment with the MDD where appropriate (e.g. medical software) 8

2........... Objectives. 8

3........... Policy options. 9

3.1........ Policy options regarding objective IVD-1: Covering legal gaps and loopholes. 9

3.1.1..... "In-house" tests. 9

3.1.1.1.. Policy option IVD-1A: Delete the exemption for "in-house" tests. 9

3.1.1.2.. Policy option IVD-1B: Clarify the scope of the exemption for "in-house" tests and require a mandatory accreditation for "in-house" tests manufacturers. 9

3.1.1.3.. Policy option IVD-1C: Clarify the scope of the exemption for "in-house" tests, require a mandatory accreditation for "in-house" tests manufacturers and subject high risk (class D) "in-house" tests to the requirements of the IVDD   9

3.1.2..... Genetic tests. 9

3.1.2.1.. Policy option IVD-1D: No legislative change and clarification by guidance. 9

3.1.2.2.. Policy option IVD-1E: Amendment of the legal definition of an IVD to include all tests providing information "obtained by analysis of the genetic material", with a negative list of genetic tests excluded from the IVDD   9

3.1.2.3.. Policy option IVD-1F: Amendment of the legal definition of an IVD to include tests providing information "about the predisposition to a medical condition or a disease" 10

3.1.3..... Companion diagnostics in personalized medicines. 10

3.1.3.1.. Policy option IVD-1G: No legislative change regarding companion diagnostics. 10

3.1.3.2.. Policy option IVD-1H: Regulation of companion diagnostics within the framework of the legislation on medicinal products. 10

3.2........ Policy options regarding objective IVD-2: Appropriate and robust classification and conformity assessment of IVDs. 10

3.2.1..... Classification. 10

3.2.1.1.. Policy option IVD-2A: No change to the classification of IVDs. 10

3.2.1.2.. Policy option IVD-2B: Adoption of the GHTF classification rules and adaptation of the conformity assessment procedures to the relevant GHTF guidance. 10

3.2.2..... Batch release verification. 10

3.2.2.1.. Policy option IVD-2C: Batch release verification for high risk IVDs by the manufacturer under the control of a Notified Body (legislative clarification) 10

3.2.2.2.. Policy option IVD-2D: Systematic batch release verification for high risk IVD by an independent laboratory  11

3.3........ Policy options regarding objective IVD-3: Clear and updated legal requirements for enhanced safety and performances of IVDs. 11

3.3.1..... Clinical evidence. 11

3.3.1.1.. Policy option IVD-3A: No legislative change regarding clinical evidence. 11

3.3.1.2.. Policy option IVD-3B: Legislative clarification of the requirements for the clinical evidence for IVDs  11

3.3.1.3.. Policy option IVD-3C: Legislative clarification of the requirements for the clinical evidence for IVDs and demonstration of the clinical utility. 11

3.3.2..... Point-of-care or near-patient IVDs. 11

3.3.2.1.. Policy option IVD-3D: No change regarding point-of-care or near-patient IVDs. 11

3.3.2.2.. Policy option IVD-3E: Clarification of the legal requirements in respect to point-of-care or near-patient IVDs  11

3.3.3..... Alignment with the MDD where appropriate (e.g. medical software) 12

3.3.3.1.. Policy option IVD-3F: no alignment with the MDD.. 12

3.3.3.2.. Policy option IVD-3G: Alignment to the MDD where appropriate. 12

4........... Impact of policy options. 12

4.1........ Impact of policy options IVD-1A to IVD-1C ("in-house" tests) 12

4.2........ Impact of policy options IVD-1D to IVD-1F (genetic tests) 14

4.3........ Impact of policy options IVD-1G to IVD-1H (companion diagnostics) 15

4.4........ Impact of policy options IVD-2A to IVD-2B (classification) 15

4.5........ Impact of policy options IVD-2C to IVD-2D (batch release verification) 18

4.6........ Impact of policy options IVD-3A to IVD-3C (clinical evidence) 20

4.7........ Impact of policy options IVD-3D and IVD-3E (PoC/NP-tests) 21

4.8........ Impact of policy options IVD-3F and IVD-3G (alignment with the MDD) 21

5........... Conclusions. 21

6........... Monitoring and evaluation. 22

6.1........ Scope of the IVDD.. 23

6.1.1..... "In-house" tests. 23

6.1.2..... Genetic tests. 23

6.2........ Classification of IVDs. 23

1.           Problem definition

1.1.        Problem IVD-1: Scope – regulatory gaps or uncertainties

1.1.1.     "In-house" tests

Article 1(5) of the IVDD makes provision for an exemption for in vitro diagnostic medical "devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity". These tests are usually called “in-house" tests. The concept of such tests has led to diverging, and sometimes very broad, interpretations in the different Member States. This exemption has come under criticism since it dos not ensure a uniform high level of safety and performances for "in-house" tests across Europe. Moreover, from the perspective of industrial manufacturers, the exemption from the requirements of the IVDD may lead, in certain cases, to unfair competition between CE marked IVDs and "in-house" tests. However, for certain medical conditions or in emergency situations, only "in-house" tests may be available. This requires therefore a careful assessment if there is a need to clarify or limit the scope of the exemption and/or to submit some or all "in-house" tests to certain requirements of Directive 98/79/EC.

1.1.2.     Genetic tests

Currently, the IVDD only applies to genetic tests that have a medical purpose, e.g. prenatal diagnostic tests, diagnostic tests of diseases, tests used in conjunction with the use of a specific medicinal product, etc. Beside these tests with a direct medical purpose, the medical purpose cannot always be established for some predictive tests, lifestyle tests, nutrigenetic tests, etc. which provide information on the basis of the analysis of a human body sample. This might lead to different interpretations on the qualification of these products within the European Union. In addition, there are increasing concerns regarding genetic tests without a clear medical purpose (e.g. some predictive tests)[1]. These concerns are related, among others, to the lack of quality, of scientific evidence and of clinical validity or clinical utility of these tests.

1.1.3.     Companion diagnostics in personalized medicines

There are a growing number of tests which are developed and/or used in direct combination with specific medicinal products or which are co-developed with new medicinal products. These tests may be used for the selection of patients suitable for the respective medication, for optimal and individualized dosing of medicinal products, for the exclusion of populations expected to suffer from severe adverse side effects, etc. Currently, most companion diagnostics are self-certified by the IVD manufacturers. The increasing development of personalized medicines[2], and the close relationship between the companion diagnostics and the medicinal products, has raised the question whether a specific regulatory framework for companion diagnostics would be needed.

1.2.        Problem IVD-2: Classification of IVDs and their appropriate conformity assessment, including batch release verification

The classification of IVDs according to the risk linked to their use, in particular in case of failure or misdiagnosis, is currently different from the approach taken for the other medical devices. The IVDD addresses the level of risk by listing "high-risk" IVDs (e.g. tests for the determination of blood groups and for the detection of HIV or hepatitis infection) in its Annex II. While this system gives a high level of legal certainty, it does not go along with technological evolution since the enumerative list needs to be adapted every time a new "high-risk" IVD is being developed. So far, the list has never been amended but the inclusion of assays for the detection of variant Creutzfeld-Jacob Disease is under way. However, the process is lengthy, and until any amendment of Annex II takes effect, new high-risk IVDs can be placed on the market under the manufacturer's self-certification.

The Global Harmonization Task Force (GHTF) adopted a guidance document GHTF/SG1/N045:2008 entitled "Principles of in vitro Diagnostic (IVD) Medical Devices Classification"[3]. Such rules-based risk classification is more robust to technological evolution. A majority of respondents to the 2008 and 2010 public consultations were in favor of the adoption of the GHTF classification which would replace the current Annex II of the IVDD.

The conformity assessment procedure that an IVD must follow before its placing on the market is directly linked to the IVD's risk class. If the GHTF classification was to be adopted, it would also be necessary to adapt the conformity assessment procedures to the new classification rules. The GHTF guidance document GHTF/SG1/N046:2008, entitled "Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices"[4], sets out the elements of conformity assessment applicable to the different classes of IVDs.

In addition, the IVDD requires a verification of manufactured IVDs listed in its Annex II, List A. This process is called "batch release verification". The testing of batches of high risk IVDs before their release shall ensure the consistency and the uniform level of quality of these tests, thus preventing low quality batches to be placed on the European market. However, the relevant provisions[5] have led to diverging interpretations and their implementation is not uniform in the EU which may lead to competitive disadvantages for certain manufacturers. While at least one Member State (Germany) requires systematic batch release verification to be performed by an independent laboratory, the batch release verification is performed by the manufacturer under the control of a Notified Body in other Member States.

1.3.        Problem IVD-3: Unclear legal requirements and need for their adaptation to technological progress

1.3.1.     Clinical evidence

The essential requirements of the IVDD contain requirements regarding the performances of IVDs. In particular, the demonstration of performances should include, where appropriate, the analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including control of known relevant interference, and limits of detection, stated by the manufacturer[6]. These requirements are a mix of analytical and clinical performances requirements but are misunderstood as requiring only the demonstration of analytical performances. A vast majority of respondents to the 2010 public consultation were therefore in favor of clarifying the concept of demonstration of performances by introducing more detailed requirements on the clinical evidence required for an IVD in order to support the intended purpose, proportionate to the risk related to its use.

1.3.2.     IVDs intended for point-of-care or near-patient testing

There are a growing number of tests which are performed outside a laboratory environment but near to a patient by a healthcare professional in order to make a diagnosis and/or to determine the appropriate treatment. These tests are often referred to as "point-of-care tests" or "near-patient tests"[7] (hereafter referred to as "PoC/NP-tests"). The benefit of PoC/NP-tests, i.e. to obtain rapidly results which can be directly taken into account by the healthcare professional, is obvious. However, the problem is that the users, in general, are not qualified in clinical chemistry since they are not laboratory professionals. Some concerns have been expressed that the current requirements of the IVDD are not sufficiently addressing the special circumstances in which PoC/NP-tests are used. According to a study on PoC/NP-tests available on the Dutch market, the technical documentation (risk-analysis and instructions for use) were of good quality in one third of the cases, while in another one third the quality was moderate, and in one quarter of the cases insufficient or absent (the results of the remaining tests being inconclusive)[8].

1.3.3.     Alignment with the MDD where appropriate (e.g. medical software)

Directive 2007/47/EC introduced a number of amendments in the MDD/AIMDD which are also relevant for IVDs, in particular as regards the essential requirements for medical software, the incorporation of the relevant essential requirements of the Machinery Directive and the principles of design for patient safety and design for lay, professional, disabled or other users. The revision of the IVDD would therefore give the opportunity to align it with the MDD, where appropriate.

2.           Objectives

The overall objectives pursued by the revision of the regulatory framework for medical devices as set out in the main part of this impact assessment (section 3.1.) are also the guiding principles for the specific issues of the IVDD. These general objectives can be further detailed by the specific objectives set out below. Each of them contributes to the achievement of the overall objectives.

Ø Objective IVD-1: Covering of legal gaps and loopholes

Ø Objective IVD-2: Appropriate and robust classification and conformity assessment of IVDs 

Ø Objective IVD-3: Clear and updated legal requirements for enhanced safety and performances of IVDs

3.           Policy options

3.1.        Policy options regarding objective IVD-1: Covering legal gaps and loopholes

3.1.1.     "In-house" tests

3.1.1.1.  Policy option IVD-1A: Delete the exemption for "in-house" tests

Deleting Article 1(5) IVDD would mean that "in-house" tests would be subject to the IVDD and would have to meet the requirements set out in that directive.

3.1.1.2.  Policy option IVD-1B: Clarify the scope of the exemption for "in-house" tests and require a mandatory accreditation for "in-house" tests manufacturers

This policy option would amend the current Article 1(5) of the IVDD by defining "health institution" and by deleting the notion of "immediate vicinity". It would allow laboratories that are not located in the immediate geographical area, but belong to the same legal entity, to manufacture "in-house" tests and would require that "in-house" tests manufacturing laboratories are accredited according to ISO 15189[9] or similar requirements. The "in house" tests themselves would remain exempted from the requirements of the IVDD.

3.1.1.3.  Policy option IVD-1C: Clarify the scope of the exemption for "in-house" tests, require a mandatory accreditation for "in-house" tests manufacturers and subject high risk (class D) "in-house" tests to the requirements of the IVDD

This option builds upon option IVD-1B but would exclude class D "in-house" tests from the exemption. They would thus be subject to the requirements of the IVDD, in particular the essential requirements (including clinical evidence), conformity assessment procedure and the vigilance system.

3.1.2.     Genetic tests

3.1.2.1.  Policy option IVD-1D: No legislative change and clarification by guidance

This policy option would not lead to a change of the legal definition of an IVD. The Commission would rather clarify the definition by an interpretation regarding genetic tests through a guidance document.

3.1.2.2.  Policy option IVD-1E: Amendment of the legal definition of an IVD to include all tests providing information "obtained by analysis of the genetic material", with a negative list of genetic tests excluded from the IVDD

This policy option would require an amendment of the legal definition of an IVD in order to include in its scope all tests that provide information "obtained by analysis of genetic material". Tests without any medical purpose, such as paternity tests or forensic tests, would need to be explicitly excluded by means of a negative list.

3.1.2.3.  Policy option IVD-1F: Amendment of the legal definition of an IVD to include tests providing information "about the predisposition to a medical condition or a disease"

This policy option would also require an amendment of the legal definition of an IVD in order to include in its scope all tests that provide information "about the predisposition to a medical condition or a disease". This would cover a wide range of predictive genetic tests, but not genetic tests without any medical purpose. A negative list would therefore not be necessary.

3.1.3.     Companion diagnostics in personalized medicines

3.1.3.1.  Policy option IVD-1G: No legislative change regarding companion diagnostics

With this policy option, companion diagnostics would continue to be regulated as IVDs under the IVDD. If the GHTF classification rules were adopted (see policy option IVD-2B), companion diagnostics would be classified within class C[10]. A Notified Body would be therefore systematically involved in the conformity assessment procedure.

3.1.3.2.  Policy option IVD-1H: Regulation of companion diagnostics within the framework of the legislation on medicinal products

This policy option would submit companion diagnostics to the medicinal products legislation and would require the corresponding amendment of Directive 2001/83/EC or the adoption of a specific legislation on companion diagnostics.

3.2.        Policy options regarding objective IVD-2: Appropriate and robust classification and conformity assessment of IVDs 

3.2.1.     Classification

3.2.1.1.  Policy option IVD-2A: No change to the classification of IVDs 

This policy option would maintain the current system of listing high risk IVDs in Annex II to the IVDD.

3.2.1.2.  Policy option IVD-2B: Adoption of the GHTF classification rules and adaptation of the conformity assessment procedures to the relevant GHTF guidance

This policy would require the adoption of the GHTF classification for IVDs[11] which would replace the current list in Annex II to the IVDD. The conformity assessment procedures would need to be adapted accordingly to the relevant GHTF guidance[12].

3.2.2.     Batch release verification

3.2.2.1.  Policy option IVD-2C: Batch release verification for high risk IVDs by the manufacturer under the control of a Notified Body (legislative clarification)

This policy option would lead to small amendments of the relevant provisions of the IVDD regarding batch release verification, clarifying that the batch release testing is to be performed by the manufacturer under the control of a Notified Body without mandatory testing by an independent laboratory.

3.2.2.2.  Policy option IVD-2D: Systematic batch release verification for high risk IVD by an independent laboratory

This policy option would require an amendment of the relevant provisions of the IVDD to mention that an independent and recognised laboratory would have to perform the verification of manufactured high risk IVDs by batches before they could be placed on the market. It would also imply setting the criteria for the laboratories to be designated to perform such batch release testing.

3.3.        Policy options regarding objective IVD-3: Clear and updated legal requirements for enhanced safety and performances of IVDs

3.3.1.     Clinical evidence

3.3.1.1.  Policy option IVD-3A: No legislative change regarding clinical evidence

This policy option would not lead to amendments of the relevant IVDD provisions with regard to the demonstration of the clinical evidence for the performance evaluation of IVDs.

3.3.1.2.  Policy option IVD-3B: Legislative clarification of the requirements for the clinical evidence for IVDs 

This policy option would clarify the existing requirements on clinical evidence within a specific annex[13] detailing the analytical and clinical performances to be demonstrated by the manufacturer before placing an IVD on the market. It would be spelled out that the demonstration of the clinical evidence would need to be proportionate to the risk of the IVD. Where appropriate, the clinical evidence would include the demonstration of the negative and positive predictive values[14], based on the prevalence of the disease.

3.3.1.3.  Policy option IVD-3C: Legislative clarification of the requirements for the clinical evidence for IVDs and demonstration of the clinical utility

In addition to the demonstration of the clinical evidence, this option would also require the demonstration of the clinical utility of an IVD before its placing on the market. Clinical utility is described as the usefulness of the results obtained from testing with the IVD and the value of the information to the individual being tested and/or the broader population[15]. It would thus require the manufacturer to demonstrate, beyond the scientific validity and the clinical performances of an IVD, how it supports clinical decisions for patient management, such as effective treatment or preventive strategies.

3.3.2.     Point-of-care or near-patient IVDs

3.3.2.1.  Policy option IVD-3D: No change regarding point-of-care or near-patient IVDs

Policy option 3D would not lead to any clarification of the requirements applicable to point-of-care or near-patient IVDs.

3.3.2.2.  Policy option IVD-3E: Clarification of the legal requirements in respect to point-of-care or near-patient IVDs

On the contrary, policy option 3E would lead to the clarification of the general requirements in order to address specific concerns in relation to point-of-care or near-patient IVDs, in particular regarding the information to be supplied by the manufacturer in the instructions for use. It would also concern the demonstration of the clinical evidence for which the specific conditions of use need to be taken into account (i.e. point of care environment and comparison to comparable tests performed in laboratories).

3.3.3.     Alignment with the MDD where appropriate (e.g. medical software)

3.3.3.1.  Policy option IVD-3F: no alignment with the MDD

Policy option 3F would not incorporate the relevant modifications introduced in the MDD by Directive 2007/47/EC also into the IVDD.

3.3.3.2.  Policy option IVD-3G: Alignment to the MDD where appropriate

On the contrary, policy option 3G would incorporate, where appropriate, the relevant modifications introduced by Directive 2007/47/EC into the MDD also into the IVDD. This would concern the essential requirements for medical software, the incorporation of the relevant essential requirements of the Machinery Directive and the principles of design for patient safety and design for lay, professional, disabled or others users.

4.           Impact of policy options

4.1.        Impact of policy options IVD-1A to IVD-1C ("in-house" tests)

Policy option IVD-1A (delete the exemption for "in-house" tests) would ensure a level playing field between "in-house" tests manufacturing laboratories and manufacturers by avoiding unfair competition between them.

However, this option would have a high negative impact on public health since a broad range of "in-house" tests are not commercially available. The removal of the exemption would limit the access to certain tests for European patients and citizens.

During the 2010 public consultation, respondents pointed out that the exemption for "in-house" tests is mainly used by public laboratories to make tests for rare medical conditions, tests for cytogenetic and other whole-genome testing, seldom-use tests for common analytes, alternatives in test methodology or to customize tests for common genetic disorders. The stakeholders underlined that the exemption may also be used for rapid responses to public health treats, e.g. SARS, Influenza H5N1, H1N1. Moreover, the exemption seems also to have a positive impact on the research and development process for IVDs.

No data exists as regards the volume of "in-house" tests or on the number of laboratories using the "in-house" tests exemption ("in-house" tests are usually made in hospitals, but not all hospitals necessarily make "in-house" tests). The extent of "in-house" tests, however, does not seem to be too significant. Postnatal testing for newborn appears to be the most important area of "in-house" tests. According to data provided by the National Health System (NHS) in the United Kingdom, postnatal "in house" tests were used for the testing of 400 disorders. For more than 300 disorders, the number of testing provided was lower than 100 per year. Only testing for 16 disorders were performed more than 1000 times a year. This tends to demonstrate that a commercial marketing of "in-house" tests to perform such postnatal testing is unlikely to take place, due to the relatively low volume of sales expected.

In addition, respondents highlighted that this policy option would have a significant economic impact on hospitals and on healthcare systems. For example, in the United Kingdom, it is estimated that the mandatory use of CE marked tests for newborn screening laboratories would lead to an additional cost of £6.2 mio./year. 

For the above reasons, option IVD-1A is not retained.

Policy options IVD-1B (clarify the scope of the exemption for "in-house" tests and require a mandatory accreditation for "in-house" tests manufacturers) and IVD-1C (same as option IVD-1B and subject high risk (class D) "in-house" tests to the requirements of the IVDD) would clarify which laboratories shall benefit from the "in-house" tests exemption and therefore would reduce the divergences between the Member States. These policy options would also lead to the reduction of borderline cases and of situations of unfair competition for manufacturers.

The deletion of the requirements for "immediate vicinity" would have a positive social impact since "in-house" tests would be allowed to be used on samples taken in other locations and it would address the issue of health institutions with several geographical locations. The suggestion made by some stakeholders to limit the exemption to health institutions belonging to the public sector would not be appropriate since, in some Member States, health institutions may be organised as private bodies. A definition of the term "health institution" to the extent that it shall be understood as a body whose primary purpose is the care or treatment of patients and/or the promotion of public health would be beneficial since it would exclude free-standing laboratories which provide diagnostic services for which the exemption has never been intended. 

Both policy options 1B and 1C would align the situations in the Member States by requiring the mandatory accreditation of laboratories according to ISO 15189, or similar requirements. Mandatory accreditation would have an economic impact which consists of the accreditation fees (if any) and the compliance costs to the accreditation standard. The costs could vary between EUR 5,000 and EUR 13,000 for the initial accreditation, if provided by a for profit accreditation laboratory, but it may also be provided by authorities. It is not possible to have a global estimation of the costs as the number of laboratories manufacturing "in-house" tests is not precisely known. It needs to be also noted that many of those laboratories are already accredited, either on voluntary basis or due to national requirements. Mandatory accreditation would have a significant positive impact in terms of safety and quality of the testing process since ISO 15189 requires, among others, that "if in-house procedures are used, they shall be appropriately validated for their intended use and fully documented". Accreditation of laboratories manufacturing "in-house" tests was considered by many stakeholders as a key requirement during the 2010 public consultation.

Policy option IVD-1C would go one step further than policy option IVD-1B by submitting high risk (class D) "in-house" tests to the requirements of the IVDD.  The economic impact on laboratories would therefore be higher due to the implementation of these requirements, including the involvement of a Notified Body. This economic impact, however, would need to be balanced with a higher level of health protection. Moreover, such "in-house" tests could be CE marked and therefore marketed within the EU.

Submitting class D devices to the requirements of the IVDD is proportionate from a public health standpoint since any failure of these tests can lead to major public health damages due to the fact that class D devices are mainly intended:

o to be used to detect the presence of, or exposure to, a transmissible agent in blood, cells, tissues or organs in order to assess their safety and their suitability for transfusion or transplantation;

o to be used to detect the presence of, or exposure to, a transmissible agent that causes a life-threatening, often incurable, disease with a high or currently undefined risk of propagation;

o to be used for blood grouping or tissue typing to ensure the immunological compatibility in case of transfusion or transplantation.

Those devices correspond largely to the tests currently listed in Annex II list A of Directive 98/79/EC, for which the intervention of a Notified Body is already required before their placing on the European Union market. Most of them are usually commercially available on the European Union market. In addition, in case of emergency situations where class D tests would need to be quickly deployed, the specific provision[16] of Directive 98/79/EC (that allows competent authorities to authorise the placing on the market within their territory of devices for which the conformity assessment procedures have not been carried if the use of such tests is in the interest of protection of health) would be maintained and clarified in order to avoid any risk of shortage. Last but not least, this option would also ensure harmonised safety and performance requirements for class D IVDs throughout Europe in a context of increasing mobility of patients, in particular due to the implementation of Directive 2011/24/EU on patients' rights in cross-border healthcare.   

Option IVD-1B could be considered as the minimum requirement to be set. Option IVD-1C, however, is considered the preferred option because it ensures a higher level of safety and a harmonised level of safety and performances for high risk IVDs, regardless of the place of manufacture in the Internal Market.

4.2.        Impact of policy options IVD-1D to IVD-1F (genetic tests)

The option IVD-1D (no legislative change) would not change the status quo. Even if the Commission intended to clarify which genetic tests were covered by the IVDD, such guidance would not be legally binding and would not enhance the legal certainty. This option would therefore not be effective and should be discarded.

Policy option IVD-1E (amendment of the legal definition of an IVD to include all tests providing information "obtained by analysis of the genetic material", with a negative list of genetic tests excluded from the IVDD) would considerably extend the scope of the IVDD and would therefore require exclusions by means of a negative list. Such a list would require to be regularly updated to the technological development. Due to the length of legislative procedures, this approach would bear the risk that certain non-medical tests – if not included in the negative list – would become subject to the IVDD even though the essential requirements, including the requirements regarding clinical evidence and risk/benefit analysis, would not be appropriate. This option would therefore not be an adequate means to address the problem and should also be discarded.

Policy option IVD-1F (amendment of the legal definition of an IVD to include tests providing information "about the predisposition to a medical condition or a disease") would constitute a moderate extension of the IVDD. It would lead to a legal certainty favourable to the Internal Market without including genetic tests that do not have any intended medical purpose. The economic impact would be that manufacturers of genetic tests which currently escape from the IVDD due to legal uncertainty would clearly be covered and would need to demonstrate compliance, usually with the involvement of a Notified Body in the conformity assessment procedure. Genetic tests which would not satisfy the safety and performances requirements of the IVDD would disappear from the market. This would be a desired consequence of this option since it would lead to a high level of protection of public health against low quality genetic tests which do not provide reliable results. Due to the positive social impact, which outweighs possible economic costs for some manufacturers, policy option IVD-1F is the preferred option and should be retained[17].

4.3.        Impact of policy options IVD-1G to IVD-1H (companion diagnostics)

During the 2010 public consultation, the respondents almost unanimously expressed the view that companion diagnostics should continue to be regulated under the IVDD which would back policy option IVD-1G (no legislative change). 

Option IVD-1H (regulation of companion diagnostics within the framework of the legislation on medicinal products) would lead to en extension of the competences of the European Medicines Agency or of the national medicinal products agencies since the clinical validity of the companion IVD would be part of the assessment of the medicinal product in the context of the marketing authorisation. This option may lead to problems for IVDs that have several intended uses and might submit them to two different regulatory regimes. This option was not supported by stakeholders during the 2010 public consultation. In addition, a regulation under the medicinal products legislation would imply developing the companion diagnostic at the same time as the medicinal product, which would significantly increase the time to market and subject the manufacturers of companion diagnostics to high regulatory burdens and make them (more) dependent on the manufacturer of the medicinal product. It could therefore negatively impact the competition and the development of innovative tests. Option IVD-1H should be therefore discarded.

Policy option IVD-1G, to the contrary, would not add any burden on economic operators. In case of the adoption of the GHTF classification rules (see policy option IVD-2B), the regulation of companion diagnostics under the IVDD would ensure an appropriate level of safety and performances for these products. Therefore policy option IVD-1G is the preferred option and should be retained.

4.4.        Impact of policy options IVD-2A to IVD-2B (classification)

Policy option IVD-2A (no legislative change) would maintain the status quo, i.e. a list of high risk IVDs in an annex to the IVDD. It would keep the high level of legal certainty as regards the IVDs subject to the strictest conformity assessment procedure. However, it would not automatically classify newly developed IVDs in the appropriate risk class, but would require legislative action (possibly through amendment of the annex to the IVDD by delegated act). Option IVD-2A should be therefore discarded.

Policy option IVD-2B (adoption of the GHTF classification rules and adaptation of the conformity assessment procedures to the relevant GHTF guidance), on the contrary, would move the classification to a rules-based risk classification system as it exists already for the other medical devices, classifying IVDs into 4 risk class as follows:

1.  GHTF classification system for IVDs

2.

CLASS || RISK LEVEL || EXAMPLES

A || Low Individual Risk and Low Public Health Risk || 3. Specimen receptacles

B || Moderate Individual Risk and/or Low Public Health Risk || Pregnancy self testing

C || High Individual Risk and/or Moderate Public Health Risk || Blood glucose self testing

D || High Individual Risk and High Public Health Risk || HIV test

The classification rules have been developed at GHTF level (GHTF/SG1/N045:2008) and have been implemented so far by Australia. They are accompanied by GHTF principles on conformity assessment (GHTF/SG1/N046:2008). The adoption of the GHTF classification system would enhance the robustness of the regulatory framework to technological progress since innovative IVDs would automatically be classified in the appropriate risk class. This would lead to a considerable increase in the protection of public health and patient safety. A timely access to market of innovative IVDs would be ensured. In addition, it would constitute an important step towards international harmonisation in the field of IVDs, and thus facilitate trade in this sector.

The adoption of the GHTF classification and of the conformity assessment schemes for IVDs, altogether would lead to an increased involvement of Notified Bodies in the conformity assessment process. It will ensure the safety and performances of IVDs placed on the EU market. However, it will lead to costs for manufacturers of most class B IVDs and class C IVDs which, under the current legislation, are able to certify the conformity of their products themselves (self-certification). No or only little impact can be expected for IVDs of class A (they would remain under self-certification) and of class D (they correspond largely to the IVDs currently listed in Annex II, list A, of the IVDD).

 Industry considers that class B IVDs and class C IVDs represent respectively around 50% and 35%, of the 40,000 IVDs present on the European market, i.e. 20,000 class B IVDs and 14,000 class C IVDs.

The following costs estimation related to the adoption of the GHTF classification system is based on data from 11 manufacturers provided by the European Diagnostics Manufacturer Association (EDMA).

Under the GHTF system, the Notified Bodies would need to assess the manufacturer’s quality system in case of class B IVDs. The estimated initial costs related to a classification in class B, which include Notified Body fees, updating of technical documentation and changes to the labelling, would range from EUR 1,100 to EUR 2,059 (weighted medium: EUR 1,220). It means that the adoption of the GHTF classification system and the corresponding changes to the conformity assessment procedures would have an initial economic impact of around EUR 24mio. for class B IVDs manufacturers.

For class C IVDs, in addition to the quality system assessment, the Notified Bodies would need to examine also the design documentation. This could either be done for every IVD or, by analogy to the requirements for class IIb devices under the MDD, on a representative basis for each generic device group. In the costs estimation, only 9,800 out of the 14,000 class C IVDs have been taken into account since around 30% of IVDs which would fall into class C according to GHTF rules are already today subject to conformity assessment with the involvement of a Notified Body (because they either belong to Annex II, list B, of the IVDD or are IVDs for self-testing). The initial economic impact related to a classification in class C, which again include Notified Body fees, updating of technical documentation and changes to the labelling, would range from EUR 12,000 to EUR 26,190 (weighted medium: EUR 14,906).

30% of the above mentioned costs would be recurrent due to annual surveillance audits. 60% of the costs would recur every 5 years for the renewal of certificates.

The following table provides an overview the yearly costs, over 5 years, in case of adoption of GHTF classification model and conformity assessment for the IVD sector

Yearly costs for adoption of GHTF classification and conformity assessment for the IVD sector

|| Year 1 (submission of documentation to a Notified Body for pre-market assessment and labelling adjustments) || Year 2 (annual surveillance) || Year 3 (annual surveillance) || Year 4 (annual surveillance) || Year 5 (renewal of certificates)

Class B ca. 20000 || EUR 24 mio. || EUR 7.2 mio. || EUR 7.2 mio. || EUR 7.2 mio. || EUR 14.4 mio.

Class C ca. 9800 || EUR 146 mio. || EUR 43.8 mio. || EUR 43.8 mio. || EUR 43.8 mio. || EUR 87.6 mio.

The total initial economic impact of the change of the classification system could therefore be estimated at around EUR 170 mio. To a large extent, these costs are related to the submission of documentation to a Notified Body for pre-market assessment or labelling adjustments and are therefore also mentioned in the chapter on administrative costs in the main part of this impact assessment.

To mitigate the economic impact on manufacturers, a sufficient transitional period (i.e. 5 years) should be foreseen. In addition, the classification according to internationally recognised rules would lead to benefits in terms of competitiveness due to international harmonization, provided that the GHTF classification rules were adopted as such. It is impossible to provide hard figures as regard the economic benefits for manufacturers deriving from the adoption of the GHTF classification rules. But the IVD industry itself expects simplification of regulatory procedures in third countries (especially smaller markets) as well as in the EU.  

The disadvantage of a rules based classification system, i.e. the need to determine the class on a case-by-case basis, would need to be addressed by a quick and EU-wide uniform mechanism to settle classification questions (see policy option 3B in the main part of the impact assessment).

The current conformity assessment modules of the IVDD, to a large extent, are in line with the GHTF principles on conformity assessment. However, some concerns were raised during the 2010 public consultation regarding the procedure laid down in Annex VI of the IVDD since it does not include an assessment of the vigilance system of the manufacturer. It would therefore need to be amended accordingly. Moreover, according to the feedback from respondents to the 2010 public consultation (which confirmed findings from a 2008 survey among Notified Bodies), the conformity assessment procedure laid down in Annex VI (EC verification in case of type-examination) is not used by manufacturers. Moreover, Annex VI does not require manufacturers of high risk IVDs to put in place a quality system which is contradictory to the fact that, even in the case of self-certification, manufacturers must have a quality system. It is therefore suggested deleting this module in order to increase patient safety while simplifying the conformity assessment pathways, without significant impact on economic operators.

In view of the above, the replacement of the current Annex II listing system by the GHTF classification rules, coupled with some adaptations of the conformity assessment procedures, would be considered beneficial in terms of robustness of the regulatory system and would ensure a high level of protection of public health. Option IVD-2B is therefore the preferred option and should be retained. Despite the economic impact on manufacturers, this option was also supported by 87% of the respondents to the 2010 public consultation (88% of the competent authorities, 88% of the manufacturers, 87% of the clinical laboratories and medical associations, 83% of hospitals, 100% of genetic associations and notified bodies). The manufacturers' support was expressed both by SMEs (e.g. Bactus AB[18]) and by larger companies (e.g. Roche, Johnson & Johnson).

The costs would be compensated by the positive impact in terms of public health and safety and by advantages in terms of competitiveness deriving from a move towards harmonization with Europe's main trade partners, which is of utmost importance since the majority of IVD manufacturers market their products both in and outside the European Union . Adoption of the GHTF classification rules would also meet the Council's request to improve the system of risk-based classification particularly for IVDs[19].

4.5.        Impact of policy options IVD-2C to IVD-2D (batch release verification)

The concept of batch release verification for high risk IVDs as such was not questioned during the 2010 public consultation, but clarification was considered necessary regarding how and by whom the testing of batches before release onto the market should be performed, in order to eliminate the current discrepancies in the implementation of this concept. The majority of stakeholders underlined that batch release testing should be performed by the manufacturer in the context of the quality management system under the supervision of a Notified Body and that additional testing of batches performed by an independent laboratory would only be a duplication of the testing already performed by the manufacturer.

Batch release testing by an independent laboratory has a significant cost. According to data provided by the European IVD industry, policy option IVD-2D (systematic batch release verification for high risk IVD by an independent laboratory) would likely have the following impact:

it is estimated that class D (i.e. Annex II, list A) IVDs represent roughly 5 to 10% of the number of IVDs on the market. According to data provided by economic operators, the cost of testing a batch performed by an independent laboratory may vary between EUR 1,000 and EUR 1,500 for each batch, compared to a fee range from EUR 100 to EUR 200 when the testing is performed by the manufacturer under the supervision of a Notified Body.

The number of batches manufactured for class D IVDs ranges from around 10 to 50, depending on the shelf-life of the IVDs. The tests used for the determination of blood grouping have a short shelf-life and it is estimated that a new batch of these products is manufactured each week. It was not possible to have an idea of the repartition between class D IVDs with a  high number of batches produced each year and those requiring a lower number of batches.

Number of class D IVDs on the market || Estimated number of batches per year || Cost for a batch release testing performed by an independent laboratory || Cost of a batch release testing performed by manufacturer under the supervision of a Notified Body

2,000 to 4,000 || 10 to 50 || 1,000€ to 1,500€ || 100€ to 200€

Total costs/year || || 20-300mio.€ || 2-40mio.€

The above table shows that the cost for batch release testing by an independent laboratory may be up to 10 times higher than testing by the manufacturer under the control of a Notified Body. Option IVD-2D would therefore lead to additional costs of between EUR 18mio. and EUR 260mio., with an important impact on manufacturers of IVDs used for the determination of blood grouping.

These costs could have been justified in case of added value for the protection of public health. However, despite long-lasting discussions on this issue and an explicit question in the 2010 public consultation, no strong evidence has been provided so far that the batch release verification by an independent laboratory would actually identify a meaningful number of low-quality and/or unsafe batches of high risk IVDs. Option IVD-2D should be therefore discarded.

Option IVD-2C (batch release verification for high risk IVDs by the manufacturer under the control of a Notified Body (legislative clarification)) would ensure an appropriate level of protection of public health while leading to some savings for manufacturers since it would be clarified that batch release testing by an independent laboratory could not be required by the individual Member States.

In view of the above, option IVD-2C is considered the preferred option and should be retained. The clarification that batch release verification is to be done by the manufacturer under the control of a Notified Body should be accompanied by additional requirements regarding the methods, the reference materials and the panels used for the batch release testing which should be approved by the Notified Body. A network of reference laboratories might be set up to provide scientific expertise for the development of testing methods to be specified in Common Technical Specifications for high-risk IVDs and to define other aspects related to the state of the art. They could also organise sample testing in the context of market surveillance activities. 

4.6.        Impact of policy options IVD-3A to IVD-3C (clinical evidence)

Policy option IVD-3A (no legislative change regarding clinical evidence) would not lead to an improvement of the current regulatory situation, which is perceived by almost 90% of the respondents to the 2010 public consultation as not sufficiently clear since it is understood by many as setting only requirements regarding the analytical validity of the IVDs. The respondents of the 2010 public consultation rather suggested that the requirements regarding the clinical evidence needed for IVDs should be more detailed in the legislation (by adding a specific Annex on clinical evidence to the IVDD[20]) and adapted to the different risk classes. The future EU requirements should be aligned with GHTF guidance on clinical evidence which is currently under preparation. Option IVD-3A would not achieve this objective and should therefore be discarded.

Option IVD-3B (legislative clarification of the requirements for the clinical evidence for IVDs) would lead to a clarification of the legal requirements on the demonstration of clinical evidence and would therefore eliminate divergences regarding the interpretation of the current provisions which contribute to a fragmentation of the Internal Market. This would also provide more reliable and precise information to the users and would therefore have a positive impact in terms of protection of public health. The economic impact of such requirements is considered negligible because these data should already be part of the technical documentation of IVDs placed on the EU market. However, there may be cases where the demonstration of the clinical evidence would not be proportionate, for example for some genuinely innovative tests for which clinical performances may only be established after a certain period of "real use" experience. The legislation should therefore make provision that, for “new”[21] tests, the requirement to demonstrate clinical performances could be delayed to a moment after its placing on the market, if duly justified either by the specific characteristics of the IVD or on the ground of public health protection. Option IVD-3B would therefore be an effective and proportionate mean to clarify the concept of clinical evidence in the IVDD. 

Policy option IVD-3C (same as policy option IVD-3B and introduction of the concept of "clinical utility") would go further and would make the demonstration of the clinical utility of an IVD a precondition for its placing on the market. A broad majority of respondents expressed their opposition to this option during the 2010 public consultation. They underlined that the demonstration of the clinical utility was a moving concept, evolving with the scientific progress, and should rather be determined by the user (i.e. the healthcare professional) on a case-by-case basis, depending on the context in which the test is used.

Certain IVDs are intended to provide general information on a physiological state of a person, such as the level of calcium in blood. The clinical utility, however, would depend on other factors outside the manufacturer’s remits and the intended use. Moreover, it might be nearly impossible to demonstrate the clinical utility of most innovative tests. Respondents to the 2010 public consultation therefore were of the opinion that such a requirement would negatively impact the development and the placing on the market of innovative IVDs. However, it needs to be acknowledged that manufacturers often need to demonstrate the clinical utility for reimbursement purposes. It is therefore argued that it could make sense to require the demonstration of the clinical utility already at the time of the placing on the market. This position, however, does not take into account that reimbursement policy falls within the competences of the Member States and should be clearly distinguished from the regulatory purposes of the IVDD. It would also lead to delayed access to market which would likely be detrimental for manufacturers but also for patients and users. Policy option IVD-3C would therefore not be proportionate and should be discarded.

In light of the above, option IVD-3B is the preferred option and should be retained.

4.7.        Impact of policy options IVD-3D and IVD-3E (PoC/NP-tests)

Policy option IVD-3D (No change regarding point-of-care or near-patient IVDs) would not solve the problems that have been identified and should therefore be discarded.

On the contrary, policy option IVD-3E (clarification of the legal requirements in respect to point-of-care or near-patient IVDs) would spell out in the essential requirements, in particular in the context of the information to be supplied by the manufacturer, that the specific circumstances of use of these tests need to be taken into account by the manufacturers in the context of the risk-analysis and in the instructions for use. The option would not introduce new requirements on manufacturers but would rather specify the aspects specifically applicable to PoC/NP-tests. It would clarify the rules and facilitate the functioning of the Internal Market. It would lift the safety and performances level to the level of those manufacturers who already comply with the legal requirements and the spirit of the legislation. As it was shown in the study of the Dutch National Institute for Public Health and the Environment (RIVM)[22], around 33% are already in compliance while the rest is not. The economic impact would not be significant but policy option IVD-3E would have a positive impact on public health protection as well as on the Internal Market and should therefore be retained.

4.8.        Impact of policy options IVD-3F and IVD-3G (alignment with the MDD)

Policy option IVD-3F (no alignment with the MDD) would maintain the status quo and would leave legal discrepancies, potentially leading to legal uncertainties, between the MDD and the IVDD. Policy option IVD-3F should be therefore discarded.

On the contrary, policy option IVD-3G (alignment with the MDD where appropriate) would not add new requirements on manufacturers but would take over, where appropriate, improvements introduced into the MDD by Directive 2007/47/EC also into the field of IVDs. The requirements are already inherent in the essential requirements but by spelling out specific requirements on medical software or regarding the design principles, manufacturers will have a clearer legal basis on which they need to base their risk-benefit analysis. Again, the economic impact would not be significant but policy option IVD-3G would have a positive impact on public health protection and should therefore be retained.

5.           Conclusions

The following policy options are the preferred ones for specific aspects related to the revision of the IVDD:

 

Ø Option IVD-1C: Clarify the scope of the exemption for "in-house" tests, require a mandatory accreditation for "in-house" tests manufacturers and subject high risk (class D) "in-house" tests to the requirements of the IVDD

Ø Option IVD-1F: Amendment of the legal definition of an IVD to include tests providing information "about the predisposition to a medical condition or a disease"

Ø Option IVD-1G: No legislative change regarding companion diagnostics

Ø Option IVD-2B: Adoption of the GHTF classification rules and adaptation of the conformity assessment procedures to the relevant GHTF guidance

Ø Option IVD-2C: Batch release verification for high risk IVDs by the manufacturer under the control of a Notified Body (legislative clarification)

Ø Option IVD-3B: Legislative clarification of the requirements for the clinical evidence for IVDs

Ø Option IVD-3E: Clarification of the legal requirements in respect to point-of-care or near-patient IVDs

Ø Option IVD-3G: Alignment with the MDD where appropriate

Most of the policy options suggested for the revision of the IVDD are clarifications of existing provisions. Their economic impacts are estimated to be insignificant, while the positive impact on public health and on the functioning of the Internal Market is high.

Policy option IVD-2B (adoption of GHTF classification rules), however, would significantly increase, in absolute terms, the costs for manufacturers to bring an IVD to the market. Nevertheless, broken down on each manufacturer, the costs do not appear unreasonably high. The higher costs would be due to the increased involvement of Notified Bodies in the conformity assessment procedure which would considerably lift the level of assurance of the safety and performances of IVDs for the benefit of public health and perception of the IVD sector as a whole. Enhanced robustness of the classification system, as well as international harmonisation, are additional advantages achieved by this option which, altogether, would compensate for the higher costs.

Combined with the improvements of the horizontal aspects pursued by the revision of the entire regulatory framework for medical devices (Notified Bodies’ oversight, enhanced transparency, strengthened post-market safety, statutory Medical Device Expert Group etc.), the suggested policy options for the revision of the IVDD would lead to a modern set of rules for IVDs which would ensure a high level of public health, facilitate the functioning of the Internal Market (e.g. clearer rules, predictability, uniform interpretation) and support the innovativeness and competitiveness of the IVDs manufacturers.

6.           Monitoring and evaluation

As mentioned under section 5, the policy options suggested for the revision of the IVDD are mostly legal clarifications of existing provisions (e.g. clarifications on clinical evidence of IVDs, on batch testing, on "in-house" tests).

For most of them, the indicator of success will be therefore the reduction of divergences within the European Union regarding the interpretation of the corresponding provisions of the IVDD and an increased legal certainty for stakeholders.

However, to monitor and evaluate the implementation of the future legislative act concerning IVDs in respect to the specific issues discussed in this Annex 2, the following indicators can be taken into account:

6.1.        Scope of the IVDD

6.1.1.     "In-house" tests

Currently, laboratories that manufacture "in-house" tests may or may not be accredited. An indicator of success for policy option 1C would be an increased number of laboratories manufacturing "in-house" tests accredited according to ISO 15189, or similar requirements.

The accreditation requirement, together with the fact that class D "in-house" will be submitted to the requirements of the IVDD, should improve the level of safety and performances of "in-house" tests manufactured in the European Union, and therefore contribute to a higher level of patient safety. An increased level of safety and performances of "in-house" tests manufactured in the European Union will be an indicator of success of policy option 1C.

The introduction of a definition for "health institution" is expected to increase the legal certainty and to avoid diverging, and sometimes too broad, interpretation of this notion in the European Union. An indicator of success of policy option 1C will be that situations that may come about whereby certain tests are unduly considered as "in-house" tests, escape from the IVDD and might have an insufficient level of safety and performances, would no longer occur. 

6.1.2.     Genetic tests

An indicator of success for policy option 1F would be a decreased number of borderline cases in terms of qualification of genetic tests.

This policy option should also lead to a higher level of health protection since any genetic test pursuing a medical purpose will have to fulfil the requirements of the IVDD. An indicator of success of policy option 1F will be the disappearance from the European Union market of low quality genetic tests which, while pursuing a medical purpose, do not provide reliable results.

6.2.        Classification of IVDs

Indicators of success for policy option 2B would be a smooth transition to the new classification system for IVDs, accompanied by a limited number of borderline cases in terms of risk classification.

A higher level of safety and performances of IVDs is also expected due to the greater than before involvement of Notified Bodies in the conformity assessment process. A lower number of vigilance cases related to IVDs will be an indicator of success for policy option 2B.

The change toward a classification system according to internationally recognised rules should lead to benefits in terms of competitiveness due to international harmonization. A facilitated international trade in the IVD sector would be therefore an indicator of success of policy option 2B.

