EUROPEAN COMMISSION

Strasbourg, 16.12.2025

COM(2025) 1023 final

2025/0404(COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I

(Text with EEA relevance)

{SWD(2025) 1050-1052 final}

EXPLANATORY MEMORANDUM

1.CONTEXT OF THE PROPOSAL

•Reasons for and objectives of the proposal

The medical devices sector is a very diverse and innovative driver of economic growth in Europe. The sector plays a key role in boosting the competitiveness of the European Union and ensuring the functioning of the Member States’ healthcare systems and, ultimately, achieving a high level of public health protection. A medical device can be any instrument, apparatus, appliance, software, implant, reagent for in vitro use, or any material or article intended by the manufacturer to be used, alone or in combination with other materials or articles, for human beings for a medical purpose, e.g. for the diagnosis, treatment, alleviation, prevention, monitoring, prediction or prognosis of a disease, injury or other condition.

Medical devices cover a wide range of products, such as sticking plasters, syringes, surgical masks, eyeglasses, wheelchairs, medical apps, body scanners, and implantable devices such as heart valves, pacemakers or knee and hip replacement joints. Examples for in vitro diagnostic medical devices (IVDs) include influenza or COVID-19 tests, HIV tests, gene mutation tests or blood grouping tests. According to the World Health Organization, there are an estimated 2 000 000 different kinds of medical devices on the global market, categorised as belonging to more than 7 000 generic device groups 1 . There are more than 38 000 medical technology companies in Europe. Small and medium-sized enterprises (SMEs) make up around 90% of the industry, most of which are small and micro-sized companies which employ fewer than 50 people. Altogether, the medical technology industry employs more than 930 000 people in Europe. The European medical technology market was estimated to be worth approximately EUR 170 billion in 2024 2 .

Regulation (EU) 2017/745 on medical devices (the ‘Medical Devices Regulation’ or ‘MDR’) 3 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the ‘In Vitro Diagnostic Medical Devices Regulation’ or ‘IVDR’) 4 of the European Parliament and of the Council (collectively referred to in this proposal as ‘the Regulations’) provide a strengthened regulatory framework for medical devices and in vitro diagnostic medical devices (‘IVDs’). As set out in their first two recitals, the MDR and IVDR aim to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices and for in vitro diagnostic medical devices, which ensures a high level of safety and health while supporting innovation. These Regulations aim to ensure the smooth functioning of the internal market, taking as a base a high level of protection of health for patients and users, and taking into account the SMEs that are active in this sector.

To achieve these objectives and to address issues with the previously applicable legislation, the Regulations have, among other things, set stricter requirements for the level of clinical evidence that must be gathered by manufacturers to demonstrate compliance of their devices with the relevant rules. The Regulations also provide for a more robust system of conformity assessment to check the quality, safety and performance of devices placed on the EU market. Under the MDR and the IVDR, devices are divided into four risk classes 5 , depending on their intended purpose and inherent risks. Depending on the risk class of the device, the manufacturer must involve an independent third-party conformity assessment body (‘notified body’) in the conformity assessment, before it can affix a CE marking to the device and place it on the market. When the MDR and IVDR took effect, the number of designated notified bodies was very low, which created bottlenecks in the mandatory pre-market certification process. To date, 51 notified bodies have been designated under the MDR and 19 under the IVDR.

The MDR took effect on 26 May 2021 6 , and the IVDR on 26 May 2022. The much stricter requirements established by the Regulations, which also apply to existing devices, the limited certification capacity of the notified bodies and the insufficient preparedness of the manufacturers posed the risk of supply shortages and disappearance of critical devices from the market. Therefore, the transitional period specified in Article 120 of the MDR has been extended by Regulation (EU) 2023/607 7 and will end either on 31 December 2027 or on 31 December 2028, depending on the device’s risk class and subject to certain conditions. The transitional periods specified in Article 110 of the IVDR have been extended by Regulation (EU) 2022/112 8 and by Regulation (EU) 2024/1860 9 ; they will end on either 31 December 2027, 31 December 2028 or 31 December 2029, depending on the IVD’s risk class and subject to certain conditions, which are similar to those provided for in the MDR.

The repeated extension of the transitional periods was only a short-term solution to mitigate the risk of shortages. It could not solve the underlying structural problems in the implementation of the MDR and IVDR. In view of the many challenges in the implementation of the two Regulations, in 2024 the European Commission launched a targeted evaluation of the MDR and IVDR. Despite the significant progress that has been made in the practical implementation of the MDR and IVDR, the targeted evaluation (which is being finalised at the same time as this proposal) has identified shortcomings in the regulatory framework. These weaknesses affect the availability of devices and the competitiveness of EU manufacturers (in particular of the many micro, small and medium-sized companies) and hinder innovation in medical technology. This, in turn, has a negative impact on healthcare quality and patient safety. The results of the targeted evaluation are presented in Section 3 of this explanatory memorandum.

This proposal aims to streamline and future-proof the regulatory framework. Its main objective is to simplify the applicable rules, reduce the administrative burden on manufacturers and enhance the predictability and cost-efficiency of the certification procedure by notified bodies, while preserving a high level of public health protection and patient safety, and thus to help achieve the initial objectives of the Regulations. The objectives of the MDR and IVDR are still pursued by all relevant actors. However, the lack of sufficiently predictable timelines for the certification process and the diverging practices across the EU continue to undermine the efficiency of the process to obtain the CE marking. Moreover, several requirements under the Regulations are disproportionate to the actual risks posed by the devices, which results in unnecessarily high costs and burdens. Overly onerous requirements may prompt manufacturers, especially SMEs, to discontinue supplying devices or to delay their launch, with potential negative consequences for patient care and public health. They may also negatively impact the competitiveness of the EU medical devices market compared to other jurisdictions around the world.

This proposal is a response to requests from the European Parliament 10 , several Member States 11 and numerous stakeholders for a simplification of the regulatory framework for medical devices and for measures to ensure the availability of devices. A new regulation is needed to remedy the problems that have been identified, which otherwise would have a considerable impact on the medical devices market and, consequently, on the quality of healthcare provided to patients in the EU.

The proposal aims to improve the functioning of the current regulatory framework, in particular as regards the smooth functioning of the single market, while ensuring a high level of health protection for patients. It builds on the key features of the existing framework, notably the decentralised approach (whereby responsibilities are allocated to the Member States) and the involvement of notified bodies in the conformity assessment procedure, like in other EU legislation based on the New Legislative Framework. However, the aim is to establish a leaner and more cost-effective regulatory framework and to promote further harmonisation, creating a more competitive and innovative EU market.

The Medical Device Coordination Group (MDCG) was established in accordance with Article 103 of the MDR and is composed of representatives of the national competent authorities and chaired by the Commission. In the proposal, the MDCG is retained as the main governing body.

The proposal strengthens the coordination between notified bodies through the coordination group (NBCG-Med) which was established in accordance with Article 49 of the MDR and creates a direct reporting line from the NBCG-Med to the MDCG. While notified bodies will remain under the responsibility of the Member States, the proposal aims to improve the oversight and regular monitoring of notified bodies through involvement of experts from the Commission and other Member States.

Expert panels 12  have been introduced by the MDR to provide scientific and clinical advice relating to medical devices and IVDs, as well as to provide opinions on the clinical evaluation assessment reports drawn up by notified bodies for certain high-risk devices and on the performance evaluation reports concerning certain high-risk IVDs. Since 2022, the European Medicines Agency (EMA) has provided the secretariat for the expert panels 13 . The proposal aims to broaden the scope of expertise available in the expert panels and expand their advisory function in regulatory decision-making. In addition, the Commission’s proposal also includes support from the EMA to the competent authorities to improve coordination between them, especially with regard to borderline cases and classification issues, derogations from applicable conformity assessment procedures and possibly other requirements, clinical evaluations and investigations, vigilance and market surveillance. 