[1]               European Technology Assessment Group, Direct to Consumer Genetic Testing, Nov. 2008; Süddeutsche Zeitung, 19.6.2009, "Blick ins Erbgut verwehrt"; Financial Times, 14.6.2010: "FDA in genetic test crackdown as clients are given wrong results"; Daily Mail, 31.5.2011: "Call to ban mail-order DNA disease testing kits that claims to predict life-threatening illnesses".

[2]               Clinica, March 2011, p.22-28, "Perfect companions" and "Improving the regulatory framework for companion diagnostics".

[3]               http://www.ghtf.org/documents/sg1/sg1final_n045.pdf

[4]               http://www.ghtf.org/documents/sg1/sg1final_n046.pdf

[5]               Annex IV, section 6 and Annex VII, section 5 to the IVDD ("verification of manufactured products covered by Annex II, List A").

[6]               Annex I, A, 3 of the IVDD

[7]               GHTF/SG1/N045:2008 regarding Principles of In Vitro Diagnostic (IVD) Medical Devices Classification defines "near-patient testing" as "testing performed outside a laboratory environment by a healthcare professional not necessarily a laboratory professional, generally near to, or at the side of, the patient".

[8]               See National Institute for Public Health and the Environment (Netherlands), Point-of-care diagnostic devices: an assessment of safety related technical documentation items, 2010 (RIVM report 360050025/2010).

[9]               ISO 15189: Medical laboratories – Particular requirements for quality and competence

[10]             Rule 3 of GHTF/SG1/045:2008: IVD medical devices are classified in Class C if they are intended for use: […] in screening for selection of patients for selective therapy and management, or for disease staging, or in the diagnosis of cancer. Example: personalized medicine.

[11]             GHTF/SG1/N045:2008 regarding Principles of In Vitro Diagnostic (IVD) Medical Devices Classification. 

[12]             GHTF/SG1/N046:2008 regarding Principles of Conformity Assessment of In Vitro Diagnostic (IVD) Medical Devices.  

[13]             Similar to Annex X of the MDD specifying the requirements regarding clinical evaluation. 

[14]             Negative predictive value is defined as the proportion of subjects with a negative test result who are correctly diagnosed. Positive predictive value (or precision rate) is defined as the proportion of subjects with positive test results who are correctly diagnosed

[15]             GHTF/SG5(WD)NxR3: Clinical evidence for IVD medical devices – Key definitions and Concepts (state of play: 20 Max 2011).

[16]     Article 9(12) of Directive 98/79/EC.

[17]             This option is also in line with recent enhanced control by the US FDA of genetic tests offered direct to consumers, see Clinica, June 2011, p. 6: "US FDA scrutiny of DTC genetic tests continues".  

[18]             Swedish company manufacturing IVDs falling under classes B and C according to GHTF classification system

[19]             Council Conclusions adopted on 6 June 2011, section 6, 2nd indent.

[20]             In the MDD and AIMDD, a specific annex exists for clinical evaluation.

[21]             The concept of "new product" is already used in Article 10(4) of the IVDD but would need to be clarified.

[22]             See footnote 8

TABLE OF CONTENTS

Appendix 1 – . Summary of Responses to the 2008 Public Consultation

Appendix 2 – . Summary of Responses to the 2010 Public Consultation

Appendix 3 –.. Conclusions of the Council of the EU on Innovation in the Medical Devices Sector

Appendix 5 – . Regulatory Framework for Medical Devices

Appendix 6 –.. Statistics regarding National Competent Authorities Reports (NCARs) in the Field of Vigilance

Appendix 6a – Statistics regarding National Competent Authorities Reports (NCARs) in the Field of Vigilance

Appendix 6b – Statistics regarding incident reports in the Field of Vigilance

Appendix 7 – . Possible Tasks of a Medical Device Expert Group

Appendix 8 – . Possible Tasks to be fulfilled at EU level

Appendix 9 – . Overview of the costs and benefits of the preferred policy options

Appendix 10 – Legal Form of the Revision of the Medical Devices Directives

Appendix 11 – Analysis of the PIP breast implants case in the light of the envisaged revision of the EU regulatory framework for medical devices ("stress test")

Appendix 1 – Summary of Responses to the 2008 Public Consultation

|| EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY  DIRECTORATE-GENERAL Consumer goods Cosmetics and Medical Devices

Brussels, 5 December 2008

ENTR/F/3/D(2008) 39582

Recast of the Medical Devices Directives

Summary of responses to the public consultation

I. Introduction

The public consultation on the "Recast of the Medical Devices Directives" was announced in a press release on 8 May 2008. On the same day, a questionnaire and background information were made available online on the "Medical Devices" website of the European Commission[1].

Stakeholders (authorities, industry, notified bodies, health professionals and patient groups) were informed by e-mail about the launch of the public consultation. The official deadline for comments was 2 July 2008, but interested parties were informed that replies submitted after this deadline would still be taken into account.

The Commission received 200 responses to the public consultation. The principal contributor was industry (federations and individual companies, mainly manufacturers of medical devices) with 92 responses. Healthcare professionals and academics submitted 33 responses. Regulatory authorities submitted 27 responses (19 of which were from the EU/EFTA Member States' competent authorities, 4 from GHTF members, 2 from regional authorities, 1 from NBOG and 1 from another ministry of a Member State). Notified Bodies (including NB-Med and Team-NB) submitted 18 responses. Other contributions came from patients and consumers (8), consultants and medical devices experts (7), standardisation bodies (7), health insurance and social security schemes (4) and others (4).

In terms of regions, 24 responses were received from EU-wide associations, 44 from the UK, 31 from Germany, 21 from France, 13 from the USA, 12 from Belgium, 9 from the Netherlands, 6 from Sweden, 5 from Austria, 4 each from Ireland, Norway and Spain, 3 each from Australia, Malta and Switzerland, 2 each from Denmark, Finland and Italy and one response each from Canada, Czech Republic, Japan, Latvia, Lithuania, Poland and Slovenia.  

The following figures show the breakdown of responses by contributors and by countries.

Thirty-three respondents asked for their submissions to be treated in confidence. The other responses were published on the Commission's "Medical devices" website mentioned above. 

II. General comments

Generally speaking, most respondents confirmed that the current legal framework for medical devices left some room for improvement to strengthen the regulatory system. There was broad support for the view that some weaknesses which the Commission had highlighted in the questionnaire (e.g. inconsistent oversight of notified bodies, no uniform level of expertise in notified bodies, lack of regulation of certain products) needed to be addressed. Also, further elements of centralisation were considered useful, although the suggestion to expand the role of the European Medicines Agency (EMEA) to include medical devices was rejected by a majority of respondents.

As regards the timing, by far the majority of respondents (in particular those from the Member States and industry) considered the exercise to be premature. They pointed to the recent revision of Directives 90/385/EEC and 93/42/EEC[2], to be implemented by 21 March 2010, and the adoption of the New Legal Framework for the Marketing of Products[3] which was due to take effect as of 1 January 2010. It was argued that it would be advisable to wait for these changes to be implemented, in order to better assess the need for further adjustments. There was also some criticism of the timing of the launch of the public consultation (May 2008), which had left many stakeholders confused as regards its possible impact on the transposition of Directive 2007/47/EC, which was due on 21 December 2008.  

The rejection of a larger role for EMEA by the vast majority of respondents was mainly based on the fear that the involvement of EMEA would represent a move towards the adoption of a pharmaceuticals-like regulation for medical devices. Such an approach could lead to undue delays and higher costs for placing new devices on the market which, according to the majority of contributions, would have an adverse effect on SMEs, which make up around 80% of the sector. In this context, respondents often quoted the 2002 report of the Medical Devices Experts Group (MDEG), which had highlighted the fundamental difference between the legal framework for pharmaceuticals and the legal framework for medical devices.

In general, respondents were unable to estimate the socio-economic impact of the various proposals outlined in the questionnaire and attributed this to the vague manner in which the proposals were described. Some SMEs were concerned that the costs of putting a medical device on the market would multiply. Several Notified Bodies had made more detailed estimates of the additional costs that would be involved in merging the directives, changing their scope and including the EMEA in the evaluation process.   

III. Comments on specific items of the questionnaire

1. Legal simplification

On the issue of whether the existing Directives ought to be merged into a single legal text, no clear trend emerged. The majority of respondents considered that it was feasible to merge Directive 90/385/EEC relating to active implantable medical devices and Directive 93/42/EEC relating to medical devices, and their amending and implementing measures. Some respondents felt that this was desirable, while others adopted a neutral stance, based on the view that such a merger would not bring about significant advantages, but instead would require a considerable amount of human resources.

As regards Directive 98/79/EC on in vitro diagnostic medical devices, the majority of respondents - in particular those from industry - argued in favour of keeping this piece of legislation separate from the legislation for other medical devices. Regulatory authorities were divided on whether the IVD Directive should be kept separate or merged with the other Directives. However, there was broad support from all contributors for a revision of the IVD Directive.       

2. Risk-based classification

There was almost unanimous support for the classification of IVD medical devices to be changed to a rules-based risk classification (based on the GHTF guidance) in place of the current list, even though this would lead to more IVDs being subject to third party conformity assessment than under the current system. According to the respondents, such a classification would raise standards of public health, be more flexible and bring the European rules into line with GHTF guidelines.      

3. Non-regulated medical devices

Most respondents confirmed that medical devices consisting exclusively of non-viable human cells and/or tissues and/or their derivatives, and medical devices incorporating such cells and/or tissues and/or their derivatives with an action ancillary to that of the medical device, are currently not regulated at EU level. Some respondents felt that the definition should be extended to include those medical devices for which human tissues are “utilised” during manufacture.

Many respondents took the view that medical devices consisting of or incorporating non-viable human tissue or cells should be regulated under the Medical Devices Directives, e.g. by extending (and reforming) the provisions of Directive 2003/32/EC regarding non-viable animal tissues or cells. However, a significant minority of respondents considered pharmaceutical legislation, in particular the 'Advanced Therapies' Regulation, to be more suitable for non-viable human tissues and cells.

Submissions from tissue banks raised concerns about the relationship between the possible future regulation of non-viable human tissues and cells and Directive 2004/23/EC concerning quality and safety standards for the donation etc. of human tissues and cells. 

In addition, several respondents referred to other devices (or related services) which they considered as currently not or not sufficiently clearly regulated by the Medical Devices Directives. These included:

– IVD manufactured and used within the same health institution (see Art. 1(5) IVD Directive),

– veterinary medical devices,

– assisted reproduction/fertilisation technologies,

– devices to prepare or to administer human autologous cells,

– devices for reprocessing,

– diagnosis services,

– predictive tests,

– devices including materials derived from transgenic animals,

– devices including phytochemistry products, lactic acid bacteria against e.g. vaginosis,

– pharmaceuticals used as a manufacturing agent rather than serving an ancillary role,

– microbial or rhDNA derived proteins / molecules,

– health software,

– “alternative cigarettes”,

– tattooing products,

– invasive and non-invasive custom-made medical devices.

4. Implantable / invasive devices for aesthetic purposes

There was broad support for the regulation of implantable or invasive devices for aesthetic purposes. However, the term "quasi-medical device" was rejected by almost all respondents as inappropriate. Opinions were divided as to the most appropriate regulatory framework. Some favoured the inclusion of such devices in the cosmetics legislation, while others preferred a regulation under the General Products Safety Directive (GPSD) or a 'stand-alone' regulation. Others, in turn, supported inclusion in the regulatory framework for medical devices. Some respondents considered that implantable or invasive devices were already sufficiently regulated either under the GPSD or within the Medical Devices Directive (Article 1(2)(c): "modification of the anatomy").

Most contributions from industry, except for those producing devices which have both a medical and a cosmetic purpose (e.g. corrective and plano contact lenses), stated that the Medical Devices Directives should not be opened up to devices that do not have a medical purpose in order to avoid derogation from the risk/benefit principle and deviating from the GHTF model.

Those contributions which were in favour of a regulation under the Medical Devices Directives regarded option 2 of the questionnaire (item 4) as the most feasible, as it suggested regulating products which belong to a category of devices that includes products with a medical purpose (e.g. contact lenses, wrinkle fillers). A possible wording was suggested, such as "for the purposes of this Directive … a device with cosmetic purpose must meet the requirements set out in …". While many respondents rejected the idea of drawing up a list of devices with aesthetic purposes to be regulated as medical devices (option 3 of the questionnaire), others considered the combination of options 2 and 3 to be the most suitable way to ensure legal certainty. In such a case, the possibility of adapting the list should be easy.

5. Revision of the "New Approach"

First of all, there was full support for the view that the "New Approach" provides the right regulatory framework for medical devices and that a pre-market authorization procedure by regulatory authorities with longer deadlines and higher fees (EMEA was given as an example) would not increase public health, but would be detrimental to the competitiveness and innovativeness of the industry, and thus ultimately be against patients' interests.

The aspects of the revised "New Approach" which were most frequently mentioned as being of particular relevance were:

– accreditation,

– designation and monitoring of Notified Bodies,

– post-market surveillance,

– obligations for importers and distributors.

Especially on the designation and monitoring of Notified Bodies, almost all contributions tackling this issue urged a more harmonised and/or centralised mechanism (beyond the current work being carried out by NBOG) in order to ensure a uniformly high level of expertise of Notified Bodies.

 

As regards those aspects where deviations from or requirements additional to the general rules were considered appropriate for the medical devices sector, the following issues were mentioned:

– the possibility of delegating the designation/monitoring of Notified Bodies to non-governmental bodies is deemed unsuitable (concerns over Article R14(3) of Annex I to Decision 768/2008);

– the current expertise of the European co-operation for Accreditation (EA) is considered insufficient for the medical devices sector;

– the need to ensure that the specific competencies of Notified Bodies are verified;

– a specific "CE" marking to distinguish the medical device from other products (e.g. "CE med");

– greater involvement by the regulators in standardisation work.

6. Essential requirements

The overall tenor of the responses was that the essential requirements have proved appropriate as a response to technological change and, in general, did not need amending. Several respondents mentioned the July 2007 Report of the N&ET Working Group on nanotechnology, which concluded that adaptation of the essential requirements for devices incorporating or consisting of free nanoparticles was unnecessary. It was often pointed out in the responses that the essential requirements should remain in line with the relevant GHTF guidelines (some suggested awaiting the outcome of the ongoing revision of the GHTF document). In addition to the general satisfaction with the current state of play, many contributions focussed on specific issues to be taken into account.

For example, many respondents suggested that traceability and identification should be addressed in the essential requirements, particularly in the context of the discussion on a "unique device identifier (UDI)".

Several respondents requested that e-labelling should be reflected in the essential requirements. A small number of respondents suggested that the essential requirements could be reduced for well established "low risk" medical devices, quoting the example of the labelling requirements for class I devices.

Some respondents were of the opinion that specific essential requirements (e.g. in line with the requirements set in the Advanced Therapies Regulation) would be necessary if medical devices incorporating non-viable human tissues and cells were included in the scope of the Medical Devices Directives. Others, on the contrary, considered the requirements for non-viable animal tissues and cells (Directive 2003/32/EC) to be appropriate for non-viable human tissues and cells, albeit with an improved consultation mechanism between Notified Bodies and Competent Authorities.

With regard to devices for aesthetic purposes (e.g. non-corrective contact lenses), most respondents considered that these should meet the same essential requirements applicable to devices of the same category with a medical purpose, but that the risk/benefit analysis needed to be adapted (e.g. risk "as low as reasonably possible").  

Several respondents suggested explicitly including the relevant essential health and safety requirements of the Machinery Directive, which are currently mentioned only as a general reference in Article 3 of Directive 93/42/EEC. Along the same lines, there were suggestions that aspects from horizontal legislation (e.g. protection of the environment or safety at work) should be included in the essential requirements in order to establish a self-contained regime for medical devices, and thus be excluded from the horizontal legislation.

For IVD, several respondents considered that evidence of their clinical validity and/or utility should be required and that specific requirements should be laid down for genetic tests, in particular for predictive tests (e.g. the ethical, social and legal aspects to be taken into account).  

Other specific suggestions to adapt the essential requirements related to:

– wireless interference,

– combination products,

– sterile devices,

– definition of "state of the art".

7. National specific requirements

Respondents reported a number of specific measures adopted by the Member States in the field of medical devices which are liable to create obstacles to the internal market, such as:

– registration requirements,

– the application of pharmaceutical legislation for clinical evaluation of medical devices,

– labelling requirements,

– device identification requirements,

– requirements for latex-free devices,

– requirements for X-ray devices,

– requirements pursuant to Council Directive 97/43/Euratom on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure,

– requirements regarding the contents of first-aid kits,

– requirements for UV cabins,

– requirements for accessory therapeutic devices,

– differences between batch testing and witness testing for IVD. 

The Commission was urged, in particular by respondents from the industry but also by some Member States, to take action within the current regulatory framework to ensure a level playing field.

   

As regards the adoption of more harmonised requirements, the majority of respondents appeared to react negatively, and considered the framing of voluntary (international) standards and/or the drawing up and regular updating of MEDDEV guidance as their preferred option over detailed specifications in a binding Community act. Nevertheless, some suggestions were made regarding, for example, tolerable amounts of dangerous substances in medical devices being made legally binding.

8. Notified Bodies

There was unanimous support for improving the way in which Notified Bodies currently work. Most respondents believed that this should be done first of all by tightening up the designation and monitoring of Notified Bodies to ensure a uniform high level of competence. Many respondents, including the Notified Bodies themselves, supported central oversight of their designation by Member States. In this context, it was often mentioned that NBOG should be given legal status to adopt binding measures (e.g. the NBOG Handbook).

Individual respondents suggested a review of the remuneration of Notified Bodies, which should be kept separate from the individual manufacturer and be dealt with instead  by an industry-financed fund.

As regards the detailed proposals set out in the questionnaire, the feedback was generally positive, albeit with certain reservations:

· Transparency

There was broad support for greater transparency in the work and functioning of Notified Bodies. This would increase confidence in the evaluation procedure and lead to a better acceptance of the results, including outside Europe. However, annual reports were only considered useful if they complied with harmonised criteria. Other respondents even questioned the benefit of an annual reporting requirement; a fully workable EUDAMED was considered to be the most suitable means to increase transparency.

· Information exchange between Notified Bodies and Competent Authorities

An improved information exchange between Notified Bodies and Competent Authorities was generally considered useful, but there were fears that this could lead to increased bureaucracy. Several Member States pointed to the existing practice of information exchange and considered additional rules to be unnecessary. 

· Cooperation between Competent Authorities

Strengthened cooperation between Competent Authorities was regarded as key to strengthening the whole system. Suggestions made by several Member States included mandatory "peer reviews" between designating authorities, as well as mandatory inquiries by Competent Authorities in the case of alleged poor performance by a Notified Body. NBOG was mentioned by many respondents as already being a useful platform which ought to be given statutory powers to adopt binding rules. However, it was recognised that NBOG had its limits and that cooperation alone was not sufficient to achieve a uniformly high level of competence of Notified Bodies. Several respondents therefore suggested an 'overarching structure' or a 'central oversight' of the activities of the Competent Authorities.

· Sanctions and penalties

The majority of respondents confirmed that legal sanctions and penalties were already in place and ought to be effectively applied, including the ultimate sanction - namely the withdrawal of the designation of Notified Body. NBOG or another "independent body" should ensure the consistent application of sanctions and penalties.

· 'Forum shopping'

A view commonly expressed by respondents was that manufacturers should retain the freedom to choose the Notified Body, but that any abuse of this freedom (i.e. 'forum shopping') needed to be addressed by measures that ensured a uniformly high level of competence of all Notified Bodies.

· Safeguard clause and withdrawal of certificate

The majority of responses to the question of whether a successful safeguard clause should automatically lead to the withdrawal of the certificate for the medical device in question were against an automatic arrangement and in favour of a case-by-case approach. However, at the same time, there was a good deal of support for this proposal, particularly from many of the Notified Bodies. 

 

With regard to the two options presented in the questionnaire (tightening of controls on nomination and monitoring; or centralised system of designation and control of monitoring), by far the majority of respondents were of the opinion that designation and monitoring should remain the responsibility of Member States and not be transferred to the Commission or another central body. However, at the same time, there was strong support for clear rules allowing Member States to take a harmonised approach in their designation and monitoring activities. Accreditation, in particular combined with specific sectoral requirements, was often mentioned as a suitable instrument. Others suggested an expert panel to oversee the Member States' activities. 

 

9. Extension of the role of the European Medicines Agency (EMEA)

The question of whether the competences of the EMEA should be extended to include medical devices was the most controversial issue in the questionnaire. Within industry and among the Notified Bodies, the involvement of EMEA in the evaluation of medical devices was rejected almost unanimously. While acknowledging EMEA's skills in the area of pharmaceuticals, it was pointed out that it had no expertise in the field of medical devices. It was feared that long and costly procedures for the pre-market authorisation of pharmaceuticals were not compatible with the rapid pace of innovation and changes in devices or, compared to pharmaceuticals, with the relatively low return on investments. Many respondents argued that any involvement of the EMEA in the evaluation process would signal the demise of SMEs in the medical devices sector. Instead, it was proposed that the regulatory Committee provided for in Article 7(1) of Directive 93/42/EEC should be strengthened and used more frequently.

Most consultants and medical devices experts also rejected the extension of EMEA's role to include medical devices. However, there was also some support for such an extension and specific proposals were put forward, such as central approval of all medical devices under the umbrella of EMEA (timelines between 30 and 120 days), with the centrally accredited and designated Notified Bodies acting as experts to support the work of a Medical Devices Committee in EMEA. 

Among healthcare professionals, academics, patients and consumers, there was a higher level of support for EMEA (or another central body) participating in the evaluation of "high risk" medical devices. However, they warned that a new medical devices division might be the "poor relation" of the pharmaceuticals section of EMEA, and so a revised structure and budget were needed. Some also emphasized the need to be sure that EMEA's involvement would not create obstacles to timely access to innovative medical devices for patients.

The responses from the Member States brought to light a number of differing opinions. The involvement of the EMEA as such was widely rejected as being inappropriate to the medical devices sector (costs, delays, adverse effects for SMEs and public health). Nevertheless, many Member States argued in favour of a central body or structure (e.g. a separate Medical Devices Agency, Health Products Agency, Management Committee an 'overarching structure' or a network of testing centres) which would bring together the regulatory expertise for medical devices. Such a central body could set out the views of the public authorities on new technologies, exercise scrutiny of the performance of Notified Bodies and give scientific advice to manufacturers during the development phase. Some Member States felt that their views could sufficiently be accentuated if the (improved) consultation procedure under Directive 2003/32/EC regarding non-viable animal tissues were extended to include other devices.

10. Devices for which the EMEA could participate in the evaluation process

Given the widely expressed opposition to EMEA (see under 9.), few respondents supported the proposal to define those highest risk devices subject to EMEA's participation in the evaluation. As regards non-viable human tissues and cells with an ancillary action to that of the device, many respondents rejected the assumption that it was logical to submit them to EMEA for evaluation in the same way as viable human tissues and cells under the Advanced Therapies Regulation (ATMP Reg.). On the contrary, it was argued that in 2007 there had been the political will to exclude non-viable human tissues and cells with ancillary action from the ATMP Reg. and that, consequently, the medical devices regulatory framework (e.g. by analogy with non-viable animal tissues and cells) was the appropriate vehicle. Notified Bodies were seen as sufficiently competent to analyse medical devices incorporating non-viable human tissues and cells. In this context, a mechanism for consultation with EMEA on non-viable human tissues and cells was given favourable consideration. Others, however, took the view that non-viable human cells and tissues should be subject to the ATMP Reg.

As regards other devices suitable for undergoing a procedure involving EMEA (or another central body), respondents who supported EMEA's involvement mentioned class III devices, active implantable devices and HIV-tests. Some respondents mentioned pacemakers, while others took the view that pacemaker technology was well developed and therefore no involvement by EMEA would be required.

Furthermore, one Member State suggested applying a combination of "high risk", "novelty" and "non-existence of standards/guidelines" criteria as conditions for submitting medical devices to a central committee for evaluation.

 

11. Procedural aspects of EMEA's participation in the evaluation process

The majority of respondents pointed out that product assessment and quality management evaluation should continue being carried out by one entity, namely Notified Bodies, and therefore maintained their opposition to an extension of EMEA's role (see under 9.).

Both option 1 (no Notified Bodies involved in evaluation of highest risk devices) and option 2 (application directly to EMEA and Notified Bodies act as "rapporteurs") were rejected almost unanimously. If it were decided to extend EMEA's role, options 3 (systematic submission of evaluation reports to EMEA) or 4 (informing EMEA of all applications and choice of EMEA to select evaluation reports for scrutiny) combined with possibility 2 (positive opinion of EMEA required) were regarded as the most feasible way forward.

   

12. Access by EMEA to evaluation reports of Notified Bodies

In general, there was support for access by public authorities to evaluation reports for all devices (not only high risk devices) in order to ensure a high level of evaluation by Notified Bodies. However, opinions were divided as to whether this should be the responsibility of EMEA (or another central body) or of the national Competent Authorities. Many Member States asked that this should remain the responsibility of their authorities. Concern was voiced that this type of "overview" should not weaken the position of Notified Bodies and should not ultimately lead to the creation of a kind of appeal body for manufacturers to question negative evaluations by Notified Bodies.

13.  Vigilance

In principle, respondents supported the further improvement and strengthening of the vigilance system. However, the difference between vigilance for pharmaceuticals and vigilance for medical devices was stressed, especially by industry and Member States, while some respondents from health professionals' and patients' groups suggested establishing closer links between the two vigilance systems (e.g. extension of EudraVigilance to include medical devices).

· Reporting by healthcare professionals and patients; publication of corrective actions

Most Member States appear to have provision for mandatory reporting by healthcare professionals/institutions. Some respondents contested the usefulness of such compulsory regulation, pointing to the UK's voluntary reporting scheme which had a comparatively higher reporting outcome than the average. Most respondents believed that, in order to avoid "over-reporting", reporting should be done only by healthcare professionals/institutions, which should act as a "filter", and not by patients. The publication by Competent Authorities of corrective actions taken by manufacturers was considered useful by some respondents, but only when associated with a clear disclaimer that such publication would not constitute an enforcement action.

· Periodical review by the Notified Body of manufacturers' vigilance system

Respondents were almost unanimous in their opinion that the review of the manufacturers' vigilance system was already part of the Notified Bodies' duty to carry out periodical audits. Some respondents suggested that class I manufacturers should also be regularly monitored.

· EMEA to coordinate vigilance reports and detect signals

Some respondents (e.g. healthcare professionals and patients) supported the idea of entrusting EMEA with the coordination of vigilance reports. This was widely rejected by industry and Member States, which emphasised Eudamed as the appropriate tool to disseminate vigilance reports throughout the EU. Among the Notified Bodies there was support for setting up a central system to coordinate vigilance reports, but without the involvement of EMEA.      

· Commission to impose restrictive measures

The proposal that the Commission should be given powers to impose restrictive measures in vigilance cases tended not to be endorsed.

· Exchange of information regarding incidents and corrective actions at international level

Respondents broadly supported an improved exchange of information between GHTF members and beyond.  

14. Market surveillance

In the context of market surveillance, the need for effective and immediate implementation of EUDAMED was emphasised. Industry and Notified Bodies, as well as several Member States, put the case for EUDAMED to become the central registration tool for medical devices in order to do away with costly multiple registration in Member States. However, Member States pointed out that in order for this to happen EUDAMED would need to include all the information necessary to carry out market surveillance.

Many respondents referred to the new rules on market surveillance laid down in Regulation (EC) No 765/2008 which would improve the surveillance system, including for the medical devices sector. However, the involvement of EMEA was widely rejected as inappropriate and/or disproportionate.

 

15. Borderline cases

The need for an effective procedure to ensure consistency and legal certainty with regard to borderline and classification cases throughout the EU was recognised by the vast majority of respondents. Most of them felt that empowering the Article 7(1) Committee to take decisions in this respect was the most appropriate way forward (as already provided for in Directive 2007/47/EC). A role for the EMEA was rejected by the majority of respondents, although many recognised the advantage of having dual expertise for medicinal products and medical devices within one entity, especially for drug/device combination products.   

In many submissions it was argued that the power to decide about borderline issues should not be limited to medical devices vs. medicinal products, but should embrace other sectors such as cosmetics, biocides and food (a kind of "supra-Directives Committee on Borderlines").     

16. Convergence on GHTF model

By far the majority of respondents supported further convergence on the GHTF model, but also noted that GHTF had issued guidance allowing flexibility in the adaptation to the respective jurisdictions. Some respondents, however, argued that the European model was more advanced in terms of the protection of health and safety. It was also underlined that further convergence would only be useful if other jurisdictions also took over GHTF guidance and if recognition of certificates issued by Notified Bodies by other jurisdictions was ensured (reinforcement of Mutual Recognition Agreements).

Industry, in particular, but also some Member States, called for increased EU representation and participation in GHTF. 

17. Imports of medical devices

All respondents stated that, in principle, the requirements for domestic and for imported medical devices ought to be and in fact were the same. The provisions of Regulation (EC) No 765/2008 with regard to importers and distributors, as well as increased controls at customs, would help to enforce requirements with regard to imported products. Government audits outside the EU and increased cooperation with the GHTF members were also suggested.

Several respondents active in the field of dental healthcare called for dental implants originating from outside the EU/EFTA to be subject to an evaluation by a Notified Body. Other individual respondents suggested that ethical labour conditions should become an additional criterion for the evaluation of imported products.

18. Exports of medical devices

Many respondents supported the idea that medical devices exported to countries which lacked specific legislation on medical devices should meet the EU requirements, but at the same time they stated that the CE marking was already required by many jurisdictions which did not have their own regulations for medical devices. However, there were also major concerns regarding the EU competence to regulate in this field and to subject EU manufacturers to additional burdens compared to their foreign competitors.

  

The possibility for Notified Bodies to issue export certificates quickly and inexpensively would be welcomed by many respondents, since it could replace the different practices in Member States with regard to certificates of free sale.

19. Measures against counterfeiting

Although counterfeiting was regarded as a limited problem in the field of medical devices, by far the majority of respondents were in favour of preventive measures to ensure the traceability of devices. The preferred options were a unique device identifier (UDI) applied at global level and stricter requirements for importers and distributors. In addition, many respondents suggested that campaigns to raise public awareness of counterfeited products would be useful.

 

20. Suggestions for simplification

While respondents seem to be generally satisfied with the current regulatory framework, they listed several aspects which ought to be simplified in future legislation, such as:

– registration requirements in Member States,

– overlapping of directives (e.g. applicable requirements of the Machinery Directive and of the Personal Protective Equipment (PPE) Directive),

– classification rules (unclear distinction between I and IIa; classification of dental implants; usefulness of a classification database),    

– procedures under Article 14 b of Directive 93/42/EEC and Article 13 of the IVD Directive,

– settlement of borderline issues,

– impossibility of issuing a declaration of conformity for class I devices,

– role of "own brand labellers", distributors, assemblers,

– delimitation of devices and accessories,

– fragmented implementation by Member States and slow reaction by the Commission.

21. Nature of the legal act: regulation or directive?

The advantage of a directly applicable regulation which does not entail the risk of divergent transposition by Member States was widely recognised as a useful way to achieve a level playing field. However, many respondents stated that the benefits would not outweigh the considerable resources needed to transcribe the EU regulatory framework into a regulation. A number of respondents also pointed to the risk that an EU regulation might ultimately lead to stricter rules.

22. Conformity assessment modules

The majority of respondents rejected the idea of condensing the various conformity assessment modules currently in existence into a single module (i.e. Annex II) as being contrary to the principles of the New Approach and not flexible enough for the specific needs, in particular of SMEs. However, at the same time it was frequently suggested that Annex II should be made available to all manufacturers independently of the class of their device.

On the other hand, many respondents supported a reduction in the number and complexity of conformity assessment procedures (deletion of Annex VI was frequently mentioned). For example, it was suggested that the relatively seldom used "type-testing" should be confined to duly justified exceptions.

     

IV. Miscellaneous issues

Several respondents made suggestions which went beyond the proposals set out in the questionnaire. Among others, these related to:

– regulation of advertising for medical devices,

– inclusion of medical purpose in the legal definition,

– adaptation of conformity assessment procedure for industrially produced individual implants currently considered as custom-made devices,

– prescription requirement for all contact lenses,

– introduction of a "Humanitarian Medical Device" (similar to Humanitarian Use Device under FDA rules) for medical devices intended for patients with rare diseases, 

– reduction and replacement of animal testing,

– clinical trials of medical devices, including blood derivatives currently not defined,

– dental surgeon to be considered as a manufacturer of custom-made devices,

– restricted distribution of certain devices (e.g. drug/device products only through pharmacies),

– clarification of the German-language version of Article 1(4) and (4a), section 7.4. of Annex I and Rule 13 of Annex IX to Directive 93/42/EEC ("liable to act") – substances of low concentration not to be regarded as a combination product,

– more exemptions from Rule 17 (animal tissues) if a medical device is not active,

– Class I medical devices with high incident rates to be reclassified or subjected to evaluation with Notified Body involvement,

– possibility for manufacturers from Member States without Notified Bodies to submit applications in English,

– indication of manufacturing site on the label and in the instructions for use,

– requirement for manufacturers of custom-made devices to comply with professional qualification requirements,

– regulation of medical device support products (i.e. those needed for maintenance, service training etc.),

– making available of the statement provided for in Annex VIII to Directive 93/42/EEC for custom-made devices should be compulsory.

Appendix 2 – Summary of Responses to the 2010 Public Consultation

|| EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Consumer Affairs Cosmetics and Medical devices

Brussels, 23 February 2011

REVISION OF DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 27 OCTOBER 1998 ON IN VITRO DIAGNOSTIC

MEDICAL DEVICES

SUMMARY OF RESPONSES TO THE PUBLIC CONSULTATION

I. Introduction

In the context of the simplification of the regulatory environment, and in the light of the technological progress and of emerging weaknesses identified regarding key elements of the regulatory framework, a public consultation was launched in 2008 on the Recast of the Medical Devices Directives[4]. This public consultation was mainly focused on horizontal issues regarding the revision of the legal framework for medical devices. Many responses received to the public consultation underlined the need to revise some specific aspects of Directive 98/79/EC.

In June 2010, the Commission launched a public consultation targeted on issues related to in vitro diagnostic medical devices.

The stakeholders were not consulted on the possible amendments of horizontal aspects such as designation and monitoring of Notified Bodies, vigilance, market surveillance, need for further centralisation etc. which are currently under discussion in the framework of the recast of Directives 90/385/EEC and 93/42/EEC. These amendments would apply, mutatis mutandis, also to the revision of the IVD Directive.

Stakeholders were invited to submit their comments by 15th September 2010. Several comments received beyond the date were still taken into account. Altogether, the Commission received 183 responses. The repartition of answers by categories of stakeholders is indicated below. Mainly, answers were received from users (clinical laboratory associations, medical associations, hospitals and healthcare professionals) with 69 responses, from associations and laboratories active in the field of genetics (44 answers), from manufacturers and industry association (32 answers), from Competent Authorities (17 answers) and from Notified Bodies (13 answers).

As the questionnaire included a broad range of questions which were not of interest for all the stakeholders, the majority of the answers are only partial answers.

Among the 183 responses, 21 specified that the submission should be treated as confidential. The other answers are published together with this summary on the Commission website[5],

II. General Comments

The main message received though this consultation was that the revision of the IVD Directive is welcomed by the stakeholders, which was a confirmation of the feedback received from the previous public consultation.     

   

The main highlights from this public consultation were that there is a broad support for the adoption of a risk-based classification. The second area where a broad consensus emerged was the need to keep an exemption for "in-house" testing. While some clarification would be needed, it was underlined in this public consultation as a major issue for clinical laboratories and users, especially in the field of genetic diseases.

The users (healthcare professionals, clinical laboratories) mainly provided answers only to the specific question regarding "in-house" tests, which was their main focus within this public consultation. Therefore to improve the reading of the results, the statistics presented for the analysis of the answers will be performed for each question based on the number of answers received to this specific question.

III. Comments on specific items of the questionnaire

1. Classification

Question 1:

– Would you consider the adoption of a risk-based classification for in vitro diagnostic medical devices as an improvement of the current European regulatory framework?

– Are you aware of any consequences for the protection of public health?

– Can you provide economic data linked to a change-over to this GHTF classification system?

The answers provided in the context of this public consultation confirmed the quasi unanimous support from stakeholders regarding the adoption of a risk based classification, which was already highlighted in the 2008 public consultation.  

Among the 116 answers received, nearly 93% agreed on the fact that the adoption of a risk-based classification based on the Global Harmonisation Task Force (GHTF) model[6], would have a positive impact in terms of flexibility, allowing for a better protection of public health while being able to ensure a timely access to the market for new tests. In addition, the regulatory framework would become more robust to the technological progress.

Few economic data were provided during this public consultation. However it was underlined by some stakeholders that this alignment would increase the costs for the regulatory requirements, as the risk-based classification based on the GHTF model would require more frequently the involvement of notified bodies for the conformity assessment procedures, in particular for Class B and C tests. The majority of the respondents argued that this would increase costs for manufacturers significantly and finally underlined that these additional costs might be paid by the end users.

But the same stakeholders also pointed out that these increased costs should be balanced with the improvement of safety for public health brought by the implementation of more stringent regulatory requirements for some categories of tests. The issue of the higher costs might be addressed by allowing manufacturers a sufficient transitional period. According to the manufacturers, a sufficient transitional period (5 years) would avoid a disproportionate impact on SMEs and on manufacturers without lowering the benefits of the adoption of a risk based classification.

Additionally, some submissions pointed out that the adoption of a risk-based classification, provided that it would be based on the GHTF model, would facilitate the exports for European manufacturers and would have therefore a very positive impact on competitiveness. Manufacturers underlined that the adoption of a risk based classification not based on the GHTF model would represent additional costs which would not be balanced against any financial benefit.

Another issue raised by some stakeholders was the fact that the risk based classification has to be detailed enough to avoid any controversial or inconsistent implementation. It was pointed out that any inconsistent application of the risk-based classification would lead to discrepancies and fragmentation within the internal market.

Other respondents underlined that the adoption of such a risk based classification should be implemented at the same time as appropriate guidelines or should be followed by the creation of an efficient and rapid mechanism to solve borderline and classification issues at EU level.

Some answers in the field of genetic testing raised concerns about the appropriateness of the GHTF model risk-based classification to genetic tests. These respondents suggested that this classification for genetic tests should take into account the impact of the potential test results on the patient and their family, as well as the likelihood of tests being performed and interpreted correctly, especially by lay users, the risk of incorrect measurement, the purpose for which the test is used and the potential consequences of error in the measurement.

2. Conformity assessment procedure

Question 2:

In the context of a possible adoption of a risk-based classification according to the GHTF model (see above 1.) do you see a need for amending the current conformity assessment procedures for in vitro diagnostic medical devices?

108 answers to this specific question were received. Among these answers, 75% underlined that an amendment of the current conformity assessment procedure would be necessary.

The analysis of the respondents by categories showed that the highest percentage of positive responds came from Competent Authorities, Notified Bodies and manufacturers.

The following question, asked the respondents to provide some details about the conformity assessment procedures to be amended.

Question 3:

If yes, in your view which are the conformity assessment procedures that should be deleted or amended and why?

A majority of stakeholders underlined that Annex VI should be deleted, as this conformity assessment procedure is rarely used and does not include an assessment of the vigilance system, or should be limited to specific products like IVD instruments. Few respondents suggested keeping a wide range of possibilities in the conformity assessment procedures.

Many stakeholders underlined the need to align the conformity assessment procedure with the GHTF model.

Some respondents identified that the adoption of a risk-based classification system based on the GHTF model will lead to major amendments regarding the conformity assessment procedure to be applied for self-tests. These self-tests will not fall under a particular category within the GHTF classification and therefore will not be classified differently from the same test to be used by healthcare professionals. This will lead to a major change as self-tests have specific requirements regarding the conformity assessment procedure to be applied according to the current Directive. Many answers, in particular from Notified Bodies, suggested deleting the possibility to perform a conformity assessment procedure according to Annex III.6[7] for self-tests, and underlined the need to align the conformity assessment procedures for self-tests to those applied for Annex II List B tests (e.g. tests for the detection and quantification in human samples of rubella, toxoplasmosis…) .

Other stakeholders mentioned the need to clarify the requirements set up in Annex V (Type examination).

Question 4:

Would you consider appropriate to require for all IVDs, except for those in class A of the GHTF classification, at least the pre-market control of the manufacturer's quality management system by a third party as laid down in GHTF/SG1/N046:2008?  

82 answers were received to this specific question. Among these answers, 72 were positive, representing 88% of positive answers.

Most of the respondents confirmed that a Quality Management System (QMS) should be put in place for Class B, C and D IVD medical devices according to the GHTF model and that this QMS should be controlled by a third party, as laid down in the GHTF documents. In addition some respondents underlined that the requirements on the QMS should be extended also to class A IVD medical devices.

However some stakeholders pointed out that even if such a QMS system controlled by a third party would be necessary, this would not be sufficient alone to ensure the safety of the products.

Question 5:

In the context of the "batch release verification", do you consider that a control of each batch of manufactured high-risk IVDs should be required prior to their placing on the market?

If yes, what would be the purpose of batch release verification and which IVDs should be subject to such a control?

If yes, how (testing, verification of the results of the tests) and by whom (manufacturer under the control of notified bodies, notified bodies, independent laboratories) these controls should be performed?

115 answers were received. Among these answers, 83% considered that there is a need to have a batch release testing for high-risks IVD.

According to the respondents, the purpose of this batch release testing would be to ensure consistency between batches and a uniform level of quality for high-risk tests. Other stakeholders underlined that the purpose of this verification is also to ensure   compliance of each batch of a high-risk IVD medical device with the Common Technical Specifications set up for tests listed in Annex II List A of Directive 98/79/EC. Other answers stated that the purpose of the batch release verification is to provide independent evidence that the sensitivity, specificity and quality of each batch of an IVD medical device are acceptable when compared to the original approved assay for the purpose of the granting the CE marking. Few respondents underlined that this batch release testing performed before the placing on the market of the tests precludes low quality batches of high-risks tests to be placed on the market.

However, if a majority of respondents agree on the general purpose and the benefits of the batch release testing, there are some divergent opinions on how and by whom this batch release verification should be performed. A large amount of answers pointed out that this verification should be performed by the manufacturer, and must be part of the Quality Control and Quality Management System of the manufacturer, under the control of the Notified Bodies. This control could be based on a systematic verification or be subject to periodic inspection by the Notified Body. These respondents also pointed out that the methods, the reference materials and the panels used for this batch release testing should be approved and controlled by the Notified Body.

Some answers underlined the need for a batch release testing to be performed by an independent laboratory or by the Notified Body. However, other answers pointed out that the batch release testing performed by an independent laboratory would be too costly and would not bring an added value in terms of safety and quality.

However, the answers from manufacturers underlined quasi-unanimously that an internal batch release testing is already performed by manufacturers as an integral part of their Quality Management System, under the supervision of the Notified Bodies for high-risk products. They pointed out in their replies that a batch release testing performed by independent laboratories would be a duplicate of the manufacturer testing. Furthermore, they suggested that the batch release testing should be performed by the manufacturer and that the procedure to be used for the batch release testing, including the reference methods and the panels to be tested should be validated by the Notified Body. The notified body would then verify the results of this batch testing.

Question 6:

Should the use of Common Technical Specifications (CTS) be maintained for high-risk IVDs? Should CTS also be adopted for other IVDs?

101 answers to this specific question were received. Among these answers, 92% underlined the need to maintain the CTS at least for tests used in the context of blood transfusion and/or for Class D tests, according the GHTF classification.

Although the majority of the respondents were in favour of not extending the CTS to other IVD tests, few answers stated that it might be beneficial to extend the CTS to tests within the Class C IVD medical devices according to the GHTF model.

Among the answers received, the Notified Bodies unanimously pointed out the need to keep the CTS.

3. Scope

            3.1 Specific exemption for "in-house tests"

Article 1(5) of Directive 98/79/EC makes provision for an exemption for devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity. These tests are referred below as “in-house tests”.

The question is to determine if there is a need to clarify or limit the scope of this exemption and/or to submit some "in-house tests" to certain requirements of Directive 98/79/EC.

Question 7:

Would it be necessary to maintain the exemption provided for by article 1(5) of Directive 98/79/EC and why?

 

144 answers were received.

According to 86% of the respondents the exemption provided in Article 1(5) of Directive 98/79/EC should be kept. In particular some respondents pointed out to some specific situations where the availability of in house tests is necessary. Examples given were for instance for novel analytes, rare disease testing, customized tests for common genetic diseases and population-specific tests and test panels. According to those respondents, the abolition of the exemption would result in the lack of availability of some specific testing and would be detrimental to patients. Another reason pointed out by the respondents for maintaining the exemption was the need for rapid response to changes in test requirements. Reference was made in the contributions to the recent years' rapid emergence of global health threats from infectious agents (e.g. SARS, Influenza H5N1, H1N1). Such outbreaks require the rapid development and deployment of new assays for detection, monitoring and vaccine development and, according to these respondents, it would not be possible to implement such testing in the time-scale required if each new assay had to go through the CE marking process. Contributions also pointed to the economic consequences on healthcare systems as well as to the consequences on research and innovation of an abolition of the exemption provided by Article 1(5) of Directive 98/79/EC.

However, in order to prevent unfair competition between CE marked in vitro diagnostic medical devices and in-house tests, various contributions pointed to the need of better defining the exemption and restricting it to situations were there is no similar commercially IVD devices available or where the commercially available IVD devices does not address the needs of the users with regard to the performances or to the intended purpose of the devices. Other contributions suggested that the exemptions should only apply to low risk, low volume tests and that all high risk tests should be subject to the same standards and level of scrutiny. Some respondents were of the opinion that similar conditions as for custom made medical devices shall be established instead of the current exemption. Finally some respondents considered that any allowed exemption for in-house tests should be specific and kept within strict limits e.g. taking into consideration the need for devices for detection of rare parameters, and not be based on just the aspects of being in-house manufacture. These respondents suggested therefore removing the exemption for in-house tests and replacing it by a specific regulation.

Question 8:

If the exemption provided for by article 1(5) of Directive 98/79/EC should be clarified or limited, which of the following items you would consider as appropriate in order to clarify the scope of this exemption and ensure a high level of safety:

 Item 1:  Better define the concepts of "in-house test", "health institution", “premises of a manufacture or premises in the immediate vicinity”. Could you suggest an appropriate definition for these terms?

Item 2:  Require that all "in-house tests" fulfil the essential requirements of the Directive 98/79/EC, without being subject to a CE marking?

Item 3: Require that all high risk "in-house tests" are excluded from the exemption provided for by article 1(5) of Directive 98/79/EC and then have to fulfil the essential requirements of the Directive 98/79/EC including the involvement of a notified body?