•Consistency with existing policy provisions in the policy area

Given the urgent need to take action, the proposal is presented as an immediate follow-up to the targeted evaluation of the MDR and IVDR. It pursues similar objectives as the Commission proposals adopted in April 2023 for a reform of the EU pharmaceuticals legislation 14 . Consistency with the proposed regulations replacing Directive 2001/83/EC and Regulation (EU) No 726/2004 is ensured. This proposal is also consistent with the Commission proposal for a Biotech Act 15 , scheduled for adoption at the same time as this proposal, which contains, among other things, proposed amendments to the Clinical Trials Regulation 16 , such as a coordinated assessment procedure for combined studies involving medicinal products, IVDs and/or medical devices. This proposal also aligns the relevant MDR provisions with the new Regulation on substances of human origin (SoHO) 17 . 

•Consistency with other Union policies

The proposal contributes to the achievement of the Commission’s objective to improve the EU’s competitiveness by making business easier and supporting research and innovation. The Competitiveness Compass 18  reiterates the need to simplify the regulatory environment, to reduce burden and to foster innovation, in particular in technology-based sectors.

The Communication entitled ‘A simpler and faster Europe’ 19 has set new targets for the reduction of administrative burden and for prioritising new simplification measures.

This proposal is also consistent with the Commission’s Strategy for European Life Sciences 20 , which pointed out that the risks of losing competitiveness to other regions are especially high in areas such as medical devices, as legislation is not sufficiently innovation-friendly, future-proof and lacks clear paths to access markets. The Commission therefore committed to propose a legislative initiative striking the balance between simplifying EU regulations related to medical devices and in vitro diagnostics, and effectively protecting patient safety and public health, also considering health emergencies.

The proposal is consistent with EU policies in the fields of safety, health and environment, as it safeguards a high standard of patient safety and public health protection, while reducing overly burdensome requirements and streamlining procedures. The proposal is complementary to EU policies in the fields of single market and artificial intelligence, as it lays down regulatory tools which pursue the same objectives as the existing provisions in those areas.

2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

•Legal basis

•Subsidiarity (for non-exclusive competence)

•Proportionality

•Choice of instrument

3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

•Ex-post evaluations / fitness checks of existing legislation

•certain requirements, especially in relation to conformity assessment procedures, are overly complex, burdensome, lengthy and costly​;

•the application of legal requirements by national authorities and notified bodies is not sufficiently aligned; ​

•current coordination mechanisms are not sufficiently efficient and effective; ​

•there is no sufficient technical-regulatory advice available at EU level;​

•adaptive pathways for breakthrough innovation and orphan or ‘niche’ devices do not exist;

•the Regulations have unintended negative impacts on innovation, competitiveness and patient care;

•there is a need for improved coherence with other EU law, such as the Clinical Trials Regulation.

•Stakeholder consultations

•Collection and use of expertise

•Impact assessment

•Regulatory fitness and simplification

•Fundamental rights

4.BUDGETARY IMPLICATIONS

The proposal has budgetary implications for the EU, primarily with regard to additional resources needed to ensure: (1) a stronger oversight of notified bodies and a uniform application of the regulatory framework; (2) access to external additional scientific, technical and regulatory expertise to support evidence-based decision-making; and (3) support from the European Medicines Agency (EMA) for better coordination of activities undertaken by national authorities in relation to the implementation of the MDR and IVDR, in particular in the areas of vigilance and market surveillance, borderline and classification decisions, clinical investigations and performance studies, and derogations in exceptional cases relating to patient health and safety. The ‘financial statement’ provides detailed information about the budgetary implications and the human and administrative resources required. This approach leverages the established role of expert panels and the EMA to efficiently address the needs of the sector within the current system framework, thereby drawing on the strengths of existing EU regulations.

The proposal authorises the Commission to set fees for certain activities required under the existing MDR and IVDR and the proposed amendments, such as the assessment and monitoring of notified bodies and the provision of scientific and regulatory advice. Those activities may therefore be funded, at least partially, through fees, with the possibility to introduce reduced rates for SMEs. However, other activities, especially those relating to improved coordination among national authorities to improve the functioning of the single market and simplify compliance for economic operators, cannot at this stage be financed from the financial contributions of the entities subject to the regulatory framework. A specific rule for user fees is needed, as such rules exist in other sectors in the EU and other jurisdictions.

The impact on the EU budget of the costs of enhanced coordination will eventually reduce costs for economic operators thanks to benefits stemming from uniform practices in the singlemarket, streamlined procedures and a more robust and predictable regulatory infrastructure that enhances competitiveness and stimulates innovation. Moreover, the proposed amendment strengthens the EU's ability to effectively prevent and respond to public health threats, such as shortages in the supply of medical devices and safety concerns, thereby minimising the costs associated with any inefficiencies in the regulatory framework. Crucially, this effort also aims to simplify existing regulations, reduce administrative burdens, and refine the certification processes for notified bodies, leading to a significant reduction in overall expenses for manufacturers, all while safeguarding public health and patient safety.

5.OTHER ELEMENTS

•Implementation plans and monitoring, evaluation and reporting arrangements

•Detailed explanation of the specific provisions of the proposal

2025/0404 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4), point (c), thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee 29 ,

Having regard to the opinion of the Committee of the Regions 30 ,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1)Regulations (EU) 2017/745 31 and (EU) 2017/746 32 of the European Parliament and of the Council establish regulatory frameworks to ensure the smooth functioning of the internal market as regards medical devices and in vitro diagnostic medical devices, respectively, taking as a base a high level of protection of health for patients and users. At the same time, Regulations (EU) 2017/745 and (EU) 2017/746 set high standards of quality and safety for medical devices and in vitro diagnostic medical devices in order to meet common safety concerns as regards such devices. Furthermore, both Regulations significantly reinforce key elements of the previous regulatory framework set out in Council Directives 90/385/EEC 33 and 93/42/EEC 34 and in Directive 98/79/EC of the European Parliament and of the Council 35 , such as the supervision of notified bodies, risk classification, conformity assessment procedures, clinical evidence requirements, vigilance and market surveillance, and require the setting up of the European database on medical devices (Eudamed) to enable transparency and traceability in respect of medical devices and in vitro diagnostic medical devices.

(2)The extension of the transitional periods provided for in Article 120 of Regulation (EU) 2017/745 and Article 110 of Regulation (EU) 2017/746 mitigated the risk of shortages of medical devices and in vitro diagnostic medical devices in the Union, but did not address underlying structural problems related to the implementation of both Regulations.

(3)In its targeted evaluation 36 of Regulations (EU) 2017/745 and (EU) 2017/746, the Commission confirmed that the Regulations have strengthened the regulatory framework through stricter requirements on the designation and oversight of notified bodies, the conduct of conformity assessments, and the generation of clinical evidence. However, the evaluation also highlighted several shortcomings and inefficiencies in the regulatory framework, resulting in unnecessary burdens for manufacturers. Overly complex and often disproportionate requirements, costly, lenghthy and unpredictable conformity assessment procedures affect the availability of devices, the competitiveness of manufacturers in the Union, in particular of small and medium-sized enterprises, and innovation in medical technology. This has a negative impact on the level of healthcare and patient safety in the Union.

(4)To address the shortcomings identified, the existing rules should be simplified, and administrative burden should be reduced without jeopardising the high level of public health and patient safety. Moreover, the predictability and cost-efficiency of the application of both Regulations should be enhanced to achieve their initial objectives.

(5)Regulation (EU) 2017/745 includes in its scope certain groups of devices which are similar to medical devices but for which the manufacturer claims only an aesthetic or another non-medical purpose. To enhance legal certainty and to ensure consistency, it should be clarified that accessories for such products without a medical purpose are also included within the scope of Regulation (EU) 2017/745.

(6)The provisions in Regulation (EU) 2017/745 should be adapted to Regulation (EU) 2024/1938 of the European Parliament and of the Council 37 , the new Union legislation in the area of substances of human origin (SoHO).

(7)To avoid a double layer of regulatory requirements, products that combine a medical device and an in vitro diagnostic medical device should be subject either to Regulation (EU) 2017/745 or to Regulation (EU) 2017/746, depending on the product’s principal mode of action, whilst the general safety and performance requirements of the other Regulation should apply to the part of the device that has an ancillary function.

(8)The definition of nanomaterial in Regulation (EU) 2017/745 should be updated to bring it in line with Commission Recommendation of 10 June 2022 on the definition of nanomaterial 38 .