Item 4: Submit the health institutions and premises referred to in Article 1(5) of Directive 98/79/EC that manufacture "in house tests" to accreditation, based on ISO 15189, or equivalent regulation at national level?

Please indicate one or more items that you would consider as appropriate while explaining why you consider these items as appropriate and providing data where possible.

With regards to item 1, while some respondents were of the opinion that it is more appropriate for the national Competent Authority to continue to provide any further guidance required on these definitions and that the Directive itself does not need to be more prescriptive.  92 contributors were in favour of introducing some clarifications in the concepts of "in-house test", "health institution", “premises of a manufacture or premises in the immediate vicinity” in order to ensure a better implementation of this provision. To the notion of "in-house tests" was sometime preferred the notion of "home brew tests" or "Laboratory Developed Tests (LDTs)". While some respondents were in favour of clarifying the concept of "premises in the immediate vicinity" to address for instance the issue of networks of public service laboratories with shared governance structure, some contributors suggested deleting this geographical concept. Only a few respondents provided with proposals for definitions but some contributors pointed out to the risk of narrowing too much the exemption and to the difficulty of producing definitions that would be acceptable and applicable in all Member States. Some contributors suggested limiting the exemption to public-sector health institution laboratories which are under the regulatory supervision of the national authorities and distinguishing between commercial and non-commercial ventures. On the contrary a few contributions were against any proposition that an exemption should be confined to public health laboratories.

Items 2 and 3 were less supported by the respondents with respectively 41 and 27 supportive answers. In particular, for the item 2, respondents pointed out to the burden of compliance equivalent to that imposed by CE-marking. Some respondents suggested introducing some minimal provisions such as the inclusion of in house tests into the vigilance system, the registration of in house tests and, for in house tests in class D, the compliance with CTS and applicable essential requirements.

The proposal made in item 4, i.e. to submit the health institutions and premises referred to in Article 1(5) of Directive 98/79/EC that manufacture in house tests to accreditation, based on ISO 15189, or equivalent regulation at national level, was supported by 81 contributors. Extensive reference was also made to ISO 13485 and ISO 17025. Some respondents suggested combining items 3 and 4, including high risk devices falling in both Class D and Class C.

Question 9:

If the exemption provided for by article 1(5) of Directive 98/79/EC should not be maintained, would you consider it necessary to exempt in vitro diagnostic medical devices intended for diagnosis and monitoring of diseases or conditions affecting not more than 5 in 10,000 persons in the European Union from the scope of the IVD Directive and, if yes, why?

108 answers were received.

The proposal to exempt in vitro diagnostic medical devices intended for diagnosis and monitoring of rare diseases or conditions as defined above was not supported by 69% of the respondents.

Contributors pointed out to some difficulties in this approach such as cases where there is no commercially available test for infrequent but not rare conditions, cases where there is no commercially available test for a specific condition e.g. newly identified condition and cases where conditions may be different in the Member States. 

            3.2 Genetic test

The interpretation of the scope of Directive 98/79/EC is that only genetic tests that have a medical purpose are covered by this Directive.  However the medical purpose might not be so clear for some other tests like predictive tests or lifestyle tests, and may lead to different interpretation on the qualification of these products within the European Union.

Question 10:

Do you see a need for a clarification of the scope of Directive 98/79/EC to make clear that it covers all genetic tests that have a direct or indirect medical purpose while clarifying that tests without any direct or indirect medical purpose remain outside the scope of the Directive 98/79/EC.

If you consider that there is a need to clarify the scope of Directive 98/79/EC as regards genetic tests, which of the following items would you consider as appropriate:

Item 1:

Extend the scope to all genetic tests by adding a specific indent in the definition of in vitro diagnostic medical devices regarding devices which pursue the purpose of providing information concerning “results obtained by analysis of the genome”. Should, in this case, an exclusion be introduced in the Directive 98/79/EC as regards some categories of tests (negative list) e.g. paternity, DNA comparison?

Item 2:

Clarify that tests, including genetic tests, with a direct or indirect medical purpose are included within the scope of Directive 98/79/EC.

The contributors were asked to choose between two items.

The item 1 was to enlarge the scope by including "results obtained by analysis of the genome" in the definition of in vitro diagnostic medical devices, and by introducing a negative list of some categories of genetic tests. This idea was judged as inappropriate by 83% of the respondents arguing for instance that the proposed additional indent in the definition of in vitro diagnostic medical devices is not broad enough to cover for example some tests based on analysis of RNA, protein or other (combinations of) biomarkers. The suggested wording could leave the status of such tests unclear.

In addition a negative list would be, according to some respondents, difficult to update and to be comprehensive and precise enough.

The item 2 suggested the inclusion of "direct or indirect medical purpose" in the in vitro diagnostic medical devices definition.

This proposal was not supported by 54% of the contributions. Among those who were in favour of this option, the need of a clear definition of what is a direct and indirect medical purpose was pointed out in several answers. Some contributors were of the opinion that the addition of the word “prediction” to the definition of a medical device in Article 1(2)(a) might help addressing the issue, and in particular the uncertainty around certain tests with a (claimed) predictive value. Some contributors were of the opinion that such clarification should be made in a MEDDEV and not in the Directive itself.

Question 11:

Do you see a need to create additional requirements or restrictions for direct-to-consumer genetic tests in order to ensure a better level of health protection? If yes, on which aspects?

80 answers were received.

86% of the respondents agreed that additional requirements or restrictions for direct-to-consumer genetic tests should be created to ensure a better level of health protection. Appropriate medical intervention and counselling were mentioned as important aspects to be addressed. Some contributors were of the opinion that the same requirements as those currently requested for self-testing devices should apply.

Some respondents pointed out to the need to ban the direct sale to the public of genetic tests and advertising directly targeting the general public. According to these respondents the genetic tests for health purposes must be carried out by qualified staff in centres accredited by the health authorities. Extensive reference was made to the OECD guidelines on quality assurance for molecular genetic testing.

            3.3 Diagnostic services

There are an increasing number of tests which are performed within an economic operator's facility (within the EU or outside) without placing the in vitro diagnostic medical devices on the market. Despite Recital 11 and Article 9(13) of Directive 98/79/EC[8] it may not always be clear that IVD’s used in such a situation are subject to Directive 98/79/EC. There are increasing concerns regarding the validity and the reliability of the results of such tests and the understanding of the result by lay users. In principle, these tests performed by the manufacturer should be subject to the same requirements than in vitro diagnostic medical devices that are placed on the market.

Question 12:

Do you see a need to amend the definition of "putting into service" to make it clear that it covers also the in vitro diagnostic medical devices that are not placed on the market but used for the delivery of results within the Community?

76 answers were received.

Reference was made to Recital 11 and Article 9(13) of Directive 98/79/EC but for the sake of clarity the need to amend the "putting into service" definition was supported by 84% of the respondents. While acknowledging possible difficulties in the implementation, those respondents were of the opinion that the definition of ‘putting into service’ should also be applicable to diagnostic services, including the diagnostic services which are performed outside the EU, and of which the test result are communicated inside the EU

Question 13:

Do you see a need to introduce other specific requirements for tests used for diagnostic services, especially when the results of the tests are provided directly to consumers, such as minimum requirements for advertising?

74 answers were received.

81% of the respondents were in favour of introducing specific requirements for tests used for diagnostic services, especially when the results of the tests are provided directly to consumers.

Examples of additional requirements mentioned were requirements for marketing and advertising (for instance CE-mark and Notified Body number mentioned in the advertising), establishment of standard operation procedures, procedures for incident notification and patient information, involvement of healthcare professionals in the delivery or redaction of the results delivered directly to the consumer. The respondents highlighted the importance that the information transmitted to the consumer is comprehensible, objective and not misleading while providing sufficient explanations, for instance with regard to the achieved quality of test results and the limits of validity of the method and with the need for further advice or consultation through a healthcare professional where needed. Information on the institution offering the testing service, such as for instance information on its accreditation, was mentioned by some contributors.  Some respondents pointed out to the difficulties of enforcement of certain of these requirements. Extensive reference was made to the Human Genetics Commission’s report A "Common Framework of Principles for direct-to-consumer genetic testing services"[9] . Some contributors pointed out that the issue of advertising should be addressed in the context of all three medical devices Directives.

            3.4 Point-of-care / near-patient in vitro diagnostic medical devices

There is a growing number of tests which are performed outside a laboratory environment but near to a patient by a healthcare professional, who is not necessarily a laboratory professional, in order to make a diagnosis and to determine the appropriate treatment. These tests are often referred to as "point-of-care" or "near-patient" tests[10].

Question 14:

Do you see a need to add specific requirements for "point of care" or "near-patient" in vitro diagnostic medical devices? If yes, regarding which aspects (e.g. information supplied by the manufacturer)?

93 answers were received.

Among these answers, 60 answers (65%) underlined the need to set up specific requirements for point of care or near-patient testing.

Few respondents pointed out that the current requirements in the Directive already address this issue as the intended user must be taken into account for the CE marking. However most of the respondents underlined that the current requirements are not sufficient. They suggested that the clinical validity of the test must be demonstrated in the same conditions than those in which the test will be used. According to the respondents, the manufacturer shall demonstrate that the tests performed in a point of care environment provide the same level of clinical sensitivity or specificity than the test performed in a clinical laboratory. In addition, it was underlined that these tests and the users of these tests should be subject also to a Quality Management System, including Quality Controls, maintenance and External Quality Evaluation schemes, as well as to an appropriate training to the use of these tests.

Few respondents underlined that a diagnosis should not be performed on the basis solely of such a test and that the results should be confirmed by a clinical laboratory.

Other aspects raised by many respondents were the need to add some specific requirements regarding the handling of these tests by healthcare professionals as well as the need to have the instructions for use understandable by lay person. The aim of the additional requirements would be to avoid any possible misleading tests or inappropriate interpretation of the results. Specifically, the need to have a clear and appropriate explanation on the meaning of the diagnosis sensitivity and the diagnosis specificity as well as on the negative and positive predictive values was underlined by a majority of respondents.

Some respondents pointed out that the IVD Directive should exclude the possibility to perform in house tests in a point of care environment, due to the lack of appropriate instruction for use.

In addition, few respondents underlined that genetic testing should not be performed in a point-of care environment, due to the need to have appropriate information for patients.

4. Clinical evidence

The respondents were asked to answer on the need to clarify the requirements regarding the clinical evidence. The stakeholders were also consulted on the need to extend the requirements regarding the clinical utility and on the need to set up requirements on the clinical utility.

Question 15:

Do you see a need to further clarify the requirements regarding clinical evidence for in vitro diagnostic medical devices?[11]

110 answers were received.

Among the answers, around 90% of the respondents agree on the fact that the requirements regarding the demonstration of performance for IVD medical devices need to be clarified. For the majority of the stakeholders, the current requirements on the demonstration of performance set up in the IVD directive are misleading and may be interpreted as being only analytical requirements.

In addition, the respondents agreed that the requirements regarding the clinical evidence should be more detailed in the Directive and that the Directive should include some requirements on how to demonstrate the clinical evidence.

A suggestion made by the stakeholders was to better align the requirements on clinical evidence for IVD medical devices on those required for medical devices, by introducing a specific Annex on the requirements on clinical evidence, aligned on Annex X of the Directive 93/42/EEC.

A majority of stakeholders also pointed out that the level of requirements regarding the demonstration of clinical evidence should be adapted to the different classes of the IVD medical devices.

Mainly a quasi unanimous opinion on the need of clarification of clinical evidence was expressed by the Notified Bodies and by the stakeholders in the field of genetic testing. Among the users and Competent Authorities, more than 80% of the answers underlined the need to clarify the requirements on clinical evidence.

The next questions are related to the proposition to clarify the requirements on clinical evidence in the Directive in the light of the on going work at GHTF level on the demonstration of clinical evidence for IVD medical devices and to the introduction the concept of clinical validity in the Directive.

            4.1 Clinical validity

The clinical validity[12] was defined within the public consultation as the demonstration of the performance characteristics supporting the intended use of the in vitro diagnostic medical devices and includes diagnostic sensitivity, diagnostic specificity based on the true disease status of the patient and negative and positive predictive values based on the prevalence of the disease. These two last elements (negative and positive predictive values based on the prevalence of the disease) are currently not clearly mentioned in the Directive 98/79/EC.

Question 16:

On the basis of the above, do you see a need to extend the requirements regarding the demonstration of the clinical validity in Directive 98/79/EC?

106 answers were received.

Among these answers, 81% expressed some support for extending the requirements in the Directive to the demonstration of the clinical validity for IVD medical devices.

The stakeholders agreed quasi unanimously on the fact that the requirements on the demonstration of the clinical validity should be extended at least to the demonstration of Negative Predictive Value and Positive Predictive Value.  Among the respondents, there was a large support to this proposition from Competent Authorities, Notified Bodies and users. Among manufacturers there was little support to this proposition.

Mainly the stakeholders pointed out that the requirements on clinical validity should be proportionate to the risk linked to the use of the IVD medical device and then adapted to the risk based classification.

It was underlined by few respondents that the compliance with the Common Technical Specification should be considered as part of the demonstration of the clinical validity and then that their use should be expanded to other IVD medical devices. This answer is however in contradiction with the answers provided to question 6 where a large majority of stakeholders expressed the view that the CTS should not be extended to non high- risk IVD medical devices.

            4.2 Clinical utility

For the purpose of this public consultation, the notion of clinical utility[13] was defined as the demonstration of the potential usefulness and added value to patient management decision-making. The notion of clinical utility for the purpose of this document does not include cost/benefit assessment, reimbursement issues and/or health economics issues. If a test has a utility, it means that the results provide valuable information for the purpose of making decisions about effective treatment or preventive strategies.

Question 17:

In the context of the above, do you see a need to require the demonstration of the clinical utility of the parameter in Directive 98/79/EC? If yes, how should the clinical utility be demonstrated?

Regarding the concept of clinical utility, the question raised was the need to define the clinical utility within the legal framework, according to the definition provided above and to require its demonstration by the manufacturer as a part of the conformity assessment process.

115 answers to this specific question were provided. The majority of the respondents (67%) expressed a negative opinion on the need for the demonstration of the clinical utility by the manufacturer.

Mainly, the concerns raised were that the concept of clinical utility is a moving concept that might hardly be addressed in the regulatory framework. In addition, a lot of respondents underlined that the concept of clinical utility should remain outside of the pre-market assessment process.

In addition, it was underlined that the clinical utility should not be demonstrated by the manufacturer, but should be assessed by the user. The user would have to decide on the clinical utility of a specific IVD medical device in a specific context or a specific population. Among the respondents, manufacturers, Notified Bodies and stakeholders active in the field of genetics were against introducing requirements on clinical utility within the Directive. Even users were not favourable to the introduction of such requirements in the Directive.

It was underlined that for new parameters, it will be impossible to demonstrate the clinical utility and therefore, it will limit the market access for innovative IVD medical devices. At the same time, some stakeholders underlined that for the majority of well known parameters, the demonstration of clinical utility should not be required.

However, some of the answers underlined that the demonstration of clinical utility might have an interest for direct to consumers testing or genetic testing.

5. Others

            5.1 "Conditional CE marking"

For unmet medical needs of patients, for example in the case of rare diseases or in emergency situations such as a pandemic, it might be useful to introduce a mechanism which can allow a rapid market access of certain IVDs subject to certain conditions. Currently, Article 9(12) of Directive 98/79/EC makes provision that Member States can accept IVDs in their respective territories without proper conformity assessment procedure if this is justified in the interest of public health protection. Instead of such national solutions, a “conditional CE marking” might be allowed for a limited period of time (e.g. one year renewable) and subject to specific obligations imposed on the manufacturer with a view to confirm the safety and performances of the tests.

Question 18

Would you consider the possibility of a conditional CE marking in certain situations useful? Which situations would you think of and which conditions, including procedural requirements, would you consider necessary?

The stakeholders provided 117 answers to this question. A majority of them (73%) considered that a "conditional CE marking" might be a useful in certain situation.

The respondents raised some questions regarding this "conditional CE marking", in particular regarding the aspect of who would decide to allow such a "conditional CE marking". There is a fear that this "conditional CE marking" would allow the marketing of low quality tests. Some answers underlined that if such a procedure would be put in place, a committee composed of Competent Authorities' representatives should be responsible for the decision.

It was underlined by the stakeholders that article 9(12) of Directive 98/79/EC already address the emergency situation on a national basis. A majority of Competent Authorities pointed out that they would prefer to keep this "derogation" at national level. It was underlined by the other categories of respondents that it would be useful to have such a "conditional CE marking" at European level to address the emergency, like a pandemic, as the situation of a pandemic would rarely be limited to a Member State.

The broad majority of respondents pointed out that the situations in which such a procedure would be useful are the emergency, (i.e. spread of a new disease, pandemics,..) or the timely access of tests for unmet medical needs.. In that case, the test would be subject to a post-marketing collection of data and then to a CE marking on the basis of the data collected.

However it was underlined by the stakeholders that this procedure would not be useful for "rare conditions". It was pointed out that in the case of "rare conditions", the more efficient procedure would be an exemption from the IVD Directive, as mainly these tests are performed in an in-house environment and it is very unlikely that sufficient data might be collected to obtain the CE marking.

            5.2 Companion in vitro diagnostic medical devices (e.g. pharmacogenomic assays, biomarker assays)

There are a growing number of tests which are developed and/or used in direct combination with specific medicinal products or which are co-developed with new medicinal products. These tests may be used for the selection of patients suitable for the respective medication, for optimal and individualized dosing of medicinal products, for the exclusion of populations expected to suffer from severe adverse side effects and / or other medicinal products-related indications. Currently, most companion diagnostics are self-certified by the IVD manufacturer.

Question 19:  

Which options do you see to guarantee a high quality of IVD medical devices used as companion diagnostics?

The respondents provided 125 answers to this question.

Almost unanimously, the respondents underlined that the IVD medical devices used as companion diagnostics must be subject to the IVD Directive, which will ensure an appropriate level of quality and safety for European citizens. The respondents pointed out that the implementation of a risk-based classification would address the main concerns raised about the insufficient level of scrutiny for these IVD medical devices. It would be necessary to have these IVD medical devices in Class C of the GHTF model, to ensure that a third party would be involved in the CE marking of these devices. However some respondents pointed out the need to have a closer cooperation between IVD medical device sector and the European Medicine Agency.

Some respondents underlined the need to require for these IVD tests the demonstration of the clinical utility of the combination of the medicinal product and the IVD medical device in the context of the CE marking and the marketing authorisation of the medicinal product.

It was underlined by stakeholders in the field of genetic diseases that the competence of the European Medicine Agency should be extended to pharmacogenomics, as the IVD medical device has an impact on the health outcome of the medicinal product and then the analytical and clinical validity of the IVD medical device should be part of the assessment of the benefit/risk assessment of the medicinal product.

Appendix 3 – Conclusions of the Council of the EU on Innovation in the

Medical Devices Sector

Council conclusions on innovation in the medical device sector

(2011/C 202/03, Official Journal of the European Union C 202 of 8.7.2011, p. 7)

THE COUNCIL OF THE EUROPEAN UNION,

1. RECALLING the Council conclusions of 26 June 2002 (1) and of 2 December 2003 (2) and the subsequent amendments to the legislative framework for medical devices (3);

2. DRAWING ATTENTION TO the conclusions (4) of the High Level Health Conference on innovation in medical tech­nology held in Brussels on 22 March 2011;

3. BEARING IN MIND:

is central to fostering the development of safe, effective and innovative medical devices for the benefit of European patients and healthcare professionals,

the importance of having the EU continue to play a leading role in the field of international regulatory convergence and best regulatory practice regarding medical devices, for instance through the Global Harmonisation Task Force, and be party to global initiatives such as global vigilance and global instruments for improving identification and traceability of medical devices;

the major long-term societal challenges facing Europe, such as an ageing population, which will call for inno­vative healthcare systems,

4. STRESSING that in order for innovation to benefit patients, healthcare professionals, industry and society:

the importance of medical devices in health- and social care, their contribution to improving the level of health protection and the fact that medical devices today account for a significant amount of public health expen­diture,

innovation should be increasingly patient- and user-centred and demand-driven, e.g. through increased involvement of patients, their families and users in the research, innovation and development processes in order to improve individual health and quality of life,

that the development of medical devices may deliver innovative solutions for diagnosis, prevention, treatment and rehabilitation, that could improve health and quality of life for patients, disabled persons, and their families, could contribute to mitigating the shortage of healthcare professionals and could contribute to addressing the sustainability of healthcare systems,

that innovation in medical devices should contribute to the continued improvement of patient and user safety,

the European Innovation Partnership on Active and Healthy Ageing launched by the European Commission with the aim of tackling societal challenges through innovation,

that the medical device sector in Europe comprises around 18 000 small and medium-sized enterprises (SMEs) and that this fact must be considered when future legislative and administrative measures are being adopted at European Union level and at national level,

the need to adapt EU medical device legislation to the needs of tomorrow so as to achieve a suitable, robust, transparent and sustainable regulatory framework, which innovation should be a more integrated process, building on experience and knowledge acquired in other sectors, such as IT and the development of new materials,

innovation should be based on a holistic approach (i.e. it should take into account the whole healthcare process and all patients’ needs — physical, social, psychological, etc.),

innovation should focus on public health priorities and healthcare needs inter alia in order to improve cost-effec­tiveness,

there is a need to increase research in order to identify public health needs and priorities still to be addressed and to better define patients’ medical needs,

future legislative actions in this area must, when adapting the European regulatory framework, specifically aim to increase patients’ safety while at the same time creating a sustainable legislative framework favourable to medical device innovation that can contribute to a healthy, active and independent life;

(1)  Doc. 10060/02.

(2)  Doc. 14747/03.

(3)  Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (OJ L 247, 21.9.2007, p. 21).

(4)  http://ec.europa.eu/consumers/sectors/medical-devices/files/ exploratory_process/hlc_en.pdf

5. INVITES THE COMMISSION AND THE MEMBER STATES to:

promote measures that make use of valuable innovative solutions with proven benefit, and improve information and training for healthcare professionals, patients and patients’ families regarding their use,

C 202/8

EN

Official Journal of the European Union

8.7.2011

further map and share national and European best practices regarding innovation and enhance the deployment of research to facilitate, where relevant, the transfer of experiences gained in national or regional studies and pilot projects to the multinational, multire­gional or European level,

ensure stronger collaboration and dialogue between the various actors involved in the innovation process (e.g. through networks and clusters),

promote valuable innovation through public procurement policies while taking into account safety aspects,

take existing measures into account, and when necessary consider further measures which enhance the capacity for innovation, for instance the use of innovative funding systems directed, in particular, towards SMEs and that are designed to make optimum use of resources from the private and public sectors,

the system of risk based classification should be improved (in particular for in vitro diagnostic medical devices and ‘new products’ as appropriate),

clinical data from pre-marketing studies and post­marketing experience (vigilance reports, post-marketing clinical follow-up, European registers) must be collected in a transparent way and to a greater extent in order to provide the clinical evidence which fulfils regulatory purposes and can, where appropriate, assist health tech­nology assessment, whilst fully recognising and respecting national competences for the latter. Consideration should also be given to methods for ensuring that notified bodies are better equipped with the appropriate expertise to analyse such data in a mean­ingful way,

there is a need for clearer and simpler rules defining the obligations and responsibilities of all economic operators and the role of other stakeholders (in particular national competent authorities and notified bodies),

pay particular attention to interoperability and safety issues related to the integration of medical devices in e-Health systems, especially Personal Health Systems and mobile health systems (m-Health) while bearing in mind that the deployment of health ICT systems is entirely a matter of national competence,

encourage better consideration of the needs of patients and healthcare professionals in the design process of medical devices,

consider further improving the involvement of patients and healthcare professionals in vigilance in order to improve the system of notification of adverse incidents relating to the use of medical devices,

promote early dialogue between manufacturers, scientific and clinical experts, competent authorities and, where appropriate, notified bodies regarding ‘new products’ in particular, and their classification,

enhance  cooperation  between  authorities  of  relevant sectors, where appropriate,

the development of a modern IT infrastructure for a central and publicly available database must be further pursued with a view to providing key information about medical devices, relevant economic operators, certificates, clinical investigations and field safety corrective actions. In this context, the possibility of introducing a system to improve the traceability of devices, thus enhancing safety, must be studied,

where necessary, clarification should be made regarding the definition of medical devices and the criteria for their classification,

in addition, a simple and rapid mechanism must be set up for accelerated adoption of binding and consistent decisions and the implementation thereof on the deter­mination of products as medical devices and the classifi­cation of medical devices in order to address the growing number of ‘borderline’ cases between medical devices and other products subject to different regulatory frameworks (the framework for pharmaceuticals in particular, but also those for cosmetics, aesthetic products, food or biocides),

examine how and at which level the promotion of medical devices can be regulated in the most effective and efficient way;

6.  INVITES THE COMMISSION to take the following considerations into account in the course of its future legis­lative work:

mechanisms are needed to enhance reliability, predicta­bility, speed and transparency in decision-making, and make sure that it is based on scientifically validated data,

as regards the oversight of notified bodies, there is a need to continue to improve the harmonised list of criteria to be satisfied before their designation. In particular the designation process should ensure that they are designated only for the assessment of devices or tech­nologies which correspond to their proven expertise and competencies. The process should also address the need to improve monitoring of notified bodies by national authorities in order to ensure an EU-wide comparable and high-level performance of notified bodies, in this context an enhanced European coordination between competent authorities as well as between notified bodies should also be considered,

the vigilance system for medical devices must be further developed in order to allow a coordinated analysis and a rapid and coherent EU-wide response to safety issues, if needed,

it is desirable to consider a European coordination mechanism founded on a clear legal basis and mandate in order to ensure efficient and effective coordination between national authorities while creating a level playing field. Synergies with existing bodies with relevant expertise should be explored when deciding on the mechanisms for such coordination. Consideration should also be given to which activities are best carried out in cooperation between Member States,

as the medical device sector is a global one, a stronger coordination with international partners is desirable in order to ensure that medical devices are manufactured according to high safety requirements worldwide,

there is a need for a sustainable legislative framework for medical devices which ensures safety and promotes inno­vation,

it should be considered how to address regulatory gaps in the system, for instance in relation to medical devices manufactured utilising non-viable human cells and tissues,

the need for introducing more harmonised provisions relating to the content, presentation and comprehensi-bility of the instructions for use of medical devices should be further considered.

Appendix 4 – Fact Sheet: Medical Device Sector

The medical devices sector covers a dynamic, innovation driven, highly competitive industry, with a global market.

I. Product coverage

Medical devices are covered by three EU Directives (see separate fact sheet on the regulatory framework). A medical device is defined as "instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

– diagnosis, prevention, monitoring, treatment or alleviation of disease,

– diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

– investigation, replacement or modification of the anatomy or of a physiological process,

– control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

1. Examples for active implantable medical devices (covered by Directive 90/385/EEC):

– Pacemakers

– Diffusion pumps for oncological applications

– Cochlear implants

2. Examples for other medical devices (covered by Directive 93/42/EEC):

Disposables, such as

– Sticking plaster

– Tongue depressors

– Condoms

Hospital equipment, such as

– Anaesthetic equipment and workstations; respiration and inhalation equipment (lung ventilators)

– Diagnostic equipment

– Medical imaging equipment such as X-ray, scanners (e.g. PET or MRI[14])

– Laser applications, electro-cardiography, stethoscopes

– Sterilizers

– Operating theatre

– Hemodialysis

– Nuclear therapeutic equipment

– Infusion and transfusion equipment

– Incubators

– Surgery equipment (e.g. forceps, scalpels)

– Catheters

– Medical disposables (e.g. surgical drapes)

Dentistry, such as

– Equipment, including drills, chairs, UV lighting for hardening of materials

– Dental material, including amalgams, plastics, porcelain

– Dental implants

Devices with a measuring function, such as

– Blood glucose meters

– Fever thermometers

Ophthalmic devices and hearing instruments, such as

– Spectacles, glasses, contact lenses

– Audative prostheses, hearing aids

Protheses, implantable and non-implantable as well as internal and external orthopaedics, such as

– Walking aids

– Artificial limbs

– Hip, shoulder and knee replacements

– Cardiac valves

– Corsets

Aids for disabled, such as

– Wheelchairs

– Portable ventilators

– Rehabilitation equipment

3. Examples for in vitro diagnostic medical devices (IVDs)

Reagents and instrumentation for

– Safety of the blood supply (HIV, hepatitis, blood grouping etc)

– Detection of infectious diseases (Specific flu strains, chlamydia, etc)

– Blood chemistry (cholesterol, HDL/LDL, transaminases, etc.)

– Monitoring of diseases (blood glucose in diabetes, etc.)

– Screening assays (PSA for prostate cancer, etc)

– Tests for the determination of pregnancy

– Specimen receptacles for the containment and preservation of human specimens

II. Market data 

1. Market volume

Global market (2009): Sales volume of around €313bn (€283bn for medical devices including €80bn for medical imaging equipment, plus estimated €30bn for IVDs)

Largest markets (2009): USA (ca. 36%), Europe (ca. 30%), Japan (ca. 11%), China (ca. 3%)  

European (EU/EFTA) market (2009): Sales volume of around €95bn (€85bn for medical devices including €28bn for medical imaging equipment, plus €10bn for IVDs)

Largest markets in the EU (2009): 1) Medical devices[15]: Germany (€21bn), France (€17bn), UK (€11bn); 2) IVDs: Germany (€2.17), France (€1.7bn), Italy (€1.68bn), Spain (€1.09), UK (€0.7bn)

Annual growth rate: 1) Medical devices: ca. 5% in 2009; 2) IVDs: 3.6% (2008-2010)

Re-investment in R&D (2009): 1) Medical devices: 6-8% (ca. €6.5bn) of sales volume; 2) IVD: ca. 10% (ca. €1bn)

Percentage of health care expenditure spent for medical devices (2009): 1) Medical devices: EU average 4.2% (rates in Member States range from 2% - 11%); 2) IVD: EU average 0.8% (rates in Member States range from 0.3% - 3.9%)

2. Industry

Medical device business entities in Europe: around 22,500

SMEs: more than 80%; in the IVD sector more than 90%

Employment: around 500,000 individuals in Europe

Big companies: Abbott, Agfa HealthCare, BD, Boston Scientific, Covidien, GE Healthcare, Johnson & Johnson, Medtronic, Philips Healthcare, Roche Diagnostics, Siemens Healthcare, Stryker,   Toshiba.

Recent mergers & acquisitions: Synthes by Johnson & Johnson (orthopaedics, $21bn, April 2011), Beckman Coulter by Danaher (diagnostics, $6.8bn, Feb. 2011), Millipore by Merck KGaG (diagnostics, $7bn, Feb. 2010), Alcon by Novartis (eye care, $28.1bn, Jan. 2010)

III. European industry associations

Ø Medical Technologies Industry in Europe (EUCOMED)

Ø European Coordination of the Radiological and Electromedical Industry (COCIR)

Ø European Diagnostic Manufacturers Association (EDMA)

Ø European Hearing Instrument Manufacturers Association (EHIMA)

Ø European Federation of Precision Mechanical and Optical Industries (EUROM)

Ø European Industrial Federation Committee on Medical Technology (EUROM VI)

Ø European Contact Lens and Lens Care Industry's Association (EUROMCONTACT)

Ø Federation of European Dental Industry (FIDE)

Ø European Association of Authorized Representatives (EAAR)

Appendix 5 – Regulatory Framework for Medical Devices

I. EU legislation

The EU regulatory framework for medical devices is built on three main Directives:

Ø Council Directive 90/385/EEC on the approximation of laws of the Member States relating to active implantable medical devices (hereafter AIMDD)[16],

Ø Council Directive 93/42/EEC concerning medical devices (hereafter MDD)[17], and

Ø Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (hereafter IVDD)[18].

All three directives are harmonization measures based on the former Article 100a of the Treaty establishing the European Community, which is now Article 114 of the Treaty on the Functioning of the European Union. Their main objectives are the creation of an internal market for medical device whilst ensuring a high level of protection of public health and patient safety.   

Special provisions covering medical devices incorporating substances derived from blood were introduced in 2000[19]. AIMDD and MDD were amended for the last time by Directive 2007/47/EC which was due to be implemented by March 2010. The IVDD has not been substantially amended since its adoption.

The legislative acts are complemented by a number of implementing measures adopted by the Commission:

Ø Commission Decision 2010/227/EU on the European Databank on Medical Devices,

Ø Commission Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices,

Ø Commission Directive 2003/32/EC introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin,

Ø Commission Directive 2003/12/EC on the reclassification of breast implants in the framework of Council Directive 93/42/EEC concerning medical devices,

Ø Commission Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices, as amended for the last time by Commission Decision 2009/886/EC.

Further implementing measures are currently being prepared as regards

Ø variant Creutzfeldt-Jakob Disease (vCJD) assays for blood screening, diagnosis and confirmation (addition to List A of Annex II to the IVDD and amendment of the common technical specifications for IVD),

Ø electronic instructions for use of medical devices, and

Ø revision of Commission Directive 2003/32/EC concerning medical devices manufactured utilising tissues of animal origin.

II. Main elements of the EU medical device legislation

The three main Directives are based on the concept of the 'New Approach' to technical harmonisation and standardisation, defined by the Council in 1985[20] and reviewed in 2008 with the adoption of the 'New Legislative Framework for the Marketing of Products'[21].

1. Product requirements

AIMDD, MDD and IVDD lay down the essential requirements for safety and performance that medical devices products have to meet when they are placed on the market or put into service in the EU. Before being placed on the market or put into service, devices must be subject of a risk assessment, a risk management process and a risk/benefit analysis by the manufacturer. In this context, risks to be taken into consideration relate to issues such as chemical, physical and biological properties, infection and microbiological contamination, construction and environmental properties and protection against radiation. Furthermore, medical devices must achieve the performances intended by the manufacturer.

In order to allow technological progress and to ensure that new devices placed on the market reflect the current state of the art, the Directives do not specify technological solutions to be adopted by manufacturers. Instead, manufacturers have to substantiate how risks have been taken into consideration and dealt with, both at the level of the design and the manufacture of the device. Use of European “harmonized standards” provides a presumption of conformity with the essential requirements to which such standards specifically relate.

2. Conformity assessment / Notified Bodies

The Directives contain a number of conformity assessment procedures, the use of which depends on the device's classification in one of the four risk classes (I, IIa, IIb and III). Except for low risk devices (class I) for which the manufacturer itself certified conformity, the conformity assessment procedure involve independent conformity assessment bodies, so-called Notified Bodies, designated and monitored by national authorities. The extent and depth of the Notified Body's assessment depends on the risk class of the device and covers the quality system of the manufacturer and/or the design of the device. Manufacturers must submit intended changes to their quality system and/or to the design of their device to a Notified Body for assessment. Notified Bodies must perform periodic surveillance inspections to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system.     

3. Free movement of medical devices

After successful completion of the applicable conformity assessment (either self-certification or delivery of a certificate by a Notified Body), the manufacturer must affix a CE marking on the product. Member States may not create any obstacle to the placing on the market or putting into service of devices which bear the CE marking. Due to the EEA Agreement, the Mutual Recognition Agreement with Switzerland and the Customs Union with Turkey, the principle of free movement of CE marked medical devices applies to 32 European countries (EU, EFTA, Turkey).

Member States retain the right to adopt restrictive measures against CE marked devices which may compromise the health or safety of patients (safeguard clause), against products on which the CE marking is either unduly affixed or missing (wrongly affixed CE marking) or in relation to a given device or group of devices for which the observance of particular requirements is deemed necessary to ensure protection of health and safety (particular health monitoring measure). The use of the right to adopt such measures is subject to the respect of procedural requirements which include the information of the other Member States and of the Commission. The latter one is required to inform as to whether a safeguard clause measure or a particular health monitoring measure is justified.           

4. Clinical investigation and evaluation

With regard to devices other than IVD, the manufacturer must collect clinical data to demonstrate the conformity with the essential requirements. 'Clinical data' is defined as the "safety and/or performance information that is generated from the use of a device". The data can be sourced from

Ø clinical investigation(s) of the device concerned (which is generally required for implantable devices and class III devices), or

Ø clinical investigation(s) or other studies reported in the scientific literature of a similar device for which equivalence can be demonstrated, or

Ø published or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence can be demonstrated.

Clinical investigations must be notified to the authorities of the Member States where the investigation shall be conducted. Competent authorities and ethics committees assess the acceptability of the envisaged investigation within a period of 60 days. 

The evaluation of the clinical data to demonstrate the conformity of a device with the essential requirements, including side-effects and acceptability of the benefit/risk ratio, ('clinical evaluation') must follow a defined methodologically sound procedure based on

Ø a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, if equivalence can be demonstrated, or

Ø a critical evaluation of the results of all clinical investigations, or

Ø a combination of both.

The clinical evaluation is part of the documentation to be submitted by the manufacturer to the Notified Body for conformity assessment. 

5. Vigilance

The vigilance procedure is part of the regulatory requirements to ensure the safety of devices after their placing on the market or putting into service. Manufacturers are held to notify the authorities of the Member States of any incident that has occurred with a medical device. Incidents in terms of the Directives are

Ø any malfunction deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in their state of health, or

Ø any technical or medical reason in relation to the characteristics or performance of a device leading to a systematic recall of devices of the same type.

Member States have to take the necessary steps to ensure that any information by manufacturers about incidents is recorded and evaluated centrally. As part of national policy, a Member State can also require medical practitioners or the medical institutions to inform the competent authorities of any such incidents. In that case, it shall ensure that the manufacturer of the device concerned, or his authorised representative established in the EU, is also informed of the incident.

Due to the global market of medical devices, vigilance has an international dimension. In the framework of the Global Harmonisation Task Force for medical devices (GHTF)[22], a system has been set up to inform about serious incidents with a medical device among the participating countries, the so-called National Competent Authority Reports (NCAR) Exchange Programme, which allows exchanging information about incidents at a global scale[23]. 

III. Implementation

Whilst the legal framework has remained stable over the last two decades, it requires a careful and resource-intensive management and implementation, in particular at the national level. As the Directives cover an enormous variety of products and risks, there is a need for wide co-ordination and consultation between authorities and Commission. In order to ensure a coherent implementation of the Directives, Commission, national authorities and stakeholders have created a number of informal working groups[24], in addition to the formal Comitology Committee foreseen in the Directives.

The main platform for discussion on implementation issues is the Medical Devices Experts Group (MDEG), chaired by the Commission. Participants are the national competent authorities and stakeholders such as representatives of industry, Notified Bodies, healthcare professionals and European standards bodies. MDEG has set up a number of specific working groups dealing with issues such vigilance, clinical investigation and evaluation, IVD specific matters or borderline and classification issues. MDEG endorses legally not binding guidance documents, so-called MEDDEVs[25], that reflect the consensus view of authorities and stakeholders on issues of interpretation or implementation. Consensus found on borderline and classification issues are included in the Manual on Borderline and Classification[26] which is regularly updated by the Commission.

Under the oversight of the network of Competent Authorities for Medical Devices (CAMD), national authorities have set up the Notified Bodies Operations Group (NBOG) and the Compliance and Enforcement Group (COEN) to co-ordinate the policies in the fields of, respectively, Notified Body oversight and market surveillance. Meetings are chaired by a national authority and hosted by the Commission. More recently, Member States have set up a Central Management Committee (CMC) aiming at achieving greater consistency in the interpretation and implementation of the Directives by improving decision-making between the national regulatory authorities.

Appendix 6a – Statistics regarding National Competent Authorities Reports (NCARs) in the Field of Vigilance

General overview of NCARs exchanged at European level (EU/EFTA) from 2007 – 2010

Total  2007 = 222 Total  2008 = 434 Total  2009 = 611 Total  2010 = 748 Total  2010 = 748

Number of NCARs sent by EU/EFTA countries in 2010 

Total = 748

Repartition of NCARs between MD/AIMD and IVD in 2009 and 2010

2009

2010

NCARs regarding MD and AIMD according to risk classes in 2009 and 2010

2010

2009

 

Appendix 6b – Statistics regarding incident reports in the Field of Vigilance

According to the public information made available on the websites of the four competent authorities who exchanged the largest number of NCARs in 2010, the numbers of reported incidents are as follows (NB: the criteria for the statistics published by the authorities are not harmonised):

Germany (source: homepage of the Bundesinstitut für Arzneimittel und Medizinprodukte, www.bfarm.de):

Year || 2010 || 2009 || 2008

Reported incidents || 5,780 || 4,894 || 4,883

United Kingdom (source: homepage of the Medicines and Healthcare Products Regulatory Authority, www.mhra.gov.uk):

Year (financial year) || 2010/11 || 2009/10 || 2008/09

Reported incidents || 10,449 (investigated: 2,940) || 9,270 (investigated: 2,932) || 8,884 (investigated: 2,888)

Ireland (source: homepage of the Irish Medicines Board, www.imb.ie):

Year || 2010 || 2009 || 2008

Reported incidents || 1,678 || 1,335 || 1,160

France (source: homepage of the Agence française de sécurité sanitaire des produits de santé, www.afssaps.fr):

Year || 2010 || 2009 || 2008

Reported incidents || 10,575 || 10,097 || 10,865

· The majority of incidents are reported by manufacturers.

Incidents reported by: || Germany (2004-2010) || UK (2007/08-2010/11) || Ireland (2010) || France (2008-2010)

Manufacturers || 76% || 43-48% || 49% || 42%

Users || 16% || 31-38% (NHS) || 6% || 52%

Other sources || 8% || 26-14% || 45% || 6%

· The numbers of recalls/field safety corrective actions are as follows:

|| Germany (2005-2010) || UK (2007/08-2010/11) || Ireland (2009) || France (2010)

Number/percentage of recalls/field safety corrective actions || 24% || 35% || 676 actions with direct impact on Irish market || 37%

Appendix 7 – Possible Tasks of a Medical Device Expert Group

Possible role of a new statutory Medical Device Expert Group under a future regulatory framework for medical devices (composed of experts appointed by the EEA Member States, CH, TR) + sub-groups for Notified Bodies' Oversight (ex-NBOG) Post-Market Safety (ex-Vigilance and ex-COEN) Clinical Investigations and Evaluation (ex-CIE) Borderline & Classification (ex-Borderline and Classification WG) Standardisation and CTS (new + ex-IVD TG) Eudamed/UDI WG (ex-Eudamed WG) Notified Bodies' Coordination (ex-NB-Med) New & Emerging Technologies (ex-NET)  (with appropriate participation of representatives of patients, healthcare professionals, industry and Notified Bodies)

I. Designation and Monitoring of Notified Bodies 1. Scrutinize and provide opinion regarding assessment reports concerning Notified Bodies 2. Elaborate harmonised criteria for the designation and monitoring of Notified Bodies

II. Monitoring of Conformity Assessment Procedures Select files for submission of a summary evaluation report by a Notified Body and scrutinize these reports  

III. Device Specific Requirements Elaborate harmonised requirements in relation to certain devices or technologies, including their assessment by Notified Bodies (e.g. CTS for IVD)

IV. Borderline and Classification Provide opinion on a suggested qualification of a product and the classification of a device (incl. participation in a cross-sectoral advisory borderline group)  

V. Post-Market Safety (Vigilance and Market Surveillance) 1. Serve as platform for the coordination of the analysis of certain incidents (e.g. in case of high-risk incidents or divergent opinions of competent authorities) 2. Provide an opinion regarding reactions concerning device types with high incident rates (e.g. device specific requirements and/or enhanced monitoring of conformity assessment) 3. Endorse actions for coordinated national market surveillance (e.g. resource sharing, common projects and information campaigns, see for example Art. 25 of Reg. 765/2008) and monitor the follow-up 4. Provide an opinion on national restrictive measures notified to the Commission pursuant to a safeguard clause or a health monitoring measure

VI. Clinical Investigations (CI) 1. Serve as platform for the coordination of the technical analysis of a single submission for a multi-national clinical investigation 2. Serve as platform for the coordination of restrictive measures (halting, modification, temporary interruption of CI) in case of serious issues arising during the CI

Appendix 8 – Possible Tasks to be fulfilled at EU level

Possible tasks to be fulfilled at EU level under a future regulatory framework for medical devices

I. Designation and Monitoring of Notified Bodies 1. Organise and participate in assessments of Notified Bodies (initial assessment and periodical assessment every 3-5 yrs) Option 1: Assessment by "EU assessors" together with the Member State were NB is established Option 2: Assessment by a 'joint assessment team' composed of assessors from 2 Member States and 1 EU assessor 2. Provide support for the following activities of the MDEG: Ø Scrutiny and delivery of opinion regarding assessment reports concerning Notified Bodies Ø Elaboration of harmonised criteria for the designation and monitoring of Notified Bodies, in order to feed into delegated or implementing acts for adoption by the Commission, where necessary

II Monitoring of Conformity Assessment Procedures Provide support for the following activities of the MDEG: Ø Selection of files for submission of a summary evaluation report by a Notified Body and scrutiny of these reports  

III. Device Specific Requirements Provide support for the following activity of the MDEG: Ø Elaboration of harmonised requirements in relation to certain devices or technologies, including their assessment by Notified Bodies (e.g. CTS for IVD) in order to feed into delegated or implementing acts for adoption by the Commission, where necessary

IV. Borderline and Classification Provide support for the following activity of the MDEG: Ø Delivery of opinion on a suggested qualification of a product and the classification of a device (incl. participation in a cross-sectoral advisory borderline group) in order to feed into delegated or implementing acts for adoption by the Commission, where necessary

V. Post-market Safety (Vigilance, Post-market Clinical Follow-up and Market Surveillance) Vigilance: 1. Provide support for the following activities of the MDEG: Ø Serving as platform for the coordination of the analysis of certain incidents (e.g. in case of high-risk incidents or divergent opinions of competent authorities) Ø Delivery of opinion regarding reactions concerning device types with high incident rates (e.g. device specific requirements and/or enhanced monitoring of conformity assessment) 2. Monitor incident reports, identify trends/signals and ensure appropriate follow-up Market Surveillance: 3. Provide support for the following activities of the MDEG: Ø Endorsement of actions for coordinated national market surveillance (e.g. resource sharing, common projects and information campaigns, see for example Art. 25 of Reg. 765/2008) and monitoring of the follow-up Ø Delivery of opinion regarding national restrictive measures notified to the Commission pursuant to a safeguard clause or a health monitoring measure, in order to feed into delegated, implementing or others acts for adoption by the Commission, where necessary

VI. Clinical Investigations (CI) 1. Receive applications from sponsors for multi-national CI as single entry point = single submission 2. Provide support for the following activities of the MDEG: Ø Serving as platform for the coordination of the technical analysis of a single submission for a multi-national clinical investigation Ø Serving as platform for the coordination of restrictive measures (halting, modification, temporary interruption of CI) in case of serious issues arising during the CI

VII. Development and maintenance of IT tools 1. New IT application for secure transmission of data from Notified Bodies Ø Repository of reports regarding the assessment of Notified Bodies Ø Notification by Notified Bodies of new applications for conformity assessment concerning high risk devices Ø Submission of summary evaluation reports by Notified Bodies for selected devices and follow-up 2. Further development of Eudamed Ø More developed vigilance module establishing a data-processing network and allowing a central reporting of incidents by manufacturers Ø Central registration of economic operators and listing of medical devices with integration of an Unique Device Identification (UDI) database Ø Single submission of applications for multi-national clinical investigations

VIII. External Scientific and Clinical Expertise, Reference Laboratories, Informal Clearing Mechanism 1. Set up a panel composed of clinical and scientific experts in different fields of medical devices and provide administrative support 2. Set up and manage a network of Reference Laboratories in the field of medical devices 3. Prepare mandates for expert opinions upon request of the Commission (e.g. to decide about safeguard clause; to prepare implementing measures etc.) 4. Organise scientific and/or regulatory 'early advice' for manufacturers (in particular SMEs) and/or Notified Bodies 5. Set up and manage an informal (web-based) clearing mechanism to support uniform application of legal requirements for manufacturers, Notified Bodies, competent authorities and other stakeholders

IX. Standardisation* 1. Participate in the development of standards in the field of medical devices at international (ISO, IEC) and European (CEN, CENELEC) level 2. Prepare the Commission's decision on the harmonisation of standards

X. Training and Public Information* 1. Provide or organise training for manufacturers, Notified Bodies and competent authorities on regulatory issues 2. Set up public information tools regarding EU regulatory requirements

XI. International Cooperation* 1. Exchange NCAR Reports through the GHTF NCAR Exchange Programme and other confidential information with certain 3rd countries (e.g. FDA, Health Canada, TGA, PMDA) 2. Participate in international cooperation and harmonisation in the field of medical devices 3. Support the promotion of the EU regulatory model at a global level

* Cross-cutting task which would need to be fulfilled by the experts in the relevant fields.

Appendix 9 – Overview of the costs and benefits of the preferred policy options

Preferred Policy Options || Costs || Benefits

Problem 1: Oversight of Notified Bodies

Policy option 1A: New minimum requirements for Notified Bodies || = (cost-neutral) || enhanced level of patient safety and public health level playing field for Notified Bodies and manufacturers

either Policy option 1B: Designation and monitoring of Notified Bodies by an EU body || ↑ EU (staff costs for 24 FTE + €200K/y travel expenses) ↓ Member States (main responsibility transferred to EU) ↑ Notified Bodies in case of increased fees for designation/monitoring || enhanced level of patient safety and public health level playing field for Notified Bodies and manufacturers reinforced recognition of CE-marking (smoother functioning of internal market and int'l trade) support of competitiveness and innovativeness of EU medical device industry

or Policy option 1C: Designation and monitoring of Notified Bodies by Member States with involvement of "joint assessment teams" || ↑ EU (staff costs for 9 FTE  + €200K/y reimbursement of nat. assessors + €200K/y travel expenses) = Member States (shared responsibility with existing resources) ↑ Notified Bodies in case of increased fees for designation/monitoring || enhanced level of patient safety and public health level playing field for Notified Bodies and manufacturers reinforced recognition of CE-marking (smoother functioning of internal market and int'l trade) support of competitiveness and innovativeness of EU medical device industry

Policy option 1G: Notification requirement regarding new applications for conformity assessment and possibility for ex ante control || ↑ EU (staff costs for 8 FTE + IT infrastructure for notification) ↑ Notified Bodies (€100K/y admin. costs for notifications and follow-up) || enhanced level of patient safety and public health level playing field for Notified Bodies and manufacturers reinforced recognition of CE-marking (smoother functioning of internal market and int'l trade) support of competitiveness and innovativeness of EU medical device industry

Problem 2: Post-market safety (vigilance and market surveillance)

Policy option 2A: Clarification of key terms and of the obligations of the parties involved in the field of vigilance || = (cost-neutral) || enhanced legal certainty ensuring appropriate follow-up of incidents enhanced level of patient safety and public health better functioning of internal market

Policy option 2B: Central reporting of incidents and coordinated analysis of certain high risk incidents || ↑ EU (staff costs for 8 FTE + IT infrastructure) = Member States (work sharing with existing resources; no duplication of work) ↓ Manufacturers (single reporting of incidents and coherent reaction throughout EU) || enhanced level of patient safety and public health better functioning of internal market support of competitiveness of EU medical device industry

Policy option 2D: Promotion of cooperation of market surveillance authorities || ↑ EU (staff costs for 2 FTE) = Member States (work sharing with existing resources; no duplication of work) = Economic operators (no costs for compliant operators) || increased efficiency of resources spent on surveillance activities enhanced level of patient safety and public health

Problem 3: Regulatory status of products

Policy option 3B: Creation of a cross-sectoral advisory group on borderline issues and possibility to determine the regulatory status of products at EU level in certain areas || ↑ EU (increased workload of COM for preparing and adopting decisions on regulatory status; reimbursement of nat. experts) ↓ Member States (possibility to transfer decision-making to EU level; avoidance of legal disputes before nat. courts) ↓ Manufacturers (less compliance costs due to application of a single regulatory regime)  || enhanced legal certainty enhanced level of patient safety and public health better functioning of internal market level playing field for manufacturers support of competitiveness and innovativeness of EU medical device industry

Problem 4: Lack of transparency and harmonised traceability

Policy option 4B: Central registration of economic operators and listing of medical devices placed on the EU market || ↑ EU (major part of budget for IT infrastructure estimated at €2mio/y, decreasing to €1.8mio/y as of 2018) ↓ Member States (responsibility for registration transferred to EU) ↓ Economic operators  (estimated reduction of admin. costs of between €81-157mio. due to single instead of multiple registrations)   || enhanced level of patient safety and public health increased transparency for patients, healthcare professionals and authorities removal of obstacles to the internal market reinforced confidence in the regulatory system support of competitiveness and innovativeness of EU medical device industry

Policy option 4C: Requirement for the traceability of medical devices || ↑ EU (development and management of a European UDI system) ↓ Member States (responsibility for UDI system transferred to EU) ↓ Manufacturers (savings due to single UDI system instead of several incompatible national systems, compensating for costs for UDI codes, labelling & upload of information in UDI database) || enhanced level of patient safety and public health avoidance of fragmentation of the internal market synergies with int'l trading partners introducing UDI systems (e.g. FDA) support of competitiveness of EU medical device industry

Problem 5: Access to external expertise

Policy option 5B: Designation of an expert panel and reference laboratories || ↑ EU (staff costs for 2-3 FTE, reimbursement of experts)  || enhanced science-based decision-making by Member States and COM to the benefit of patients, healthcare professionals, public health and manufacturers support of competitiveness and innovativeness of EU medical device industry

Problem 6: Unclear and insufficient obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales

Policy option 6A: Alignment with Decision 768/2008, additional requirements for authorised representatives and clarification of obligations in the field of diagnostic services || = (cost-neutral) || enhanced level of safety and public health better functioning of internal market

Policy option 6C: Addressing internet sales by soft-law action || ↑ EU and Member States (financing of awareness campaigns, portal or others actions) || enhanced level of patient safety and public health increased efficiency of resources spent support of competitiveness of EU medical device industry

Problem 7: Management of the regulatory system

either Policy option 7A: Extension of the responsibility of the European Medicines Agency (EMA) to medical devices and creation of a Medical Device Expert Group at this agency || ↑ EU (€1.4mio/y for reimbursement of nat. experts for meetings of MDEG and sub-groups; transfer of tasks to EMA as such would not lead to costs in addition to those mentioned under the policy options above/below, except for agencies overhead costs) = Member States (work sharing with existing resources) || effective and efficient management for the benefit of patients, healthcare professionals, manufacturers and authorities synergies in the field of drug-device  combination and borderline products consistency with majority of Member States and int'l partners support of competitiveness and innovativeness of EU medical device industry

or Policy option 7C: Management of the medical device regulatory system by the European Commission and creation of a Medical Device Expert Group supported by this institution || ↑ EU (€1.4mio/y for reimbursement of nat. experts for meetings of MDEG and sub-groups; accomplishment of tasks by COM would not lead to costs in addition to those mentioned under the policy options above/below) = Member States (work sharing with existing resources) || effective and efficient management for the benefit of patients, healthcare professionals, manufacturers and authorities use of existing resources support of competitiveness and innovativeness of EU medical device industry

Problem MD-1: Scope - regulatory gaps or uncertainties

Policy option MD-1B: Regulate products manufactured utilising non-viable human cells and tissues as medical devices || ↑ Manufacturers (costs for conformity assessment under MD legislation)  ||  harmonised level of  patient safety and public health  creation of an internal market  support of innovation

Policy option MD-1C: Regulation of certain implantable or other invasive devices without a medical purpose within the MDD || ↑↓ Manufacturers (some manufacturers increased costs for conformity assessment under MD legislation; other manufacturers reduced costs due to single regulatory regime for similar products; e.g. corrective and non-corrective contact lenses) ||  harmonised level of  patient safety and public health  creation of an internal market

Policy option MD-1F: Harmonized regulation of the reprocessing of single-use medical devices (SUD) || ↑ SUD reprocessors (need to enhance their validation process + additional labelling requirement) – mitigation of these costs by the creation of a single market for reprocessed SUD ↑ Manufacturers (decrease of the sales volumes for original SUD) || enhanced level of patient safety and public health enhanced information of patients and healthcare professionals creation of the conditions for an internal market

Problem MD-2: Adaptation of legal requirements to technological, scientific and regulatory developments

Policy option MD-2B: Review of the classification rules and essential requirements regarding specific devices or technologies || = (cost-neutral) || enhanced level of  patient safety and public health level playing field for manufacturers better functioning of internal market support of competitiveness and innovativeness of EU medical device industry

Problem MD-3: Clinical evaluation and clinical investigations, in particular those carried out in more than one Member State

Policy option MD-3A: Introduction of the term "sponsor" for clinical investigations and further clarification of key provisions in the field of clinical evaluation and investigations || = (cost-neutral) || enhanced level of  patient safety and public health better functioning of internal market

Policy option MD-3B: Coordinated assessment of multi-national investigations by the competent authorities of the Member States where the investigation is performed || ↑ EU (staff costs for 5 FTE, IT infrastructure for single submission) = Member States (work sharing with existing resources; no duplication of work) ↓ Manufacturers/sponsors (single submission; consistent outcome of technical assessment)    || enhanced level of  patient safety and public health support of competitiveness and innovativeness of EU medical device industry

Problem IVD-1: Scope – regulatory gaps or uncertainties

Policy option IVD-1C: Clarify the scope of the exemption for "in-house" tests, require a mandatory accreditation for "in-house" tests manufacturers and subject high risk (class D) "in-house" tests to the requirements of the IVDD || ↑ Laboratories (accreditation according to ISO 15189 or similar requirements + submission of class D "in house" IVDs to the requirements of the IVDD) || enhanced level of patient safety and public health enhanced legal certainty improving the functioning of internal market level playing field for laboratories

Policy option IVD-1F : Amendment of the legal definition of an IVD to include tests providing information "about the predisposition to a medical condition or a disease" || ↑ Manufacturers of genetic tests which currently escape from the IVDD (need to demonstrate compliance, usually with the involvement of a Notified Body in the conformity assessment procedure) || enhanced level of patient safety and public health enhanced legal certainty improving the functioning of the internal market level playing field for manufacturers

Policy option IVD-1G: No legislative change regarding companion diagnostics || ↑ Manufacturers  (these tests are currently self-certified by the manufacturers but, with the GHTF classification system, they will require the involvement of a notified body in the conformity assessment procedure – see costs and benefits of policy option IVD-2B) ||  enhanced level of patient safety and public health

Problem IVD-2: Classification of IVDs and their appropriate conformity assessment, including batch release verification

Policy option IVD-2B: Adoption of the GHTF classification rules and adaptation of the conformity assessment procedures to the relevant GHTF guidance || ↑ Manufacturers  (adaptation costs and increased involvement of notified bodies in the conformity assessment for class B and C IVDs – mitigation of these costs by the advantages in terms of competitiveness and international trade) || enhanced level of patient safety and public health fostering international trade support of competitiveness, innovativeness of EU medical device industry

Policy option IVD-2C: Batch release verification for high risk IVDs by the manufacturer under the control of a Notified Body (legislative clarification) || ↓ Manufacturers  (clarification that batch release testing by an independent laboratory could not be required by the individual Member States) || enhanced legal certainty improving the functioning of internal market level playing field for manufacturers support of competitiveness of EU medical device industry

Problem IVD-3: Unclear legal requirements and need for their adaptation to technological progress

Policy option IVD-3B: Legislative clarification of the requirements for the clinical evidence for IVDs || = (cost-neutral) || enhanced legal certainty improving patient safety and public health better functioning of internal market

Policy option IVD-3E: Clarification of the legal requirements in respect to point-of-care or near-patient IVDs || = (cost-neutral) || enhanced legal certainty improving patient safety and public health better functioning of internal market

Policy option IVD-3G: Alignment with the MDD where appropriate || = (cost-neutral) || enhanced legal certainty improving patient safety and public health better functioning of internal market support of competitiveness and innovativeness of EU medical device industry

Appendix 10 – Legal Form of the Revision of the Medical Devices Directives

The two questions which need to be assessed and decided as regards the legal form are

(1) whether medical devices (MD) and in vitro diagnostic medical devices (IVD) should be regulated together, i.e. within one legislative act or within two separate legislative acts, and

(2) whether the current directives should be transformed into a regulation.

1. Options considered

Option 1: Two separate legislative acts: one act concerning MD and one act concerning IVD

Option 1 would consist in the adoption of a legislative act which merges the AIMDD and the MDD, codifies them with their amending directives[27] and at the same time amends existing provisions. A separate legislative act would be adopted for IVD, codifying and amending the IVDD.

Option 2: One legislative act concerning medical devices and IVD

Option 2 would consist in a merger (including codification and revision) of all three medical devices directives (AIMDD, MDD and IVDD) in one legislative act.

Option 3:  Maintaining the legal form of a directive

According to option 3, the legislative act(s) outlined in policy options 1 and 2 would continue being in the legal form of a directive in terms of Article 288, paragraph 3, TFEU.

Option 4: Transforming the current directives into a regulation

Option 4 would mean adopting the legislative act(s) outlined in policy options 1 and 2 in the legal form of a regulation in terms of Article 288, paragraph 2, TFEU.

2. Analysis of options

2.1. Option 1 v. option 2 (one or two proposals for MD and IVD)

The AIMDD and the MDD have been separate for historic reasons. Their provisions have converged over time, in particular through amendments introduced by Directive 2007/47/EC and separate regulation of AIMD, on the one hand, and other medical devices, on the other hand, is not justified on any grounds any more. The merger and codification of the AIMDD and MDD has already been envisaged in the 2005 Simplification Programme of the Commission[28].

Option 1 and option 2 would both result in the adoption of new legislative acts repealing the existing directives. For purely formal reasons, this will have the impact that existing documentation (of manufacturers, Notified Bodies, authorities) that refers to the current directives (e.g. information brochures, websites, forms for certificates and declarations of conformity) would require updating in order to refer to the new legislative texts. If phased in over a sufficient period of time the costs will not bee very high since product developments (average life-cycle 18 months) and legislative changes in any case would require review of existing documentation.

The overall impact of a merger of the AIMDD and the MDD would be positive in terms of simplification, easier management and international alignment. Since the differences between the AIMDD and the MDD are very limited, their merger will have no substantial consequence. Already today, many Member States regulate AIMD as class III medical devices within their regulations applicable to other MD. The few specific provisions applicable to AIMD (e.g. accessories) could be maintained where necessary. Other provisions which unintentionally are out of tune between the two directives could be aligned which would have the positive impact to streamline the applicable requirements, in particular for manufacturers of AIMD which often also produce other devices subject to the MDD. A merger of the AIMDD and the MDD would also align EU legislation with guidance documents of the GHTF that do not distinguish between MD and AIMD, but consider the latter in the context of the GHTF classification criteria as class D devices[29]. 

In the 2008 public consultation on the recast of the medical devices directives, the question was raised whether, in addition to a merger of the AIMDD and the MDD, also the provisions of the IVDD should be incorporated in one legislative act applicable to all medical devices, including IVD (see policy option 2). As regards this question, it could be argued that the horizontal aspects of the revision which apply to all devices including IVD, such as the designation and monitoring of Notified Bodies or the vigilance procedure, would be better regulated within one and the same legislative act in order to avoid discrepancies arising over time. The majority of stakeholders, however, in particular industry, who responded to the 2008 public consultation were in favour of regulating IVD in a separate piece of legislation[30] in order to respect the specificities of the products (different risks and functioning).

In fact, if policy option 2 was chosen, specific provisions of the one legislative act would need to be applicable only to IVD (e.g. in house tests, clinical evidence, specific essential requirements, classification rules for IVD) while the application of other parts would need to be excluded in order to take account of the specificities of IVD (reprocessing of single-use devices, clinical investigations, specific essential requirements, classification rules for MD). This could have a negative impact on the readability of the legislative act which would need to have parts applicable to all devices, other parts applicable only to MD and again other parts applicable only to IVD. This would run counter to a simplification of the EU legislation. The handling of a more complex legislative text would likely be considered unnecessarily burdensome for the IVD industry which is relatively homogenous with most manufacturers, mostly SMEs, producing only IVD and not other MD.

In addition, the separation of requirements for medical devices other than IVD and for IVD is also the trend at international (GHTF) level where specific guidance documents have been adopted for MD other than IVD[31], or only for IVD[32] whilst some other guidance documents are currently being revised to introduce specific parts for IVD[33].

2.2. Option 3 v. option 4 (Directive or Regulation)

Pursuant to Article 296 TFEU the type of the legislative act shall be selected in compliance with the applicable procedures and with the principle of proportionality.

A Directive in terms of the 3rd paragraph of Article 288 TFEU (option 3) would be binding as to the results to be achieved but would "leave to the national authorities the choice of form and methods". A Regulation in terms of the 2nd paragraph of Article 288 TFEU (option 4), would "be binding in its entirety and directly applicable in all Member States".

The pros and cons of both legal form can be summarised as follows:

Adoption of a regulation:

· Directly applicable in all Member States without the need of transposition into national law with a single regulatory framework for medical devices as reference for economic operators (this would also apply to future amendments); 

· National differences regarding the date and/or way of transposition would be eliminated which would enhance a level playing field in the internal market. [NB: Whilst late transposition was very frequent in the case of the last amending Directive 2004/47/EC incorrect transposition of the medical devices directives has not been a major problem so far. The fragmentation of the internal market rather results in divergent interpretation and implementation practices which occur with regulations and directives alike.] The adoption of a regulation, however, would require that all Member States repeal their existing national regulations in the field of medical devices and that the European Commission would need to monitor this process; 

· More 'freedom' to conceive a new, more user-friendly legislative text;

· Faster application because no need for a transposition deadline in addition to a deadline for application.

Adoption of a directive:

· Member States could maintain a regulatory framework for medical devices at national level in coherence with their national regulatory system where the product regulation often is interlinked with areas of total national competence (e.g. requirements regarding the use of specific devices or their prescription; reimbursement);

· Possibility to use the technique of a "recast"[34]. This would prevent that provisions in the AIMDD/MDD/IVDD which the Commission does not intend to modify, in particular those recently amended by Directive 2007/47/EC (application as of March 2010), are subject to substantial changes, e.g. most essential requirements incl. labelling, classification rules and requirements regarding clinical evaluation. If all aspects of the current directives were subject to negotiations, the compliance costs for manufacturers (especially SME) would risk to increase, but also the acquired level of safety could be modified;  

· The envisaged rules regarding medical devices are less prescriptive and detailed than legislation in the field of chemicals, cosmetics, and food and feed, where many EU directives have been replaced in recent years by regulations. Basically all sector-specific EU legislations in the areas governed by the "new approach" have been adopted in the form of directives. There would be no concerns with regard to the principle of proportionality as guiding principle for the choice of the type of legislative act (Article 296 TFEU);

· Adoption of a directive would not prevent the Commission to adopt subsequent delegated or implementing acts in the form of a regulation.  

3. Conclusion                                                    

Between option 1 and option 2, the first option provides clear advantages and should be retained. The choice of the type of legislative act is less obvious and more a question of political convenience than of legal constraint. If the EU rules on medical devices were to be conceived today from scratch, the form of a regulation would likely be chosen since it would ensure a higher level of coherence as regards protection of health and safety, on the one hand, and internal market, on the other hand. It would also lead to less administrative burden on the authorities since adoption and management of the legislation would not need to be multiplied by 27. The initiative to revise the whole existing regulatory framework for medical devices therefore offers a unique opportunity to transform directives into regulations.   

Based on the above analysis, options 1 and 4 are retained. The AIMDD and the MDD should be merged and transformed into a Regulation concerning medical devices. The IVDD should be transformed into a Regulation concerning in vitro diagnostic medical devices but kept as separate legislative act.

Appendix 11 – Analysis of the PIP breast implants case in the light of the envisaged revision of the EU regulatory framework for medical devices ("stress test")

Working document for meeting on medical devices 4.5.2012

PIP case Chronology of facts[35] || EU legislation applicable at the time of the facts (Directive 93/42/EEC on medical devices, hereafter MDD[36] [37]) || EU legislation applicable since March 2010 (amendments introduced by Directive 2007/47/EC) || Envisaged amendments to be presented in the Commission proposals[38] (already envisaged prior to PIP; additional amendments due to lessons learned from PIP are marked with an *)

1. Pre-market || || ||

1.1. Conformity assessment || || ||

In July 1997, the notified body TÜV Rheinland[39] (identification number 0197) carried out the first audit of the manufacturer PIP in the context of the conformity assessment regarding soft tissue breast implants.   In 1997, TÜV Rheinland issued a quality system certificate in accordance with Annex II MDD. After recertification audits in July 2002 and Sept. 2007 , TÜV Rheinland renewed the quality system certificate.  In 2004, after the reclassification of breast implants, TÜV Rheinland issued also a design dossier examination certificate in accordance with Annex II, sect. 4, MDD. This certificate was renewed in 2009. According to the information provided by the German authorities, the assessment teams consisted of several auditors (lead auditors and auditors) and included qualified personnel for the device group "soft tissue implants". || For the conformity assessment of breast implants, notified bodies as independent third parties must be involved prior to implants being placed on the market. Manufacturers may choose any notified body that is designated for the required tasks.  Until 2003, breast implants were classified as class IIb devices (Annex IX, rule 8, MDD). The notified body's involvement was thus limited to verification of the manufacturer's quality system (Annex II, without sect. 4, MDD). Certificates issued in accordance with Annex II have a validity of 5 years. In 2003, on the request of France and UK, breast implants were reclassified as class III devices by Commission Directive 2003/12/EC. Since 1.9.2003 (or since 1.3.2004 regarding breast implants already on the market), the conformity assessment by notified bodies consists of the assessment of - the manufacturer's quality system and - the design dossier related to the device.  It is required that the body's assessment team includes at least one member with past experience of assessments of the technology concerned. || The conformity assessment process for class III MD has not been significantly amended. But is has been reinforced for IIa and IIb devices for which, in addition to the quality system, notified bodies must examine the design documentation on a representative basis (sampling regime). || On a case-by-case basis, individual conformity assessment procedures for high risk or novel devices shall be subject to  scrutiny by a committee of national experts (with rapporteur and co-rapporteur system) prior to the issuance of certificates by the notified body. Possibility to adopt, by implementing or delegated acts, mandatory requirements for certain devices regarding the documentation to be submitted by manufacturers to notified bodies and their assessment. * Notified bodies, in the context of the design dossier examination,  should carry out adequate physical or laboratory tests of the device or of its crucial components or require manufacturers to carry out such tests under their supervision (and possibility to consult reference laboratories where those are designated for specific risks or devices). * Manufacturers should  have available in their organisation a qualified person responsible for the regulatory compliance of the device released on the market with appropriate qualification, legal status and personal liability.

1.2. Safety and performance requirements, incl. clinical evaluation || || ||

PIP's technical documentation is not available to the Commission. But according to information at its disposal, PIP declared using silicone gel approved for medical use (e.g. Nusil©). There is no evidence that at the moment of the first and subsequent conformity assessments, the breast implants did not comply with the legal requirements.    It is not clear at what moment and during which periods PIP changed the design of and the material used for the implants in a way that the safety and performance requirements expected from such a medical device were not met any more (e.g. use of industrial grade silicone instead of medical silicone, increased and premature rupture, oozing of silicone).     || Annex I MDD lays down the essential requirements to be met by medical devices. The basic requirement is that "devices must be designed and manufactured in such a way that […] they will not compromise the clinical condition or the safety of patients, or the safety and health of users […] provided that any risks which may be associated with their intended 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". Specific requirements exist regarding the chemical, physical and biological properties of devices (e.g. toxicity and biocompatibility of used material, minimization of risk due to leakage of substances).      There are no specific requirements for implants. As regards breast implants, in 2001, the Commission provided guidance[40] as to which aspects should be particularly looked at and issued a mandate for a standard that lays down detailed specifications regarding breast implants[41].   According to Annex X MDD, as a general rule, demonstration of conformity with the characteristics and intended performances must be based on clinical data, in particular in the case of implantable and class III devices. || The essential requirements were reviewed and several amendments introduced such as the requirements to take into account results of validated biophysical or modeling research or to pay special attention to CMR substances.  The requirements regarding clinical evaluation have been significantly strengthened. It is now always required that demonstration of conformity with the essential requirements must include a clinical evaluation (Annex I, sec. 6a MDD). In the case of implantable and class III devices, clinical investigations must be conducted to obtain the data for the clinical evaluation, unless it is duly justified to rely on existing clinical data (Annex X, sec. 1.1a MDD). Manufacturers are obliged to conduct a post-market clinical follow-up as part of the post-market surveillance regarding their devices (Annex X, sec. 1.1c MDD).  || The essential requirements shall be further updated in the light of technological progress and international guidance.  Moreover, there shall be the possibility to adopt, by implementing or delegated acts, mandatory requirements for certain devices, incl. the required clinical evaluation.  It shall be further clarified in the legislation that "equivalence" with another implantable or class III device is not a sufficient justification to omit clinical investigations. Furthermore, manufacturers shall make publicly available a summary of the safety and performance data, incl. the relevant clinical data. Criteria for the manufacturer's post-market clinical follow-up (PMCF), as part of his post-market surveillance plan (PMS), shall be laid down.

1.3. Designation and monitoring of notified bodies || || ||

In 1994, TÜV Rheinland has been designated by Germany as notified body in the field of medical devices; the designation scope includes soft tissue implants. Between 1994 and 2011, the German authorities conducted at least once a year surveillance assessments (with 2-6 assessors). In 2002 and 2003, the assessment was 'peer reviewed' by an assessor of, respectively, the Dutch and the Danish authorities. There is no evidence that TÜV Rheinland lacked the necessary competence to conduct conformity assessments related to breast implants.    || Member States are responsible for the designation and monitoring of notified bodies in accordance with the minimum criteria laid down in Annex XI MDD, but they are vague. In 1998, the requirement was added that notified bodies need to have "sufficient scientific staff within the organisation who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified".  No provisions exist as to how the Member States must conduct the control on notified bodies. Since 2000, designating authorities of the Member States meet in the Notified Body Operations Group (NBOG) to improve the overall performance of notified bodies in the medical devices sector by promulgating examples of best practice to be adopted by both notified bodies and supervising authorities. In 2003, NBOG adopted a Designating Authorities Handbook to provide guidance for designating authorities in the execution of their responsibilities for the designation and monitoring of notified bodies. || The minimum criteria for notified bodies and the designation process have not been amended. But the Commission has been empowered to adopt, by Comitology procedure and in the light of technical progress, detailed measures necessary to ensure consistent application of the minimum criteria to be met by notified bodies for their designation by the Member States. However, efforts had been focussed on a systematic revision of the entire regulatory framework where the designation and monitoring process should be addressed. || The minimum requirements to be met by notified bodies laid down in Annex XI MDD shall be reinforced and made more detailed. Moreover, the designation and monitoring process shall fundamentally be revised. In the future, a Member State shall only designate a body after a 'joint assessment' conducted with experts from the Commission and other Member States. The draft designation shall be submitted to a committee of national experts that can issue a negative opinion. The monitoring of notified bodies shall also regularly be conducted by a 'joint assessment team'.

2. Post-market || || ||

2.1. Surveillance by notified body || || ||

As mentioned above, it is unclear as of when and in which periods PIP silicone breast implants did no longer meet the safety and performance requirements of the MDD. There is no evidence that PIP informed TÜV Rheinland about changes to the design of silicone breast implants such as the change of the design of the devices or the material used for the filling. Between 1998 and 2010, TÜV Rheinland conducted 9 regular surveillance audits (plus 2 recertification audits). Moreover, an extraordinary audit (observed by the German authorities) was conducted in February 2001 further to the UK's Medical Device Alert 2000(07) of December 2000 regarding PIP hydrogel breast implants.  As a result, hydrogel implants were withdrawn from the scope of the certificate by TÜV Rheinland. But the findings did not have an impact on the certification of silicone breast implants. || As part of the surveillance, the notified body must periodically carry out appropriate inspections and assessments. It may pay unannounced visits to the manufacturer and may carry out or ask for tests in order to check that the quality system is working properly. The manufacturer is required to inform the notified body of any changes to the approved quality system and/or product design. || For the surveillance by the notified body, the manufacturer must provide it, among others, with clinical evaluation and the results of the post-market clinical follow-up. But there is still no legally defined role of notified bodies in the vigilance system (only addressed in some guidance documents). || The role of notified bodies in the vigilance system shall be clarified (e.g. obligation of manufacturers to inform their notified body about incidents; access of notified bodies to the future EU vigilance database; obligation of notified bodies to analyse vigilance data and to take appropriate action in relation to audits and certificates). In addition, there shall be the possibility to set mandatory criteria for surveillance audits.   * In the context of their surveillance over manufacturers, notified bodies shall randomly  perform unannounced factory inspections and, in this context, check adequate samples from the production or the manufacturing process. The frequency of unannounced visits should be defined in a subsequent implementing measure to ensure a level playing field.  * Notified bodies should be required that the composition of their assessment teams assures continuous objectivity and neutrality including a rotation of auditors at appropriate intervals.  * It could also be foreseen that, at least for crucial components, a notified body should check coherence between quantity of purchased raw material/ components and quantity of output of finished products. The problem is that such obligation comes close to accountability check which does not fall in the competence of notified bodies. * Negative results of an audit shall be communicated to the Member State where the manufacturer or authorised representative is established.

2.2. Market surveillance by authorities || || ||

In 2000 and 2001, the French authorities took a number of measures regarding breast implants, such as a temporary suspension of their placing on the market and putting into service and the request to all manufacturers to provide additional documentation for their reintroduction on the market. Further to correspondence between the French authorities and PIP, AFSSAPS conducted an inspection of PIP in June 2001 in the context of the 'breast implant' campaign and found several non-conformities. Further to extensive correspondence and submission of additional reports by PIP, AFSSAPS concludes in Dec. 2001 that the non-conformities have been remedied. AFSSAPS then conducted inspections of the other breast implants manufacturers.       || There is a general requirement that Member States must ensure that only compliant devices are placed or put into service on their markets (Article 2 MDD). But there are no specific requirements in the medical device legislation as to how Member States should conduct the surveillance. Regulation 765/2008[42] (applicable since 1.1.2010) provides general requirements as regards Member States' market surveillance obligation (including proper powers and resources of national authorities and appropriate measures such as physical or laboratory checks). In addition to the product related conformity assessment, a 'manufacturing authorisation' by an authority is not required by EU legislation. || This situation has not changed.  || Specific provisions regarding market surveillance shall be introduced in the medical device legislation, such as the obligation to conduct periodic inspections (physical or laboratory checks on samples) and the coordination of surveillance programmes. Negative findings should be communicated to the responsible notified body. Member States shall also be obliged to set "effective, proportionate and dissuasive" penalties in case of violation of the legal obligations and notify them to the Commission. 

On 29 March 2010, the French authorities (AFSSAPS) adopted a decision to recall PIP silicone breast implants from the market and to suspend their placing on the market, distribution, export and use. || Article 8 and Article 18 require Member States to take action against unsafe and/or non-compliant devices.    || This situation has not changed. || The legal instruments for Member States to take restrictive measures against unsafe and/or non-compliant devices shall be clarified to enhance legal certainty for authorities when applying restrictive measures.

On 9 April 2010, the French authorities formally notified the Commission of their decision of 29 March. On 26 April 2010, the Commission informed all EU Member States (PermReps) about the situation and requested them to take the necessary measures to prohibit any placing on the market, distribution, putting into service or use of the PIP implants as well as to alert the medical professionals. In the following weeks and months, Member Sates adopted measures at national level to withdraw the devices from their markets.   || National measures that restrict or prohibit the placing on the market of unsafe and/or non-compliant devices must be notified to the Commission and the other Member States. The Commission shall keep Member States informed about progress and outcome of the safeguard clause procedure.  (Article 8 and Article 18(b)). || In Article 8 (safeguard clause), an empowerment has been added to enable the Commission to adopt, by Comitology procedure, measures regarding the prohibition or restriction of unsafe products. || Clarification of the conditions when the Commission shall be empowered to take a restrictive measure against unsafe and/or non-compliant devices. Expertise shall be available to the Commission (in house and external experts, e.g. Medical Advisory Board) to help to take a decision on a safeguard clause and to take a measure against unsafe and/or non-compliant devices.

2.4.  Vigilance || || ||   

A high number of ruptures of PIP implants occurred. Only a limited number seemed to have been reported to national authorities, in particular the French AFSSAPS and the UK's MHRA, that found unusual high rate (but still below 1%) of premature rupture.  On the basis of incident reports from healthcare professionals in France in 2007 (8 incidents = 0.11%), 2008 (27 incidents = 0.41%) and 2009 (29 incidents = 0.56%), AFSSAPS investigates the trend of higher than usual ruptures of PIP implants.   But PIP seemed to have received complaints from users (found by AFSSAPS during their inspection in March 2010) that had not been reported to AFSSAPS. This data, after analysis by AFSSAPS, shows rupture rates of between 3.5% (in 2007) to 9.39% (in 2009).  In parallel, on the basis of incident reports in the UK, MHRA investigates and concludes that the ruptures of PIP implants (in absolute terms still below 1%) occur unusually early after implantation. MHRA contacted PIP on 22.1. and 18.3.2010. AFSSAPS is informed by MHRA on 6.4.2010. In February 2010, PIP claims in a letter to MHRA that the rupture rate was only 0.3% and provides statistics about sales, ruptures and explantations regarding UK. There was likely significant underreporting by plastic surgeons to the national authorities.   || Manufacturers must have a systematic procedure in place to review experience gained from their devices on the market (post-market surveillance plan, PMS) and are obliged to report incidents[43] to the national authorities. National authorities are obliged to record and evaluate centrally the incidents brought to their attention. But these only concern the incidents reported at national level. Member States are obliged to ensure that manufacturers are informed about incidents reported by healthcare professionals (no EU obligation for healthcare professionals to report). The problem in the present case is that from the current 'incident' definition in the legislation, it is not clear if the individual rupture of a breast implant is to be considered as a "serious deterioration of the state of health" and therefore subject to the reporting requirement or not. Currently, there is no legal obligation of manufacturers to report 'trends', i.e. the accumulation of adverse events that individually do not need to be reported. Moreover, there is no legal obligation of manufacturers to inform their notified body about incidents or field safety corrective actions (some notified bodies oblige manufacturers in their contracts to notify them of vigilance issues). The operation of the vigilance system has already been further detailed by non-binding guidelines (MEDDEVs) which address the issue of trend reporting and the role of notified bodies. || The provision regarding the manufacturer's obligation to have a PMS has been reinforced and extended to post-market clinical follow-up as a continuous and active update of the clinical evaluation. || The obligations regarding the reporting of incidents and the follow-up shall be clarified. In the future, incidents shall be reported by manufacturers to a central vigilance database (part of Eudamed, managed by the Commission) accessible to Member States and notified bodies. The public shall have access to information about measures taken.  Manufacturers shall also be obliged to report "trends", i.e. accumulation of adverse events that individually do not need to be reported. Notified bodies would be obliged to analyse vigilance data and to take appropriate action in relation to audits and certificates. Furthermore, in the case of incidents that occur in several Member States, authorities shall coordinate their assessments under the lead of a coordinating authority and with support of the Commission. The Commission shall have the necessary resources to analyse reported incidents to identify signals and trends which would need action at EU level (e.g. harmonised product requirements). Commission shall be empowered to adopt EU wide measure to ensure uniform reaction to incidents. * Measures could be introduced enhancing the reporting of suspected incidents by  healthcare professionals and patients  (in analogy to the new pharmacovigilance provisions in Art 107a Dir. 2001/83/EC and Art 25 Reg. 726/2004).

On 30 March 2010, the French authorities alerted the other Member States about increased frequency of incidents in relation to PIP silicone breast implants and about their decision of 29 March 2010 to recall PIP silicone breast implants from the market and to suspend their placing on the market, distribution, export and use.  || Member States are obliged to inform the other Member States and the Commission about outcome of evaluation of incidents (Article 10(3) MDD). || Article 10 MDD has been reworded and now requires information about measures taken or contemplated to minimise recurrence of incidents. In addition, the Commission is empowered to adopt, by Comitology procedure, the procedures to implement the Article on vigilance. || A process for the coordination of the assessment  of vigilance cases affecting several Member States shall be established (see above).

In 2010 and 2011, exchange of views and update of state of play during informal meetings of the Medical Device Expert Group (MDEG) and Vigilance working group || MDEG, vigilance and other Commission working groups do not have any statutory basis. || This situation has not changed. || A committee of medical devices experts designated by the Member States shall be set up and supported by the Commission; a sub-group should be dedicated to vigilance and market surveillance issues.

2.5. Traceability || || ||

PIP did not keep records of the whereabouts of their products. Member States have difficulties identifying the women who received PIP implants. || No traceability requirements in the legislation. || This situation has not changed. || Traceability requirements shall be introduced in the new legislation. Economic operators shall ensure traceability up and down the distribution chain. In addition, based on a risk-based approach, traceability of devices shall gradually be implemented by means of a Unique Device Identification (UDI) system. * Patients should obtain an "implant card" with key information about the implanted device, incl. warnings or precautions to be taken (e.g. compatibility with diagnostic devices) and expected life cycle and recommended regular follow-up checks. 

It seems that PIP produced silicone breast implants also for other companies that marketed them with another name under their own names (so called "Own Brand Labellers", OBL). E.g. the Dutch company Rofil sold implants made by PIP under its own name as "M-Implants". The company went bankrupt but seems to have been reestablished in Cyprus. Company structures, bankruptcies and marketing practices are dubious and create additional confusion as to the identification of women having received implants made by PIP.  On 20 January 2012, the German authorities informed that the German company GFE Medizintechnik GmbH presumably during the period September 2003 and August 2004 purchased PIP silicone breast implants, processed them with titan and sold them under the name "Tibreeze".  The company also went bankrupt.  || An OBL is considered a manufacturer in terms of the MDD and must meet all the relevant requirements. The Commission has clarified this with an interpretative document in 2008.  || A provision has been introduced extending the conformity assessment procedure regarding the manufacturer's quality system to third parties that carry out the design, manufacture, testing etc. on behalf of the manufacturer. || OBL shall continue to be considered as manufacturer. They shall be required to provide information about the original equipment manufacturer (OEM) and about identical devices placed on the EU market under different names.  

3. Risk management and recommendations to patients || || ||

Between 21 December 2011 and 4 January 2012, meetings (by teleconference) of the Health Security Committee were organized by the Commission to exchange information and coordinate follow-up by national authorities. || No provisions in the medical devices legislation. The EU Health Security Committee was set up by the Council of Health Ministers in 2001. It is chaired by the Commission and made up by officials from national governments. || This situation has not changed. || A committee of medical devices experts designated by the Member States shall be set up and supported by the Commission. Besides its regular meetings, it would also be convened in crisis situations and provide the platform for regular and structured information exchange between national authorities.  

Different recommendations to patients by Member States. In January 2012, Commission has given a mandate to SCENIHR to provide a common risk assessment with regard to PIP breast implants, based on information provided by the Member States || No provisions in the medical devices legislation. The mandate to SCENHIR is given in accordance with Article 2(3) of Commission Decision 2008/721[44] (urgency procedure). But there is no scientific EU body specialised in medical devices[45]. || This situation has not changed. || A Medical Advisory Board (with possibly specialised expert panels) composed of external scientific experts in the field of different medical disciplines shall be set up to provide scientific advice to the Commission, Member States, notified bodies and manufacturers. Also EU reference laboratories and a network of national reference laboratories shall be set up for certain hazards or products groups. 

4. International || || ||

Between 1996 and 2005, the US Food and Drug Administration (FDA) conducted several inspections of PIP with regard to saline breast implants. Some of the inspections detected major deficiencies regarding quality system and manufacturing. Neither the French nor the German authorities were informed of the FDA inspections and their findings. || No international treaty in place regarding international cooperation. The Global Harmonization Task Force (GHTF) for medical devices (AUS, CAN, EU, JPN, US) is a voluntary regulatory cooperation.  Confidentiality arrangements between FDA and European authorities were agreed only later (e.g. with AFSSAPS in 2005 with DG ENTR, now DG SANCO, in 2007). || International cooperation and information exchange remains voluntary. According to the new Article 20a about cooperation at EU level, such cooperation may be part of initiatives developed at international level.     || The legal basis should be reinforced for the international cooperation and the exchange of information with 3rd country regulatory authorities, e.g. regarding audits and incidents. On the basis of reciprocity, 3rd countries shall be given access to the future EU vigilance database.  

On 10 January 2012, an information note was sent to 3rd countries about available information regarding PIP. || At international level, cooperation is voluntary. In 2005, a National Competent Authority Report (NCAR) exchange programme has been set up by the GHTF with some other participating 3rd countries in order to facilitate the dissemination of important information regarding adverse events related to medical devices. No traceability requirements as regards exported products. || || The current NCAR exchange programme shall be further deepened and extended in the context of the new International Medical Device Regulators' Forum (IMDRF). The UDI system shall be based on a globally recognized standard (currently being developed in the context of the GHTF and further pursued by the new IMDRF). 

[1]       http://ec.europa.eu/enterprise/medical_devices/consult_recast_2008_en.htm

[2]  Directive 2007/47/EC of 5 September 2007

[3]  Regulation (EC) No 765/2008 of 9 July 2008 and Decision No 768/2008/EC of 9 July 2008.

[4]       http://ec.europa.eu/enterprise/sectors/medical-devices/documents/revision/index_en.htm

[5] http://ec.europa.eu/consumers/sectors/medical-devices/index_en.htm

[6] GHTF/SG1/N045:2008 regarding Principles of In Vitro Diagnostic (IVD) Medical Devices Classification - http://www.ghtf.org/documents/sg1/sg1final_n045.pdf.

[7] Annex III (EC Declaration of conformity) point 6 foresees that for devices for self-testing the manufacturer shall lodge an application for examination of the design with a notified body.

[8]     Article 9(13) Directive 98/79/EC states: "The provisions of this Article shall apply accordingly to any   natural or legal person who manufacturers devices covered by this Directive and, without placing them on the market, puts them into service and uses them in the context of his professional activity."

[9] http://www.hgc.gov.uk

[10] GHTF/SG1/N045:2008 regarding Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (see above footnote 6) defines "near-patient testing" as "testing performed outside a laboratory environment by a healthcare professional not necessarily a laboratory professional, generally near to, or at the side of, the patient".

[11]     The GHTF is currently working on a guidance document on clinical evidence for IVDs.

[12]  The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes of 27 November 2008 distinguishes between scientific validity and clinical validity. See http://conventions.coe.int/Treaty/EN/Treaties/Html/203.htm  

[13]     The Additional Protocol mentioned in the previous footnote also introduces the notion of clinical utility. 

[14]          PET = Positron Emission Tomography, MRI = Magnetic Resonance Imaging

[15]  Medical devices here mean medical devices not including IVDs.

[16]     OJEC L189 20 July 1990

[17]     OJEC L 169 12 July 1993

[18]     OJEC L 331 7 December 1998

[19]     Directive 2000/70/EC of the European Parliament and of the Council amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivatives of human blood or human plasma, OJEC L 313 of 13 December 2000, and Directive 2001/104/EC of the European Parliament and of the Council amending Council Directive 93/42/EEC concerning medical devices, OJEC L 6 of 10 January 2002.

[20]     Council Resolution of 7 May 1985 on a New Approach to technical harmonisation and standards, OJEC C 136 of 4 June 1985.

[21]     Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance and repealing Regulation (EEC) No 339/93, OJEU L 218/30 of 13 August 2008, OJEU L 218/30 of 13 August 2008, and Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC, OJEU L 218/82 of 13 August 2008.

[22]     The GHTF was founded in 1992 by Australia, Canada, EU, Japan and USA in an effort to achieve greater uniformity between national medical device regulatory systems.

[23]     Besides the GHTF members and individual EU/EFTA countries, several third countries participate in the NCAR Exchange Programme, e.g. Cuba, Hong Kong, Saudi-Arabia, Taiwan and Thailand.    

[24]     See http://ec.europa.eu/health/medical-devices/files/meddev/2_15_3___12-2008_en.pdf

[25]     See http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

[26]     http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/version1_9_borderline_manual_en.pdf

[27]     Including Commission Directive 2003/12/EC on the reclassification of breast implants and Commission Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements.

[28]     COM(2005)535.

[29]     See GHTF/SG1/N15:2006 – Principles of Medical Device Classification under Rule 8.

[30]     See section 1 of the Summary of responses to the public consultation.

[31]     SG5/N2R8:2007 – Clinical Evaluation, SG5/N3:2010 – Clinical Investigations; SG5/N4:2010 – Post-market clinical follow-up studies.

[32]     GHTF/SG1/N045:2008 – Principles of In Vitro Diagnostic (IVD) Medical Devices Classification; GHTF/SG1/N046:2008 – Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices; SG1-N63:2011 – Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices.

[33]     SG1(PD)/N068R05 on Essential Principles; GHTF/SG1/N070:2011 on Label and Instructions for use.

[34]     The Legal Service of the Commission confirmed that the recast technique could be used for the revision of the medical devices directives despite the fact that the new legislative measures would be based on an additional Treaty article, i.e. Article 168(4)(c) TFEU. However, different opinions exist as to whether a directive could be "recast" into a regulation, see Opinion of 14.11.2008 of the Consultative Group of the Legal Services of the Commission, the European Parliament and the Council.

[35]     According to the information at the disposal of the Commission.

[36]     National transposition measures to be applicable as of 1 January 1995.

[37]     The transitional provisions for devices in conformity with preceding national regulations do not seem to be relevant for this case.

[38]     Subject to adoption by the Commission after completion of the internal procedures (inter-service consultation etc.).

[39]     TÜV Rheinland Product Safety GmbH, now TÜV Rheinland LGA Product GmbH.         