(9)Clinical data are an important source of information for demonstrating the safety and performance of a device. However, the process of generating clinical data is often lengthy and costly. The definition of clinical data should be broadened to enable the use of data generated through studies on the device concerned that are published in scientific literature, but not necessarily peer-reviewed. 

(10)Devices that are well-established technologies have a lower risk profile than other devices of the same risk class. They are therefore subject to certain exemptions or more proportionate requirements in Regulation (EU) 2017/745. To make the application of those provisions more flexible and future-proof, a definition of term well-established technology devices should be included in that Regulation, based on guidance developed by the Medical Device Coordination Group 39 , and the existing lists of devices in Articles 18, 52 and 61 of Regulation (EU) 2017/745 should be replaced by a reference to the newly defined term.

(11)To ensure legal certainty and to safeguard the principle of free movement of goods, the coordination mechanism between national competent authorities for decisions on the regulatory status of a product and on the classification of a device, should be streamlined and, where appropriate, involve external expertise from an expert panel, supported by the European Medicines Agency (EMA). The decision on the regulatory status, however, should remain with the national authorities or, where appropriate, with the Commission acting through implementing acts.

(12)The manufacture and use of devices within health institutions (‘in-house devices’) under certain conditions is essential for the provision of health care in cases where the needs of the target patient group cannot be met by devices available on the market. While the strict conditions for the exemption of such in-house devices from most of the requirements set out in Regulation (EU) 2017/745 or Regulation (EU) 2017/746 should in principle remain in place, some flexibility should be introduced in order to remove unnecessary administrative burden on health institutions, to promote clinical research on in-house devices and to enable the access of patients to in-house devices where no alternatives exist. For example, some documentation obligations should be removed, especially under Regulation (EU) 2017/746 for health institutions accredited to EN ISO 15189. The transfer of an in-house device to another health institution should be possible where justified in the interest of public health, patient health or patient safety. Also, to provide legal certainty for health institutions, when a device becomes available on the market that serves the target patient group’s needs in an equivalent manner to the in-house device, the health institution should have a lengthy transition period until the exemption for in-house manufacturing ceases to apply. Due to their importance for preparedness and response to public health emergencies, the condition that no device is available on the market serving the target patient group’s needs in an equivalent manner, should be removed for in-house in vitro diagnostic medical devices. 

(13)Laboratories that conduct clinical research in the context of clinical trials of medicinal products subject to Regulation (EU) No 536/2014 often develop tests in-house to meet patient needs in clinical trials. Where those tests are not manufactured on an industrial scale and are not commercialised, the situation of such laboratory-developed tests is similar to in-house devices manufactured and used within a health institution. The exemption from certain requirements of Regulation (EU) 2017/746, as provided for in Article 5(5) of that Regulation, should therefore also apply to laboratory-developed tests used exclusively for clinical trials.

(14)To ensure a level playing field between devices sold online and those sold via traditional distribution channels, certain information requirements applicable to distance sales should be strengthened. In particular, it should be clarified that Member States may also order, on grounds of public health, the cessation of activity of providers of diagnostic or therapeutic services by way of information society services, as defined in Directive (EU) 2015/1535 of the European Parliament and of the Council 40 , without prejudice to national law regulating the medical profession. 

(15)While it should remain the responsibility of each Member State to determine the language in which information should be supplied to the users within their territory,  Member States should consider accepting such information in other languages of the Union that are commonly understood in the medical field, especially regarding devices intended for professional users, in order to reduce costs for translations.

(16)To reduce complexity and enhance consistency, redundant provisions that simply state that requirements in other provisions within Regulation (EU) 2017/745 or Regulation (EU) 2017/746, or in other legislation, apply, should be removed.

(17)Some manufacturers have their devices designed and manufactured by another legal or natural person. Whilst Regulations (EU) 2017/745 and (EU) 2017/746 have increased transparency regarding the person that designs and manufactures the device, the responsibilities of the manufacturer regarding its access to the parts of the technical documentation that may be drawn up by the original equipment supplier should be clarified, also for the purpose of supervision by competent authorites. 

(18)To facilitate and streamline the application of the information obligation in cases of the interruption or discontinuation of supply of certain devices as laid down in Regulations (EU) 2017/745 and (EU) 2017/746, and to enhance legal certainty regarding the devices that are subject to that information obligation, a central IT tool for the notification and information sharing should be made available. Moreover, the EMA should be empowered to draw up and publish a list of devices covered by the information obligation. The support provided by the EMA in situations of interruption or discontinuation of supply should also take into account the contribution provided by the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Regulation (EU) 2022/123 of the European Parliament and of the Council 41 . To ensure a high level of public health protection, continuous access and availability of medical devices and in vitro diagnostic medical devices, and to strengthen health emergency preparedness and response, Member States and the Commission should have the possibility to request manufacturers of devices, which are included in the list of devices covered by the information obligation, to provide information regarding risks and weaknesses within the supply chain that may affect the supply of such devices. That information can be used for assessing possible vulnerabilities in the supply chain of critical devices, for example within the framework of the MDSSG.  

(19)Having regard to advances in digital communication and digital compliance tools and in order to reduce administrative burden, it should be specified that communication between the relevant actors and compliance with legal obligations, including the drawing up of documentation, reports and other documents as well as conformity assessment procedures should in principle be possible in digital form. Moreover, where no specific format is required, digital formats, such as electronic signatures, should be accepted by default.

(20)To simplify rules and reduce compliance costs, some overly prescriptive requirements, such as the qualification requirements for the person responsible for regulatory compliance or the  permanent and continuous availability of that person when not part of the manufacturer’s organisation, should be removed. Also, unnecessary reporting and certification requirements regarding the repackaging or relabelling of devices that are already placed and further distributed within the internal market, for example outside the manufacturer’s official distribution schemes, should be removed.

(21)The Commission Report 42 on the operation of Article 17 of Regulation (EU) 2017/745 highlighted that the application of the rules on single-use devices is fragmented across the Union and the relevant requirements are complex to implement, resulting in a very limited and unattractive market for the reprocessing of single-use devices. To simplify the rules regarding single-use devices and to increase the re-use of devices for economic and environmental reasons, it should be the responsibility of the manufacturer to determine whether and how a device can be reprocessed, based on the device’s characteristics and properties. Unless the indication of single-use is duly justified by the manufacturer, devices should be subject to reprocessing, whilst single-use devices or devices which cannot be further reprocessed should be subject to full refurbishing.

(22)The unique device identification (UDI) system and the registration of devices in the European database for medical devices (Eudamed) are fundamental tools for ensuring the traceability and transparency of devices made available on the Union market. To enhance clarity and legal certainty, the respective provisions related to those tools laid down in Regulations (EU) 2017/745 and (EU) 2017/746 should be clarified and streamlined.

(23)The use of artificial intelligence in medical devices and in vitro diagnostic medical devices can help foster innovation and improve diagnosis and treatment of patients. The parallel application of Regulations (EU) 2017/745 and (EU) 2017/746, as applicable, and Regulation (EU) 2024/1689 43  of the European Parliament and of the Council could lead to overlaps of requirements and stifle innovation. To prevent those overlaps and to simplify the regulatory framework for artificial intelligence-enabled devices, the application of Regulation (EU) 2024/1689 to those devices should be limited to those provisions referred to in Article 2(2) of that Regulation. The references to Regulations (EU) 2017/745 and (EU) 2017/746 in Annex I to Regulation (EU) 2024/1689 should therefore be moved from Section A to Section B. Where needed, the Commission may use its implementing and delegated powers to lay down specific requirements regarding artificial intelligence, taking into account the requirements set out in Chapter III, Section 2, of Regulation (EU) 2024/1689. Moreover, notified bodies that are designated to assess high-risk AI systems falling under Regulations (EU) 2017/745 or (EU) 2017/746, as applicable, should meet also the specific AI-related requirements set out in Article 31 of Regulation (EU) 2024/1689. 

(24)The summary of safety and clinical performance under Regulation (EU) 2017/745 and the summary of safety and performance under Regulation (EU) 2017/746 ensure transparency regarding the clinical evidence on which the safety and performance assessment of the device is based. As the drawing up and updating of such a summary is costly, the range of devices subject to that requirement should be clearly limited to those devices for which a systematic assessment of the device’s technical documentation is required pursuant to Regulations (EU) 2017/745 and (EU) 2017/746. Moreover, the summary should be drawn up in a way that is clear for the intended user of the device. To reduce burden and enhance cost-efficiency, additional versions for other persons, such as patients, should not be required. Moreover, as the draft summary is in any case part of the documentation to be submitted to the notified body, a separate validation of the summary by the notified body should not be required. In addition, duplication of information to be provided in the summary and in the instructions for use should be avoided.