[40]     In 2001, the Commission published Communication COM(2001)666 on Community and national measures in relation to breast implants. Among others, it contains detailed guidance on essential safety requirements and conformity assessment schemes of Directive 93/42/EEC in relation to breast implants.

[41]     See EN ISO 14607 which addresses in particular intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

[42]     Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products.

[43]     Incidents are defined in Directive 93/42/EEC as "(a) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; (b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer".

[44]     Commission Decision setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment.

1. [45]     From 1997 to 2004, a Scientific Committee on Medicinal Products and Medical Devices did exist.

COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT ON THE REVISION OF THE REGULATORY FRAMEWORK FOR MEDICAL DEVICES

Accompanying the documents

Proposals for Regulations 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 and on in vitro diagnostic medical devices

TABLE OF CONTENTS

1........... Procedural issues and consultation of interested parties.................................................... 9

1.1........ Stakeholder consultation................................................................................................. 9

1.1.1..... Public consultations......................................................................................................... 9

1.1.2..... Further dialogue with stakeholders.................................................................................. 9

1.1.3..... Conclusions of the Council of the European Union......................................................... 10

1.2........ Consultation of other Commission's services.................................................................. 10

1.3........ Contacts with Third Countries....................................................................................... 11

1.4........ External studies............................................................................................................. 11

1.5........ Scrutiny by the Commission's Impact Assessment Board............................................... 11

2........... Problem definition......................................................................................................... 11

2.1........ Background.................................................................................................................. 11

2.2........ Problem identification.................................................................................................... 13

2.2.1..... Problem 1 – Oversight of Notified Bodies..................................................................... 14

2.2.2..... Problem 2 – Post-market safety (vigilance and market surveillance)............................... 15

2.2.3..... Problem 3 – Regulatory status of products.................................................................... 17

2.2.4..... Problem 4 – Lack of transparency and harmonised traceability...................................... 19

2.2.5..... Problem 5 – Access to external expertise...................................................................... 20

2.2.6..... Problem 6 – Unclear and insufficient obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales............................................................................. 21

2.2.7..... Problem 7 – Management of the regulatory system........................................................ 22

3........... Objectives.................................................................................................................... 22

3.1........ Overall objectives......................................................................................................... 22

3.2........ Specific objectives........................................................................................................ 24

3.2.1..... Objective 1: Uniform control of Notified Bodies............................................................ 24

3.2.2..... Objective 2: Enhanced legal clarity and coordination in the field of post-market safety.... 24

3.2.3..... Objective 3: Cross-sectoral solution of "borderline" cases.............................................. 24

3.2.4..... Objective 4: Enhanced transparency regarding medical devices on the EU market, including their traceability    25

3.2.5..... Objective 5: Enhanced involvement of external scientific and clinical expertise................. 25

3.2.6..... Objective 6: Clear obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales............................................................................................. 25

3.2.7..... Objective 7: Governance - efficient and effective management of the regulatory system... 25

4........... Policy options............................................................................................................... 25

4.1........ "No EU action"............................................................................................................. 25

4.2........ Fundamental change: marketing authorisation of medical devices.................................... 26

4.3........ Evolution: reinforcement of the current regime keeping the same legal approach.............. 29

4.4........ Policy options regarding Objective 1: Uniform control of Notified Bodies....................... 29

4.4.1..... Policy option 1A: New minimum requirements for Notified Bodies................................. 29

4.4.2..... Policy options 1B – 1D: Changes to the process of designation and monitoring of Notified Bodies        29

4.4.2.1.. Policy option 1B: Designation and monitoring of Notified Bodies by an EU body............ 29

4.4.2.2.. Policy option 1C: Designation and monitoring of Notified Bodies by Member States with involvement of "joint assessment teams"........................................................................................................ 30

4.4.2.3.. Policy option 1D: Designation and monitoring of Notified Bodies by Member States in accordance with the model provisions of Decision 768/2008/EC............................................................................. 30

4.4.3..... Policy options 1E - 1G: Review of the conformity assessment process........................... 30

4.4.3.1.. Policy option 1E: No change to the conformity assessment process................................ 30

4.4.3.2.. Policy option 1F: Systematic ex ante control of conformity assessment reports for specific device types            30

4.4.3.3.. Policy option 1G: Notification requirement regarding new applications for conformity assessment and possibility for ex ante control.............................................................................................................. 31

4.5........ Policy options regarding Objective 2: Enhanced legal clarity and coordination in the field of post-market safety 31

4.5.1..... Policy option 2A: Clarification of key terms and of the obligations of the parties involved in the field of vigilance.................................................................................................................................... 31

4.5.2..... Policy options 2B – 2C: Reporting of incidents and coordination of analysis................... 32

4.5.2.1.. Policy option 2B: Central reporting of incidents and coordinated analysis of certain high risk incidents   32

4.5.2.2.. Policy option 2C: Decentralised reporting of incidents, but coordinated analysis of certain high risk incidents     32

4.5.3..... Policy option 2D: Promotion of cooperation of market surveillance authorities................ 32

4.6........ Policy options regarding Objective 3: Cross-sectoral solution of "borderline" cases......... 32

4.6.1..... Policy option 3A: Creation of a cross-sectoral advisory group on borderline issues......... 33

4.6.2..... Policy option 3B: Creation of a cross-sectoral advisory group on borderline issues and possibility to determine the regulatory status of products at EU level........................................................................ 33

4.7........ Policy options regarding Objective 4: Enhanced transparency regarding medical devices on the EU market, including their traceability.............................................................................................. 33

4.7.1..... Policy options 4A – 4B: Registration of economic operators and listing of devices.......... 33

4.7.1.1.. Policy option 4A: Network of national databases........................................................... 33

4.7.1.2.. Policy option 4B: Central registration of economic operators and listing of medical devices placed on the EU market.......................................................................................................................... 33

4.7.2..... Policy option 4C: Requirement for the traceability of medical devices............................. 34

4.8........ Policy options regarding Objective 5: Enhanced involvement of external scientific and clinical expertise 34

4.8.1..... Policy option 5A: Creation of a pool of experts............................................................. 34

4.8.2..... Policy option 5B: Designation of an expert panel and reference laboratories for specific areas in medical technology.................................................................................................................................... 34

4.9........ Policy options regarding Objective 6: Clear obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales................................................................. 35

4.9.1..... Policy option 6A: Alignment with Decision 768/2008/EC, additional requirements for authorised representatives and clarification of obligations in the field of diagnostic services...................................... 35

4.9.2..... Policy options 6B – 6C: Internet sales........................................................................... 35

4.9.2.1.. Policy option 6B: Legislative measures regarding internet sales....................................... 35

4.9.2.2.. Policy option 6C: Addressing internet sales by soft-law action........................................ 35

4.10...... Policy options regarding objective 7: Efficient and effective management of the regulatory system          35

4.10.1... Policy option 7A: Extension of the responsibility of the European Medicines Agency (EMA) to medical devices and creation of a Medical Device Expert Group at this agency....................................... 35

4.10.2... Policy option 7B: Creation of a new EU regulatory agency for medical devices only and of a Medical Device Expert Group at this agency.......................................................................................... 36

4.10.3... Policy option 7C: Management of the medical device regulatory system by the European Commission and creation of a Medical Device Expert Group supported by this institution...................................... 37

4.10.4... Policy option 7D: Creation of a Medical Device Expert Group managed by the Member States           37

5........... Analysis of impact and comparison of the policy options................................................ 37

5.1........ Impact of policy options 1A-1D (designation and monitoring of Notified Bodies)........... 38

5.1.1..... Impact of policy option 1A (new minimum requirements for Notified Bodies)................. 38

5.1.2..... Impact of policy option 1B (designation and monitoring of Notified Bodies by an EU body).... 38

5.1.3..... Impact of policy option 1C (designation and monitoring of Notified Bodies by Member States with involvement of "joint assessment teams").............................................................................................. 39

5.1.4..... Impact of policy option 1D (designation and monitoring of Notified Bodies by Member States in accordance with the model provisions of Decision 768/2008/EC)............................................................ 40

5.2........ Impact of policy options 1E – 1G (conformity assessment procedures by Notified Bodies) 42

5.2.1..... Impact of policy option 1E (no change to the conformity assessment process)................ 42

5.2.2..... Impact of policy option 1F (systematic ex ante control of conformity assessment reports for specific device types).................................................................................................................................... 42

5.2.3..... Impact of policy option 1G (notification requirement regarding new applications for conformity assessment and possibility for ex ante control)........................................................................................ 43

5.3........ Impact of policy options 2A to 2D (enhanced coordination in the field of post-market safety)   46

5.3.1..... Impact of policy option 2A (clarification of key terms and of the obligations of the parties involved in the field of vigilance)...................................................................................................................... 46

5.3.2..... Impact of policy option 2B (central reporting of incidents and coordinated analysis of certain high risk incidents).................................................................................................................................... 46

5.3.3..... Impact of policy option 2C (decentralised reporting of incidents, but coordinated analysis of certain serious incidents which have an impact on more than one Member State)................................... 47

5.3.4..... Impact of policy option 2D (promotion of cooperation of market surveillance authorities, including designated test laboratories)................................................................................................................. 48

5.4........ Impact of policy options 3A and 3B (cross-sectoral solution of "borderline" cases)......... 49

5.4.1..... Impact of option 3A (cross-sectoral advisory group on borderline issues)...................... 49

5.4.2..... Impact of option 3B (cross-sectoral advisory group on borderline issues and possibility to determine the regulatory status of products at EU level)....................................................................................... 49

5.5........ Impact of policy options 4A to 4C (enhanced transparency regarding medical devices on the EU market, including their traceability)........................................................................................................... 50

5.5.1..... Impact of policy option 4A (network of national databases)........................................... 50

5.5.2..... Impact of policy option 4B (central registration of economic operators and listing of medical devices placed on the EU market).................................................................................................................. 51

5.5.3..... Impact of policy option 4C (traceability of medical devices)........................................... 54

5.6........ Impact of policy options 5A – 5B (enhanced involvement of external scientific and clinical expertise)    56

5.6.1..... Impact of policy option 5A (creation of a pool of experts)............................................. 56

5.6.2..... Impact of policy option 5B (designation of an expert panel and reference laboratories)... 56

5.7........ Impact of policy options 6A – 6C (clear obligations and responsibilities of economic operators, including in the field of diagnostic services and internet sales)................................................................. 57

5.7.1..... Impact of policy option 6A (alignment with Decision 768/2008/EC, additional requirements for authorised representatives and clarification of obligations in the field of diagnostic services).............. 57

5.7.2..... Impact of policy option 6B (legislative measures regarding internet sales)........................ 58

5.7.3..... Impact of policy option 6C (addressing internet sales by soft-law action)........................ 58

5.8........ Impact of policy options 7A – 7D (management of the regulatory system)...................... 59

5.8.1..... Impact of policy option 7A (extension of the responsibility of the European Medicines Agency (EMA) to medical devices and creation of a Medical Device Expert Group at this agency).......................... 61

5.8.2..... Impact of policy option 7B (creation of a new EU regulatory agency for medical devices only and of a Medical Device Expert Group at this agency)............................................................................. 63

5.8.3..... Impact of policy option 7C (management of the medical device regulatory system by the European Commission and creation of a Medical Device Expert Group supported by this institution)................. 64

5.8.4..... Impact of policy option 7D (creation of a Medical Device Expert Group managed by the Member States)       65

6........... Overview of preferred options, legal form and overall impacts........................................ 66

6.1........ Overview of preferred policy options............................................................................ 66

6.2........ Legal form.................................................................................................................... 69

6.3........ Synergies...................................................................................................................... 71

6.4........ Administrative costs...................................................................................................... 71

6.4.1..... Administrative costs for a notification mechanism with possibility for an ex ante control of conformity assessment reports (policy option 1G)............................................................................................. 72

6.4.2..... Administrative costs for the central reporting of incidents (policy option 2B)................... 72

6.4.3..... Administrative costs for the registration of economic operators, the listing of medical devices and upload of UDI-related information in a central European databank for medical devices (policy options 4B and 4C)      72

6.4.4..... Administrative costs related to the indication of the UDI on the label (policy option 4C).. 72

6.4.5..... Administrative costs related to the adoption of GHTF classification for IVD and corresponding conformity assessment procedures (policy option IVD-2B, see Annex 2)........................................ 73

6.5........ Simplification potential.................................................................................................. 73

6.5.1..... Codification, merger of AIMDD and MDD, and transformation into regulations............. 73

6.5.2..... Co-regulation............................................................................................................... 73

6.5.3..... Central registration and listing........................................................................................ 74

6.6........ Financing...................................................................................................................... 74

7........... Subsidiarity and proportionality..................................................................................... 75

8........... Monitoring and evaluation............................................................................................. 76

8.1........ Alignment of national legislations to the future EU regulatory framework for medical devices     76

8.2........ Oversight of Notified Bodies......................................................................................... 76

8.3........ Post-market safety........................................................................................................ 77

8.4........ Cross-sectoral solution of borderline cases.................................................................... 77

8.5........ Enhanced transparency and traceability......................................................................... 77

8.6........ Enhanced involvement of external scientific and clinical expertise.................................... 78

8.7........ Clear obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales................................................................................................................. 78

8.8........ Effective and efficient management of the regulatory system............................................ 78

8.9........ Consultation and reporting............................................................................................ 78

9........... List of acronyms and abbreviations used in the Impact Assessment................................ 79

1.           Procedural issues and consultation of interested parties

The "recast" of Directives 90/385/EEC and 93/42/EEC and their amending directives was first envisaged in the Commission's Communication "Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment"[1]. However, a number of additional aspects have come into play which prompted the Commission to consider that not only a simplification was needed but also a strengthening of the whole legal framework for medical devices. Moreover, Directive 98/79/EC on in vitro diagnostic medical devices, which has not been substantially amended since its adoption, also needs to be revised. Its revision is addressed in the present impact assessment as well.

The revision of the regulatory framework for medical devices was mentioned in the Commission Work Programmes 2010[2] and 2011[3]. In both cases, the 'roadmaps' were published on the homepage of the European Commission's Secretariat-General[4].

1.1.        Stakeholder consultation

1.1.1.     Public consultations

In mid-2008, the Commission held a public consultation on the recast of the general regulatory framework for medical devices. The consultation was published on the Commission's website[5] and was widely announced to public authorities (European and third countries) and stakeholders (industry, Notified Bodies, healthcare professionals and patient and consumer groups). The Commission received 200 responses. A summary report of the responses (Appendix 1) as well as the individual responses (unless submitted confidentially) were published on 5 December 2008 on the Commission's website[6].

A second consultation on specific aspects related to in vitro diagnostic medical devices and the revision of Directive 98/79/EC was held in the second half of 2010. It was equally widely announced among interested parties and the public[7]. The Commission received 183 responses. A summary report of the responses (Appendix 2) as well as the individual responses (unless submitted confidentially) were published on 23 February 2011 on the Commission's website[8].

1.1.2.     Further dialogue with stakeholders

During 2009, 2010 and 2011, the issues to be tackled in the context of the revision of the regulatory framework for medical devices were regularly discussed at meetings of the Medical Devices Expert Group (MDEG), the Competent Authorities for Medical Devices (CAMD) and specific working groups in the fields of Notified Bodies, borderline and classification, clinical investigation and evaluation, vigilance, market surveillance, in vitro diagnostics medical devices (IVD) and in an ad hoc working group on Unique Device Identification (UDI)[9]. A special MDEG meeting was held on 31 March and 1 April 2011. Moreover, the Heads of Medicines Agencies (HMA) and the CAMD organised a joint workshop regarding the development of the legal framework for medical devices on 27 April 2011 and on 28 September 2011. A further special MDEG meeting was held on 6 and 13 February 2012 to discuss issues related to the two legislative proposals, based on working documents containing initial drafting proposals. Written comments made on these working documents were taken in account for the further development of the proposals.

In addition, Commission's representatives regularly participated in conferences to present the ongoing work on the legislative initiative and discuss with stakeholders. Targeted meetings took place at senior level with representatives from industry associations and with Notified Bodies. Aspects linked to the appropriate regulatory framework were also discussed in the context of the "Exploratory Process on the Future of the Medical Device Sector" organised by the Commission from November 2009 to January 2010[10]. On 22 March 2011, the Commission and the Hungarian Presidency organised a high-level conference on innovation in medical technology addressing the role of the medical device sector in the context of Europe's healthcare challenges and the appropriate regulatory framework for this sector to meet the needs of tomorrow.

1.1.3.     Conclusions of the Council of the European Union 

The above-mentioned high-level conference was followed-up by Conclusions of the Council of the European Union on innovation in the medical device sector adopted on 6 June 2011 (Appendix 3)[11] which contain a number of recommendations as regards the issues to be addressed in the context of the revision of the medical devices directives.

1.1.4.     Resolution of the European Parliament on defective silicone gel breast implants

As of end 2011, the existing regulatory framework for medical devices has come under harsh criticism in the media and the political arena, in particular after findings of the French health authorities that a French manufacturer (Poly Implant Prothèse, PIP) over several years apparently used industrial silicone instead of medical grade silicone for the manufacture of breast implants contrary to the approval provided by the notified body, causing harm to thousands of women around the world. On 14 June 2012, the European Parliament adopted a Resolution of the Parliament[12], inter alia, calling on the Commission to develop an adequate legal framework to guarantee the safety of breast implants and medical technology in general and even to shift to a system of pre-market authorisation for certain categories of medical devices, including at least medical devices of class IIb and III. 

1.2.        Consultation of other Commission's services

At an early stage, a large number of Commission departments were invited to an inter-service coordination group meeting on 7 October 2008 to inform other services about the envisaged legislative initiative. After the transfer of responsibilities for the medical devices regulations from DG ENTR to DG SANCO as of 1 February 2010, an Impact Assessment Steering Group (IASG) was set up to which the following departments were invited: SG, LS, ENTR, COMP, EMPL, ENV, RTD, JRC, INFSO, MARKT, JUST, TRADE and BUDG.

The IASG met on 18 November 2010, 8 April 2011 and 14 July 2011.

1.3.        Contacts with Third Countries

The market for medical devices is a global one. Since the early 1990s, regulators and industry representatives of the EU, the US, Canada, Japan and Australia have sought to bring about the convergence of their respective regulations in this sector in the context of the Global Harmonization Task Force (GHTF)[13]. The regulators of the other four GHTF members submitted comments on the 2008 and 2010 public consultations and the members of the GHTF were regularly informed about the progress of the legislative initiative. This revision will provide an opportunity to align EU regulations for medical devices with international guidelines developed by the GHTF.

Regular bilateral exchange of views took place with the US Food and Drug Administration (FDA) in the context of the annual meetings in the field of medical devices, medicinal products and cosmetic products.

The EFTA countries, Turkey and Croatia participated in the Medical Devices Expert Group meetings and targeted working group meetings where the changes to the regulatory system were regularly discussed.

After their adoption by the College, the proposals will need to be notified pursuant to Articles 2.9.2 and 5.6.2 of the WTO TBT Agreement.

1.4.        External studies

For the preparation of this legislative initiative no specific external studies have been mandated. However, the following study was taken into account:

· Impact Assessment of Policy Options for Combating Counterfeiting of Medical Devices and for Developing Safer Distribution Channels for Parallel Trade in Medical Devices, Europe Economics, 2010.

1.5.        Scrutiny by the Commission's Impact Assessment Board

The draft impact assessment was submitted to the Commission's Impact Assessment Board (IAB) on 23 August 2011. The IAB provided a favourable opinion on 23 September 2011 and made some recommendations. Those recommendations have been taken into account for the final version of the impact assessment report. In particular, the baseline option was better explained, the justification for a scrutiny mechanism allowing for an ex ante control of certain medical devices was further elaborated, the proportionality of the policy option to submit high risk 'in house' tests to the scope of the future regulations on IVDs as well as the impact of the alignment with international guidelines in the field of IVDs were better explained. Moreover, additional data regarding incidents reported in the context of the vigilance system were gathered and the competitiveness-related impacts on EU manufacturers were further elaborated.

Finally, the findings related to the defective PIP silicone breast implants which became known only at the end of 2011 and in the course of the first semester 2012 have been taken into account.         

2.           Problem definition

2.1.        Background

The main characteristics of the medical devices sector are:[14]

· huge spectrum of products, from sticking plasters or wheelchairs to X-ray machines, scanners, pacemakers, drug-eluting stents or blood tests, but no exact data exist as regards the number of different types of devices on the market[15];

· EU market (2009): around €85bn[16], plus around €10bn for IVD[17], with growth even during the economic and financial crisis;

· extremely innovative[18], with trends towards more drug-device combination products, 'smart' implantable devices, telemedicine, artificial organs[19], neuroengineering (e.g. cochlear or retina implants), companion diagnostics for personalised medicine[20], use of tissues, cells or other biologics and nanotechnologies[21];

· high reinvestment rate in R&D, average 6-8% of the sales, for IVDs up to 10%;

· around 22,500 individual medical technology companies, more than 80% are SMEs (in the IVD sector 90%), employing around 500,000 persons in Europe[22];

· EU average percentage of total healthcare expenditure spent on medical devices (2009): 4.2%, for IVDs 0.8%.

The regulatory framework for medical devices is composed of three main directives:[23]

· Council Directive 90/385/EEC on active implantable medical devices (AIMDD),

· Council Directive 93/42/EEC on medical devices (MDD), and

· Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDD).

The first two directives are very similar whilst the IVDD takes account of the specificities of the sector. The aims of all three directives are to ensure the functioning of the internal market and a high level of protection of human health and safety. Their main characteristics are:

· "New Approach" directives, based on the Treaty's 'internal market' article (now Article 114 of the Treaty on the Functioning of the European Union), to which the New Legislative Framework for the Marketing of Products applies[24];

· essential requirements for the safety and performance of medical devices included in the directives;

· detailed product specifications laid down in harmonised standards;

· no pre-market authorisation by a regulatory authority;

· classification of devices in different risk classes:

Risk classification according to Annex IX of the MDD || class I (low risk) || class IIa (low to medium risk) || class IIb (medium to high risk) || class III (high risk)[25]

Examples || sticking plasters; corrective glasses || dental filling materials; tracheal tubes || X-ray machines; urethral stents || cardiovascular catheters; hip, shoulder and knee joint replacements

Risk classification according to the IVDD (NB: the review of the classification of IVD is addressed in Annex 2 to this impact assessment) || not listed in Annex II of IVDD (i.e. low risk) || not listed in Annex II of IVDD but intended for  self-testing (i.e. low to medium risk) || listed in Annex II, List B, of IVDD (i.e. medium to high risk) || listed in Annex II, List A, of IVDD (i.e. high risk)

Examples || tests for the measurement of cholesterol level in blood || self-tests for the determination of pregnancy || reagents for evaluating the risk of trisomy 21 || reagents for detection of HIV or hepatitis B, C and D infection

· for medium and high risk devices: conformity assessment by an independent third party, so-called "Notified Body";

· for low risk devices: conformity certified by the manufacturers themselves;

· once certified, devices bear the CE marking which allows them, in principle, to circulate freely in the  EU/EFTA countries and Turkey.

The Member States have broad competences in respect to the implementation of the medical devices directives, such as for example the designation and monitoring of Notified Bodies, the supervision of clinical investigations, the investigation of vigilance cases and the surveillance of devices on the market. 

2.2.        Problem identification

The existing regulatory framework for medical devices has demonstrated its merits but it has been in place for 20 years and like any regulatory regime dealing with innovative products, needs revision. Moreover, it has recently come under harsh criticism, in particular due to the PIP silicone breast implant scandal (see section 1.1.4) or problems occurring with certain metal-on-metal hip joint replacements.  Several weaknesses which undermine the main objectives of the three medical devices directives, i.e. the safety of medical devices and their free circulation within the internal market were identified in the Commission's 2008 public consultation (see section 1.1.1). In the light of the envisaged revision of the EU regulatory framework for medical devices, the Commission's services analysed the PIP breast implant case ("stress test", Appendix 11). This analysis detected further shortcomings of the existing regulations in addition to the already identified weaknesses. The findings, however, do not suggest that the system for regulating medical devices is fundamentally unsound.  

The present revision of the medical devices directives aims at overcoming the weaknesses, taking into account lessons learned from the PIP case, while maintaining the overall objectives of the legal framework. Its main part focuses on the systemic issues which are relevant for both the AIMDD/MDD and the IVDD. Issues that are relevant either only for the AIMDD/MDD or only for the IVDD, respectively, such as their respective scopes, clinical investigations (for MD), the review of the classification of IVD or clinical evidence (for IVD), are discussed in detail, respectively, in Annexes 1 and 2 to this impact assessment; the results are summarised in section 6 of this main part.

Besides the 27 EU Member States, the four EFTA countries and Turkey have also transposed the directives and participate in the European regulatory system for medical devices. A single market of 32 countries is a challenge to the uniform interpretation and implementation of the legal requirements as well as to the coordination of the activities of the national competent authorities in the area of their competences, both pre- and post-market. Due to imprecise legal requirements and different levels of expertise, human resources and powers of the competent authorities, the level of control exercised over Notified Bodies and over the medical devices placed on the market is fragmented.

This leads to an uneven level of protection of the patients, users and public health. Moreover, this lowers the confidence in the CE marking which should guarantee the free movement of devices within the EU and which is also recognised by several 3rd countries as proof of compliance with their own national safety requirements, often with the support of a certificate of free sale issued by the competent authority responsible for the exporting manufacturer.

Due to the absence of a central database regarding medical devices available on the EU market, stakeholders, in particular users, claim a lack in transparency in the regulatory process. This has prompted several Member States to impose registration systems in order to have an improved knowledge of devices put into service within their territory. Such national measures, however, do not give rise to a general overview of CE marked devices and create obstacles to the internal market.

Participation in the informal and non-statutory working groups which aim at the exchange of views and the coordination of activities of national authorities (e.g. Notified Body Operation Group, Compliance and Enforcement, Clinical Investigation and Evaluation, Vigilance WG, Medical Devices Expert Group on Borderline and Classification) and Notified Bodies (NB-Med) is voluntary and the guidance documents drawn up by them (MEDDEV, Manual on borderline and classification, NBOG-BPG, NB-Med Recommendation)[26] are not legally binding and are therefore not suitable to enforce a high level of patient safety and the functioning of the internal market.

2.2.1.     Problem 1 – Oversight of Notified Bodies

Notified Bodies take responsibilities in areas of public interest and remain answerable to the competent authorities. The primary task of Notified Bodies is to carry out an assessment of the manufacturer's quality management system and/or the design of a device before those medical devices which require a third party certification are placed on the market. Currently 78 Notified Bodies are designated by 24 EU/EFTA states[27], Turkey[28] and Australia[29] under the AIMDD, MDD and IVDD[30] (August 2011). Authorities and manufacturers report significant differences as regards, on the one hand, the designation and monitoring of the Notified Bodies and, on the other hand, the quality and depth of the conformity assessment performed by them, in particular in relation to the assessment of the manufacturers' clinical evaluation or the use of their existing powers such as unannounced factory inspections or product checks. Notified Bodies themselves acknowledge the differences[31], which ultimately lead to varying levels of protection of patients' and users' safety which, from a public health perspective, is an issue of concern. In addition, it distorts competition between manufacturers of similar products.  

Example: The Commission received complaints from manufacturers of a new type of catheters as regards the quality and depth of the conformity assessment carried out by one Notified Body in respect of their competitor's devices. After a lengthy investigation of this issue, the designation of this Notified Body for the specific type of devices was withdrawn by the responsible Member State as the body did not demonstrate the necessary level of competence and expertise to conduct the conformity assessment for this type of products.

The competition between Notified Bodies must not be distorted by bodies which perform their tasks without having sufficient skills and expertise at their disposal. It is therefore crucial for the functioning of the system that the authorities responsible for the designation and monitoring of Notified Bodies exercise a close, independent and consistent control to ensure that Notified Bodies are designated only for the assessment of devices or technologies which correspond to their proven expertise and competence. The minimum requirements currently laid down in the medical devices directives, however, are very vague. The coordination group of Member States' competent authorities in the field of Notified Bodies (NBOG) issued a "Designating Authorities' Handbook"[32], but this Handbook does not have any legal status and adherence is at the discretion of the individual competent authority. In addition, there is currently no mechanism which ensures that competent authorities carry out supervision in accordance with commonly agreed criteria.

As regards the oversight of Notified Bodies, the Council of the European Union confirmed the need to improve the harmonised criteria for the designation of Notified Bodies and "to ensure that they are designated only for the assessment of devices and technologies which correspond to their proven expertise and competencies"[33].

2.2.2.     Problem 2 – Post-market safety (vigilance and market surveillance)

The right and obligation of Member States to collect and analyse information about serious incidents occurring with devices and to restrict or ban the marketing of a device when it may compromise the health and safety of a patient, user or third person or when the CE marking has been illegally affixed to a product[34] is a central pillar of the regulatory system for medical devices in order to strike a reasonable balance between pre-market control of devices and their post-market surveillance.

Incidents within the meaning of the three medical devices directives are reported to the competent authorities of the Member States concerned. After assessment of the incident and the manufacturers' proposed field safety corrective action (FSCA), Member States must inform each other about measures taken or contemplated in order to minimise the recurrence of such incidents[35]. In 2010, Member States exchanged 748 National Competent Authorities Reports (NCARs), but the number differs hugely between Member States. While Germany accounts for roughly 40% of all NCARs, the UK for around 20% and Ireland for about 15%, other Member States submit very few or no NCARs (see statistics in Appendix 6a)[36].

NCARs represent only a share of the incidents which are originally reported to the competent authorities by manufacturers, users, patients or others. This is due to several reasons:

Firstly, the conditions for the exchange of NCARs are not clearly stated in the current directives. They were clarified by means of non-binding guidelines in December 2009 (MEDDEV 2.12-1 rev 6 – Guidelines on the Medical Devices Vigilance System) still leaving competent authorities with the discretion not to exchange NCARs when the manufacturer's corrective action is not considered to be essential to protect the safety of patients or users[37].

Secondly, many reported incidents do not require further action or measures by the competent authorities, for example when the incident was not due to the device but to the user. According to information of the German competent authority, the Bundesinstitut für Arzneimittel und Medizinprodukte, around 76% of the 22,428 incidents reported during the period 2005-2010 did not lead to further measures. According to information of the UK competent authorities, the Medicines and Healthcare Products Regulatory Authority, around 65% of reported incidents did not lead to further action. 

Actually, there are no consolidated statistics regarding the total number of incidents reported in the 27 Member States. According to the public information made available on the websites of the four competent authorities who exchanged the largest number of NCARs in 2010, the numbers of reported incidents are around 10,000/year in the UK and France and around 6,000 in Germany (see Appendix 6b). But it should be noted that the criteria for the statistics published by the authorities are not harmonised.

This appears to show, firstly, that manufacturers do not report serious incidents to the competent authorities according to the same criteria since the obligations of manufacturers (including the obligation to set up a post-market surveillance plan) are spelt out in the annexes of the directives only in general terms. Moreover, the NCAR statistics raise questions with regard to the criteria according to which Member States exchange information regarding reported incidents and measures taken to minimise the risk of recurrence. Furthermore, apart from the information exchange, no coordination is ensured between the competent authorities as regards the assessment of incidents and the corrective measures which have an impact on more than one Member State.

Examples for restrictions imposed by Member States on medical devices in the context of the vigilance system are:

Ÿ       product withdrawal (recalls): certain infusion pumps, drug-eluting coronary stents, joint or breast implants, removed from the market for safety reasons;

Ÿ       batch removal: removal of contaminated batches/lots of syringes or of swabs; 

Ÿ       reduced shelf life or stricter storage conditions of in vitro diagnostics following incident reports that demonstrated a lack of performance under certain circumstances;   

Ÿ       specific patients follow-up: strict instructions concerning the medical follow up of patients with certain implanted devices whose safety or performance is put into question after incidents were reported;

Ÿ       stricter instructions for use of specific software used in radiotherapy or for radiodiagnostics.

Experience with the application of the vigilance system and other legal instruments available to the Member States (e.g. safeguard clauses, particular health monitoring measures, illegally affixed CE marking) has shown that national competent authorities react in different ways to the same problems. Whilst in some Member States the placing on the market or putting into service of a given device is banned or restricted, it may freely circulate in other Member States.

Example: After the report of an incident with an insulin pump, one Member State ordered the recall of the product while in other Member States the manufacturer was obliged simply to provide additional information to the health professionals.

This practice puts into question a harmonised level of protection of patients and users in the EU and also creates obstacles to the internal market[38].

2.2.3.     Problem 3 – Regulatory status of products

The demarcation between the medical devices directives and the other regulatory frameworks applicable to e.g. medicinal products, biocides, food or cosmetics is not always clear. In the case of food and medical devices, the respective legislations are even overlapping. Since a decision on the regulatory status of a product falls within the competence of Member States, divergent interpretations in respect to "borderline" cases lead to the application of different legal regimes in the various Member States and lengthy discussions between authorities. This is especially the case for some ingested products (e.g. antacid products, simethicone containing products), osmotic laxatives, products containing micro-organisms or substances administered to the human body for which the principal mode of action often is not scientifically clearly determinable[39]. The difficulty of determining whether the principal mode of action is metabolic, pharmacological, immunological or not is likely to increase with the development of new and more drug-device combination products which are an important area of innovation. Currently, a request for a preliminary ruling is pending before the European Court of Justice (C-109/12) relating to capsules containing living lactic acid producing bacteria for restoration of the vaginal bacterial flora which have been qualified as medicinal products by the authorities of a Member State. The same product, however, is available in some Member States as CE-marked medical device.

"Borderline" cases also exist between medical devices and IVD which need to be decided since the AIMDD/MDD and the IVDD currently are mutually exclusive.

Despite existing guidance documents, Member States take different positions with regard to the regulatory status of a product. This leads to the situation that a given product is considered a medical device in one or several Member States while, in other Member States, it is considered a pharmaceutical, a consumer product or something else. Different interpretations exist also with regard to the rules on the classification of a medical device (e.g. class I, IIa, IIb or III) which has an impact on the requirements applicable to the device.

Between 2006 and 2010, 114 borderline and classification problems have been circulated among the Member States through the so-called 'Helsinki procedure'[40]. Some of them are borderline cases with other legislations (e.g. qualification of products used in in vitro fertilisation procedures), others concern the classification of a specific medical device (e.g. classification of medical devices containing silver as an antimicrobial) and the majority of the cases concerns both aspects (e.g. qualification and classification of biofunctional textiles).

Around 50 particularly difficult ones, either resulting from an inconclusive 'Helsinki procedure' or on specific request from stakeholders, were discussed in plenary meetings of the informal Medical Devices Expert Group on Borderline and Classification[41] and consensus amongst the competent authorities could be reached. These consensus statements are published in the so-called Manual on Borderline and Classification which is publicly available. However, some controversial cases remain unsolved despite long discussions within the above mentioned Expert Group. The application of different regulatory regimes to the same product compromises both the protection of patient safety and the internal market.

Examples: Products against head-lice are regulated as medical devices, medicinal products, cosmetics or under specific national legislation depending on the Member State. Active coal solution or some heparin-containing products used for the rinsing of catheters are regulated either as medical devices or as medicinal products in the various Member States.

Moreover, even where a consensus is found, the consensus statements published in the Manual are not legally binding and competent authorities or national courts may decide at any moment not to follow them. This reduces the legal certainty and prompts criticism from stakeholders. The right of a Member State to submit a substantiated request to the Commission to adopt a Comitology measure as to whether a product falls within the definition of a medical device or not (or with regard to the classification of a device) has not been effectively used.

Example: So far, the only substantiated request submitted by a Member State concerned a product (hygienic tampons containing lactic acid producing bacteria) not to be considered a medical device which would have left the question of the applicable regulatory regime unanswered.

The Commission itself cannot trigger the procedure on its own initiative and it would need further device-specific expertise to adopt an EU measure in a timely manner. The lack of uniform qualification (or classification) of a product across the EU creates a fragmentation of the internal market (as a manufacturer must follow different legal regimes in order to sell the same product in different Member States) and may put patient safety at risk.

2.2.4.     Problem 4 – Lack of transparency and harmonised traceability

Transparency

No exact data exist as regards the number, the types and the approval status of medical devices on the European market. The European associations representing the medical technology industry give an estimate of around 500,000 different medical devices available[42] whilst the number of IVD is estimated to be around 40,000 by the European IVD manufacturers association. According to information provided by the Italian authorities, more than 320,000 medical devices (other than IVD) have been registered in the database established in 2007 by the Italian Ministry of Health[43]. In the newly set up Turkish database, more than 1.7 million medical devices are registered[44]. From a public health point of view authorities need to have at their disposal consistent information about medical devices on the market. Many interested parties, in particular patients, healthcare professionals[45], Health Technology Assessment (HTA)[46] bodies[47], insurers and third countries, consider the regulatory pathway of medical devices opaque and lacking in transparency since there is no access to key data regarding the characteristics, the clinical data and the conformity assessment path of certain medical devices, in particular implantable or other high risk devices.

The scope of the European databank for medical devices (Eudamed) is limited to information about class I device manufacturers and authorised representatives, certificates, vigilance reports and clinical investigations and it is not accessible to the public (patients, healthcare professionals etc.). Moreover, Eudamed as currently conceived requires the uploading of information by the 32 competent authorities (EEA countries, Switzerland and Turkey). This is burdensome for the Member States since they are required to set up their own systems for collecting the data to be entered into Eudamed.

In addition, for medical devices of classes IIa, IIb and III, for active implantable medical devices and for IVD listed in Annex II of Directive 98/79/EC and IVD for self-testing, the directives allow Member States to request to be informed of all data allowing for the identification of these devices when they are put into service within their territory. Around 15 Member States[48] have made use of this right which means that a manufacturer of medium or higher risk devices, or his authorised representative, must notify the competent authorities of these Member States when the device is sold in their countries. Several Member States have set up their own electronic registration tools. Multiple registration requirements in individual Member States place a considerable administrative burden on manufacturers and authorised representatives when they want to market a product in different Member States.

Example: The introduction of a medical device databank by Italy with extensive information requirements and the levy of a fee prompted the European Commission to start an infringement procedure which resulted in an amendment of the Italian regulations.

Traceability

Traceability of medical devices is currently not regulated by the medical devices directives. This has prompted some European countries to impose traceability requirements on economic operators (manufacturers, importers, distributors, hospitals) at national (e.g. Turkey) or sometimes even at regional level (e.g. Spain) through a Unique Device Identification (UDI) mechanism. UDI is a series of numeric or alphanumeric characters that is created through a coding system. It allows the unambiguous identification of a specific product on the market and represents the “access key” to device related information stored in the UDI database. The UDI comprises the device identifier and the production identifier. The establishment of this code considerably enhances traceability even though the word "unique" does not imply serialisation of every single device, e.g. those devices marketed in lots and batches. Traceability contributes to enhance patient safety in cases where restrictive measures have to be taken on specific devices, such as a recall of products already placed on the market. It can also contribute to the fight against counterfeiting.

Example: According to information of the UK authorities it is envisaged that hospitals of the NHS need to require medical devices to bear a GS1 code when purchased by public procurement in order to enhance traceability and to increase efficiency.

The national systems, however, are not compatible with each other and do not allow traceability across borders which would be necessary for an EU-wide high level of patient safety. Moreover, products or their packaging need to be adapted to the different sets of rules. In addition, the UDI mechanisms are often linked to databases so that manufacturers have to enter data in different national (or even regional) databases as already described in the preceding section, thus increasing their administrative burden and hampering the internal market.

2.2.5.     Problem 5 – Access to external expertise

The medical devices directives currently do not make provision for a structured involvement of external experts (e.g. healthcare professionals, academics) in the regulatory process. Notified Bodies usually seek expert advice in the context of conformity assessment procedures but at EU level the dialogue on regulatory or safety issues usually takes place between regulatory authorities and manufacturers except in cases when a scientific opinion is sought from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)[49] on specific issues.

Regulators, medical societies and manufacturers have expressed the need to better involve scientific and clinical experts in the dialogue and make their advice available in the regulatory decision-making process to keep pace with the innovation of products. The Council thus suggested the promotion of "early dialogue between manufacturers, scientific and clinical experts, competent authorities and, where appropriate, notified bodies, regarding 'new products' in particular, and their classification."[50]

2.2.6.     Problem 6 – Unclear and insufficient obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales

The obligations of manufacturers and/or authorised representatives are not bundled in the operative body of the directives but often need to be deduced from requirements mentioned within the annexes such as for example requirements relating to clinical evaluation and post-market safety/clinical follow-up. In the field of IVD, all manufacturers need to have a quality system (QS) in place whilst this is not clearly spelled out in the MDD for class I manufacturers. Some Member States require from the manufacturers established on their territory to supply a documentation of the QS when they inspect them but the practice is not harmonised.

As regards authorised representatives who, in principle, shall act instead of a non-EU manufacturer with regard to the latter's obligations under the directives, no minimum requirements exist. However, to fulfil this role authorised representatives need to be more than a mere mail-box but satisfy minimum criteria to contribute to the safety of devices of non-EU manufacturers placed on the EU market. Importers and distributors (including parallel traders and those selling over the internet) are currently not covered at all leading to different levels of protection of patient safety and to obstacles to the internal market.

Example: Member States enforce medical device regulations in different ways on parallel traders of medical devices since different opinions exist as to which requirements should be applicable to parallel trade in this field and as to whether activities usually performed by a parallel trader (e.g. repackaging or relabelling) would make this economic operator a manufacturer in terms of the directives. 

Furthermore, uncertainties exist as to the application of the directives where (mainly) diagnostic devices, in particular IVD, are used by an economic operator to provide test results at a distance, either to a healthcare professional or directly to a consumer, without the diagnostic device itself being placed on the market or put into service in the EU. For example, in the field of IVD, laboratories offer to persons situated within the internal market to provide testing carried out on the basis of a body specimen which consumers may send per normal mail. Despite recital 11 and Article 9(13) of the IVDD it is not always clear whether IVD used in such a situation are subject to the directive. The problem is not limited to IVD but also exist with regard to diagnosis made on the basis of medical imaging devices. There are increasing concerns regarding the validity and the reliability of the results provided at a distance and their understanding by lay users.

Examples: Especially in the field of genetics or food intolerance, testing is offered to consumers/patients at a distance without that the tests themselves are paced on the market.

Concerns also exist as regards possible risks related to sales of medical devices over the internet, in particular as regards counterfeit products. Even though devices bought over the internet within the EU or from third countries are subject to the same requirements as devices sold in the 'traditional' way, enforcement is more difficult.

Examples: Counterfeit contact lenses and condoms[51] offered over the internet have been detected.

2.2.7.     Problem 7 – Management of the regulatory system

The management of the regulatory system at EU level has shown weaknesses which have been reported by various interested parties, i.e. healthcare professionals, patients, insurers, manufacturers and the media. It is considered as not sufficiently efficient and effective. Indeed, there is no legal basis in the medical devices directives to ensure an overview of the situation at EU level and appropriate coordination between the Member States. This holds true in particular in terms of identification of devices placed on the market, of designation and monitoring of Notified Bodies, of assessment of products, of vigilance and of market surveillance. In addition, there is no legal basis to ensure a gathering of expertise at EU level. This leads to a lack of uniform application of the rules and of common reactions in the European market. This compromises both patient safety and the good functioning of the internal market.

In the absence of a governance structure with a legal basis, the Commission and the Member States have taken steps to achieve a certain degree of harmonised implementation. They have set up informal working groups which usually meet in Brussels and are chaired by Commission or Member States' representatives (21 meetings were organised in 2010). However, in the absence of any reference in the directives to the management of the system at EU level, the informal working groups produce guidance documents which serve a good purpose but cannot address fundamental issues.  

Moreover, there is no appropriate structure to ensure the sustainability and the efficiency of these activities. The Commission currently has less than 7 Full Time Equivalent (FTE) working on issues related to medical devices. There is a lack of

· administrative, technical and scientific support to the cooperation between Member States;

· solid IT tools to manage the system;

· consolidated scientific and clinical expertise.

Therefore, when deciding on the appropriate solutions to improve the current legal framework, it will be also necessary to decide "who" would be most suitable to provide the necessary input and structure to manage the system at EU level in a sustainable, efficient and credible manner.  

The Council called for a "European coordination mechanism founded on a clear legal basis and mandate in order to ensure efficient and effective coordination between national authorities while creating a level playing field. Synergies with existing bodies with relevant expertise should be explored when deciding on the mechanism for such coordination"[52].

3.           Objectives

3.1.        Overall objectives

When addressing the problems described above, the following three overall objectives should be pursued:

· Overall objective A: To ensure a high level of protection of human health and safety

The major objective pursued by the revision of the regulatory framework for medical devices is that the level of safety set by the medical devices directives is further enhanced and assured also for new and emerging device technologies which are being or will be developed. The Council stressed that "future legislative actions in this area must […] specifically aim to increase patients' safety while at the same time creating a sustainable legislative framework favourable to medical device innovation that can contribute to a healthy, active and independent life"[53].

· Overall objective B: To ensure the smooth functioning of the internal market

By adopting the 'Single Market Act', the European Commission reconfirmed its commitment to further deepen the internal market thus optimising its benefits for businesses and citizens[54]. The preceding 2010 Monti-Report[55] pleaded for a stronger single market and noted that the regulatory framework for goods needed regular updating in order to cope with ever-changing business and stem creeping obstacles at national level. The objective of this revision is to put in place a regulatory framework which is applied with consistency across the EU and which enhances the "reliability, predictability, speed and transparency in decision-making" as suggested by the Council in its Conclusions[56]. This will allow manufacturers and other economic operators, in particular SMEs which represent around 80% of the device industry (90% in the IVD sector) and are most affected by diverging national implementation of the medical device directives, to exploit the full potential of the internal market while ensuring a high level of health protection.

· Overall objective C: To provide a regulatory framework which is supportive for innovation and the competitiveness of the European medical device industry

The medical device industry is considered one of the most innovative sectors in Europe where innovative devices come to the market earlier than in other advanced jurisdictions. According to data provided by the European medical device industry, medical devices are available in Europe in average around 18 months earlier than in the US and more than two years earlier than in Japan where only around one-half of devices that are available in Europe reach the market[57]. Several studies or surveys conducted in the U.S. point to the faster pre-market assessment in Europe compared to FDA clearance of medical devices[58] whilst safety levels were considered equal[59]. The EU regulatory framework for medical devices today is considered innovation-friendly. These positive aspects should not only be maintained but further improved by means of simpler and more predictable, transparent and efficient regulations. It should support investment and dynamic growth in Europe, with particular attention to the needs and future potential of SMEs in the medical devices sector.

An example of the innovative developments in the sector is the trend towards more combination products. According to a survey, an estimated 30% of new products under development are such "combination products"[60]. 

The EUROPE 2020 strategy for smart, sustainable and inclusive growth[61] called for an ‘Innovation Union’ to improve the framework conditions for innovation[62]. The regulatory framework for medical devices should therefore be supportive of innovation so that users and patients have access to safe, innovative and effective devices. This also fits with the “Innovation Partnership for Active and Healthy Ageing” where medical technology plays an important role in allowing older people to live independently and be active in society. At the same time, the competitiveness of the European medical device industry should be further improved and secured over coming decades.

3.2.        Specific objectives

These general objectives can be further detailed by the specific objectives set out below. Each of them contributes to the achievement of the overall objectives.

3.2.1.     Objective 1: Uniform control of Notified Bodies

The aim is to ensure that the legal requirements concerning the pre-market evaluation laid down in the legal texts are applied and implemented effectively in all Member States in a consistent and efficient way. Concretely, this means

– that Notified Bodies are designated only for the assessment of devices or technologies which correspond to their proven expertise and competence;

– that the position of Notified Bodies vis-à-vis manufacturers is strengthened and that all follow the same high standards and criteria when they assess the conformity of medical devices.

3.2.2.     Objective 2: Enhanced legal clarity and coordination in the field of post-market safety

In the post-market phase, the objective is to ensure complete information regarding safety issues and to enhance the coordination of competent authorities regarding incidents (so called vigilance) or regarding non-compliant products. The aim is to avoid duplication of work and inconsistent reactions to the same problem in different Member States.

3.2.3.     Objective 3: Cross-sectoral solution of "borderline" cases

In order to determine the regulatory status of a given product or type of product, the scopes of the relevant legislations need to be clearly delimited from each other. Moreover, experts from different regulatory fields may need to discuss the question together. The aim is to set up a mechanism involving other relevant regulatory authorities (pharmaceuticals, biocides, food, cosmetics etc.) which would allow for the EU-wide determination as to which legislation is applicable to a given product or type of product.

3.2.4.     Objective 4: Enhanced transparency regarding medical devices on the EU market, including their traceability

The aim is to considerably enhance transparency by developing modern IT tools building on the Eudamed databank, which would meet the expectations of patients, healthcare professionals, hospitals and authorities regarding information on medical devices placed on the EU market. This would allow better tracking and tracing of certain devices in the interest of patient safety. Better traceability would help to contact users of devices when these devices need to be modified or taken off the market and to identify counterfeit devices.

3.2.5.     Objective 5: Enhanced involvement of external scientific and clinical expertise

The objective is to have access at EU level  to scientific and clinical expert advice to support decision-making, taking into account "real use" experience with devices and the needs of patients and users.

3.2.6.     Objective 6: Clear obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales

A clear and simple description of the obligations and responsibilities of the relevant economic operators (manufacturers, authorised representatives, importers, distributors) should make it easier for them to comply with the requirements and for competent authorities to enforce them, so ensuring that only safe products are placed on the EU market or put into service. In this context, clarification should be provided that devices used in the framework of commercial diagnostic services provided to the EU market fall within the scope of the legislation on medical devices. Addressing the issue of internet sales will enhance the safety of devices offered via the internet and contribute to the fight against counterfeit products.

3.2.7.     Objective 7: Governance - efficient and effective management of the regulatory system

A well structured and result-oriented coordination between the national competent authorities as well as between them and the Commission is necessary to ensure a high level of patient safety and the good functioning of the internal market. Effective coordination and information exchange will lead to mutual trust in the action of the competent authorities. It will also allow sharing of resources and avoid duplication of action. To yield fruit, the tasks to be fulfilled at EU level (e.g. organisation of expert group meetings, document management, development and maintenance of IT tools, pooling of experts, central contact point for authorities and stakeholders, in particular manufacturers) need to be effectively and efficiently managed. At the same time, the governance model chosen needs to be financially sound and sustainable.

4.           Policy options

Before presenting the different policy options to address the objectives pursued by this revision, some preliminary remarks should be made to set the frame for the discussion of the individual options.

4.1.        "No EU action"

The baseline scenario consists in "no EU action", i.e. no change to the current regulatory framework. The option “no EU action at all” had to be discarded from the outset because the Commission is committed to aligning, where appropriate, existing legislation to the New Legislative Framework for the Marketing of Products[63]. More importantly, no action would mean that the problems described above would continue to exist, or even increase, putting public health at risk. The PIP breast implants scandal made it evident that "no EU action" is not a defendable policy choice.

In addition, no action at EU level would likely prompt Member States to take action at national level which would further undermine the internal market. The Council of the European Union, in its conclusions of 6 June 2011, therefore recognised "the need to adapt the EU medical device legislation to the needs of tomorrow so as to achieve a suitable, robust, transparent, and sustainable regulatory framework […]"[64] and invited the Commission to address several issues when preparing future legislation.        

The "no EU action" option has been taken as the baseline to measure the potential impacts of the policy options against the status quo. The impacts of the different policy options assessed later on in this report are illustrated with ('+') for positive, ('-') for negative or ('o') for neutral impacts. That means that all specific policy options are compared to the baseline option by describing its benefits and disadvantages compared to the 'no EU action'. It should be noted that the impact of the baseline option in most instances would not be neutral but negative in terms of public health/patient safety, internal market and/or economic costs for operators.

4.2.        Fundamental change: marketing authorisation of medical devices

The option to transfer the responsibility for the assessment of the safety and performance of medical devices from Notified Bodies to a regulatory authority and to replace the CE marking by a marketing authorisation, such as exists in the field of pharmaceuticals, has also been discarded. Despite calls in the aftermath of the PIP breast implant scandal to shift to a system of pre-market authorisation (see Resolution of the European Parliament referred to in section 1.1.4), the case has not provided any evidence that a marketing authorisation granted by a governmental authority would have prevented deliberate fraudulent practices of a manufacturer occurring once a product is approved for being placed on the market. In fact, the PIP case rather evidences the need for a reinforced system for post-market safety which is dealt with in the policy options relating to objective 2.      

A decentralised marketing authorisation (done by Member States) would have a significant negative impact on the internal market for medical devices. In fact, the CE marking that automatically allows devices on which it is affixed access to the whole EU market would be replaced by the application of the mutual recognition of national marketing authorisations which would not offer automatic access to the market of other Member States. Under such a regime, a Member State could refuse a device authorised by another Member States access to its market because it considers that this device does not ensure an appropriate level of protection of health and safety. It would therefore run counter to one of the main objectives of the current directives.

A central marketing authorisation (at EU level) would require building a new EU public body with a sufficiently skilled staff to assess devices, similar to the US FDA[65]. It would have enormous impact on the EU budget, on manufacturers in terms of costs and administrative burden and on innovation in terms of costs for regulatory compliance and time to market[66]. According to data provided by industry, the R&D costs to bring a new medicinal product to the market have significantly increased over time and are estimated at around 1bn€[67]. In contrast, the development costs for a significantly new medical device are estimated at up to 10m€[68]. The following tables focus on procedural aspects and indicate the average costs and approval times incurred by a manufacturer under the medicinal products and under the medical devices legislation. They show that costs for obtaining a marketing authorisation under the medicinal products legislation significantly exceed the costs for obtaining a CE marking under the medical devices legislation.   

Medicinal products legislation

|| Costs for market access (standard application for non-SME pharmaceuticals manufacturer) || Costs for market access (standard application for SME pharmaceuticals manufacturer) || Compliance costs post-market || Time to market

Scientific advice || 76,300 € || 7,630 € (max. -90%) || ||

Inspection || 19,100 € || 1,910 € (max. -90%) || ||

Marketing authorisation || 254,100 € || 254,100 € if success 0 € if failure || ||

Annual fee || || || 91,000 € ||

Time for marketing authorisation || || || || 210 days[69] (excl. stop the clock periods)

Total || 349,500 € || 263,640 € || 91,000 €/year || 210 days (= 7 months) (excl. stop the clock periods)

 

Medical devices legislation (under the assumption of a classification as class III medical device)

|| Costs for market access (non-SME) || Costs for market access (SME) || Compliance costs post-market || Time to market

Notified Body fee (initial certification of  quality system and design dossier examination) || 10,000€ - 30,000€ || No specific SME regime; but costs for the assessment of the quality system usually lower the smaller the company is. || ||

Annual surveillance audit (quality system) || || || 1,000€ - 3,300€ (around 33% of initial QS audit) ||

Notified Body fee for renewal || || || 6,600€ - 20,000€ every 5 years (around 66% of initial certification) ||

Average time for pre-market assessment || || || || In average 10-15 weeks assessment time by Notified Body [70] (for certain devices types, e.g. devices combined with a medicinal substance that has an ancillary action  or devices manufactured utilising certain animal tissues, a consultation procedure prolongs the process)[71]

Total || 10,000€ - 30,000€ || || 2,320€ - 7,300€/year || 10-15 weeks (= +/- 3 months)

A change towards a marketing authorisation would also have consequences on Notified Bodies which would have to cease their activity in the field of medical devices.

Such a fundamental change was widely rejected during the public consultation and the subsequent dialogue with competent authorities, manufacturers and most other stakeholders, even though there were also some voices of healthcare professionals, health insurance organisations and HTA bodies[72] who recommended a centralisation of the evaluation of high-risk devices. However, in the absence of evidence which would support that a centralised evaluation by a regulatory authority[73] in order to achieve the objectives of this revision, such a radical shift in the regulatory system would be inappropriate.

4.3.        Evolution: reinforcement of the current regime keeping the same legal approach

Between the two extreme scenarios described above in sections 4.1. and 4.2. it exists the possibility to build on the strengths of the "New Approach" on which the current regime is based while remedying the weaknesses identified. This will allow to evolve the existing system which has served as a model for international convergence of the legislation on medical devices and to make it fitter for purpose. The individual policy options developed below under section 4.4. are to be seen within this frame of a further evolution of the current regulatory regime. It has to be noted that some options are alternatives whilst others may be cumulative.

4.4.        Policy options regarding Objective 1: Uniform control of Notified Bodies

The options to be discussed in this chapter concern

– the designation and monitoring of the conformity assessment bodies, i.e. the Notified Bodies, by the authorities (options 1A – 1D) and

– the conformity assessment carried out by these Notified Bodies (options 1E – 1G).  

4.4.1.     Policy option 1A: New minimum requirements for Notified Bodies

This option would require the amendment of the current Annex 8 of the AIMDD, Annex XI of the MDD and Annex IX of the IVDD which set the minimum criteria to be met for the designation of Notified Bodies. The criteria should be made clearer and more detailed in order to reduce the discretion of the designating authority during the evaluation of the conformity assessment bodies and to enhance their overall competence. The new minimum requirements would take account of Article R17 of Decision 768/2008/EC on a common framework for the marketing of products[74] but would in addition introduce sector-specific requirements.

4.4.2.     Policy options 1B – 1D: Changes to the process of designation and monitoring of Notified Bodies

4.4.2.1.  Policy option 1B: Designation and monitoring of Notified Bodies by an EU body

This option would transfer the responsibility for the designation and monitoring of Notified Bodies from the Member States to the EU. It would require that an EU body (e.g. the Commission or an agency) carries out the initial assessment of a candidate body and periodical surveillance assessments together with the authority of the Member State where the body is established. Such model exists in the field of ship inspections and surveys, where the Commission, assisted by the European Maritime Safety Agency, grants recognition to organisations which meet the minimum legal requirements[75].

4.4.2.2.  Policy option 1C: Designation and monitoring of Notified Bodies by Member States with involvement of "joint assessment teams"

This option would leave the ultimate responsibility for the designation and supervision of Notified Bodies with the Member States. However, the initial assessment of a candidate body, as well as regular surveillance assessments, would be carried out by a "joint assessment team" composed of assessors from the Member State where the body is established together with assessors of one or two other Member States and of an EU body (Commission or an agency). In addition, there should be the possibility to admit assessors of third countries which have concluded Mutual Recognition Agreements or other cooperation arrangements with the EU in the field of medical devices (e.g. US, Canada, Australia).

The designation by the responsible Member State should be based on the results of the recommendations of the "joint assessment team" to be submitted to a forum composed of experts designated by the Member States (MDEG, see below in section 4.10.1) which should also settle cases of divergent opinions within the joint assessment team. In addition, the designating Member State would have to submit annual reports to the MDEG regarding the periodic surveillance assessments carried out between the "joint assessments".

4.4.2.3.  Policy option 1D: Designation and monitoring of Notified Bodies by Member States in accordance with the model provisions of Decision 768/2008/EC

This option would align the procedure for the designation and monitoring of Notified Bodies in the field of medical devices to the model provisions set out in Articles R13 to R26 of Decision 768/2008/EC. In brief, this option would leave the responsibility for the designation with the individual Member States, enhance the importance of accreditation of Notified Bodies and give Member States and the Commission the right to raise objections against the notification of a designated Notified Body within two weeks of this notification if the body was accredited or within two months where accreditation was not used.

4.4.3.     Policy options 1E - 1G: Review of the conformity assessment process

4.4.3.1.  Policy option 1E: No change to the conformity assessment process

This option would rely on the strengthened oversight of Notified Bodies (see policy options 1A-1D) as well as possibly corrective measures to be taken ex post to ensure that they apply equally high standards and criteria during their conformity assessments. No additional layer of scrutiny prior to the issue of certificates by the Notified Bodies would be added.

4.4.3.2.  Policy option 1F: Systematic ex ante control of conformity assessment reports for specific device types

This option would oblige Notified Bodies to systematically submit their preliminary conformity assessment reports for certain devices or technologies to a forum composed of experts designated by the Member States (MDEG, see section 4.10.1) for scrutiny before a certificate could be issued.

On the basis of a number of criteria, the Commission could specify in a delegated or implementing act which device types would be submitted to a systematic prior scrutiny. The criteria to define those device types could be the following:

– new technology, i.e. a breakthrough technology which may have a significant clinical impact;

– "high risk" due to components or source material (e.g. tissues) or due to the impact in case of failure;

– increased rate of incidents;

– existence of significant discrepancies in the conformity assessment carried out by different Notified Bodies;

– existence of public health concerns regarding a specific device type or technology.

Within a predefined standstill period (e.g. three months)[76], the MDEG could raise concerns which would have to be taken into account by the Notified Bodies. A kind of precedent exists in the field of medical devices manufactured utilising animal tissues where a procedure was established in 2003 which requires a prior consultation of competent authorities before Notified Bodies can issue certificates[77].

4.4.3.3.  Policy option 1G: Notification requirement regarding new applications for conformity assessment and possibility for ex ante control

This policy option would create the obligation for Notified Bodies to notify the competent authorities and the Commission of new applications for design-examination, including a description of the main features of the medical devices concerned. This obligation should be limited to high-risk devices (class III MD and class D IVD[78]). On a case-by-case basis, a forum composed of experts designated by the Member States (MDEG, see section 4.10.1) could then identify those devices or technologies for which they would require the Notified Body to submit to them a summary of its preliminary conformity assessment reports, wait during a predefined standstill period (e.g. 3 months) and take possible comments of the forum into account before issuing a certificate of conformity.

In addition, for devices of class IIa and IIb and IVD of class B and C[79], the Commission would be empowered, to determine by a delegated or implementing act certain device types for which a prior scrutiny of the preliminary conformity assessment by the forum would be temporarily required during a certain period of time (e.g. three to five years). The criteria for adopting such measure would be the same as the ones listed in policy option 1F.

4.5.        Policy options regarding Objective 2: Enhanced legal clarity and coordination in the field of post-market safety

4.5.1.     Policy option 2A: Clarification of key terms and of the obligations of the parties involved in the field of vigilance

This option would make provision to

– introduce the terms "field safety corrective action" (FSCA) and "field safety notice" (FSN) in accordance with international guidelines[80];

– clarify the obligations and the roles of competent authorities, Notified Bodies and economic operators in the field of vigilance and post-market safety.

4.5.2.     Policy options 2B – 2C: Reporting of incidents and coordination of analysis

4.5.2.1.  Policy option 2B: Central reporting of incidents and coordinated analysis of certain high risk incidents

This policy option would establish a vigilance data-processing network and vigilance database (possibly a module of Eudamed) allowing for the central reporting of incidents[81] by manufacturers to the competent authorities concerned. In addition, Member States would have to enter information about serious incidents they have identified after analysis of reports from other sources (e.g. healthcare professionals, patients). All national competent authorities concerned would have access to the information simultaneously. The analysis of certain incidents (e.g. in case of high risk incident, disagreement on FSCA, lack of resources at national level) should be coordinated under the lead of a coordinating competent authority. The findings, would lead, if needed, to a corrective action consistent in all Member States concerned and could also lead to the adoption of a regulatory measure applicable in the whole EU. If a reported incident led to a FSCA, the corresponding FSN would be publicly available via the EU-wide vigilance database. In addition, trends and signals would be analysed on the basis of the centrally reported incidents.

4.5.2.2.  Policy option 2C: Decentralised reporting of incidents, but coordinated analysis of certain high risk incidents

This policy option would keep the current form of reporting of incidents to the individual national competent authorities and information sharing between them. But it would require that the analysis of certain incidents (e.g. in case of high risk incident, disagreement on FSCA, lack of resources at national level) be coordinated under the lead of a coordination competent authority. The findings would lead, if needed, to a FSCA consistent for all Member States affected and could also lead to the adoption of a regulatory measure applicable in the whole EU.

4.5.3.     Policy option 2D: Promotion of cooperation of market surveillance authorities

Market surveillance is a core competence of the Member States. Regulation (EC) No 765/2008 strengthened the role of the national surveillance authorities and the coordination among them. Article 24 of this Regulation requires Member States to ensure efficient cooperation and exchange of information between their market surveillance authorities whilst Article 25 stipulates that the sharing of resources and experience may be set up by the Commission, in cooperation with the Member States concerned, in particular regarding actions for common projects, information campaigns etc. This policy option would build upon these rules and make some existing skills, knowledge and equipment, including those of designated reference laboratories, available to other Member States[82].

4.6.        Policy options regarding Objective 3: Cross-sectoral solution of "borderline" cases

A precondition for a consistent definition of the regulatory status of a given product is a clearer delimitation of the respective scopes of the relevant legislations to the application of different regulatory frameworks to the same type of product in the various Member States.

4.6.1.     Policy option 3A: Creation of a cross-sectoral advisory group on borderline issues

This option would set up, either in the revised MDD/IVDD or at a later stage by an autonomous act of the Commission, a multidisciplinary advisory group of national experts in the field of medical devices, medicinal products, food, cosmetics, biocides etc. to provide advisory opinions as regards the regulatory status of a given product or type of product.

4.6.2.     Policy option 3B: Creation of a cross-sectoral advisory group on borderline issues and possibility to determine the regulatory status of products at EU level

In addition to the creation of a multidisciplinary advisory group (see policy option 3A), this option would empower the Commission to adopt implementing acts as to whether a given product or type of product falls within the scope of a specific legislation. This possibility already exists in the AIMDD/MDD as well as in legislation on certain foodstuffs[83]; it is also foreseen in the new Regulation […] on biocides[84]. Article 17 of Regulation 1394/2007 on advanced therapy medicinal products (ATMP) allows manufacturers to request EMA to deliver a scientific recommendation as to whether a tissue engineered product falls within the definition of an ATMP. But a provision that would allow for determining the regulatory status of a given product or category of products does not exist in the IVDD or in the EU legislation on medicinal products, cosmetics or general foodstuff with which potential borderlines exist. This policy option would thus require the amendment of the EU rules covering e.g. medicinal products, general foodstuff and cosmetics and introduce into them a provision enabling the Commission to adopt implementing measures regarding the regulatory status of a product.

4.7.        Policy options regarding Objective 4: Enhanced transparency regarding medical devices on the EU market, including their traceability

4.7.1.     Policy options 4A – 4B: Registration of economic operators and listing of devices 

4.7.1.1.  Policy option 4A: Network of national databases

This option would build a network of national databases to make the data collected at national level available at EU level. This would require standardised data collection by the participating Member States which could either be those who decided to set up national databases or all, if so required by EU legislation. No requirements regarding traceability would be introduced.

4.7.1.2.  Policy option 4B: Central registration of economic operators and listing of medical devices placed on the EU market

This policy option would develop the European databank for medical devices (Eudamed) into a central IT tool

– for the registration of EU manufacturers, authorised representatives, importers and certain distributors, and

– for the listing of medical devices which are placed on the EU market or put into service.

It would do away with multiple and divergent registration/listing requirements established by Member States.

The IT tool should be publicly available as regards basic information about the manufacturers and the devices. The detail of information would depend on the risk class and, for devices belonging to a higher risk class (e.g. implantable devices and class III devices), would also include key clinical data (summary of safety and clinical performance data[85]). Other parts would only be accessible to competent authorities and/or Notified Bodies.

4.7.2.     Policy option 4C: Requirement for the traceability of medical devices

This policy option would build upon Article R7 of Decision 768/2008 according to which economic operators shall be identified along the supply chain[86]. It would provide the legal basis for the later implementation in the EU of a system of traceability based on a globally compatible "unique device identification" (UDI) in line with international guidance developed by the GHTF[87] and with the UDI requirement currently being implemented by the US FDA[88].The implementation should be gradual, starting with class III devices (e.g. coronary stents) or devices for which a need to trace has been identified (e.g. devices with a high level of incidents).  It would require manufacturers to obtain an UDI code, allocate it to the product and provide information to a UDI database.

4.8.        Policy options regarding Objective 5: Enhanced involvement of external scientific and clinical expertise

4.8.1.     Policy option 5A: Creation of a pool of experts

This option would provide that a pool of experts at EU level with proven knowledge in the field of medical devices/technology is set up. This pool of experts could be consulted on an ad hoc basis upon request by competent authorities, the Commission, manufacturers or Notified Bodies.

4.8.2.     Policy option 5B: Designation of an expert panel and reference laboratories for specific areas in medical technology

This option would set up, either in the revised MDD/IVDD or at a later stage by an autonomous act of the Commission, an expert panel composed of clinicians and academics in various fields of medical technology and designate reference laboratories (especially in the field of IVD). Their role would be to provide expert advice in the pre-market and post-market phase of the life-cycle of a medical device to the Commission and to competent authorities regarding specific safety issues detected in the context of vigilance or post-market surveillance activities (e.g. safeguard clause procedures).

4.9.        Policy options regarding Objective 6: Clear obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales

4.9.1.     Policy option 6A: Alignment with Decision 768/2008/EC[89], additional requirements for authorised representatives and clarification of obligations in the field of diagnostic services

This option would incorporate in the MDD and IVDD the model provisions of Articles R2-R7 of Decision 768/2008 regarding manufacturers, authorised representatives, importers and distributors. Whilst Decision 768/2008 defines an authorised representative and what it should be allowed to do, the Decision does not specify the minimum requirements an economic operator needs to fulfil in order to exercise the role of an authorised representative properly. Therefore, some sector-specific minimum requirements for authorised representative would be set up. In addition, it would be clarified that medical devices and IVD used in the context of a commercial diagnostic service provided in the EU need to be in conformity with the legal requirements.

4.9.2.     Policy options 6B – 6C: Internet sales

4.9.2.1.  Policy option 6B: Legislative measures regarding internet sales

This option would incorporate in the MDD and IVDD specific requirements regulating the sale of medical devices and IVD over the internet, contributing to address the problem of counterfeit products and to ensure the application of the legal obligations.

4.9.2.2.  Policy option 6C: Addressing internet sales by soft-law action

This policy option would not foresee specific requirements relating to internet sales but address the problem by means of soft law such as information campaigns, voluntary portals and/or code of conducts for internet sellers. The Member States, possibly with support of the Commission, should coordinate such actions in the field of internet sales at EU level and with third countries, contributing to address the problem of counterfeit products and to ensure the application of the legal obligations.

4.10.      Policy options regarding objective 7: Efficient and effective management of the regulatory system

4.10.1.   Policy option 7A: Extension of the responsibility of the European Medicines Agency (EMA) to medical devices and creation of a Medical Device Expert Group at this agency

This policy option would extend the mandate of the EMA and transform it into a European regulatory agency for medicinal products and medical devices ("European Health Products Agency", name to be chosen).

As mentioned in the problem description and the objectives, enhanced coordination between national competent authorities is the cornerstone for achieving a more harmonised implementation of the regulatory framework for medical devices. Several of the policy options therefore suggest tasks for a forum composed of experts designated by the Member States[90], for the purpose of this report called Medical Device Expert Group (MDEG)[91]. This MDEG would be given a legal basis in the new legislation[92].

Representatives of patient organisations, healthcare professionals, manufacturers and Notified Bodies could be invited to participate in the MDEG to provide additional expert views. The MDEG would be supported, where appropriate, by specialist multi-stakeholder subgroups for specific areas such as Notified Bodies, post-market safety, clinical investigations and evaluation built upon the current informal working groups of the Commission and involving patient organisations, healthcare professionals, manufacturers and Notified Bodies.

The MDEG would be established at the "European Health Products Agency" and the agency's secretariat would provide administrative, technical and scientific support for it as EMA's secretariat currently does for the scientific committees established at EMA. The European regulatory agency would also be entrusted with the tasks necessary to ensure a sustainable management of the regulatory regime for medical devices, such as organisation of the assessment of Notified Bodies, coordination in the field of post-market safety, management of an expert panel and a network of Reference Laboratories, and the setting up and management of IT infrastructure (see list of possible tasks in Appendix 8). This option would require the amendment of Regulation (EC) No 726/2004 concerning the establishment of the EMA[93] and a financial commitment of the Union budgetary authority for appropriate staffing of qualified personnel in the field of medical devices[94].

This option would not devolve decision-making power from Member States to the EU, but it would institutionalise the coordination between Member States and make available scientific and technical expertise to the Commission and the national authorities in the context of the fulfilment of their regulatory tasks. It would build on the existing "effective and efficient Community method" for which the EMA Secretariat and the network of competent authorities are known in the field of pharmaceuticals[95].

4.10.2.   Policy option 7B: Creation of a new EU regulatory agency for medical devices only and of a Medical Device Expert Group at this agency

Instead of using an existing structure, this policy option would set up a new regulatory agency[96] specifically for medical devices. The MDEG would be established at this new agency which would provide it with administrative, technical and scientific support. The new agency would also carry out the other tasks needed to ensure the EU governance of the system, such as organisation of the assessment of Notified Bodies, coordination in the field of post-market safety, management of an expert panel and a network of Reference Laboratories, and the setting up and management of IT infrastructure (see list of possible tasks in Appendix 8). The agency should have legal personality and staff qualified in the field of medical devices.

4.10.3.   Policy option 7C: Management of the medical device regulatory system by the European Commission and creation of a Medical Device Expert Group supported by this institution

This option would mandate the European Commission to provide the necessary administrative, technical and scientific support to the MDEG. The Commission would also carry out the other tasks needed to ensure the EU governance of the medical device system mentioned in policy options 7A and 7B and listed in Appendix 8. The activities would mainly be performed by the Commission's Joint Research Centre (JRC)[97].

4.10.4.   Policy option 7D: Creation of a Medical Device Expert Group managed by the Member States

This option would limit itself to create the statutory basis for a MDEG composed of the Member States' experts which would be managed by the Member States themselves. It would carry forward the Member States' initiative for a "Central Management Committee" set up in 2010[98]. The support staff could be allocated by the national competent authorities on a voluntary basis like for example for the Heads of Medicines Agencies network in the field of pharmaceuticals[99]. Alternatively or in addition, an EU body (EMA or the Commission) could be mandated to provide the secretariat like EMA does for the Co-ordination Groups for Mutual Recognition and Decentralised Procedures for human and veterinary medicines (CMDh and CMDv) in accordance with Article 27 of Directive 2001/83/EC and Article 31 of Directive 2001/82/EC.

5.           Analysis of impact and comparison of the policy options

In this chapter, the likely economic, social and environmental (intended and unintended) impacts of the policy options as well as potential trade-offs and synergies will be assessed.

As a general remark it needs to be stated that the medical devices directives do not address environmental aspects linked to medical devices and the revision does not intend to extend their scope to issues related to the protection of the environment. The assessment will therefore address environmental impacts only when a specific policy option gives rise to consider them (e.g. reprocessing of single-use devices, see Annex 1). The focus, however, will lie on the economic impact (e.g. costs for industry and public budget) and on the social impact (e.g. patient safety and public health).

Moreover, the requirements laid down in the medical devices directives apply to European and third country manufacturers in the same way so that no distinction needs to be made as regards the impact on third countries.

5.1.        Impact of policy options 1A-1D (designation and monitoring of Notified Bodies)

5.1.1.     Impact of policy option 1A (new minimum requirements for Notified Bodies)

The strengthening of the minimum requirements for Notified Bodies is not expected to have a noteworthy economic impact on those Notified Bodies that act in accordance with recognised professional conformity assessment standards in the field of medical devices as laid down in guidance documents and relevant international standards[100]. While the new minimum requirements would make them formally enforceable, it will not involve significant additional effort on the part of those Notified Bodies which are already complying with the spirit of the legislation other than the production of updated evidence.

Notified Bodies which currently do not meet the substantive requirements to carry out appropriate conformity assessment in the field of medical devices will either incur compliance costs to meet the new requirements or their designation would need to be limited or withdrawn.

The positive impact would be to ensure that only Notified Bodies with the necessary competence, experience and skills will be allowed to assess the conformity of medical devices. It will enhance the level of patient safety and public health and ensure a level playing field in the internal market.

5.1.2.     Impact of policy option 1B (designation and monitoring of Notified Bodies by an EU body)

This option would lead to the transfer of competences from the Member States to the EU and would therefore have an impact on the EU budget. A NBOG report[101] indicates that competent/designating authorities in average have 3.5 assessors available which would mean that around 80 assessors are employed by national competent/designating authorities in the field of medical devices. In most cases, however, the assessors are either not exclusively responsible for Notified Bodies but also for other tasks related to medical devices, or not only responsible for Notified Bodies in the field of medical devices. No reliable figures exist as regards FTE responsible for the oversight of Notified Bodies at Member States' level in the field of medical devices.

Entrusting the tasks of designating and monitoring of Notified Bodies in the field of medical devices to a EU body would mean that new structures at EU level would have to be built up requiring in particular the recruitment of qualified staff who would assess (inspect) the Notified Bodies. Based on the current number of Notified Bodies (78 in August 2011) around 20 assessors (FTE) would need to be available at EU level to carry out the assessment.

Assessment activity || Estimated amount of man-days per NB || Estimated amount of man-days for 78 NB

Initial audit || 9–15 man-days || 702–1170 man-days

Surveillance audit with observed audit || 9-15 man-days || 702–1170 man-days

Preparation of assessment || 9-15 man-days || 702–1170 man-days

Follow-up of assessment || 9-15 man-days || 702–1170 man-days

Total (average) || 36 man-days || 2808 man-days

If the average amount of man-days is taken (936 man-days for initial audits, 936 man-days for preparation and 936 man-days for follow-up), a minimum of 2808 man-days would be required. 1 FTE is equal to around 220 man-days/year. Taking into account absences, training and travel times 20 FTE would be required to cope with the assessment of 78 Notified Bodies.

In addition to the EU assessors, 4 FTE would be needed for administrative support to ensure appropriate logistics and document management. The costs for human resources will be estimated in section 5.8. (management of the regulatory system). Travel expenses of roughly 200,000€/year would need to be added.

It would be crucial that sufficient and qualified assessors are available in the start-up phase of the implementation of such new process since Notified Bodies' oversight is the cornerstone of the medical device regulatory framework. It could be expected that the number of Notified Bodies will decrease as a consequence of more stringent requirements and their consistent enforcement so that the number of FTE assessors needed to perform this task could be reduced in subsequent years.

Member States could generate savings since they would be discharged of their responsibility to inspect Notified Bodies.

The advantage of a transfer of the Notified Bodies' oversight to the EU level would be that all Notified Bodies would be controlled by one authority which is independent of national interests. This would give a high assurance that the requirements would be implemented in a consistent way all over the EU. It would also lead to a world-wide high esteem of the European system of third party certification. Auditors of third countries which have concluded Mutual Recognition Agreements (MRAs) or other cooperation arrangements with the EU in the field of medical devices could be permitted to participate in the inspections which would facilitate a more effective and transparent implementation of these international agreements and thus support the global acceptance of CE marked medical devices.

A certain disadvantage would be that the day-to-day contact between Notified Bodies and "their" competent authorities which enables practical routine questions to be resolved would disappear. Several Member States expressed reservation when this change of the system was discussed with them. On the other hand, this could also be seen as an advantage since it would increase the independence of the inspectors. A disadvantage would also be that the implementation and full functioning of the new regime would require a relatively long period of time due to the need to recruit and train qualified inspectors at EU level and the high number of Notified Bodies to be assessed.

5.1.3.     Impact of policy option 1C (designation and monitoring of Notified Bodies by Member States with involvement of "joint assessment teams")

This option would mainly rely on existing resources at Member States' level. At EU level, the organisation of the 'joint assessments' (e.g. list of eligible assessors, composition of the assessment teams, document management, reimbursement) as well as participation in the onsite inspections would have to be ensured. This would require around 6 FTE for operative tasks and 3 FTE for support tasks.

In addition, the temporary 'secondment' of national auditors to 'joint assessment teams' would require the reimbursement of their expenses from the EU budget. The amount of man-days required to inspect the currently 78 Notified Bodies would be the same for this policy option as in option 1B. Taking into account that the above-mentioned 6 FTE would participate in the assessments and the national assessors would remain employed by their competent authorities (absences, training etc. would therefore be at their charge) it would mean that around 2200 man-days (equivalent to 10 FTE) would need to be reimbursed by the EU budget. Applying the current daily allowance rate of 92€/day for experts, a sum of around 200,000€/year would need to be reimbursed; travel expenses of roughly 200,000€/year would need to be added (on the basis of average expenses of 650€ for intra-EU travels plus several travels to Notified Bodies' subsidiaries in third countries).

The advantage of this option would be that the existing structures would remain in place and that only the coordinating task would be transferred to the EU level. Furthermore, the participation of staff of the national designating/competent authorities would foster the exchange of best practices and lead to capacity building which would enhance the competence of national designating/competent authorities in all Member States. This will be helpful as these authorities would maintain the full responsibility for the regular surveillance audits to be documented in annual reports.

Like option 1B this option would also lead to a world-wide high esteem of the European system of third party certification; inspectors of MRA and other international cooperation partners could be admitted to participate in the joint audits.

Option 1C could probably be implemented relatively quickly since it would build on existing structures and human resources available at national level.

5.1.4.     Impact of policy option 1D (designation and monitoring of Notified Bodies by Member States in accordance with the model provisions of Decision 768/2008/EC)

This last option would not have economic impacts and, as regards the designation of Notified Bodies, it would simply align the medical devices legislation with Decision 768/2008/EC on a common framework for the marketing of products.

It can, however, be predicted that this option alone would not significantly change the differences between Member States as regards their oversight of Notified Bodies. More than 80% of the Notified Bodies designated under the AIMDD/MDD/IVDD are accredited[102]. Therefore, in most cases, the 2-weeks objection period would thus apply during which a meaningful scrutiny by other Member States or the Commission could not be carried out. Moreover, the experience in other fields shows that when Member States and the Commission have been notified of designations from Member States which do not use accreditation[103], no objections or additional queries have been received from other Member States and the control exercised by the Commission was equally limited due to the scarcity of resources. It also needs to be noted that the other Member States and the Commission would only be notified after the designation decision had been adopted at national level. In conclusion, it cannot be expected that the scrutiny procedure foreseen by Article R23 of Decision 768/2008/EC alone would lead to a noteworthy improvement of the current situation as described in Problem 1.

Comparison of options 1A to 1D:

It should be recalled that in section 4.1. the 'no EU action' was discarded. Actually, no changes to the designation and monitoring of Notified Bodies would further reduce the level of protection of public health and patient safety and further impair the functioning of the internal market. Option 1A is complementary to any of the options 1B to 1D and would in any case be a necessary measure to provide a sound legal basis for the assessment of conformity assessment bodies by the authorities and therefore is a condition sine qua non for improving the oversight of Notified Bodies.  

With regard to the three options in relation to the designation and monitoring process, option 1D is considered not sufficiently effective to remedy what has been identified as the weakest point of the current regulatory framework. It is therefore not the preferred option. But it could be combined with option 1C where the designation would remain the competence of the individual Member State. In this case, Option 1D would provide an additional safeguard that a Member State duly takes into account the findings of the 'joint assessment' and possible recommendations of the Medical Device Expert Group. In addition, the MDD and IVDD would incorporate the model provisions of Decision 768/2008.

The most effective option as regards improving the oversight of Notified Bodies would be option 1B. But it would also be the most costly one for the EU budget and it would likely require a longer implementation time than other options. Moreover, it might be met with reservation by Member States on grounds of the principle of subsidiarity. The effective implementation of option 1B would depend on setting up a strong management structure at EU level so that its choice is interrelated with the policy option to be chosen among options 7A-7D (see below section 5.8).

Option 1C would be the second most effective way of achieving specific objective 1. It would require less EU financing and could be implemented rather quickly. It would have the advantage over option 1B that it constitutes a cooperative approach building upon Member States' responsibilities and capacities and therefore would not raise concerns in terms of the subsidiarity principle. If chosen, it should be combined with option 1D.

For the above reasons, option 1A should be retained in any case. Option 1D, taken alone, is discarded. The choice between options 1B and 1C depends foremost on a political decision whether the EU should assume full responsibility for the assessment and designation of Notified Bodies in the field of medical devices or whether the ultimate responsibility shall remain at Member States' level. For this reason, in this impact assessment the choice between policy options 1B and 1C for the designation and monitoring process is left open.

|| Minimum requirements for Notified Bodies || Designation and monitoring of Notified Bodies

Impacts || Option 1A || Option 1B || Option 1C || Option 1D

Social impact (public health, patient safety, trust) || ++ || +++ || +++ || --

Economic impact (EU and national budgets, costs for NB and economic operators) || O || --- || -- || O

5.2.        Impact of policy options 1E – 1G (conformity assessment procedures by Notified Bodies)

5.2.1.     Impact of policy option 1E (no change to the conformity assessment process)

The improvement of the oversight of Notified Bodies would already be an important step towards more consistency in the conformity assessments performed by these bodies. During the regular surveillance audit, the assessors review the conformity assessment performed by the Notified Bodies and at that stage can identify discrepancies in the conformity assessment procedures. It could therefore be argued that it is not needed to review the conformity assessment prior to the delivery of certificates. In addition, the establishment of a voluntary "early advice" process with the involvement of external experts (see options 5A and 5B) could address concerns which might exist regarding genuinely new devices or technologies. Policy option 1E would therefore not change the conformity assessment process and would not have any impact compared to the status quo.

The option would, however, not allow a direct comparison of the performance of Notified Bodies and ensure the application of uniform standards, e.g. in respect to the assessment of the manufacturer's clinical evaluation. It would not enable public authorities either to be systematically informed at an early moment about new devices coming to the EU market for which accompanying measures regarding their use possibly would need to be adopted (e.g. prescription requirements or qualification requirements for users). 

5.2.2.     Impact of policy option 1F (systematic ex ante control of conformity assessment reports for specific device types)

The main negative economic and social impact of a systematic ex ante review of the Notified Bodies' preliminary conformity assessments for specific device types or technologies would be the slowdown of the procedure which would affect one of the most lauded aspects of the European system of pre-market evaluation of medical devices, i.e. rapid access to market and support of innovation. The impact would depend on the length of the review process; three months, as currently applicable to medical devices manufactured utilising animal tissues, would likely be the period of choice. This would mean that certain products would come onto the market up to three months later, leading to a delay in patients having access to an innovative device or technology and a certain loss of income for manufacturers. In practice, the delay would likely be longer if a "stop-the-clock" mechanism would be applied.

In addition, the submission of preliminary summary evaluation reports would generate administrative costs for the Notified Bodies for drawing up the necessary documentation and filing it to the MDEG.

This negative effect would not affect all medical devices or technologies but only those which have been determined by a Commission measure on the basis of the criteria set out in the legislation. A disadvantage of this option would be that it would take time until the Commission has adopted a measure defining the device type or technology subject to preliminary scrutiny of the Notified Body's assessment. Therefore, the reaction to a specific situation (e.g. increased number of incidents for a specific device) could be too slow.

The number of draft conformity assessment reports which would have to be submitted for review would depend on the categories of devices selected for the ex ante review and cannot be quantified since it depends on future developments in the sector as well as on findings regarding high risks, incidents rates or discrepancies in Notified Bodies' assessments. It could roughly be estimated that several hundreds of preliminary assessments could be subject to a systematic ex ante control mechanism per annum if applied. Such large numbers would be difficult to manage and probably only a small part would actually require a substantial review of the Notified Body's preliminary assessment.

On the benefits side, it can be argued that a mechanism for an ex ante review would increase the level of protection for all European patients and users because it would ensure that high risk or novel devices are appropriately assessed before they reach the patient or user, and in particular that they have been submitted to an appropriate clinical evaluation. But it is not possible to quantify the number of possible cases where non-conformities would actually be identified so that the level of increase in the protection of patients and users against unsafe devices is not predictable either. 

Other benefits would consist in establishing a level playing field between manufacturers because all Notified Bodies would be bound to apply the same criteria for their assessment. Furthermore, competent authorities would be informed at an early stage about high risk and novel devices in the pipeline for being placed on the European market and could intervene at an early stage from a public health perspective. This may lead to fewer restrictive measures by competent authorities in the post-market phase which would eventually have a positive impact on the functioning of the internal market.

To carry out a scrutiny diligently, the regulatory authorities would need to allocate appropriate staff to actually review the preliminary assessment reports of the Notified Bodies. Otherwise the submission and standstill would only be a bureaucratic hindrance without added value.

At EU level, the management of the review process would require additional human resources of at least 10 FTE. Besides this, it would generate administrative costs (translations, meetings, reimbursement of experts).

5.2.3.     Impact of policy option 1G (notification requirement regarding new applications for conformity assessment and possibility for ex ante control)

Currently, no data is available at EU level as regards the exact number of medical devices, let alone a breakdown according to the different risk classes of devices. It can roughly be estimated that around 5-10% of the devices present on the market fall in the highest risk-class III or class D IVD[104]. In absolute terms this could be between 27,000 and 54,000 types of devices. The number of devices would have to be divided by 5 years (validity of certificates). Devices from the same manufacturer with similar characteristics could be included in the same conformity assessment.

There would be an economic impact related to the development and continuous maintenance of the IT infrastructure to be used by the Notified Bodies for the notification of applications. The IT should be set up by the EU body (Commission or agency) to ensure a consistent notification format and would need to be borne by the EU budget. The costs for IT will be part of the overall IT budget estimated below under 5.8.

Costs for Notified Bodies:

It can be estimated that the Notified Bodies altogether receive around 5,000 applications a year for design-dossier examination, including review of significant amendments. If the notification requirements only apply to new applications, roughly around 2,500 notifications with regard to design-dossier examinations for class III/D devices a year could be expected. If it was ensured that the electronic notification was based on a format used in any case by the Notified Bodies for their internal file management, the administrative costs would be very low and would probably require not more than one additional hour per notification. Cost for 1 hour can be estimated at 30€. The aggregate costs can therefore be estimated at around 75,000€/year.

Only a small percentage of the applications notified would actually concern genuinely "new" or problematic devices or technologies. In addition, due to limited capacities and strict deadlines the MDEG would need to make a selection of the cases for which it would request Notified Bodies to submit a preliminary assessment. A reliable estimation cannot be made but an expectation is that not more than 50 preliminary assessments/year should be submitted.

It can be estimated that 0.5 – 1 man/days would be needed for drawing up a summary of a preliminary assessment. Assuming that around 50 files would be selected, between 25 and 50 man/days would be spent by Notified Bodies. Costs for 1 man/day can be estimated at 250€ so that the aggregate costs can be estimated at between 6,250€ and 12,500 €/year.

In case of comments submitted by the MDEG, the Notified Body would need to analyse the comments and respond to them which may be estimated at 2 man/days. Assuming that in 50% of the submitted files comments are issued, 50 man/days would be spent on the follow-up. The aggregate costs can be estimated at around 12,500€.

Altogether, the administrative costs can be estimated at between 93,750 and 100,000€/year.

Social impacts:

Like option 1F, also the present option would increase the level of protection for all European patients and users because it would ensure that high risk or novel devices are appropriately assessed before they reach the patient or user, and in particular that they have been submitted to an appropriate clinical evaluation. This option would also ensure a level playing field between manufacturers to the benefit of the internal market.

Moreover in some individual cases, the pre-market assessment procedure could be slowed down when the submission of the summary of the preliminary assessment is requested on a case-by-case basis. But in contrast to option 1F, the review process by a MDEG would only be triggered where these experts have identified possible concerns on the basis of the notification.  

Required human resources:

The MDEG experts, between their meetings, would need to identify the critical cases for which submission of a summary of the preliminary conformity assessment is requested, and to review the summaries submitted.

At EU level, the management of the notification procedure and ad hoc review process would require additional human resources of at least 8 FTE. Besides this, it would generate limited administrative costs depending on the cases identified for review (translations, meetings, reimbursement of national and external experts).

Comparison of policy options 1E – 1G:

A comparison of the three options is inherent in the above description of the pros and cons. Policy option 1E would not contribute to the achievement neither of the specific objective 1 (uniform control of Notified Bodies) nor of the general objectives A and B (high level of protection of human health and safety; functioning of the internal market). On the other hand, it would be the option preferred by industry since it would not slow down the conformity assessment process and therefore be considered as the most suitable to ensure a supportive regulatory framework for innovation (overall objective C). Policy options 1F and 1G, on the contrary, would effectively achieve the overall objectives A and B (high level of protection of human health and safety; functioning of the internal market) as well as specific objective 1 (uniform control of Notified Bodies).

However, option 1F would systematically slow down the regulatory pathway for certain devices coming to the market and possibly reduce Europe's advantage for ensuring rapid access to innovative medical technologies through a decentralised, flexible and timely pre-market assessment system. This may hamper realisation of overall objective C which is to provide a regulatory framework which is supportive to innovation.

Option 1G may also slow down the access of new products to the market but only case-by-case under the responsibility of the MDEG where it has identified a concern. It is therefore more flexible and more proportionate. Therefore policy option 1G is retained. It would however require that the review process does not lead to unreasonable delays and does not become the rule rather than the exception (see monitoring and evaluation).

The experience with Directive 2003/32/EC concerning medical devices manufactured utilising animal tissues (see section 4.4.3.2) supports the choice for option 1G. Even though the impact of the application of Directive 2003/32/EC cannot be measured in quantitative terms (and the Commission is not informed about the consultations under this piece of legislation), the feedback from several national authorities is that this mechanism has considerably improved the quality of manufacturers' risk analysis and management regarding devices manufactured utilising animal tissues and Notified Bodies' conformity assessments in this respect. Significant flaws were identified in the beginning when the consultation procedure came into application (April 2004) whilst the vast majority of summary evaluation reports submitted nowadays are considered fine. Scrutiny by competent authorities seems to have prompted manufacturers to shift to 'safer' source countries or higher quality starting material. It can be said that the process has contributed to increasing the safety of such devices and may have prevented some devices for which the manufacturer could not provide the required safety data from coming to the market.