(25)In accordance with Regulations (EU) 2017/745 and (EU) 2017/746, notified bodies exercise a key function in the medical device regulatory system as the issuance of a certificate by a notified body is a prerequisite for market access of most devices. In order to ensure that devices benefit from uniform and predictable conditions for market access, the accountability of notified bodies and the degree of harmonisation of their conformity assessment activities should therefore be enhanced. For that purpose, the process for the assessment of applicant notified bodies and their designation should be streamlined. Moreover, the oversight of notified bodies should be tightened through the involvement of joint assessment teams also in the monitoring of notified bodies. In light of such changes, the full reassessment of notified bodies every five years is no longer required and should therefore be removed.

(26)To streamline the assessment and monitoring of notified bodies, the joint assessment teams should include the national authority responsible for the notified body as well as experts from other Member States and experts nominated by the Commission. Moreover, the national authority responsible for the notified body should be tasked with deciding on disputes between manufacturers and notified bodies that arise in the context of conformity assessment procedures.

(27)Even though most notified bodies are private for-profit entities, they exercise their function in the public interest. With regard to manufacturers that are micro or small enterprises within the meaning of Commission Recommendation 2003/361/EC 44  and with regard to orphan devices, notified bodies should therefore be required to reduce their fees for conformity assessment activities in accordance with Regulations (EU) 2017/745 and (EU) 2017/746. 

(28)To enhance predictability regarding the fees charged by notified bodies for conformity assessment activities of devices in accordance with Regulations (EU) 2017/745 and (EU) 2017/746 and to prevent excessively high fees, the Commission should be empowered to adopt implementing acts to set the level and structure of fees by the notified bodies, without prejudice to the potential application of Articles 101 and/or 102 of the Treaty on the Functioning of the European Union to the way notified bodies set their prices or carry out their economic activities.  

(29)Devices are classified in different classes depending on their level of risk. Some of the classification rules should be adapted to reflect the inherent risk of devices, resulting in a lower risk classification, such as for reusable surgical instruments or accessories for active implantable devices.

(30)For lower and medium-risk devices, the involvement of notified bodies in the conformity assessment process should be reduced so that it is proportionate to the risk class of the device. For example, for class IIa and non-implantable class IIb devices, or most class C devices, where the notified body is to assess the technical documentation on a sampling basis, it should be clarified that the technical documentation assessment is only needed for one representative device of a category of devices or a generic device group, or in the case of class B devices only for one device from the manufacturer’s product portfolio. Additional technical documentation assessment during surveillance activities should only be carried out when potential concerns exist based on data available from the post-market surveillance system. As class A sterile devices are of low risk, notified body involvement for those devices should be removed.

(31)To support innovation and the development and availability of breakthrough technology and of devices intended for small groups of patients, the conformity assessment procedures should be adapted to address the specific situation of those devices. For that purpose, criteria for breakthrough devices and orphan devices should be included in Regulations (EU) 2017/745 and (EU) 2017/746,  based on guidance developed by the Medical Device Coordination Group. If the status as a breakthrough device or orphan device is confirmed by an expert panel, the review of the device by the notified body should be prioritised, if necessary with additional advice from the expert panels.  

(32)The clinical evaluation consultation procedure provided for in Regulation (EU) 2017/745 is a tool to scrutinise the assessment of notified bodies regarding certain high-risk devices. The procedure should be focused on devices where that exceptional scrutiny gives an additional assurance for patient safety. The scope of the clinical evaluation consultation procedure should therefore be limited to class III implantable devices, removing from its scope class IIb active devices intended to administer and/or remove a medicinal product. However, there should be the possibility to add specific types of high-risk devices to the scope of the clinical evaluation consultation procedure  by way of delegated act, where justified on grounds of patient safety. 

(33)The performance evaluation assessment procedure provided for in Regulation (EU) 2017/746 is not effective for certain class D devices as it mixes up the responsibilities of expert panels and notified bodies. It should therefore be removed and replaced with an early scientific advice process for high-risk in vitro diagnostic medical devices that provides for the possibility of manufacturers to seek advice from expert panels on their performance evaluation strategy. 

(34)When the validity of a certificate for medical devices or for in vitro diagnostic medical devices issued by a notified body expires, notified bodies are to assess whether the certificate can be renewed. This creates administrative burden, uncertainty and unnecessary costs. The maximum validity period of certificates issued by notified bodies should therefore be removed, unless the notified body considers it necessary to limit the validity on justified grounds, such as in the case of a certificate issued with conditions where the manufacturer has to collect additional clinical data after certification in the post-market phase, as may be the case for breakthrough technology devices.

(35)In order to respond to a public health emergency at Union level recognised in accordance with Regulation (EU) 2022/2371 of the European Parliament and of the Council 45 , or to ensure the supply of medical devices and in vitro diagnostic medical devices falling under the definition of medical countermeasures within the framework of Council Regulation (EU) 2022/2372 46 , the Commission should be able to authorise, by means of implementing acts, the placing on the market or putting into service of devices for which a conformity assessment in accordance with Regulations (EU) 2017/745 and (EU) 2017/746 has not been carried out. Moreover, where specific CE marked devices are needed, for example in greater numbers or with an adapted intended purpose, to respond to a public health emergency or a disaster or crisis, Member States, or the Commission, should be able to exempt manufacturers from certain requirements related to the manufacturing, design or intended purpose of the device.

(36)To ensure that the legal framework governing the highly innovative sectors of medical devices and in vitro medical devices is future-proof and able to support innovation, Member States and the Commission should be able to establish regulatory sandboxes in the field of medical devices or in vitro diagnostic medical devices to facilitate the development and testing of innovative devices or regulatory approaches under strict oversight.

(37)Article 4 of Directive 2010/63/EU of the European Parliament and the Council 47  prescribes that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of an animal-based procedure. Non-animal tests such as New Approach Methodologies (NAMs), which include innovative in-vitro (cell or tissue-based), in-chemico (chemical-based), in-silico (computer-based) approaches, or combinations of these, can increasingly replace or complement animal-based tests for safety and performance studies. The use of non-animal methods, including NAMs, to provide scientific evidence in clinical and non-clinical studies should therefore be promoted.

(38)As the safety and performance of many devices other than high-risk devices can be sufficiently demonstrated using non-clinical data, including NAMs, the possibility to use non-clinical data to confirm the safety and performance of a device in the conformity assessment should therefore be made more prominent in Regulation (EU) 2017/745.

(39)Clinical data are often available for devices that are equivalent to the device under conformity assessment. In order to make the conditions under which manufacturers can claim equivalence more flexible, the requirement in Regulation (EU) 2017/745 for a contract with the manufacturer of the equivalent device granting access to its technical documentation should therefore be removed and the equivalence criteria be adapted. 

(40)Post-market clinical follow-up (PMCF) is an important requirement in Regulation (EU) 2017/745 to identify any safety issues that might appear during real world use of the device. To reduce the number of reports that manufacturers are required to draw up, manufacturers should be able to include the findings of the PMCF directly in the updated clinical evaluation report, without the need to draw up a separate PMCF evaluation report.

(41)The obligation to prepare a periodic safety update report (PSUR) is an important tool provided for in Regulations (EU) 2017/745 and (EU) 2017/746 that requires manufacturers to verify the safety and performance of a device during its lifetime. In order to avoid unnecessary costs and administrative burden for manufacturers and to make the obligation more proportionate, the frequency for updating the PSUR should be reduced depending on the risk class of the device. 

(42)Unnecessary overlaps and duplication of assessments between different actors in the regulatory system negatively impact the efficiency and consistency of that regulatory system. Therefore, the roles and responsibilities of competent authorities and notified bodies, in particular regarding the assessment of vigilance cases, should be clarified and any unnecessary elements removed.

(43)There is a growing number of clinical studies involving, simultaneously, a clinical trial of a medicinal product subject to Regulation (EU) No 536/2014 of the European Parliament and of the Council 48 , a performance study of an in vitro diagnostic medical device subject to Regulation (EU) 2017/746 or a clinical investigation of a medical device subject to Regulation (EU) 2017/745 (‘combined studies’). To address concerns raised regarding the complexity of applying multiple Regulations to those combined studies, sponsors should be enabled to submit a single application for a combined study leading to its coordinated assessment under Regulation (EU) No 536/2014. Regulations (EU) 2017/746 and Regulation (EU) 2017/745 should not be applicable where a single application has been submitted.

(44)Regulation (EU) 2024/2847 of the European Parliament and of the Council 49 requires manufacturers to notify actively exploited vulnerabilities and severe incidents having an impact on the security of products with digital elements in order to ensure that the relevant national computer security incident response teams (CSIRTs) designated as coordinators, and the European Union Agency for Cybersecurity (ENISA), have an adequate overview of vulnerabilities and incidents impacting the internal market. Medical devices and in vitro diagnostic medical devices, however, are exempted from Regulation (EU) 2024/2847. While cybersecurity related incidents need to be reported in accordance with existing vigilance rules in Regulations (EU) 2017/745 and (EU) 2017/746 when they qualify as serious incidents, cybersecurity related incidents that do not concern public health or patient safety, are not reported. This is an important cybersecurity gap. Manufacturers of connected devices should therefore be obliged to report also those incidents to the CSIRTs and ENISA through Eudamed. 

(45)The key actors under Regulations (EU) 2017/745 and (EU) 2017/746, namely manufacturers, competent authorities, notified bodies and the Commission, should have access to experts with relevant scientific, clinical, technical and regulatory expertise. Enhanced coordination and access to expertise result in a predictable and reliable regulatory framework. The type of expertise available in the expert panels range of areas in which expert panels provide advice and their involvement in the regulatory system set out in Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be expanded. The mandate of the EMA to support the expert panels in accordance with Regulation (EU) 2022/123 should be amended accordingly.

(46)Regulations (EU) 2017/745 and (EU) 2017/746 provide for a decentralised regulatory system. Effective coordination between national authorities is essential to ensure the smooth functioning of the internal market and a coherent application of the requirements laid down in the Regulations to ensure a uniform high level of protection of patient safety and public health. For an effective and efficient coordination, national authorities need scientific, technical and administrative support, which can be provided in the most adequate way by the EMA, as it already manages the medical device expert panels. The EMA should therefore be mandated to provide, on behalf of the Commission, the necessary support for the coordination between national competent authorities to facilitate uniform application of Regulations (EU) 2017/745 and (EU) 2017/746 . 

(47)The Union participates in the International Medical Device Regulators Forum (IMDRF) 50 , which is a voluntary group of regulators from around the world that aims to accelerate international regulatory harmonisation and convergence in the field of medical devices and in vitro diagnostic medical devices. To a large extent, the Union regulatory system for medical devices reflects guidelines developed in the framework of the IMDRF. To increase efficiency, reduce duplication of regulatory efforts and promote global convergence, the Commission and Member States should actively participate in, and make use of, international regulatory cooperation and reliance mechanisms or reliance programmes.

(48)To avoid the risk of misunderstanding regarding kits that are in vitro diagnostic medical devices and that integrate products which are subject to other Union legislation, such as medicinal products, it should be clarified that products which are included in kits should be in conformity with the legislation applicable to those products. 

(49)Regulation (EU) 2017/746 introduced specific provisions for companion diagnostics. In light of the experience gained from the application of those provisions, it is necessary to clarify in the definition of companion diagnostics that a companion diagnostic may be linked to more than one medicinal product. Moreover, to avoid any unnecessary duplication in the assessment of companion diagnostics, it should be clarified that the consultation of a medicinal products authority should only be necessary regarding novel companion diagnostics and that a consulted medicinal products authority should not repeat the assessment carried out by a notified body. 

(50)Performance studies are an important source of clinical evidence for in vitro diagnostic medical devices. The rules applicable to the conduct of performance studies should be simplified in cases where they do not present any additional risks to the subjects of the study, such as in cases where the study involves routine blood draws from non-vulnerable individuals or where studies on companion diagnostics are conducted using left-over samples.

(51)The transition from the previous regulatory framework to that under Regulations (EU) 2017/745 and (EU) 2017/746 has led to the discontinuation of certain devices intended for small groups of patients, as the costs for the transition made it economically difficult for manufacturers to undertake conformity assessment in accordance with those Regulations. The discontinuation of those orphan devices jeopardises the level of care and patient protection, where no alternative diagnosis or treatment methods are available. Manufacturers should therefore be allowed, subject to certain conditions, to continue marketing orphan devices that were lawfully marketed in accordance with the Directives 90/385/EEC, 93/42/EEC and 98/79/EC without the need to conduct a conformity assessment procedure pursuant to Regulations (EU) 2017/745 and (EU) 2017/746.

(52)Certain Annexes to Regulations (EU) 2017/745 and (EU) 2017/746, which further specify the obligations and requirements applicable to notified bodies, economic operators and devices, should be aligned with the changes made in the corresponding provisions of those Regulations and to reflect the same objectives, namely simplification, burden reduction, enhanced cost-efficiency of the certification process and further digitalisation.

(53)To reduce costs and length of conformity assessment procedures for medical devices that integrate a medicinal substance or a SoHO, the consultation of the medicinal products authorities or the SoHO authorities should be streamlined and shortened. Substance-based medical devices that are systematically absorbed by the human body are medical devices. They do not incorporate any substance that, if used separately, would fall under Union legislation on medicinal products. The consultation of a medicinal products authority in the framework of the conformity assessment of such substance-based medical devices is not appropriate and should therefore be removed.

(54)Regulations (EU) 2017/745 and (EU) 2017/746 delegated to the Commission the power to adopt delegated acts in accordance with Article 290 TFEU in order to amend certain non-essential provisions in Regulations (EU) 2017/745 and (EU) 2017/746. Having regard to the experience with the application of those Regulations and the necessity to maintain a level of flexibility regarding the often very technical and procedural requirements in the Regulations, the power to adopt delegated acts should be provided also for other non-essential provisions in Regulations (EU) 2017/745 and (EU) 2017/746, to adapt them to experience gained from their application, scientific or technical progress or developments at international level. 

(55)Regulations (EU) 2017/745 and (EU) 2017/746 conferred on the Commission the power to adopt implementing acts. In order to ensure uniform conditions of implementation of those Regulations additional implementing powers should be conferred on the Commission. 

(56)Since the objectives of this Regulation, namely simplification and burden reduction of the rules on medical devices and on in vitro diagnostic medical devices, while preserving the objectives of Regulations (EU) 2017/745 and (EU) 2017/746 as such, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(57)Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be amended accordingly.

(58)In order to allow all affected parties sufficient time to take the necessary measures to comply with this Regulation, the application of certain provisions should be deferred. However, provisions that do not require time for preparation should be applicable from the date of the entry into force of this Regulation.

(59)This Regulation introduces binding requirements for cross-border digital public services within the meaning of Regulation (EU) 2024/903 of the European Parliament and of the Council 51 . An interoperability assessment has therefore been completed. The Digital Dimensions chapter of the Legislative Financial and Digital Statement constitutes the resulting report,

HAVE ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EU) 2017/745

Regulation (EU) 2017/745 is amended as follows:

(1)Article 1 is amended as follows:

(a)in paragraph 2, the first sentence is replaced by the following:

‘This Regulation shall also apply, as from the date of application of common    specifications adopted pursuant to Article 9, to the groups of products without    an intended medical purpose that are listed in Annex XVI, and their    accessories, taking into account the state of the art, and in particular existing    harmonised standards for analogous devices with a medical purpose, based on    similar technology.’; 

(b)paragraph 4 is replaced by the following:

‘4.For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI and their accessories, to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’.’; 

(c)in paragraph 6, point (g) is replaced by the following:

‘(g)organs intended for transplantation falling within the scope of Directive 2010/53/EU of the European Parliament and of the Council* or substances of human origin falling within the scope of Regulation (EU) 2024/1938 of the European Parliament and of the Council**, or their derivatives, or products containing or consisting of them; however, this Regulation does apply to devices manufactured utilising derivatives of substances of human origin which are non-viable or are rendered non-viable;

______________________

*Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj ).

**Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14, ELI: http://data.europa.eu/eli/dir/2010/53/oj).’;

(d)paragraph 7 is replaced by the following:

‘7.Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746 that has an action ancillary to that of the device in which it is incorporated, shall be governed by this Regulation. In that case, the relevant general safety and performance requirements set out in Annex I to Regulation (EU) 2017/746 shall apply with regard to the safety and performance of the in vitro diagnostic medical device part. 

However, if the action of the in vitro diagnostic medical device is principal and not ancillary to that of the device in which it is incorporated, the integral product shall be governed by Regulation (EU) 2017/746. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply with regard to the safety and performance of the device part.’; 

(e)paragraph 10 is amended as follows:

(i)the first subparagraph is replaced by the following:

‘Any device which, when placed on the market or put into service, incorporates, as an integral part, non-viable substances of human origin or their derivatives that have an action ancillary to that of the device in which they are incorporated shall be assessed and authorised in accordance with this Regulation.’; 

(ii)in the second subparagraph, first sentence, the reference to ‘Directive 2004/23/EC’ is replaced by a reference to ‘Regulation (EU) 2024/1938’; 

(2)Article 2 is amended as follows: 

(a)in point (1), the second subparagraph is replaced by the following:

‘The following products shall also be deemed to be medical devices:

–devices for the control or support of conception;

–products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4).’;

(b)point (7) is replaced by the following:

‘(7)‘generic device group’ means a set of devices having the same or similar intended purposes and a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;’; 

(c) points (18), (19), (20) and (21) are deleted;

(d)point (48) is replaced by the following:

‘(48)‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from any of the following: 

–clinical investigations of the device concerned or of a device for which equivalence to the device concerned can be demonstrated; 

–other studies published in scientific literature on the device concerned or of a device for which equivalence to the device concerned can be demonstrated; 

–other clinical experience published in peer-reviewed scientific literature with the device concerned or a device for which equivalence to the device concerned can be demonstrated; 

–clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;’; 

(e)the following points (72), (73), (74), (75) and (76) are added:

‘(72)‘well-established technology device’ means a device that belongs to a generic device group, which fulfils the following criteria:

(a)it has simple, common and stable design; 

(b)it has not been associated with safety issues in the past; 

(c)it has well-known clinical performance characteristics and comprises standard of care devices with little evolution in indications and the state of the art; 

(d)it has a long history on the Union market;’; 

(73)‘combined study’ means a clinical trial, as defined in Article 2(2), point (2), of Regulation (EU) No 536/2014, of one or more medicinal products, combined with a performance study of one or more in vitro diagnostic medical devices as defined in Article 2, point (42), of Regulation (EU) 2017/746, and/or with a clinical investigation of one or more devices;

(74)‘regulatory sandbox’ means a controlled environment set up by a competent authority which offers manufacturers or prospective manufacturers the possibility to develop, test, validate and use, where appropriate in real-world conditions, an innovative product or technology potentially falling within the scope of this Regulation, pursuant to a sandbox plan for a limited time under regulatory supervision;

(75)‘sandbox plan’ means a document agreed between the participating manufacturer(s) or prospective manufacturer(s) and the competent authority describing the objectives, conditions, timeframe, methodology and requirements for the activities carried out within the regulatory sandbox;

(76)‘Union regulatory sandbox’ means a controlled environment set up by the Commission for testing alternative or new regulatory requirements or enforcement practices and appraising their validity in comparison with existing requirements and practices under this Regulation for a limited time.’; 

(3)Articles 3 and 4 are replaced by the following:

‘Article 3

Amendment and implementation of certain definitions

1.The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of well-established technology device set out in Article 2, point (72), in the light of technical and scientific progress and taking into account definitions agreed at Union and international level. 

2.The Commission may, by means of implementing acts, draw up non-exhaustive lists of devices that fall under, or of devices that do not fall under the definition of well-established technology device in Article 2, point (72).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). 

Article 4

Regulatory status of products

1.The competent authorities of the Member States shall coordinate their activities when determining whether a specific product, or category, or group of products, falls within the definition of ‘medical device’ set out in Article 2, point (1), or the definition of ‘accessory for a medical device’ set out in Article 2, point (2), or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex.

2.The Member States shall ensure an appropriate level of consultation of the relevant competent authorities of the Member States in the fields of in vitro diagnostic medical devices, medicinal products, substances of human origin (SoHO), biocides, food products, cosmetics or other products subject to Union legislation, where the determination of whether a product has the regulatory status of a device involves aspects concerning the borderline with any of those types of products. If that is the case, Member States shall also ensure an appropriate level of consultation of the relevant advisory or regulatory bodies established in the relevant Union legislation, such as the European Medicines Agency (EMA), the SoHO Coordination Board, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA). 

3.Where a competent authority of a Member State, after having performed an evaluation in accordance with Article 94, considers that a product that is CE marked in accordance with Article 20, does not fall within the scope of this Regulation, it shall consult the competent authorities of the other Member States regarding its envisaged measure determining the regulatory status of the product in question. 

4.Where a competent authority of a Member State raises a substantiated disagreement regarding the envisaged measure referred to in paragraph 3, the consulting authority shall refer the matter to an expert panel as referred to in Article 106 and give utmost consideration to the opinion of that expert panel. 

5.The results of the coordination activities of the competent authorities in accordance with this Article and the opinions of the expert panel delivered in accordance with paragraph 4 of this Article and Article 4a(2) shall be made publicly available, without disclosing any confidential information as referred to in Article 109. 

6.The Commission may, by means of implementing acts, lay down the procedure, including timelines, for the application of paragraphs 1 to 4 of this Article and of Article 4a. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).’; 

(4)the following Article 4a is inserted:

‘Article 4a

Opinion on and
determination of the regulatory status of a product

1.A competent authority, a notified body, a manufacturer, a developer of a product or the Commission may submit a substantiated request for an opinion from an expert panel referred to in Article 106 on the question whether a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. Where, in such a request, the requester considers that the product in question is a device, the request shall also specify the proposed classification of the device in accordance with Article 51 and Annex VIII. 

2.The expert panel shall provide its opinion without undue delay. The requester shall give utmost consideration to the opinion of the expert panel. 

3.Having regard to the expert panel opinion referred to in paragraph 2 or in Article 4(4), a Member State may submit a substantiated request to the Commission to determine whether a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’, or whether a product falls within the scope of Annex XVI or is an accessory for a product listed in that Annex. 

The Commission shall decide on the substantiated request of the Member State or on its own initiative, by means of implementing acts, which shall be adopted in accordance with the examination procedure referred to in Article 114(3).

The Commission may ask the expert panel for clarifications or refer the opinion back to the expert panel for further consideration, including in cases where a Member State’s substantiated request raises new questions of a scientific or technical nature.

4.This Article shall not apply where within the framework of another Union legislation the regulatory status of the product, or category or group of products concerned has been determined as falling within the scope of that other Union legislation, or where a procedure for the determination of the regulatory status is ongoing within the framework of another Union legislation.’;

(5)Article 5 is amended as follows:

(a)paragraph 5 is amended as follows:

(i)the first subparagraph is amended as follows:

(1)point (a) is replaced by the following:

‘(a)the devices are not transferred to another legal entity, except to another health institution in the duly justified interest of public health, patient safety or patient health, or to prepare or respond to a public health emergency;’; 

(2)point (d) is replaced by the following:

‘(d)upon request by a competent authority, the health institution provides information upon request on the use of such devices, which includes the justification referred to in points (a) and (c);’;

(3)point (f) is replaced by the following:

‘(f)the health institution draws up documentation that is sufficiently detailed to enable the competent authority to ascertain that the relevant general safety and performance requirements set out in Annex I are met;’;

(4)point (g) is deleted; 

(ii)the second subparagraph is replaced by the following:

‘Member States shall retain the right to restrict the manufacture or the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.’;

(iii)The following three subparagraphs are added:

‘For the purposes of the first subparagraph, point (a), in the case of a transfer of the device to another health institution, the transferring and receiving health institutions shall ensure traceability of the device.