At the same time, option 1G would also remedy shortcomings of the rather rigid process established by Directive 2003/32/EC since it would provide the flexibility to take account of developments which take place in the manufacturers' risk analysis and management regarding problematic devices and Notified Bodies' conformity assessment in this respect. Instead of forcing all devices of a specific type or category into a review process, competent authorities could select those which actually give rise for concerns on the basis of summary information provided by the Notified Bodies. This approach would ensure that any slow-down of the process is proportionate to the objective pursued. Moreover, the scrutiny would be carried out jointly by the competent authorities, thus allowing for work-sharing among them and avoiding that Notified Bodies are confronted with several opinions of individual authorities which may not necessarily be compatible.

|| Conformity assessment process

Impacts || Option 1E || Option 1F || Option 1G

Social impact (public health, patient safety, trust) || O || ++ || ++

Impact on innovation || O || --- || -

Economic impact (EU and national budgets, costs for NB, costs for manufacturers) || O || -- || -

5.3.        Impact of policy options 2A to 2D (enhanced coordination in the field of post-market safety)

5.3.1.     Impact of policy option 2A (clarification of key terms and of the obligations of the parties involved in the field of vigilance)

The positive impact of this option would be to align the EU vigilance system with European and international guidance developed over the recent years and introduce into a legally binding text terms like "field safety corrective action" and "field safety notice" which are already in use in Europe by means of a guidance document[105]. There would therefore be no additional costs for manufacturers since most competent authorities already follow the guidelines in their application of the general and vague legal requirements in the field of vigilance.

The clarification of the legal obligations of manufacturers and Notified Bodies regarding post-market safety, some of them currently hidden in the annexes on conformity assessment, will enhance legal certainty. The current directives are silent in respect of the role of Notified Bodies in the vigilance system even though they are responsible for the (pre-market and continuous) assessment of the manufacturer's vigilance procedures and post-market surveillance plan (PMS). In practice, Notified Bodies are often required by the competent authorities to participate in the investigation of specific vigilance cases. As a result, it would be beneficial for all parties involved, in particular for the Notified Bodies, to clarify their role. Systematic information of Notified Bodies about incidents related to products for which they had performed the conformity assessment will provide added value for their assessment activity and may trigger a more timely decision as regards a suspension, restriction or withdrawal of a certificate they have issued.

All the above suggested amendments would not lead to significant costs but they would considerably enhance the legal certainty as regards the role and obligations of economic operators, Notified Bodies and authorities in the vigilance systems. This will increase the assurance that incidents are appropriately followed up and enhance the functioning of the internal market.

5.3.2.     Impact of policy option 2B (central reporting of incidents and coordinated analysis of certain high risk incidents)

The costs for this option would consist in the establishment of the IT infrastructure for a central reporting of incidents and the recruitment of human resources necessary to ensure the coordination of the analysis of high risk and certain other incidents.

The costs for the development and maintenance of an IT infrastructure will be part of the overall IT budget estimated below under 5.8.

With the data available to the Commission, it is not possible to estimate with sufficient precision the number of incident reports to be entered by manufacturers. The competent authorities of the 'bigger' Member States receive around 5,000 incident reports from manufacturers (see Appendix 6b). But the available data does not allow identifying reporting of the same incident in several Member States; according to information from industry, a high percentage of reports are filed in several Member States to comply with the legal requirements. Roughly, it can be expected that at least 10,000 individual reports (possibly two or three times as much) would be notified by manufacturers. In addition to those report, Member States would enter information regarding serious incidents they have been made aware of by other sources. Based on the number of NCARs exchanged between competent authorities in recent years (e.g. 748 in 2010) and the fact that some Member States sent very few or no NCAR at all, it can be expected that every year around 1,000 or more incidents reported to the central database would in principle qualify for being checked to identify trends and signals[106], supported by specialised software. Moreover, it can be estimated that in 5-10% of those cases a more in depth coordinated analysis would be needed at EU level under the lead of the coordinating competent authority (due to the high risk of the incident or divergent options regarding the appropriate corrective action). Some of them possibly would need to be followed-up by the preparation of a measure to be adopted at EU level. Around 6 qualified FTE and 2 FTE support staff would be necessary to exercise these tasks.

The positive impacts would be manifold:

First of all, the same high level of safety would be ensured for all patients and users in the EU and distortion of the internal market would be avoided. All competent authorities that are concerned would be informed at the same time. An incident which justifies a recall of the product in one Member State to protect the safety of its citizens would, with all probability, justify the same action in another Member State where the product with the same failure is on the market.

Secondly, trends or signals could be identified more easily at EU level whereas for example an isolated analysis of a small Member State's market would not give rise to concerns. This would trigger the necessary consequences like e.g. extra controls of the Notified Bodies involved in the analysis of the devices with high incident rates. It would therefore also support the objectives of strengthening the Notified Bodies' oversight.

Thirdly, a coordinated approach would avoid duplication of investigations and analysis by several competent authorities. It would thus save resources deployed by the Member States.

And finally, the costs for the manufacturers would be reduced. A single central notification of incidents would replace multiple individual notifications. Moreover, a coordinated reaction to incidents would ensure that manufacturers are required to take corrective actions in a coherent way. It would thus avoid that a manufacturer would have to recall his product in one Member State whilst it would be required to provide 'only' a warning in another Member State or an updated version of the device in a third Member State. The coordination of the analysis of vigilance cases will generate significant savings for manufacturers. However, it is not possible to estimate the costs savings in quantitative figures because industry could not provide data as regards the cost of diverging vigilance systems in the various Member States. But especially for SMEs the savings would be relatively high since it would reduce their costs for dealing with different requests from several authorities.

5.3.3.     Impact of policy option 2C (decentralised reporting of incidents, but coordinated analysis of certain serious incidents which have an impact on more than one Member State)

This option would not incur costs for an IT infrastructure since this would be left to the Member States. The coordination task would be limited to the coordination of vigilance cases which have an impact on more than one Member State and would require at least 3 FTE.

The positive impact would be limited to a coordinated approach regarding the analysis of certain serious incidents. Like option 2B, this option would avoid duplication of investigations and analysis by several competent authorities which would save resources deployed by the Member States and ensure that manufacturers are required to take corrective actions in a coherent way. However, unlike option 2B, there would be no positive impact related to a single central notification of incidents. Manufactured would therefore still be burdened by multiple notifications and Member States would need to manage their own incident reporting tools.

5.3.4.     Impact of policy option 2D (promotion of cooperation of market surveillance authorities, including designated test laboratories)

For effective market surveillance in a single market, close cooperation between the national competent authorities is essential. The sharing of resources and experience would not lead to additional costs but rather to savings at national level where duplication of work would be avoided. Surveillance activities (e.g. coordinated checks, information campaigns) would become more effective so that the money is spent more efficiently. Moreover, often laboratories need to be involved for the analysis of samples of certain devices (e.g. sterile devices, IVDs). The laboratories should work in accordance with internationally approved procedures or criteria-based performance standards and use recognised methods of analysis. The designation of reference laboratories[107] with scientific and technical expertise within the field of medical devices can contribute to a high quality and uniformity of analytical results which would be the basis for coordinated surveillance measures throughout the EU.

To implement this option, 2 FTE would be needed at EU level. But it would not immediately create additional costs but only set the framework for the establishment of European Union Reference Laboratories and a network of national reference laboratories, possibly with the involvement of the Commission's Joint Research Centre. EU funding for the designated reference laboratories would need to be made available over time. But a recent evaluation of EU-RefLabs in the field of food and feed and animal health has concluded that the EU funding of a decentralised network of reference labs is cost efficient and provide good value for money[108]. The positive impacts are primarily an increased and equal level of safety of products in the market (in particular those which are not subject to a pre-market assessment by Notified Bodies) and savings at national level due to the avoidance of duplication of work.

Comparison of policy options 2A to 2D:

Policy option 2A is necessary for any effective implementation of the vigilance system as it would ensure legal certainty and facilitate uniform application of the rules. It should therefore be retained in any case as a condition sine qua non for improving the vigilance system.

A choice needs to be made between option 2B (central vigilance reporting) and option 2C (decentralised vigilance reporting). The additional costs required for implementation of option 2B appear justified as this option would provide a real EU added value in terms of protection of public health, functioning of the internal market, sharing of information and expertise between Member States and reduction of costs of manufacturers.  Option 2B is therefore the preferred option, which would also be in line with the Council Conclusions requesting a further development of the vigilance system "to allow a coordinated analysis and a rapid and EU-wide response to safety issues"[109]. Option 2D is complementary and a sector-specific concretisation of the general policy on reinforcing market surveillance in the EU. Options 2A, 2B and 2D should therefore be retained.

|| Clarification of key terms || Vigilance reporting and coordination of analysis || Market surveillance

Impacts || Option 2A || Option 2B || Option 2C || Option 2D

Social impact (public health, patient safety, trust) || ++ || +++ || + || ++

Economic impact (EU and national budgets, costs for NB and economic operators) || O || -- || -- || -

5.4.        Impact of policy options 3A and 3B (cross-sectoral solution of "borderline" cases)

5.4.1.     Impact of option 3A (cross-sectoral advisory group on borderline issues)

In the field of medical devices, this option would not cause additional costs since the Commission's Borderline and Classification Working Group has already been meeting regularly 3-4 times a year (plus meetings of sub-groups). Also in the field of cosmetics, regular meetings are held on borderline issues. Involvement of Commission services and national authorities from other sectors in an advisory group on borderline issues would likely lead to a certain increase of their workload including reimbursement of national experts. On the positive side would be an enhanced cross-sectoral voluntary coordination between authorities[110], based on a clearer definition of the scopes of the relevant legislations. This would create synergies by avoiding duplication of discussion in different fora. Controversial borderline cases could be settled ensuring the application of the appropriate regulatory control of a given product or type of products. It would therefore enhance the safety of citizens and reduce compliance costs for manufacturers who are subjected to different regulatory regimes in different Member States which often also causes costs for judicial litigation. However, there would be no legally binding decisions as regards the regulatory status of a product when it is considered a medicinal product, cosmetic, biocide or a general foodstuff which might reduce the benefits of an agreed solution in the longer term. The Commission would have only the possibility to launch infringement procedures on a case-by-case basis when it considers that the regulatory status of a product is not correctly determined in a given Member State, but the ultimate interpretation of Union law lies with the European Court of Justice.

5.4.2.     Impact of option 3B (cross-sectoral advisory group on borderline issues and possibility to determine the regulatory status of products at EU level)

This option would bring the same benefits as option 3A but in addition it would provide enhanced legal certainty since an agreed solution on a given product or type of products could be made legally binding also in fields other than medical devices, for example in the legislation applicable to medicinal products or cosmetics. This would lead to an increase in workload for the Commission services preparing the legal measures as well as costs for the organisation of additional meetings of Standing Committees in the field of medical devices, medicinal products, biocides, food and cosmetics. In the long-term, the legal clarity achieved by a binding measure would reduce the workload since discussions about cases would not be 're-opened'. A disadvantage in terms of procedure would be that EU legislation of other sectors would need to be amended which would make the legislative process more complex. Moreover, it can be expected that an introduction of the possibility to determine the regulatory status of a product at EU level would have the most significant impact in the sectors of medicinal products and food, and the delimitation between those two legislations. The evaluation of such impact goes beyond the scope of this report and would need to be assessed separately.   

Comparison of policy options 3A and 3B:

In theory it appears desirable to choose option 3B and to introduce in other sectoral legislation provisions which would empower the Commission to decide whether a given product or category of products falls within the definition provided in EU legislation since it would significantly improve the functioning of the internal market at limited additional costs. The Council also called for setting up "a simple and rapid mechanism […] for accelerated adoption of binding and consistent decisions […] on the determination of products […] in order to address the growing number of "borderline" cases between medical devices and other products subject to different regulatory frameworks"[111]. However, in the fields of medicinal products and food such an amendment would have far-reaching impacts that cannot be assessed in this report. If considered appropriate, this question should rather be further examined in the context of future amendments of the medicinal products and/or food legislation.   

The preferred option is therefore option 3B and should be retained for those sectors where the discussion of borderline questions is already well established (e.g. cosmetics). Option 3A could be seen as an intermediate solution for other sectors where the necessary amendments in the relevant legislation should not be introduced by the medical device package.

|| Solution of "borderline" cases

Impacts || Option 3A || Option 3B

Social impact (public health, patient safety, trust) || + || +++

Economic impact (EU and national budgets, costs for NB and economic operators) || - || --

5.5.        Impact of policy options 4A to 4C (enhanced transparency regarding medical devices on the EU market, including their traceability)

5.5.1.     Impact of policy option 4A (network of national databases)

In order to provide meaningful information about economic operators and medical devices on the European markets, a network of national databases would only make sense when all 32 countries that participate in the single market set up their own databases require the same type and amount of information from the economic operators established on their respective territories. More or less half of the Member States have already set up databases but the remainder would have to invest in such an IT infrastructure and bear the corresponding costs. At the same time Eudamed would have to be further developed as well to host the additional data to be uploaded from the Member States.

Such bottom-up IT infrastructure does not appear to be efficient resource spending since it would require multiple investments in IT tools which would need to be compatible with each other and the multiplication of management (human resources) and maintenance costs. Changes to the data to be collected would have to be introduced in the IT tools by all countries and at EU level.

More importantly, a network of national databases would not guarantee the desired level of transparency at EU level for the public, healthcare professionals and authorities since the accuracy of available information would primarily depend on the contribution of many different authorities.

5.5.2.     Impact of policy option 4B (central registration of economic operators and listing of medical devices placed on the EU market)

IT development costs (EU budget)

The further development of Eudamed as a central registration and listing tool, which would also need to integrate a possible UDI database (see policy option 4C) and a more developed vigilance database module (see policy option 2B), would cost around 2mio.€/year over the first four years (costs for IT specialists included). The subsequent hosting, maintenance and support would require around 1.8mio.€/year (see also the table under 5.8.). At the same time, Member States would save costs spent for the management of registration at national level.

Impact on economic operators

It would also have an economic impact on economic operators subject to a new registration and listing requirement at EU level but globally these costs would be compensated by savings due to a single registration/listing instead of multiple ones in the various Member States.

In the case of manufacturers and authorised representatives of class I devices and of IVD other than those listed in Annex II of the IVDD and those intended for self-testing, a central registration would replace the current obligation in the MDD and the IVDD that they must register with the competent authorities of the Member States in which they have their registered place of business. For these economic operators, no additional obligation would be created and possible costs related to the move towards a central registration/listing database can be kept to a minimum if the transitional period is sufficiently long and existing data uploaded in Eudamed were used.

For other economic operators and devices, a central registration would be a new requirement at EU level. But it would do away with the right of every individual Member State to require notification according to its national law.

The calculation in the table below is based on the following parameters:

· around 540,000 different devices of all classes are on the EU market (data from Eucomed and EDMA, see above section 2.1.1.)

· around 226,000 devices are low risk devices (40% of 500,000 MD are class I MD, 65% of 40,000 IVD are neither listed in Annex II IVDD nor self-testing IVD)

· around 314,000 devices are medium and high risk devices (60% of 500,000 MD are classes IIa, IIb or III MD, 35% of 40,000 IVD are listed in Annex II IVDD or self-testing IVD)

· time needed for registration/listing of one device for initial registration (preparation of file, login, data entry, validation etc.): 1 hour

· tariff for one working hour of staff (category "clerk"): 30EUR[112]

· average life-cycle of a medical device: 18 months (relevant for updating of information) and time needed for updating: 0.5 hour

· around 50% of medium and high risk devices (i.e. 157,000) available in all Member States

· 'realistic' scenario: registration/listing requirements in 15 Member States regarding medium and high risk devices

· 'worst case' scenario: registration/listing requirements in all 27 Member States regarding medium and high risk devices

Costs and saving of a central registration and listing

|| Baseline scenario: Costs for registration/listing at Member States' level (in EUR); 'realistic' and 'worst case' scenario || Policy option 4B: Costs for central registration/listing at EU level (in EUR) || Savings (in EUR) || Rationale

Initial registration

Low risk devices (class I MD, IVD not listed in Annex II IVDD and not for self-testing ca. 226,000 devices || around 6.8mio || around 6.8mio || 0 || Single registration at national level replaced by single registration at EU level

Medium and high risk devices (class IIa, IIb and III MD, IVD listed in Annex II IVDD and for self-testing) ca. 314,000 devices || from around 70.6mio to around 127.2mio || around 9.4mio || between 61.2mio and 117.8mio || Multiple registrations at national level replaced by single registration at EU level

Updating

Low risk devices (see above) ca. 226,000 devices || around 2.3mio || around 2.3mio || 0 || see above

Medium and high risk devices (see above) ca. 314,000 devices || from around 23.5mio to around 42.4mio || around 3.1mio || from around 20.4mio to around 39.3mio || see above

Total || from around 103.2mio to around 178.7mio || around 21.6mio || from around 81.6mio to around 157.1mio || Single registration at EU level

A central registration and listing tool at EU level would thus lead to around EUR 21.6mio costs for economic operators. These costs, however, would be compensated by savings of between around EUR 81.6mio and around EUR 157.1mio.

Besides the savings for economic operators, an enormous benefit would be achieved for public health by means of an increased transparency for patients, healthcare professionals, the public at large and authorities which would boost the confidence in the regulatory system, empower citizens to be informed about devices they are treated with, allow for a coordinated market surveillance and enable well informed decision-making. The EU database would be a a source of data for national databases established for intrinsically national purposes, such as reimbursement.  

5.5.3.     Impact of policy option 4C (traceability of medical devices)

In 2010, the European Commission established an ad hoc working group to discuss the traceability issues, the possible establishment of a European UDI and intermediate solutions to avoid an even further fragmented situation in the Member States which would jeopardize a future EU-wide system. This group has been open to Member States and stakeholders of the sector and until July 2011 met five times. It ensures also the interface to the discussions on UDI at GHTF level. Possible costs have also been addressed by the working group.

The introduction of a European system for the traceability of medical devices would have a significant economic impact for manufacturers, but it would at the same time hugely enhance the level of safety and public health protection. The costs for setting up such a system would be included in the costs estimated for the further development of Eudamed (see policy option 4B). For Member States, there would be no additional costs but rather a decrease since a European system would make the development of national systems redundant.

The costs for manufacturers can be broken down to the following aspects:

Attribution of UDI codes || Labelling preparations for packaging lines || Providing information to UDI database

Annual costs (e.g. membership fee in an organisation providing barcodes such as GS1) 500€ for small companies (few products) 10,000€ for big companies (numerous products) || Depending on complexity of production lines 500 – 5,000€ for manual production lines (small companies) 150,000€ for automated production lines (big companies) || Costs related to the upload of information to UDI database would be covered by central registration/listing (see policy option 4B)

The total costs cannot be estimated with sufficient reliability. According to information provided by industry associations more than 80% of the 22,000 medical device manufacturers are SME, but no data is available as regards how many of them are "small" and how many or "medium-sized" companies. More importantly, no information could be obtained as regards the number of different production lines which would determine the overall costs for adapting the labelling.

Still, the costs for labelling adaptations will be high. But they need to be put into perspective with the benefits for patient safety and public health, with the costs for 'no EU action' and with the synergies achieved by a globally compatible traceability system.

Benefits for patient safety / public health:

The main goal of a UDI system is to enhance patient safety by enabling tracking and tracing of devices through their supply chain. This would considerably enhance the effectiveness of the post-market safety due to improved incident reporting, targeted Field Safety Corrective Actions and better monitoring by the competent authorities. It can also reduce medical errors by reducing possible mix-up of devices. The establishment of a UDI system can also contribute to the fight against counterfeit devices.

Surveillance of the market as well as purchase and stock-management by hospitals will also become more efficient since UDI would become the 'access key' to different databases (by means of clearly identifying the same type of device).

Benefits for the internal market:

Without the development of a European UDI, there will be a fragmentation of the internal market, with negative consequences for public health and for the competitiveness of the sector. As indicated in the problem description, some European countries (or regions) have already started, and more Member States are likely to develop their own UDI systems. Therefore, the costs would be higher than with a European UDI as they would be multiplied by the number of different systems. Manufacturers would need to adapt their product lines according to the different types of UDI systems chosen and enter the data in various databases. In such a scenario, the costs would not be compensated by an enhanced level of patient safety at EU level because traceability would not be ensured EU-wide.

Synergies with international actions:

The US FDA is in the process of implementing a UDI system. FDA is actively involved in the development of guidance on UDI by the GHTF so that their system will likely be compatible with international 'best practice'. Since most of European medium size and big manufacturers sell their medical devices also to the US market[113], they will need to adapt to the forthcoming US FDA requirements.

To keep implementation costs limited, it would therefore be important to mirror as closely as possible the UDI system implemented in the US based on GHTF guidance (see also below under chapter 8 - Monitoring and Evaluation). This would also allow traceability of devices, and thus their enhanced post-market safety, at international level and in particular with the US. It would also likely pave the way towards a global UDI with other jurisdictions adopting the same UDI system.

Comparison of policy options 4A to 4C:

Option 4A would be neither an effective nor an efficient means to enhance transparency at EU level as regards economic operators and medical devices available on the EU market. This option is therefore discarded.

Options 4B and 4C, on the contrary, would effectively achieve the specific objective 4. They would contribute to patient safety and would lead to considerable cost savings for economic operators due to the reduction of obstacles to the internal market. The options are linked to each other and are complementary and should both be retained. Eudamed and the UDI database would need to be merged. The aim is to have only one database at European level in order to enhance transparency and traceability whilst decreasing costs for manufacturers. UDI will give the opportunity to overcome some negative aspects of the current Eudamed because it would identify every medical device by using a unique code at the EU level. Multiple entries in the database for the same product would be avoided. They would also be in line with the request of the Council that a "modern IT infrastructure for a central and publicly available database must be further [developed] with a view to providing key information about medical devices, relevant economic operators, certificates, clinical investigations and field safety corrective actions. In this context, the possibility of introducing a system to improve traceability of devices, thus enhancing safety, should be studied"[114]. The impacts are compared to the 'no EU action'. If Eudamed was not to be developed into a central databank for the registration of all devices, costs for economic operators would increase because of the multiplicity of national registrations whilst keeping the level of transparency regarding products on the EU market as limited as it is today.

|| Registration and listing || Traceability

Impacts || Option 4A || Option 4B || Option 4C

Social impact (public health, patient safety, trust) || - || +++ || +++

Economic impact (EU and national budgets, costs for NB and economic operators) || -- || ++ (due to savings compared to baseline scenario) || ++ (due to savings compared to baseline scenario)

5.6.        Impact of policy options 5A – 5B (enhanced involvement of external scientific and clinical expertise)

5.6.1.     Impact of policy option 5A (creation of a pool of experts)

In order to be meaningful, a pool (i.e. a list) of experts, who could be consulted on an ad hoc basis by the Commission or competent authorities would need to be extensive. Whilst the economic impacts would be limited (i.e. reimbursement of experts for their services), the management of such a pool (such as publication of call for expression of interest, selection, keeping up-to-date, verification of absence of conflict of interests) would be a challenge. 2-3 FTE would be needed at EU level to accomplish this task. Compared to the current situation, a pool of experts with specific knowledge in the field of medical devices available to Commission, competent authorities, Notified Bodies or manufacturers would bring some benefits in terms of well-informed and science-based decision-making but the issue of conflict of interests would rather speak against an extensive pool of experts to be consulted on an ad hoc basis.

5.6.2.     Impact of policy option 5B (designation of an expert panel and reference laboratories)

Like option 5A, also this option would bring benefits in terms of well-informed and science-based decision-making. The establishment of an expert panel composed of scientific and clinical experts of various medical disciplines, either as a stand-alone body or within a broader structure of a scientific committee, and the designation of reference laboratories would also have only limited economic impacts in terms of costs or administrative burden. 2-3 FTE at EU level would be needed for the management of the expert panel and the reference laboratories. Compared to a mere pool of experts, a panel with experts in key areas of medical technology and reference laboratories would have the advantage that their involvement in the decision-making process would become more stable so that there would be a steady exchange of knowledge between experts and regulators. Also the issue of conflict of interests could be better monitored with a panel than with a 'loose' pool of experts.

Comparison of policy options 5A and 5B:

Option 5B is superior to option 5A because the creation of an expert panel would provide a greater guarantee that independent external expertise is continuously available to the interested parties, including for the regulatory decision-making process, at no significant additional cost.

|| External expertise

Impacts || Option 5A || Option 5B

Social impact (public health, patient safety, trust) || + || +++

Economic impact (EU and national budgets, costs for NB and economic operators) || - || -

5.7.        Impact of policy options 6A – 6C (clear obligations and responsibilities of economic operators, including in the field of diagnostic services and internet sales)

5.7.1.     Impact of policy option 6A (alignment with Decision 768/2008/EC, additional requirements for authorised representatives and clarification of obligations in the field of diagnostic services)

As indicated in the impact assessment regarding the proposal to align 10 product harmonisation directives to Decision 768/2008[115], the specification of obligations of economic operators, including those offering diagnostic services to the EU market, is not expected to increase their overall costs because most of the obligations codify the normal practice of responsible and compliant companies, in particular those who have already a quality management system in place which is the general rule among medical device manufacturers on the basis of the EN ISO 13485 standard[116].

The additional requirements would concern authorised representatives which have a particular role under the AIMDD/MDD/IVDD as representatives of non-EU manufacturers in the EU. Also in this respect, no increase of the overall costs is expected for those authorised representatives who already comply with the spirit of the legislation.

The positive impact will be an increased legal certainty as regards the obligations of the different economic operators in the supply chain of medical devices. This will bring more safety as regards devices on the market and improve the functioning of the internal market. Eventually it will also lead to a reduction of costs of compliant economic operators who currently have to fight against unfair practices of non-compliant competitors.

5.7.2.     Impact of policy option 6B (legislative measures regarding internet sales)

No figures exist as regards the volume of internet sales in the field of medical devices. Since most devices are sold to hospitals or healthcare professionals through 'controlled' distribution chains, it can be assumed that the volume is not very high and especially not comparable to the sale of pharmaceuticals over the internet. Nonetheless, a market certainly exists especially for devices purchased directly by consumers (e.g. contact lenses, condoms). However, so far there is little evidence that dangerous or counterfeit devices are offered over the internet in significant numbers. Specific mandatory requirements regarding internet sales therefore appear disproportionate and would probably not be an effective tool to address the issue since 'rogue' traders, especially those outside the EU, would not be deterred by specific obligations. In reality, it is more an issue of enforcement by authorities and awareness of the buyers for which hard-law regulation is not the most appropriate instrument.

5.7.3.     Impact of policy option 6C (addressing internet sales by soft-law action)

Coordinated monitoring and information campaigns as well as a possible portal on which internet vendors that adhere to a voluntary code of conduct can register would not have an economic impact on economic operators or buyers. It would, however, lead to some expenditure at EU and national level to finance and monitor the necessary tools (awareness campaigns, setting up a portal). Some national authorities appear to finance campaigns as regards safety of products purchased over the internet, e.g. UK internet safety campaign (£9mio). Coordination between national authorities, including EU wide campaigns and cooperation with third countries, would likely be more cost-efficient since the problems linked to internet sales are not limited to national territories. The actual costs would depend on the medium and the scope of any soft-law action and would not immediately be triggered by the new legislation but on a case-by-case basis on the concrete coordinated market surveillance activities.

Comparison of policy options 6A and 6C:

The alignment with Decision 768/2008 in respect to the obligation of economic operators, including those offering diagnostic services to the EU market, as well as additional requirements concerning authorised representatives (policy option 6A) should be retained due to the positive impact on the safety of products throughout the supply chain and the enhanced legal certainty for economic operators whilst causing no or very limited costs. In addition, policy option 6C (soft-law action on internet sales), due to its flexibility, efficiency and cost-effectiveness is the preferred option to address concerns regarding internet sales of medical devices and should also be retained.

|| Clarification of obligations/responsibilities of economic operators || Internet sales

Impacts || Option 6A || Option 6B || Option 6C

Social impact (public health, patient safety, trust) || +++ || O || ++

Economic impact (EU and national budgets, costs for NB and economic operators) || O || - || -

5.8.        Impact of policy options 7A – 7D (management of the regulatory system)

The management of the future EU regulatory system will generate costs relating to (1) the human resources needed to perform at EU level the tasks necessary to implement the regulatory framework; (2) the development and maintenance of the IT infrastructure; and (3) the organisation of meetings of the MDEG (and its subgroups).

Under the assumption that the preferred policy options will eventually be retained, between 35 and 50 FTE at EU level would be needed to fulfil the tasks. The difference between 35 and 50 results from the choice between option 1B (oversight of Notified Bodies by an EU body) or option 1C (coordination of 'joint assessments') which is left to a political decision. The costs for the 35-50 staff for operational and support tasks will depend on the choice between option 7A-7D and will be estimated for each of the options.

The results of the negotiations on the Multiannual Financial Framework (MFF) 2014-2020[117] and their impact on staffing in case of new tasks assigned to an EU body would need to be taken into account for any of the four options discussed.

Summary of required HR (operational staff, excl. IT)

Tasks || Estimated required HR

Oversight of Notified bodies - Option 1B: Oversight by an EU body or - Option 1C: 'joint assessments' || 20 FTE (assessors) and 4 FTE (support staff) or 6 FTE (assessors) and 3 FTE (support staff) (and reimbursement of national assessors)

Mechanism for an ex ante scrutiny of draft conformity assessment reports || 6 FTE (engineers, clinical experts) and 2 FTE (support staff)

Coordination of post-market safety issues (vigilance and market surveillance) || 8 FTE (vigilance experts) and 2 FTE (support staff

Management of external scientific and clinical expertise || 2 FTE (scientific or medical experts) and 1 FTE (support staff)

Coordination of assessment of multinational clinical investigations (special MDD issue, see Annex 1, option MD-3B) || 4 FTE (clinical experts) and 1 FTE (support staff)

Total || In case of option 1B (Notified Body oversight by an EU body): 50 FTE (operational and support staff) In case of option 1C (Notified Body oversight through "joint assessments"): 35 FTE (operational and support staff)

Approximate costs for IT development, support and maintenance

The costs can be estimated as shown in the table below. This estimation is considered to remain unchanged whichever of the options 7A to 7D is chosen. 

Areas for IT development || Estimated costs

Development of Eudamed as central registration and listing database, incl. UDI database Development of vigilance module and data-processing network for a central reporting of incidents (plus business intelligence tools for statistical analysis of data for signal detection) Single submission of certain applications for multi-national clinical investigations Notification of applications received by Notified Bodies for certain conformity assessments and submission of summary evaluation report, incl. follow-up Depository of outcome of the assessment of Notified Bodies || Development phase 2014-2017: EUR 2 mio/year in average (10 FTE, i.e. IT developers and analysts, software licences) Implementation and maintenance phase as of 2018: EUR 1.8 mio/year in average (7 FTE, i.e. IT developers and IT support, hosting, plus developers of statistical analysis tools)

Approximate costs for meetings of Medical Device Expert Group

Medical Device Expert Group (MDEG) 8 meetings/year (2 days each) with experts from 27 Member States (EUR 17,555/day) || EUR 280,800year

MDEG sub-groups max. 32 meetings/year of max. 8 sub-groups (2 days each) with experts from 27 Member States (EUR 17,555/day) || EUR 1,123,200year

Total || EUR 1,404,000year (maximum)[118]

The reimbursement of the travel expenses of the experts designated by the Member States  for meetings of the Medical Device Expert Group and its sub-groups would amount to max. EUR 1.4mio/year. Compared to the costs currently spent for the reimbursement of national representatives attending the informal working groups (budget forecast for 2011: EUR 526,500) the increase is justified by an enhanced frequency of meetings to achieve stronger coordination. This estimation is considered to remain unchanged whichever of the options 7A to 7D is chosen.  

The question is "who" should be mandated to perform the new tasks at EU level which are needed to implement the regulatory framework. This question is addressed in the following paragraphs evaluating the impacts of the policy options regarding the management of the regulatory system.

5.8.1.     Impact of policy option 7A (extension of the responsibility of the European Medicines Agency (EMA) to medical devices and creation of a Medical Device Expert Group at this agency)

This option would build on the existing "effective and efficient Community method" for which the EMA Secretariat and the network of competent authorities is known in the field of pharmaceuticals[119] and establish it also as the pivotal EU body to coordinate activities in the field of medical devices and actively promote the communication about the regulatory requirements.

The essential positive impacts of this model are the consistency in the implementation of the legal requirements of the EU regulatory framework for medical devices whilst generating synergies where an overlap exists between the regulatory frameworks for pharmaceuticals and for medical devices (i.e. drug-device combination products, tissue engineered products, personalised medicines, borderline products). This would first of all establish an equal and high level of patient and user safety in the EU. It would also reduce compliance costs as well as the regulatory risk and burden for economic operators doing business in more than one Member State which currently are subject to inconsistent yet contradictory measures in the different Member States. Regulatory consistency would thus strengthen the functioning of the internal market to the benefit of patients and users and medical device manufacturers.

It would not change the system of formal decision-making in the EU. The Members States would remain responsible for decisions to be taken at national level for the implementation of EU regulations; their coordination would take place within the Medical Device Expert Group, composed of experts designated by the Member States. The Member States' authorities would be the main beneficiary of the administrative, technical and scientific support to be provided by the new structure. The Commission would adopt, where needed, delegated or implementing acts in accordance with Articles 290 and 291 TFEU and obtain as well technical input from the new agency and the Medical Device Expert Group. Therefore, this option would not raise concerns in terms of the subsidiarity principle.

A further positive impact of this option would be the creation of a central contact point for manufacturers, Notified Bodies and competent authorities (EU and from third countries) to provide technical advice and exchange information under the auspices of the Commission.

Finally, the allocation of competences for pharmaceuticals and medical devices under the same roof would mirror the situation in 19 of the EU Member States where the competences for medical devices and for pharmaceuticals are united in the same national agency[120].

Option 7A would have budgetary implications since the tasks of the new "European Health Products Agency" related to medical devices would require an annual subsidy from the EU budget or a re-deployment from the existing EMA budget. Contrary to the tasks of the EMA in the field of pharmaceuticals, the medical device part of the future new agency, at least at the beginning, could only be financed to a small part by fees, since the major role would be the coordination between the authorities of the Member States for which, in principle, an economic operator should not be liable to pay fees (the issue of fees is addressed in section 6.6 "Financing"). 

"European Health Products Agency" – medical device related tasks: costs for staff The costs for staff, their offices and office equipment are estimated on the basis of current staff costs at EMA, i.e. 1 AD: EUR 161,708/year; 1 AST: EUR 90,091year (2011 prices)[121] + 14% overhead costs for administrative or cross-cutting tasks[122].

35 FTE (26 AD + 9 AST) || 4,204,408€ + 810,819€ = 5,015,227€ +14% overhead = 5,717,358€

50 FTE (40 AD + 10 AST || 6,468,320€ + 900,910€ = 7,369,230€ +14% overhead = 8,400,922€

There may also be a number of risks and possible negative impacts. Whilst some interested parties (e.g. European Cardiology Society, the Belgian HTA body KCE), expressed their support for an extended role of EMA in the field of medical devices, the majority of stakeholders (in particular industry and Notified Bodies) as well as national competent authorities voiced concerns against the possible extension of the role of the current EMA to medical devices in response to the 2008 public consultation and subsequent discussions. They expressed the fear of a creeping "take-over" of the smaller medical device part by the pharmaceuticals part which would influence the elaboration and application of requirements in the field of medical devices with a "pharmaceuticals mindset" and eventually lead to the application of procedures which would not be appropriate to the device sector. They also pointed to the fact that EMA currently has no expertise in medical devices and feared that a possible new medical device part of the agency would not be appropriately staffed but remain the under-staffed 'poor relation' of the larger pharmaceuticals part.

In fact, EMA currently employs more than 700 staff and the agency already manages six committees in the field of pharmaceuticals with a seventh committee to be set up in 2012[123]. This considerable size of EMA which may further increase with the implementation of the revised pharmacovigilance legislation raises questions as regards the manageable size of a regulatory agency for which the Commission assumes responsibility and therefore needs to exercise control.

These concerns would need to be allayed by appropriate provisions in the amending EMA-Regulation and a financial commitment of the EU budget strictly targeted at the financing of the tasks related to the medical devices. This issue is also addressed in chapter 8 of this impact assessment on "Monitoring and evaluation".

5.8.2.     Impact of policy option 7B (creation of a new EU regulatory agency for medical devices only and of a Medical Device Expert Group at this agency)

Option 7B would have basically the same positive impacts as option 7A but it would not create synergies in the field of drug-device combination products and borderline products. In terms of budget, the costs for human resources and meeting organisations would also be the same but additional costs would be related to the setting up of a new agency (new seat agreement, costs for setting up and maintaining a new infrastructure etc.).

This option would have the advantage that the concerns of the medical device sector with regard to a 'take-over' of their sector by a pharmaceuticals regulator would be addressed. The disadvantage, however, would be that synergies could not be achieved, both in terms of costs (e.g. use of an existing infrastructure) and in terms of expertise. The latter is likely to be more important with a view to the growing number of drug-device combination products and of borderline cases between pharmaceuticals and medical devices.

Moreover, it is questionable whether a separate medical device agency would have the 'critical mass' in terms of cost efficiencies since smaller agencies tend to have a relatively high share of administrative staff that is not directly involved in delivering the services for which the agency has been set up. In an evaluation report of EU agencies mandated by the Commission it was therefore suggested that the minimum size for an agency should be around 100 staff[124]. The report stated that on average agencies have a share of 30% administrative staff which increases to 37% for small agencies (<75)[125] which would need to be added as overhead costs.

New EU body for medical devices only: costs for staff The costs would depend on the location chosen. In the absence of such decision, the average staff costs for the Commission are taken as a basis of the calculation, i.e. EUR 127,000/year for one AD/AST (2011 prices) + 37% overhead costs.

35 FTE (AD/AST) || 4,445,000€ +37% overhead = 6,089,650€

50 FTE (AD/AST) || 6,350,000€ +37% overhead = 8,699,500€

5.8.3.     Impact of policy option 7C (management of the medical device regulatory system by the European Commission and creation of a Medical Device Expert Group supported by this institution)

This option would constitute a modified 'status quo' in the sense that the Commission would continue to provide support for the coordination of the implementation of the EU regulatory framework, a solution favoured by many Member States and stakeholders (notably industry). But the MDEG would obtain a statutory basis and the Commission would need to dedicate considerably more resources to this task. Moreover, the Commission would need to dedicate resources to the other tasks needed to ensure the management of the regulatory system.  

If it could be assured that the Commission services responsible for the management of the regulatory system would be appropriately staffed, this option would basically have the same positive impacts as option 7A, except for the synergies with pharmaceuticals which would only be achievable to a lower degree. But it would require that the Commission allocates permanently an additional 35-50 FTE to its department(s) in charge of medical devices. An advantage would be that, contrary to options 7A and 7B, no additional overhead costs would incur since administrative or cross-cutting tasks would be provided by the existing Commission resources.

Commission: costs for staff The costs are estimated on the basis of current average staff costs of the Commission, i.e. EUR 127,000/year for one AD/AST (2011 prices)

35 FTE (AD/AST) || 4,445,000€

50 FTE (AD/AST) || 6,350,000€

There would also be no need for the Commission to dedicate resources to the oversight of an agency. On the other side, it may be argued that it is not part of the Commission's core competences to undertake tasks of primarily administrative, technical and/or scientific nature, such as the development of well-functioning IT tools, the organisation of meetings and joint assessments of Notified Bodies. Whilst this may indeed be true for most policy-oriented Commission services, the JRC has proven technical and scientific expertise in several fields and could extend this to the field of medical devices. In particular as regards improving the quality of the results of conformity assessment carried out by Notified Bodies, it was agreed by the Commission, EFTA and national competent authorities to make accessible, where appropriate, to the European Co-operation for Accreditation (EA) competences available at the JRC, in particular its Institute for Reference Materials and Measurements[126].

5.8.4.     Impact of policy option 7D (creation of a Medical Device Expert Group managed by the Member States)

This option would depend on the willingness of Member States to cooperate and coordinate among themselves in the Medical Device Expert Group and its sub-groups. It is therefore questionable if this option would actually achieve the objective of an effective and efficient management of the regulatory system. Other tasks such as the development of an IT infrastructure or access to external scientific or clinical expertise would unlikely be performed by the Member States themselves.

This option would not require financing by the EU budget, but - if appropriately done – it would consume financial and human resources of the Member States' competent authorities. Due to the financial and economic crisis, many Member States have reduced the financing and workforce of their respective authorities responsible for medical devises. It is therefore unlikely that Member States would be able to allocate resources to appropriately staff and support a Medical Device Expert Group under their management. If, alternatively or in addition, the Commission or EMA was mandated to provide the secretariat, around 4 FTE (2 AD and 2 AST) would be required to fulfil the secretarial functions[127], i.e. 508,000€/year (Commission) or 503,598€/year (EMA).

Besides the uncertainty of the success of a self-managed coordination by the Member States, this option would also lack an internal market dimension which could only be guaranteed either by the Commission or another independent EU body.

Comparison of policy options 7A-7D:

Option 7D should be discarded because it would not be an effective means to achieve the objectives of this revision. Of the remaining three options, option 7B would be the least preferable since the creation of a new agency would not be efficient compared to the possibility of extending the mandate of the existing EMA.

Options 7A and 7C would both provide an effective and efficient tool for a consistent implementation of the medical devices regulations provided that the necessary resources are allocated either to EMA or to the relevant Commission's services. The synergies which could be gained in the field of drug-device combinations products and borderline products would be stronger for option 7A while they are not excluded for option 7C either. The possibility to maintain policy-making and implementation within the Commission and an enhanced involvement of its departments which fall within the "innovation" portfolio could be seen as a strong commitment for the Commission's innovation agenda. The absence of the need to dedicate resources to the oversight of an agency would be an additional advantage for option 7C.

The choice between both options requires a political decision and cannot be taken in this impact assessment on the basis of only technical criteria.

|| Management

Impact || Option 7A (EMA) || Option 7B (new agency) || Option 7C (Commission) || Option 7D (Member States)

Enhanced coordination || +++ || +++ || +++ || -

Synergies || +++ || O || + || O

Costs for EU budget || -- || --- || - || O

Acceptance by stakeholders || - || +++ || ++ || -

6.           Overview of preferred options, legal form and overall impacts

6.1.        Overview of preferred policy options

The following table gives an overview of the preferred policy options with regard to the systemic problems and the objectives pursued by the revision of the regulatory framework for medical devices:

General Objectives

Overall objective A: To ensure a high level of protection of human health and safety Overall objective B: To ensure the smooth functioning of the internal market Overall objective C: To provide a regulatory framework which is supportive for innovation and the competitiveness of the European medical device industry

Specific Objectives || Preferred Policy Options

Problem 1: Oversight of Notified Bodies

Objective 1: Uniform control of Notified Bodies || Policy option 1A: New minimum requirements for Notified Bodies, and either Policy option 1B: Designation and monitoring of Notified Bodies by an EU body or Policy option 1C: Designation and monitoring of Notified Bodies by Member States with involvement of "joint assessment teams" and Policy option 1G: Notification requirement regarding new applications for conformity assessment and possibility for ex ante control

Problem 2: Post-market safety (vigilance and market surveillance)

Objective 2: Enhanced legal clarity and coordination in the field of post-market safety || Policy option 2A: Clarification of key terms and of the obligations of the parties involved in the field of vigilance and Policy option 2B: Central reporting of incidents and coordinated analysis of certain high risk incidents and Policy option 2D: Promotion of cooperation of market surveillance authorities

Problem 3: Regulatory status of products

Objective 3: Cross-sectoral solution of "borderline" cases || Policy option 3B: Creation of a cross-sectoral expertise on borderline issues and possibility to determine the regulatory status of products at EU level in certain legislation (not medicinal products and food) 

Problem 4: Lack of transparency and harmonised traceability

Objective 4: Enhanced transparency regarding medical devices on the EU market, including their traceability || Policy option 4B: Central registration of economic operators and listing of medical devices placed on the EU market and Policy option 4C: Requirement for the traceability of medical devices

Problem 5: Access to external expertise

Objective 5: Enhanced involvement of external scientific and clinical expertise || Policy option 5B: Designation of an expert panel and reference laboratories

Problem 6: Unclear and insufficient obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales

Objective 6: Clear obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales || Policy option 6A: Alignment with Decision 768/2008, additional requirements for authorised representatives and clarification of obligations in the field of diagnostic services and Policy option 6C: Addressing internet sales by soft-law action

Problem 7: Management of the regulatory system

Objective 7: Governance - efficient and effective management of the regulatory system || either Policy option 7A: Extension of the responsibility of the European Medicines Agency (EMA) to medical devices and creation of a Medical Device Expert Group at this agency or Policy option 7C: Management of the medical device regulatory system by the European Commission and creation of a Medical Device Expert Group supported by this institution

The following table gives an overview of the preferred policy options in relation to the specific issues in the field of medical devices (other than IVD) which are discussed in more detail in Annex 1:

Specific Objectives || Preferred Policy Options

Problem MD-1: Scope - regulatory gaps or uncertainties

Objective MD-1: Covering of legal gaps and loopholes || Policy option MD-1B: Regulate products manufactured utilising non-viable human cells and tissues as medical devices and Policy option MD-1C: Regulation of certain implantable or other invasive devices without a medical purpose within the MDD and Policy option MD-1F: Harmonized regulation of the reprocessing of single-use medical devices

Problem MD-2: Adaptation of legal requirements to technological, scientific and regulatory developments

Objective MD-2: Appropriate legal requirements taking into account technological, scientific and regulatory developments || Policy option MD-2B: Review of the classification rules and essential requirements regarding specific devices or technologies

Problem MD-3: Clinical evaluation and clinical investigations, in particular those carried out in more than one Member State

Objective MD-3: Enhanced legal certainty and coordination in the field of clinical evaluation and investigations, in particular those conducted in more than one Member State || Policy option MD-3A: Introduction of the term "sponsor" for clinical investigations and further clarification of key provisions in the field of clinical evaluation and investigations and Policy option MD-3B: Coordinated assessment of multi-national investigations by the competent authorities of the Member States where the investigation is performed

The following table gives an overview of the preferred policy options in relation to the specific issues in the field of in vitro diagnostic medical devices which are discussed in more detail in Annex 2:

Specific Objectives || Preferred Policy Options

Problem IVD-1: Scope – regulatory gaps or uncertainties

Objective IVD-1: Covering of legal gaps and loopholes || Policy option IVD-1C: Clarify the scope of the exemption for "in house" tests, require a mandatory accreditation for "in house" test manufacturers and subject high risk (class D) "in house" tests to the requirements of the IVDD and Policy option IVD-1F: Amendment of the legal definition of an IVD to include tests providing information "about the predisposition to a medical condition or a disease" and Policy option IVD-1G: Regulation of companion diagnostics under the IVD regulations and interaction with the medicinal products sector

Problem IVD-2: Classification of IVD and their appropriate conformity assessment, including batch release verification

Objective IVD-2: Appropriate and robust classification and conformity assessment of IVD || Policy option IVD-2B: Adoption of the GHTF classification rules and adaptation of the conformity assessment procedures to the relevant GHTF guidance and Policy option IVD-2C: Batch release verification for high risk IVD by the manufacturer under the control of a Notified Body and reference laboratory 

Problem IVD-3: Unclear legal requirements and need for their adaptation to technological progress

Objective IVD-3: Clear and updated legal requirements for enhanced safety and performance of IVD || Policy option IVD-3B: Legislative clarification of the requirements for the clinical evidence for IVD and Policy option IVD-3E: Clarification of the legal requirements in respect to point-of-care or near-patient IVD medical devices and Policy option IVD-3G: Alignment to the MDD where appropriate

The major costs for the EU budget generated by the preferred policy options are linked to the effective management of the future regulatory framework, and in particular to human resource requirements (35 to 50 FTE depending on the option eventually chosen), to the development and management of the IT infrastructure (e.g. Eudamed, ca. EUR 2mio/year) and to meetings between national experts (ca. EUR 1.4mio/year). For more details see under Section 5.8. For industry, the major costs will be related to the implementation of an UDI system (however compensated by a harmonised approach that is compatible with international guidelines) and, especially for the IVD sector, the introduction of a new classification system based on international guidelines. In addition, the scrutiny mechanism will lead, in certain cases, to a delay as regards access to market. Higher compliance costs for industry, however, are expected to be overcompensated by avoidance of divergent rules in the different Member States in areas not yet harmonised and different enforcement practices. In particular due to the establishment of a central registration tool, industry will be able to reduce administrative costs of up to 157mio. Also an EU vigilance portal with central reporting of serious incidents instead of multiple reporting will reduce administrative costs. It is not expected that the preferred policy options have an impact on the prices of medical devices and the public health budgets. To the contrary, tightened and uniform controls to ensure compliance with the legal requirements and enhanced traceability of the products will lead to higher safety standards and therefore lower the impact of faulty or non-performing devices on patients and on society.         