For the purposes of the first subparagraph, point (c), from the date that the health institution becomes aware that the target patient group's specific needs can be met by a device available on the market, it may continue to manufacture and use its device for a maximum period of 10 years.

For the purposes of the first subparagraph, point (h), where the device is transferred in accordance with point (a), the receiving health institution shall report any incident related to the device to the transferring health institution.’;

(b)the following paragraphs 7 and 8 are added:

‘7.The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the general safety and performance requirements set out in Annex I in order to adapt them to scientific or technical progress or to international developments or to add requirements in relation to emerging risks or technologies.

8.When adopting implementing acts pursuant to paragraph 6 of this Article, delegated acts pursuant to paragraph 7 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council***, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.

__________________

*** Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: ).’; 

(6)Article 6 is amended as follows:

(a)the following paragraph 2a is inserted:

‘2a.Any natural or legal person offering a device in accordance with paragraph 1 or a service in accordance with paragraph 2 shall provide in the offer at least the information referred to in Annex I, Section 23.2, points (a) to (d) and (m), and access to the instructions for use.’; 

(b)paragraphs 3 and 4 are replaced by the following:

‘3.Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity drawn up in accordance with Article 19 or the statement drawn up in accordance with Article 21(2) for the device concerned and cooperate with the competent authorities of the Member State where the device or the service is offered. 

4.A Member State may, on grounds of protection of public health, require a provider of a service as defined in Article 1(1), point (b), of Directive (EU) 2015/1535, or a provider of a service in accordance with paragraph 2, to cease its activity.’;

(7)in Article 7, the following subparagraph is added:

‘Without prejudice to national law regarding the exercise of the medical profession, the first subparagraph shall also apply to devices used for the provision of a service referred to in Article 6(2).’; 

(8)in Article 9(1), the first sentence is replaced by the following:

‘Where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the requirements set out in this Regulation, in particular the reports and plans to be drawn up by manufacturers, the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the conformity assessment procedures set out in Annexes IX to XI and the procedure for custom-made devices set out in Annex XIII, the clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV.’; 

(9)Article 10 is amended as follows:

(a)paragraphs 3 and 7 are deleted;

(b)paragraph 9 is replaced by the following:

‘9.Manufacturers shall put in place an appropriate quality management system to ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device. 

The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.’; 

(c)paragraph 10 is deleted;

(d)in paragraph 11, the following subparagraph is added:

‘When determining the official language of the Union in which the information set out in Section 23 of Annex I or other information to be provided by the manufacturer shall be made available, Member States shall consider accepting another official language of the Union in which the information is made available, taking into consideration the technical knowledge, experience, education or training of the average intended user(s).’;

(e)paragraph 13 is deleted;

(f)paragraph 14 is amended as follows:

(i)the third subparagraph is deleted;

(ii)the fourth subparagraph is deleted; 

(g)paragraph 15 is replaced by the following:

‘15.Where manufacturers have their devices designed and manufactured by another legal or natural person, the information on the identity of that person shall be part of the information to be submitted in accordance with Article 29(4). In those cases, the manufacturer shall ensure that the relevant parts of the technical documentation are drawn up, kept up to date and, upon request, made available to the competent authorities in accordance with paragraphs 4 and 8 of this Article by the legal or natural person that has designed and manufactured the device. In addition, the manufacturer shall draw up, keep up to date and, upon request, make available to the competent authorities the remaining parts of the technical documentation, in particular those referred to in Section 2 of Annex II and in Annex III.’; 

(h)paragraph 16 is deleted;

(10)Article 10a is amended as follows:

(a)in paragraph 1, the second subparagraph is replaced by the following: 

‘The information referred to in the first subparagraph shall be provided at least six months before the anticipated interruption or discontinuation or, if this is not possible, without undue delay after the manufacturer becomes aware of the anticipated interruption or discontinuation. The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority.’; 

(b)the following paragraphs 4, 5 and 6 are added:

‘4.The Commission, where needed in cooperation with the EMA, shall set up, maintain, and manage an IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 33. It shall also enable health institutions and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices needed for the exercise of their professional activity. 

5.The EMA, in collaboration with the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Article 21 of Regulation (EU) 2022/123, shall develop a methodology to identify the devices, or categories of devices, for which it is reasonably foreseeable that an interruption or discontinuation of supply could result in serious harm or a risk of serious harm to patients or public health as referred to in paragraph 1. Based on that methodology, the EMA, in collaboration with the MDSSG and in agreement with the Commission, shall draw up, publish and keep up to date a list of devices, or categories of devices, to which paragraphs 1, 2 and 3 shall apply. For the purpose of this paragraph, the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and of consumers may be consulted as necessary.

6.The competent authorities of the Member States or the Commission may request the manufacturers of devices included in the list drawn up in accordance with paragraph 5 to provide all necessary information regarding risks and weaknesses within the supply chain which may affect the supply of such devices, including production capacity and volume of sales.’; 

(11)in Article 11, paragraphs 4 and 5 are deleted;

(12)in Article 14, paragraph 2 is amended as follows: 

(a)in the first subparagraph, point (d) is replaced by the following:

‘(d)that, where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27(3).’; 

(b)the second subparagraph is replaced by the following:

‘In order to meet the requirements referred to in the first subparagraph, the distributor may apply a sampling method that is representative of the devices supplied by that distributor.’; 

(13)Article 15 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1.Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.’; 

(b)paragraph 2 is replaced by the following:

‘2.Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC**** shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person at their disposal.

__________________

****Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj).’; 

(c)in paragraph 3, point (c) is replaced by the following:

‘(c)the post-market surveillance obligations are complied with in accordance with Article 83;’;

(d)paragraph 6 is replaced by the following:

‘6.Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements or medical devices in the Union.’; 

(14)Article 16 is amended as follows:

(a)paragraph 1 is amended as follows:

(i)in the first subparagraph, the introductory wording is replaced by the following:

‘A distributor, an importer or another natural or legal person who places a product on the market or puts it into service shall assume the obligations incumbent on manufacturers if it does any of the following:’;

(ii)the second subparagraph is replaced by the following:

‘The first subparagraph shall not apply to any healthcare professional or any other person who, while not considered a manufacturer, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.’;

(b)paragraph 4 is deleted;

(15)Article 17 is replaced by the following:

‘Article 17

Single-use devices and reprocessing of devices that are not for single use

1.A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II. 

2.If the device is not intended for single-use, the manufacturer shall provide information about the appropriate reprocessing process for allowing reuse in the instructions for use in accordance with Annex I, Section 23.4, point (n). 

3.Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.

4.The Commission may adopt, in accordance with Article 9(1), CS on general requirements regarding reprocessing of devices or fully refurbishing of single-use devices.’;

(16)Article 18 is amended as follows:

(a)in paragraph 1, second subparagraph, the first sentence is replaced by the following:

‘The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the patient who has been implanted with the device, by any means, including in electronic or digital format, that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State.’;

(b)paragraph 3 is replaced by the following:

‘3. Implants that are well-established technology devices shall be exempted from the obligations laid down in this Article’;

(17)in Article 19, the following paragraph 2a is inserted:

‘2a.Declarations of conformity in accordance with paragraphs 1 and 2 may be provided in electronic form.’;

(18)in Article 22, paragraph 2 is replaced by the following:

‘2.The statement made pursuant to paragraph 1 shall contain at least the following information:

(a)an identification of the devices and, where applicable, other products included in the system or procedure pack, including where applicable their Basic UDI-DI; 

(b)where applicable, an identification of the notified body involved in the sterilisation activities referred to in paragraph 3; 

(c)a declaration by the natural or legal person that: 

(i)they have verified the mutual compatibility of the devices and, if applicable, other products in accordance with the manufacturers' instructions and have carried out their activities in accordance with those instructions;

(ii)they have packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together;

(iii)the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.’;

(19)Article 27 is amended as follows:

(a)in paragraph 1, after point (b) the following point (ba) is inserted:

‘(ba)a Basic UDI-DI, as defined in Part C of Annex VI;’;

(b)paragraph 2 is amended as follows:

(i)point (d) is replaced by the following:

‘(d)the entity gives access to its system for the assignment of UDIs to all interested users in accordance with a set of predetermined and transparent terms and conditions that take into account the interests of micro, small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC;’;

(ii)in point (e), the following point (iv) is added:

‘(iv)offer its system for the assignment of UDIs to manufacturers that are micro and small enterprises within the meaning of Recommendation 2003/361/EC under preferential conditions that take into account the specific needs of such enterprises and are proportionate to their size.’;

(c)paragraph 3 is replaced by the following:

‘3.Before placing a device, other than a custom-made device or investigational device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2, assign to the device a Basic UDI-DI and a UDI as defined in Part C of Annex VI. If applicable, the manufacturer shall assign a UDI-DI to all higher levels of packaging.’;

(d)the following paragraphs 3a and 3b are inserted:

‘3a.Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3), the natural or legal person responsible shall assign to the system or procedure pack, in accordance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2, a Basic UDI-DI and UDI as defined in Part C of Annex VI.