A complete overview of the estimated costs and benefits of the preferred policy options is provided in Appendix 9. The overall impact on the competitiveness of the European medical device industry cannot be quantified in absolute figures. A more robust and predictable regulatory framework that improves the functioning of the internal market and reduces administrative costs will support the competitiveness and innovativeness of the European medical device industry, including SMEs. It will enhance the confidence of third countries in the CE marking for medical devices and thus facilitate the export of European products to third country markets. At the same time, the status of Europe as a place for research and innovation in the field of medical technology will be confirmed which may contribute to attract investment in the medical device industry. By aligning EU legislation with guidelines adopted at international (i.e. GHTF) level, Europe will contribute to global convergence of medical device regulations to the benefit of industry in terms of market access abroad, and of patients and users in terms of raising the bar for globally recognised safety standards.  

SMEs will have to comply with the same requirements as regards the safety and performance of medical devices as any other manufacturers because the quality and safety of devices cannot depend on the size of the manufacturing company. Such regime would also be prejudicial to small or medium-sized manufacturers since their products would risk being stigmatised if less stringent requirements were applicable to them. Should certain activities under the future regulations be subject to fees, the interests and special needs of SMEs, and in particular micro-enterprises would be taken into account.

It is not expected that the preferred policy options would have a significant impact on the prices of medical devices to be paid by the users and/or health security systems, even though this cannot be totally excluded for individual devices. Overall, however, an enhanced level of medical device safety would eliminate the costs which are caused by unsafe devices to be born either by the individual patients (in addition to the harm caused to their health) or by the collective insurance systems.      

6.2.        Legal form

Active implantable medical devices and other medical devices (other than IVD), which currently are subject to two separate pieces of legislation (i.e. the AIMDD and the MDD) should be regulated within one legislative act. There are historic reasons for separate acts but this is no longer justified. The provisions of the AIMDD and the MDD should therefore be merged and AIMD be classified as class III devices as it is already the case in several Member States and at international level by the GHTF. Where necessary, specific provisions regarding AIMD could be maintained. The legislation on IVD, however, should be kept separate from other medical devices to reflect the specificities of the products and the IVD sector which is rather homogenous with few overlaps to the other medical devices. This approach was broadly supported by stakeholders and Member States during the two public consultations.

As regards the legal form of the two legislative proposals, the above mentioned preferred options would justify the adoption of either directives or regulations. An analysis of the pros and cons in light of Article 296 TFEU leads to the conclusion that a regulation in terms of Article 288(2) TFEU would be the more appropriate legal form since it would create a single EU regulatory framework for medical devices and thus better support the objectives pursued by this revision, i.e. the uniform interpretation and implementation of the legal requirements and thus a high level of protection of human health and safety throughout the EU.

A more detailed analysis regarding the choice of the legal form is provided in Appendix 10.

6.3.        Synergies

The preferred options will provide a robust regulatory framework with clearer rules, favour a high level of consistency in their implementation by national authorities and ensure an efficient management by an EU body. In the case of extending the mandate of the EMA, synergies would be created between the future medical device part of the new structure and EMA's existing pharmaceuticals part, which already is involved in the assessment of certain aspects of some drug-device combination products. Some synergies may also exist to a certain extent if the Commission was entrusted with the coordination of the new system.

The positive aspects of the current system (flexibility, speed and low costs) will be maintained while the negative aspects (unequal protection of public health, inconsistent implementation of legal requirements, lack of trust and transparency) will be remedied. This will enhance the safety of all European patients and users and reinforce Europe's position in the forefront of innovation in the field of medical technology. It will boost the confidence in the CE marking for medical devices both in Europe and in the world and will thus lead to a smoother functioning of the internal market and international trade. All in all, the revision of the regulatory framework for medical devices therefore contributes to the Single Market Act and to the Innovation Union, both part of the EUROPE 2020 strategy.

At international level, either the new "European Health Products Agency" or the reinforced medical device department of the European Commission will be a recognised partner for 3rd country regulators (FDA, Health Canada etc.) in the field of medical devices.

6.4.        Administrative costs

Administrative costs are defined as "the costs incurred by enterprises, the voluntary sector, public authorities and citizens in meeting legal obligations to provide information on their action or production, either to public authorities or to private parties".[128]

Five of the preferred policy options (i.e. policy options 1G, 2B, 4B, 4C and IVD-2B) will lead to administrative costs: (1) the obligation of Notified Bodies to notify new applications for conformity assessment and, if appropriate, to submit their preliminary evaluation for certain devices to the Medical Device Expert Group before the delivery of a certificate; (2) the central reporting of incidents; (3) the development of Eudamed to a central European databank for medical devices with information about the economic operators (manufacturers etc.), medical devices and UDI, (4) the labelling requirements regarding UDI, and (5) the adoption of a rules-based risk classification for IVD and the corresponding conformity assessment procedures.

To determine the administrative costs the EU Standard Cost Model is used.

∑ P x Q

where P (for price) = tariff x time

Q (quantity) = number of business and frequency

6.4.1.     Administrative costs for a notification mechanism with possibility for an ex ante control of conformity assessment reports (policy option 1G)

The price is determined by the cost for a Notified Body to notify application for conformity assessment of 'high risk', new or problematic devices and to submit, where requested, a summary of its preliminary conformity assessment and to assure the follow-up. The administrative costs are detailed above in section 5.2.3 (impact of policy option 1G).

· Altogether, the administrative costs can be estimated at between 93,750 and 100,000€/year.

6.4.2.     Administrative costs for the central reporting of incidents (policy option 2B)

Since the adoption of the MDD, manufacturers are obliged to report serious incidents to the competent authority. However, the directives do not specify to which authority the manufacturer shall report. In MEDDEV 2.12-1 rev. 6 it is stated that in general, the report shall be addressed to the competent authority of the Member State where the incident has occurred unless specified differently.

A central reporting of incidents would therefore not create any additional administrative burden since it would do away with the reporting to the individual Member States. Since an incident currently can prompt multiple reporting, a centralisation of this obligation would therefore lead to a net reduction of administrative costs of manufacturers.

6.4.3.     Administrative costs for the registration of economic operators, the listing of medical devices and upload of UDI-related information in a central European databank for medical devices (policy options 4B and 4C)

As regards the registration in a further developed Eudamed (which would integrate a UDI database), the preferred options 4B and 4C will create new obligations at EU level, in particular for class IIa, IIb and III devices. It is important to underline that the central registration and listing database and the UDI database would be merged so that costs for the collection of data and their upload would be required only once for both aims.

The price is determined by the cost for a manufacturer to upload the required information in Eudamed. The administrative costs are detailed in section 5.5.2. and show that the costs generated at EU level will be largely compensated by savings due to the replacement of multiple registrations at national level by a single registration at EU level.

· New administrative costs at EU level: around EUR 21.6mio

· Savings due to reduction of administrative costs of the same nature at national level between around EUR 81.6mio and EUR 157.1mio

The savings exceed by far the new administrative costs and therefore contribute to the Commission's action programme for reducing administrative burdens[129].

6.4.4.     Administrative costs related to the indication of the UDI on the label (policy option 4C)

Labelling requirements are considered administrative costs. The introduction of a UDI system in Europe (option 4C) would require that the UDI data carrier (linear bar code, 2D matrix code, RFID) appears on the label of the product (on the device itself and/or on the packaging).

As mentioned above, the costs for adaptation of the labelling will depend on the complexity of the products and the production lines. For manual production lines, the costs can be estimated at 500 – 5,000€. For automated production lines, the costs are far higher and can be estimated at 150,000€.

No data is available on the number of manual and/or automated production lines of European and international manufacturers. In any case, savings due to the fact that the multiplication of different systems could be avoided and more precise data would be available when the European UDI would be implemented by means of a delegated or implementing act.  

6.4.5.     Administrative costs related to the adoption of GHTF classification for IVD and corresponding conformity assessment procedures (policy option IVD-2B, see Annex 2)

The change of the classification system and the corresponding consequences on the conformity assessment of a large number of IVD (most class B and C IVD) may have an overall economic impact estimated at around EUR 170mio. A large part can be considered as administrative costs because they are related to the preparation of documentation for the assessment by a Notified Body and adaptation of the labelling (indication of Notified Body number).

6.5.        Simplification potential

As mentioned in the beginning of this impact assessment, the "recast" of Directives 90/385/EEC and 93/42/EEC was first mentioned in the Commission's 2005 Simplification Strategy and has been maintained in Annex III (simplification items) of the Commission's Work Programmes 2010 and 2011.

6.5.1.     Codification, merger of AIMDD and MDD, and transformation into regulations

The most obvious simplification aspect of this revision exercise is the transformation of the existing three main Council or Parliament and Council directives[130], their three amending directives and two Commission implementing directives[131] into two regulations of the European Parliament and of the Council. The regulations will be directly applicable and therefore make national transposition laws redundant. On the one hand, this will reduce administrative and legislative work at the level of Member States and, on the other hand, divergences due to late or incorrect transposition will be avoided so that economic operators will not need to adapt to (slightly) different national laws.

Moreover, the merger of the current AIMDD and MDD as well as the parallel revision of the current IVDD, both combined with the clarification of obligations of economic operators, will eliminate overlaps and redundancies and will increase the clarity and consistency of Union rules in the field of medical devices.

6.5.2.     Co-regulation

The envisaged proposals will maintain the regulatory approach to set the essential requirements in the legal text and use standardisation for detailed technical specifications. Moreover, the use of conformity assessment procedures, which are streamlined and simplified by the current proposals, will further ensure that the intervention by public authorities prior to the marketing of products is kept at an appropriate level. By strengthening the authorities' control of Notified Bodies, this regulatory approach is reinforced and made fitter for future challenges in the sector of medical devices.

6.5.3.     Central reporting of incidents and central registration and listing of economic operators and devices

The creation of a central European databank with interconnected electronic systems for the registration of economic operators and medical devices and for the central reporting of incidents by manufacturers will substitute the multiple registration and reporting requirements at national level by a one-stop-shop process at EU level. Within this process, the European UDI system, replacing diverging national systems, would play a key traceability role. This future IT architecture will not only reduce the administrative costs for economic operators but also provide European citizens and policy makers with a modern IT tool which informs them about the medical devices available on the Union market.

6.6.        Financing

With the adoption of the proposals by the Commission scheduled in the first semester 2012, an adoption of the legislative acts by the co-legislator can be expected by the end of 2013 so that credits for its implementation would need to be foreseen as of 2014 which would go hand in hand with the start of the next Multiannual Financial Programme (MFF) 2014-2020.

Estimated budgetary needs

Human resources – EMA or – Commission (with involvement of JRC) || – between EUR 5.7 mio/year (for 35 FTE with overhead) and EUR 8.4 mio/year (for 50 FTE with overhead) – between EUR 4.4 mio/year (for 35 FTE with overhead) and EUR 6.3 mio/year (for 50 FTE with overhead)

IT system development, maintenance, support and infrastructure || – 2014-2017: EUR 2 mio/year in average – 2018 et sqq.: EUR 1.8 mio/year in average

Meetings || – 1.4 mio/year

Reimbursement of experts – National assessors for 'joint assessment teams' (daily allowance and travel expenses) – Clinical and scientific experts || – 0.4 mio/year (only needed if policy option 1C is chosen) – 0.1 mio/year

Miscellaneous (publications, communication, translations, travel expenses etc.) || – 0.6 mio/year

Total || – EMA: between EUR 10.2 and 12.5 mio/year (2014-2017), between EUR 10 and 12.3 mio/year (2018 et sqq.) – Commission/JRC: between EUR 8.9 and 10.4 mio/year (2014-2017), between EUR 8.7 and 10.2 mio/year (2018 et sqq.)

If option 7A (EMA) was chosen, the costs linked to the tasks conferred to a new "European Health Product Agency" in the field of medical devices would need to be approved within EMA's annual budget by the budgetary authority. If option 7C (Commission/JRC) was chosen, the costs for staff would be booked either on the administrative budget line of the Commission or as operational costs of the lead Directorate-General and be transferred to the JRC in the context of an internal service agreement. As stated above, the results of the negotiations on the MFF 2014-2020 would need to be taken into account for any of the two options.

Operational expenses regarding the implementation of the AIMDD, MDD and IVDD have so far been charged on the "internal market" budget line (BL 02 03 01). Since Article 114 TFEU will remain the legal basis for the revised directives, this budget line should continue to provide funding for the implementation. With the extension of the legal base to public health (Article 168 TFEU), also the next public health programme "Health for Growth" (BL 17 03) should provide funding. Financing the implementation of the (future) legislation on medical devices is foreseen as one of the options to be presented in the impact assessment for this programme which covers the period 2014-2020.

Part of the operational expenses (e.g. IT development, 'joint assessment' of Notified Bodies) may be recaptured by fees for the registration of economic operators and listing of devices and the assessment of Notified Bodies. The legal basis for the levy of fees (as well as a decision whether there should be a refund to Member States) should be included in the legislative act to be adopted by the co-legislator. However, the amount cannot be predicted at this stage since the level of fees and, if applicable, the amount of the refund to the Member States' competent authorities[132] are not yet defined; it necessitates a specific impact assessment but it can be predicted that the level of fees would be considerably lower compared to those applied for pharmaceuticals.

7.           Subsidiarity and proportionality

The use of Union competences is governed by the principles of subsidiarity and proportionality (Article 5 TEU). The application of these principles is further specified in Protocol No 2 to the TEU and TFEU which needs to be taken into account for the preparation of the Commission proposals. The preferred options for EU action suggested in this impact assessment will respect the principles of subsidiarity and proportionality.

Legislation in the field of the internal market (Article 114 TFEU) and regarding common safety concerns in public health matters (here: high standards of quality and safety of medical products, Article 168(4)(c) TFEU) is a shared competence between Union and Member States (Article 4(2)(a) and (k) TFEU).

The current EU legislation on medical devices is based on Article 114 TFEU (ex-article 95 TEC) and its aim is to ensure a high level of protection of human health as well as the proper functioning of internal market. According to this legislation, medical devices that bear the CE marking, in principle, can freely circulate in the EU. The proposed revision of the existing directives, which will integrate the modification of the Lisbon Treaty regarding public health, can only be achieved at Union level. This is necessary to improve the level of protection of public health for all European patients and users as well as to prevent Member States from adopting varying product regulations which would result in a further fragmentation on the internal market.

Several of the preferred policy options (e.g. mechanism to settle borderline and classification issues; central registration and listing, including traceability; enhanced coordination regarding post-market safety) are explicitly geared at addressing threats to the single market, while enhancing the level of protection of public health in the EU. Also indirect threats are addressed with the reinforcement of the control of Notified Bodies which is needed to ensure the confidence in the CE-marking and to avoid negative repercussions on the free movement of devices due to restrictive national measures (e.g. based on the safeguard clauses).

Harmonised rules and procedures allow manufacturers, especially SMEs, to reduce costs related to national regulatory differences, while ensuring a high and equal level of safety for all European patients and users.

The majority of policy options suggested in this impact assessment leave the ultimate responsibility for the implementation of the harmonised rules at the level of Member States. The coordination among them as well as certain technical tasks (e.g. IT infrastructure, consolidated expertise), however, can only be ensured appropriately at EU level.

Only option 1B (designation and monitoring of Notified Bodies by an EU body) could give rise to being questioned on the ground of the subsidiarity principle, if it was chosen instead of policy option 1C (designation and monitoring of Notified Bodies by Member States with the involvement of 'joint assessment teams'). But the choice of this option would be justified by the high level of effectiveness in ensuring a uniform oversight of Notified Bodies which is a cornerstone for the functioning of the entire EU regulatory system for medical devices.

8.           Monitoring and evaluation

The successful implementation of the future regulatory framework for medical devices will depend on several factors. The following monitoring and evaluation tools could be envisaged:

8.1.        Alignment of national legislations to the future EU regulatory framework for medical devices

The new EU regulations will be directly applicable in all Member States. But since all Member States currently have their own legislation regarding medical devices based on the existing AIMDD, MDD and IVDD, they would be required to repeal their existing national regulations in the field of medical devices. The European Commission would need to monitor this process. Member States should therefore be required to communicate all national measures falling within the scope of the new EU regulations and identify those which are repealed in order to align with these regulations. The Commission would need to verify that Member States correctly align with the new EU framework. Indicator of success will be the absence of infringement cases for violation of the new regulations.

8.2.        Oversight of Notified Bodies

At the latest three years after entry into force of the new legislation, on the basis of a roadmap set up by the Commission and the Member States, all existing Notified Bodies should be assessed and designated according to the new requirements and designation process and the mechanism for notification by Notified Bodies of certain conformity assessment applications should be established.

Indicator for success of combined policy options 1A and 1B or 1C will either be the number of Notified Bodies designated under the MDD/IVDD which might decrease due to the new requirements and process and/or the level of diversification of the Notified Bodies' designation scope which is expected to increase. It should be emphasised that the reduction of the number of Notified Bodies is not as such an objective pursued by the revision even though it may be a consequence. The objective that Notified Bodies are designated in accordance with their proven expertise and competences may also be achieved by more specified designation scopes.

Indicator for success of policy option 1G will be the number of preliminary assessment reports submitted to the MDEG and the number of comments made by this group on these reports. The number of times that MDEG would make use of its "right of evocation" should be reasonable. Even though it is difficult to predict how many notifications would justify the submission of a preliminary assessment report, the number should probably not exceed 50 a year so that the system remains workable and does not overly slow down the assessment process. It should therefore be monitored that the implementation of this policy option does not lead to an unreasonable increase in time to market.

A further indicator of success of the revision of the entire regulatory framework (stronger oversight of Notified Bodies, 'early advice' process with external experts etc.) will be a decrease over time of the number of comments emitted by MDEG and an increased recognition of the Notified Bodies by third countries.

8.3.        Post-market safety

Annual statistics should be drawn up to indicate the number of incidents reported to the central vigilance database and the number of cases where a coordinated analysis led to a uniform Field Safety Corrective Action (FSCA). Indicator of success for the combined policy options 2A, 2B and 2D will be the number of cases where divergent positions exists with regard to FSCA or restrictive measures taken in the context of market surveillance which should be low and decreasing over time.

8.4.        Cross-sectoral solution of borderline cases

Indicator of success for policy option 3B will be, on the one hand, the number of meetings of a cross-sectoral advisory group on borderline issues and the number of cases solved by consensus by this group or by a legally binding measure adopted by the Commission, and, on the other hand, the decrease of cases in which different regulatory regimes are applied to the same product or type of products in various Member States.

8.5.        Enhanced transparency and traceability

The timely deployment of a performing and interoperable IT infrastructure will be key to achieve an enhanced transparency of the regulatory system for medical devices, and in particular to implement policy options 4B and 4C (central registration and listing database combined with UDI for traceability). The operational services would need to work closely with the IT specialists to conceive the development of Eudamed that meets the needs of the users. A roadmap should be set up which defines deployment progress. Indicator of success will be that 5 years after entry into force of the new legislation, a clear picture will be available at EU level as regards the economic operators and medical devices on the EU market and the key clinical data supporting the assessment of high risk devices.

As regards UDI, the indicator of success will be that, after full implementation of UDI (ca. 10 years after entry into force of the revised legislation), the possibility exists to track and trace all devices subject to the UDI requirement. An additional success indicator will be that the US and EU UDI systems (as well as possibly other UDI systems based on the GHTF guidance on UDI) are fully compatible and allow traceability between the respective jurisdictions. Close cooperation with international partners, in particular with the US FDA in the context of the regular bilateral cooperation, would be important in order to keep the impact on economic operators as low as possible.

8.6.        Enhanced involvement of external scientific and clinical expertise

With regard to the enhanced role of external experts, strict enforcement of the rules on disclosure of possible conflicts of interests will be key to ensure the independence of advice given to decision-markers as well as a high level of transparency as guarantee for trust in the system.

Indicator of success will be the number of opinions given by external scientific and clinical experts, including reference laboratories, in particular in the context of an 'early advice' procedure available to manufacturers and Notified Bodies. In order to justify the costs, around 10 opinions should be delivered per year.

8.7.        Clear obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales

The number of coordinated actions regarding internet sales of medical devices could be taken as indicator of effective implementation as well as their impact on the quantity of counterfeit devices on the EU market. Regarding diagnostics services offered at a distance in the EU, a survey should reveal the extent to which the devices used in the context of such services comply with the EU requirements.

8.8.        Effective and efficient management of the regulatory system

Immediately after adoption of the new legislation, the Commission would need to prepare the new governance model. If option 7A (extension of the mandate of EMA) was chosen, the amendment to Regulation (EC) No 726/2004 would need to be implemented by the Commission in close cooperation with the management of EMA. Qualified staff would have to be recruited in time and the infrastructure for hosting the Medical Device Expert Group would have to be set up. Within the Commission a task-force should be set up to assist EMA that the necessary arrangements are put in place to ensure the transition to a new "European Health Products Agency". The Management Board of EMA would have to ensure that national agencies that do not have a shared competence for medicines and medical devices are adequately represented.

If option 7C (fulfilment of tasks by the Commission) was chosen, the Commission would need to decide about the distribution of tasks between its services. This would require a decision on the redeployment of the necessary staff and the recruitment of qualified personnel.

8.9.        Consultation and reporting

The current informal Commission's Medical Device Expert Group , which shall be given a statutory mandate by this revision, as well as the special working groups will provide a regular platform to discuss issues related to the implementation of the new regulatory framework. The further monitoring of the implementation will continue to be done in close cooperation with the future statutory Medical Device Expert Group.

Seven or ten years after the implementation, the Commission should report to the European Parliament and to the Council about the achievements of the 'medical device package'. The report should address the impact of the new rules in respect of public health and patient safety, internal market, innovativeness and competitiveness of the medical device industry (with special attention to SMEs). The Commission should consult competent authorities and stakeholders (healthcare professionals, patients, manufacturers, Notified Bodies) when preparing its report.

9.           List of acronyms and abbreviations used in the Impact Assessment

AIMD || Active implantable medical devices

AIMDD || Active Implantable Medical Devices Directive (Directive 90/385/EEC)

ATMP || Advanced Therapies Medicinal Product

CAMD || Competent Authorities for Medical Devices

CAT || Committee on Advanced Therapies

CI || Clinical investigation

CIE COCIR || Working Group on Clinical Investigation and Evaluation European Coordination of the Radiological and Electromedical Industry

COEN || Compliance and Enforcement Group

EDMA || European Diagnostic Manufacturers Association

EFTA || European Free Trade Association

EMA || European Medicines Agency

EU || European Union

Eucomed || European Medical Technology Industry Association

Eudamed || European databank for medical devices

FDA || Food and Drug Administration

FSCA || Field Safety Corrective Action

FSN || Field Safety Notice

FTE || Full Time Equivalent

GHTF || Global Harmonization Task Force

GMDN || Global Medical Device Nomenclature

HMA || Heads of Medicines Agencies

HTA || Health Technology Assessment

IVD || In vitro diagnostic medical device

IVDD || In Vitro Diagnostic Medical Devices Directive (Directive 98/79/EC)

JRC || Joint Research Centre

MD || Medical device

MDD || Medical Devices Directive (Directive 93/42/EEC)

MDEG || Medical Device Expert Group

MEDDEV || Guidelines relating to the application of the medical devices directives

MRA || Mutual Recognition Agreement

NB-Med || Co-ordination of Notified Bodies Medical Devices

NBOG || Notified Body Operations Group

NBOG-BPG || Notified Body Operations Group - Best Practice Guidance

NCAR || National Competent Authority Report

NET || New and Emerging Technologies Working Group

PoC/NP || Point of care/Near-patient

QS || Quality system

SCENIHR || Scientific Committee on Emerging and Newly Identified Health Risks

SMEs || Small and medium-sized enterprises

SUD || Single-use device

TEC || Treaty Establishing the European Community

TFEU || Treaty on the Functioning of the European Union

UDI || Unique Device Identification

WHO || World Health Organization

WTO/TBT || World Trade Organization/Technical Barriers to Trade

[1]               COM(2005)535.

[2]               Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 31 March 2010, COM(2010)135 final, Annexes II and III.

[3]               Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 27 October 2010, COM(2010)623 final, Annexes II and III.

[4]               http://ec.europa.eu/governance/impact/planned_ia/planned_ia_en.htm

[5]               http://ec.europa.eu/health /medical-devices/documents/revision/index_en.htm

[6]               http://ec.europa.eu/health /medical-devices/documents/revision/index_en.htm

[7]               http://ec.europa.eu/health /medical-devices/documents/revision/index_en.htm

[8]               http://ec.europa.eu/health/medical-devices/files/recast_docs_2008/ivd_pc_outcome_en.pdf

[9]               For an overview of the different working groups and their composition see http://ec.europa.eu/health /medical-devices/dialogue-parties/working-groups/index_en.htm

[10]             http://ec.europa.eu/health/medical-devices/competitiveness/exploratory-process/index_en.htm

[11]             OJ C 202 of 8.7.2011, p. 7.

[12]             Resolution of 14 June 2012 (2012/2621(RSP)); P7_TA-PROV(2012)0262, http://www.europarl.europa.eu/plenary/en/texts-adopted.html.

[13]             http://www.ghtf.org/

[14]             For more details see the 'fact sheet' about the medical device sector, Appendix 4.

[15]             According to the WHO, estimates range from some 90,000 to 1.5 million in over 10,000 types of generic device groups, WHO, Medical Devices: Managing the mismatch, 2010, p. 1, http://whqlibdoc.who.int/publications/2010/9789241564045_eng.pdf; WHO fact sheet No 346, Sept. 2010, http://www.who.int/mediacentre/factsheets/fs346/en/index.html

[16]             Eucomed figures for EU 27, Norway and Switzerland, http://www.eucomed.org/medical-technology

[17]             EDMA Annual Report 2009, p. 11; http://www.edma-ivd.be/fileadmin/upl_documents/Annual_Report/2009/EDMA_2010-07-16_Annual_Report.pdf

[18]             According to information of the industry, the average life-cycle of medical devices are 18 months, even though this depends very much on the product. Heart valves or hip implants can remain unchanged during several years while other devices are constantly improved.

[19]             See report 360050011/2008 of the Dutch National Institute for Public Health and the Environment (RIVM) on artificial organs.

[20]             IVD (biomarker) are used to help predicting the outcome of a particular therapy for a given patient.

[21]             See AFSSAPS, Evaluation biologique des dispositifs médicaux contenant des nanomatériaux, rapport scientifique du 22.2.2011.

[22]             See http://www.eucomed.org/medical-technology/facts-figures.

[23]             For more details see also the 'fact sheet' about the EU regulatory framework for medical devices, Appendix 5.

[24]             Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements on accreditation and market surveillance for the marketing of products, and Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products.

[25]             AIMD (e.g. pacemakers, implantable defibrillators) correspond to class III devices.

[26]             http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/index_en.htm; http://www.nbog.eu/2.html; http://www.team-nb.org/index.php?option=com_docman&Itemid=38

[27]             AT, BE, CH, CZ, DE, DK, ES, FI, FR, GR, HU, IE, IT, LT, LU, NL, NO, PL, PT, RO, SE, SI, SK, UK.

[28]             Under the EU-Turkey Customs Union Agreement.

[29]             Under the EU-Australia Mutual Recognition Agreement.

[30]             See also the NANDO database under http://ec.europa.eu/enterprise/newapproach/nando/. All 19 Notified Bodies designated under Directive 90/385/EEC and all 25 Notified Bodies designated under Directive 98/79/EC are also designated under Directive 93/42/EEC.

[31]             See section 8 of the Summary of responses to the 2008 public consultation (see above section 1.1.1).

[32]             http://www.nbog.eu/resources/da_handbook.pdf

[33]             Council Conclusions adopted on 6 June 2011, section 6, 8th indent, see Appendix 3.

[34]             In terms of the directives "wrongly affixed CE marking". It is the case when the CE marking has been affixed unduly or is missing in violation of the directive.  

[35]             Article 8(3) AIMDD, Article 10(3) MDD and Article 11(3) IVDD.

[36]             NCAR statistics are published at the Commission's website, http://ec.europa.eu/health/medical-devices/documents/vigilance-reports/index_en.htm.

[37]          The MEDDEV states: "Information shall be disseminated between National Competent Authorities and copied to the Commission when:

                A) a FSCA is performed by the MANUFACTURER;

                B) a National Competent Authority requires the MANUFACTURER to perform an FSCA or to make changes in an FSCA that the MANUFACTURER has already initiated;

                C) there is a serious risk to the safety of patients or other USERs, but where no corrective action has yet been established, although measures are under consideration;

                D) the MANUFACTURER does not provide a final report in a timely manner.

                […] National Competent Authorities should use their discretion where corrective action is taken by a MANUFACTURER which is not considered to be essential to protect the safety of patients or other USERs Under these circumstances a National Competent Authority Report may not be necessary."

[38]             See Clinica, November 2010 p. 6, "EU device vigilance: scrutiny threatens radical change".

[39]             Directive 2007/47/EC inserted in Article 1(5)(c) MDD that when deciding whether a product falls under the MDD or Directive 2001/83/EC, "particular account shall be taken of the principal mode of action".

[40]             The "Helsinki procedure" is a consultation procedure triggered by a Member State when this Member State wants to receive the other Member States' views on a specific qualification or classification problem. While this procedure has been useful to solve some issues, some limitations exist. In particular, the participation of Member States to this procedure is on a voluntary basis, its outcomes are not legally binding and the follow-up to be given (i.e. further discussion required in a plenary meeting of the Medical Devices Expert Group on Borderline and Classification) depends mainly on the initiating Member State.

[41]             See http://ec.europa.eu/health/medical-devices/documents/borderline/index_en.htm

[42]             http://www.eucomed.org/medical-technology

[43]             Information provided by the Italian Ministry of Health (state of play: April 2011).

[44]             Information provided by the Turkish Ministry of Health (state of play: July 2011).

[45]             Alan G. Fraser et al., Clinical evaluation or cardiovascular devices: principles, problems, and proposals for European regulatory reform, in: European Heart Journal 14.5.2011; Deborah Cohen/Matthew Billingsley, Europeans are left to their own devices, in: BMJ, 2011, 342:d2839.

[46]             Health Technology Assessment (HTA) is a multidisciplinary process that summarizes information about the medical, social, economic, and ethical issues related to the use of health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value, see http://ec.europa.eu/health/technology_assessment/policy/index_en.htm.

[47]             Hulstaert, F. et al., The pre-market clinical evaluation of innovative high-risk medical devices, Belgian Health Care Knowledge Centre (KCE), 2011, KCE Report 158C; D/2011/10.273/31; Interview with Prof. Jürgen Windeler, director of IQWiG, in: Clinica, Jan/Feb 2011, p.23.

[48]             According to the results of an enquiry launched by the UK in 2009, 13 out of 22 EU/EFTA states which responded require a notification or a registration of devices when they are put into service in their respective territories.

[49]             The SCENIHR was established by Commission Decision 2008/721/EC of 5 August 2008, OJ L 241 of 10.9.2008, p. 21.

[50]             Council Conclusions adopted on 6 June 2011, section 5, 9th indent, see Appendix 3.

[51]             See e.g. the Written Question E-007016/2011.

[52]             Council Conclusions adopted on 6 June 2011, section 6, 10th indent, see Appendix 3.

[53]             Council Conclusions adopted on 6 June 2011, section 4, 6th indent, see Appendix 3.

[54]             Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions "Towards a Single Market Act", 27.10.2010, COM(2010)608final.

[55]             A New Strategy for the Single Market, Report to the President of the European Commission by Prof. Mario Monti, 9 May 2010, http://ec.europa.eu/bepa/pdf/monti_report_final_10_05_2010_en.pdf

[56]             See also Council Conclusions adopted on 6 June 2011, section 6, 1st indent, see Appendix 3.

[57]             The American Chamber of Commerce in Japan, 2008 Device Lag Study.

[58]             Josh Makower et al., FDA impact on U.S. medical technology innovation, November 2010, http://www.eucomed.be/Home/portal/press/press_releases/2010/~/media/1030872F3DF84ABF97065607D3E9507C.ashx. The study was fiercely rejected by the FDA's CDRH Director Mr Jeffrey Shuren, see http://www.massdevice.com/news/update-cdrh-chief-shuren-blasts-stanford-study-medical-device-regulations. PricewaterhouseCoopers, Medical Technology Innovation Scoreboard, January 2011, http://pwchealth.com/cgi-local/hregister.cgi?link=reg/innovation-scorecard.pdf (visited on 3 March 2011); California Health Institute and Boston Consulting Group, Competitiveness and Regulation: The FDA and the Future of America's Biomedical Industry, February 2011, http://www.bcg.com/documents/file72060.pdf (visited on 3 March 2011).

[59]             Boston Consulting Group, EU Medical Device Approval Safety Assessment, January 2011.

[60]             The combination can for example include medical devices incorporating a medicinal substance, medical devices incorporating a human blood derivative, medical devices using a material of animal origin, see Richter S., Combination Products: Navigating Two FDA Quality Systems, www.pharmamanufacturing.com (visited on 11.8.2011).   

[61]             Communication from the Commission of 3 March 2010, COM(2010)2020.

[62]             Communication of the Commission on Europe 2010 Flagship Initiative Innovation Union, 6.10.2010, COM(2010)546final.

[63]             Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements on accreditation and market surveillance for the marketing of products, and Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products. See also the legislative initiative for the alignment of 10 Directives with Decision 768/2008 under the lead of DG Enterprise and Industry.

[64]             Council Conclusions adopted on 6 June 2011, section 3, 7th indent, see Appendix 3.

[65]             The Centre for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) employs around 1,380 staff (May 2011), of which around 380 are working in the Office of Device Evaluation and around 150 in the Office of In Vitro Devices.

[66]             See in particular the studies of PricewaterhouseCoopers and Boston Conculting Group quoted in Fn. 56 and 57, respectively.

[67]             EFPIA, The pharmaceuticals industry in figures (2010), http://www.efpia.eu/Content/Default.asp?PageID=559&DocID=9158; DiMasia J.A./ Grabowski H.G., The Cost of Biopharmaceutical R&D: Is Biotech Different? Managerial and Decision Economics. 28: 469–479 (2007) http://www.manhattan-institute.org/projectfda/wiley_interscience_cost_of_biopharm.pdf.

[68]             Eucomed, response of 3 July 2008 to the public consultation, Fn.1; BVMed Branchenbericht 2010 (2.12.2010), p. 5 http://www.bvmed.de/stepone/data/downloads/50/d8/00/branchenbericht10_12.pdf.

[69]             So far, only one ATMP (ChrondroCelect, EMA product no. EMEA/H/C/000878) has been authorised under Directive 2001/83/EC. Its approval procedure lasted from 1 June 2007 to 5 Oct. 2009, i.e. 857 days.

[70]             See NB-Med response of 27 June 2008 to the public consultation. See also response of the VdTüV of 1 July 2008 which mentions 90 days as average assessment time.

[71]             For drug-device combination products: 210 days consultation period of a national pharmaceuticals authority or EMA; for devices manufactured utilising certain animal tissues: 12 weeks consultation period of national competent authorities. 

[72]             Alan G. Fraser et al., Clinical evaluation or cardiovascular devices: principles, problems, and proposals for European regulatory reform, in: European Heart Journal 14.5.2011, p. 11 ("Options would be for the divisions of NBs that assess medical devices to become the technical division of a new European medical devices agency, or they could remain decentralized while operating within an integrated system."); Hulstaert, F. et al., The pre-market clinical evaluation of innovative high-risk medical devices, Belgian Health Care Knowledge Centre (KCE), 2011, KCE Report 158C; D/2011/10.273/31, p. 19: ("Instead of trying to streamline a very fragmented system of Notified Bodies and Competent Authorities, a more straightforward way to achieve the goals discussed above could be to centralise expertise. This could be realised under the EMA umbrella, […]".

[73]             See e.g. the report of Boston Consulting Group, EU Medical Device Approval Safety Assessment, January 2011 (above Fn. 57), that does not identify a lower safety level of devices in Europe compared to the US where a system of marketing authorisation applies to certain categories of devices.

[74]             E.g. as regards legal personality, management, technical competence, capabilities, liability, confidentiality, subsidiaries and subcontrators. 

[75]             Regulation (EC) No 391/2009 of the European Parliament and of the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations.

[76]             It should also be possible to reduce or waive the standstill period when the authorities do not have any concerns so that the process can be accelerated.

[77]             Commission Directive 2003/32/EC concerning detailed specifications as regards requirements laid down in Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin. Since its application (April 2004), around 130 consultations were carried out giving rise, in the majority of cases, to comments by national competent authorities regarding e.g. the clinical benefit of the use of animal tissues and the availability of suitable alternative synthetic products presenting lower risks; the country of origin (unsure BSE status); non-validated manufacturing process; traceability of animal tissues (state of play: September 2011).

[78]             Class D IVDs according to the GHTF classification of IVDs which is discussed in detail in Annex 2 to this impact assessment.  

[79]             Class B and C IVDs according to the GHTF classification of IVDs which is discussed in detail in Annex 2 to this impact assessment

[80]             GHTF/SG2/N57R8:2006 - Medical devices post market surveillance: content of field safety notices.

[81]             Incidents is defined as: "Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health".

[82]             The IMCO Committee of the European Parliament called for sharing of best practices between Member States, joint cooperation, pooling of know-how and co-funded joint market surveillance action, see report 2010/2085(INI) of 24.2.2011 on the revision of the GPSD and market surveillance.

[83]             In some specific food legislation, provision is made that the Commission may determine whether a type of food or a given substance falls within the scope of that specific legislation or in a specific category of foodstuff, e.g. Regulation (EC) No 258/1997 on novel food; Directive 94/35/EC on sweeteners for use in foodstuff; Directive 94/36/EC on colours for use in foodstuff; Directive 95/2/EC on other additives than colours and sweeteners.

[84]             Article 3(3) of the Biocides Regulation (not yet finally adopted).

[85]             Similar to the FDA Summary of Safety and Effectiveness Data (SSED).

[86]             Article R7 of Decision 768/2008/EC on a common framework for the marketing of products states: "Economic operators shall, on request, identify the following to the market surveillance authorities, for … [period to be specified in proportion to the lifecycle of the product and the level of risk]:

                a) any economic operator who has supplied them with a product;

                b) any economic operator to whom they have supplied a product."

[87]             GHTF/AHWG(PD2)/N2R2, final adoption foreseen by the end of 2011.

[88]             http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentifiers/default.htm

[89]             Decision 768/2008/EC on a common framework for the marketing of products which is part of the New Legislative Framework for the Marketing of Products.

[90]             The three EEA member states Liechtenstein, Iceland and Norway as well as Switzerland (MRA) and Turkey (Customs Union) apply the medical devices directives in their territories and participate in the EU medical device regulatory system. Participation of experts of these countries should also be ensured.

[91]             The possible tasks of a Medical Device Expert Group are set out in Appendix 7; in the legislative proposal, another name could be given to that group. The MDEG should not be confused with the current informal Commission's working group of the same name which forms a platform for advice to the Commission and the exchange of view between Member States' representatives and stakeholders. 

[92]             The MDEG would need to be distinguished from a Committee to be established under the new 'Comitology' regime in accordance with Regulation (EU) No 182/2011.

[93]             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.

[94]             In the Commission's report of January 2010 on the evaluation of the EMA, p. 93, it is stated that, at this stage, EMA is not suited to perform evaluation of all medical devices, http://ec.europa.eu/enterprise/dg/files/evaluation/final_report_emea_january_2010_en.pdf.

[95]             Commission's report of January 2010 on the evaluation of the EMA, p.15.

[96]             A Community agency is a body governed by European public law; it is distinct from the Community Institutions (Council, Parliament, Commission, etc.) and has its own legal personality. It is set up by an act of secondary legislation in order to accomplish a very specific technical, scientific or managerial task; see http://europa.eu/agencies/community_agencies/index_en.htm See also the Commission Communication on European Agencies – The way forward, COM(2008)135.

[97]             For more information about the JRC see http://ec.europa.eu/dgs/jrc/.

[98]             http://www.cmc-md.eu/index.html. See also Clinica (Jan/Feb. 2011, p. 27): "CMC out to prove it is the answer to consistent regulation in the EU".

[99]             http://www.hma.eu/index.html.

[100]            MEDDEV 2.10-2; NBOG Designating Authorities Handbook; EN ISO/IEC 17000 series.

[101]            NBOG Report for the period 2005-2008 (May 2009).

[102]            The numbers of non-accredited Notified Bodies are 14 out of 78 (MDD), 3 out of 19 (AIMDD) and 6 out of 25 (IVDD) (state of play: August 2011).

[103]            See Article 5(2) of Regulation (EC) No 765/2008.

[104]            Based on the data available for the Italian market and provided by the Italian Ministry of Health (state of play: May 2011).

[105]            MEDDEV 2.12-1 rev.6 of December 2009: Guidelines on a medical devices vigilance system.

[106]            This estimation is supported by the comparative analysis of medical device recalls 2005-2009 by the Boston Consulting Group (Jan. 2011) that found for the 5-years period some 5,000 records of field safety notices in the five Member States with the highest number of NCAR reporting.

[107]            In the field of food and feed law (see Regulation (EC) No 882/2004), the Commission's Joint Research Centre hosts six European Union Reference Laboratory in support of a network of national reference laboratories to support the effective implementation of the legal requirements, http://ec.europa.eu/dgs/jrc/index.cfm?id=4070&lang=en

[108]            For the 26 EU-Ref-Labs in the area of food and feed and animal health, EU funding was less than 10 mio. € in 2010.

[109]            Council Conclusions adopted on 6 June 2011, section 6, 9th indent, see Appendix 3.

[110]            See e.g. the joint Medical device – Medicinal product ad hoc working group on borderlines cases.

[111]            Council Conclusions adopted on 6 June 2011, section 6, 7th indent, see Appendix 3.

[112]            According to the tariffs used as a basis for the calculation of administrative costs in the context of the Action Programme for reducing administrative burdens, provided by the Commission's Secretariat-General on the basis of ESTAT data for 2006, the EU27 average cost/hour was 14€ for a clerk. But the majority of manufacturers or authorised representatives are based in high-income Member States (e.g. Germany, UK, France, Italy, Ireland, Sweden) where the average cost/hour was well above 20€ for a clerk.

[113]            According to Eucomed, more than 90% of its members selling equally to the US and to the European market.

[114]            Council Conclusions adopted on 6 June 2011, section 6, 5th indent, see Appendix 3.

[115]            Reference no. of DG ENTR's impact assessment not yet available.

[116]            EN ISO 13485:2003: Medical devices - Quality management systems – Requirements for regulatory purposes.

[117]            The Commission's proposal for the MFF 2014-2020 is not yet adopted. But the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions "A Budget for Europe 2020" defines some core elements, COM(2011)500 final.

[118]            It is not expected that all Member States participate in all meetings so that the real costs will be less.

[119]            Commission's report of January 2010 on the evaluation of the EMA, p.15.

[120]            AT, BE, BG, CZ, DE, DK, ES, FR, GR, IE, LU, LV, PL, PT, RO, SI, SK, SE, UK (in DE, the responsibility for Notified Bodies' oversight in the field of medical devices is entrusted on a different authority; in BE a separate agency is responsible for IVD). In the remaining eight Members States (CY, EE, FI, HU, IT, LT, MT, NL) either other national agencies or the ministries are the competent authorities for medical devices.

[121]            EMA has a relatively high premise cost index (168 compared to average =100), but a low travel cost index (58 compared to average =100), Evaluation of the EU decentralised agencies in 2009, Final Report Vol. II, p. 98-99.

[122]            EMA has a ratio of 14% for administrative staff, see Evaluation of the EU decentralised agencies in 2009, Final Report Vol. II, p. 95.

[123]            CHMP, CVMP, COMP, HMPC, PDCO and CAT; the PRAC (Pharmacovigilance Risk Assessment Committee) will be set up in 2012.

[124]            Evaluation of the EU decentralised agencies in 2009, Final Report Vol. II, p. 16, 97. On the other side, the recently set up BEREC Office is planned to have only 28 staff.

[125]            Evaluation of the EU decentralised agencies in 2009, Final Report Vol. II, p. 95.

[126]            General Guidelines for the Cooperation between the European Co-operation for Accreditation and the European Commission, the European Free Trade Association and the Competent National Authorities, OJ C 116, 21.5.2009, p. 6.

[127]            For the secretariat of the CMDh EMA provides around 2 FTE and for the CMDv around 1.25 FTE.

[128]            Impact Assessment Guidelines (SEC(2009)92, Part III, page 45.

[129]            Communication of 22.10.2009, COM(2009)544.

[130]            Council Directive 90/385/EEC, Council Directive 93/42/EEC, Directive 98/79/EC of the European Parliament and of the Council, Directive 2000/70/EC of the European Parliament and of the Council, Directive 2001/104/EC of the European Parliament and of the Council, and Directive 2007/47/EC of the European Parliament and of the Council

[131]            Commission Directive 2003/12/EC and Commission Directive 2005/50/EC.

[132]            The aspect of refund is of special importance to contribute to the funding of national competent authorities as regards the fulfilment of the tasks allocated to them by the EU legislation.