3b.For devices that are the subject of a conformity assessment as referred to in Article 52(3) and in Article 52(4), second and third subparagraphs, a Basic UDI-DI referred to in paragraph 1 of this Article shall be assigned before the manufacturer applies to a notified body for that assessment.’;

(e)in paragraph 10, points (a) and (b) are replaced by the following:

‘(a)amending the list of information set out in Parts A and B of Annex VI in the light of technical progress;

(b)amending Annex VI in the light of experience obtained from the implementation of the UDI system, or in the light of international developments and technical progress in the field of Unique Device Identification.’;

(f)in paragraph 11, the following point (c) is added:

‘(c)determining the UDI related obligations laid down in this Article, Article 29 and Annex VI Part C that shall not apply to certain devices, categories or groups of devices in view of the highly individualised characterisation of those devices, or in view of their risk class, the number of devices placed on the market and the financial and administrative burden related to the assignment of UDI.’.

(20)Article 28 is amended as follows:

(a)paragraph 3, is replaced by the following:

‘3.The core data elements to be provided to the UDI database, referred to in Part B of Annex VI, shall be accessible to the public, except the element referred to in point 13 of that Part.’.

(21)Article 29 is replaced by the following:

‘Article 29

Registration of devices and systems or procedure packs

1.Before placing a device, other than a custom-made device or investigational device, on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device, as applicable. The manufacturer shall keep the information provided to the UDI database updated.

2.Before placing on the market a system or procedure pack as referred to in Article 22(1) and (3), the natural or legal person responsible shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system or procedure pack. The natural or legal person referred to in Article 22(1) shall keep up to date the information provided to the UDI database.

3.For devices that are the subject of a conformity assessment as referred to in Article 52(3) and in Article 52(4), second and third subparagraphs, the notified body shall confirm in Eudamed that the information referred to in Part B of Annex VI is correct.’;

(22)Article 30 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1.The Commission, after consulting the MDCG, shall set up and manage an electronic system to create the single registration number referred to in Article 31(2) and to collate and process information that is necessary and proportionate to identify the manufacturer and, where applicable, the authorised representative, the importer and the person referred to in Article 22(1). The details regarding the information to be provided to that electronic system by the economic operators are laid down in Part A, Section 1, of Annex VI.’;

(b)in paragraph 2, the following sentence is added:

‘Where national distributor databases require information on devices, such databases shall allow for the retrieval of the device information from the electronic systems referred to in Article 33(2), points (a) and (b).’;

(23)Article 31 is amended as follows:

(a)the title is replaced by the following:

‘Registration of economic operators’;

(b)paragraphs 1 and 2 are replaced by the following:

‘1.Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives, importers and persons referred to in Article 22(1) of this Regulation shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Part A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 52, the information referred to in Part A of Annex VI shall be provided to that electronic system before applying to the notified body.

2.Without undue delay, the competent authority shall verify the data entered pursuant to paragraph 1, obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative, the importer or the person referred to in Article 22(1).’;

(c)in paragraph 4, the words ‘one week’ are replaced by the words ‘two weeks’;

(d)paragraph 6 is deleted;

(e)paragraph 7 is replaced by the following:

‘7.The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 30 shall be accessible to the public, except the information regarding the person responsible for regulatory compliance referred to in Part A, point 1.4, of Annex VI.’;

(f)paragraph 8 is replaced by the following:

‘8.The competent authority may use the data to charge the manufacturer, the authorised representative, the importer or the person referred to in Article 22(1) a fee pursuant to Article 111.’;

(24)Article 32 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1.For class IIb implantable devices and for class III devices, other than custom-made or investigational devices and well-established technology devices, the manufacturer shall draw up a summary of safety and clinical performance.

The summary of safety and clinical performance shall be written in a way that is clear to the intended user and shall be made available to the public via Eudamed.

The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52. The manufacturer shall ensure that the summary of safety and clinical performance is available in Eudamed as part of the information on the device to be provided pursuant to Article 29(1) and mention on the label or instructions for use where that summary is available.’;

(b)in paragraph 2, point (h) is replaced by the following:

‘(h)information on any residual risks or undesirable effects, and any warnings and precautions.’;

(25)Article 33 is amended as follows:

(a)in paragraph 2, the following subparagraph is inserted:

‘By way of derogation from the first subparagraph, the Commission may decide that one or more of the electronic systems referred to in that subparagraph are not to be included in Eudamed. In that case, the Commission shall ensure that those electronic systems are interoperable with Eudamed.’;

(b)paragraph 3 is replaced by the following: 

‘3.When designing Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed, the Commission shall give due consideration to compatibility with national databases and national web-interfaces to allow for import and export of data.’;

(c)paragraph 4 is replaced by the following:

‘4.The data shall be entered into Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed by the Member States, notified bodies, economic operators and sponsors as specified in the provisions on the electronic systems referred to in paragraph 2. The Commission shall provide for technical and administrative support to users of Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed.’;

(d)paragraph 5 is replaced by the following:

‘5.All the information collated and processed by Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2.

The Commission shall ensure that public parts of Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed, are presented in a user-friendly and easily-searchable format.’;

(e)paragraph 6 is replaced by the following:

‘6.Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed, shall contain personal data only insofar as necessary for the electronic systems to collate and process information in accordance with this Regulation. Personal data shall be kept in a form which permits identification of data subjects for periods no longer than those referred to in Article 10(8).’;

(f)Paragraph 8 is replaced by the following:

‘8.The Commission shall, by means of implementing acts, lay down the detailed arrangements necessary for the setting up and maintenance of Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). When adopting those implementing acts, the Commission shall ensure that, as far as possible, the systems are developed in such a way as to avoid having to enter the same information twice within the same electronic system or in different electronic systems.’;

(g)paragraph 9 is replaced by the following:

‘9.In relation to its responsibilities under this Article and the processing of personal data involved therein, the Commission shall be considered to be the controller of Eudamed and its electronic systems as well as, where applicable, any of the electronic systems that are not included in Eudamed.’;

(26)Article 34(1) is replaced by the following:

‘1.The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed and, where applicable, any of the electronic systems that are not included in Eudamed.’.

(27)Article 35 is amended as follows:

(a)the following paragraph 6a is inserted:

‘6a.Without prejudice to other administrative or judicial remedies, a manufacturer or notified body may raise with the authority responsible for notified bodies, in a duly substantiated manner, any unresolved dispute arising from the application of the requirements set out in Annex VII and the involvement of a notified body in the conformity assessment in accordance with Article 52 and Annexes IX, X and XI. The authority shall hear and decide within 90 days. Where the manufacturer is established in another Member State than the notified body, the authority responsible for the notified body shall consult the competent authority of the Member State where the manufacturer is established. 

In duly justified cases, the authority responsible for notified bodies may seek guidance from the MDCG, which it shall take duly into account. 

Each authority responsible for notified bodies shall inform the Commission and the MDCG at least annually about the disputes raised with it pursuant to the first subparagraph, their outcome and the parties involved. That information shall be taken into consideration in the framework of the monitoring of notified bodies in accordance with Article 44.

By way of derogation from the first subparagraph and without prejudice to other administrative or judicial remedies, a Member State may choose to assign the tasks set out in this paragraph to another authority or to an out of court dispute resolution body.’;

(b)paragraph 8 is replaced by the following:

‘8.The authorities responsible for notified bodies shall coordinate their activities to be carried out in accordance with this Chapter, cooperate with each other and with the Commission and resolve issues of diverging opinions between themselves to ensure a harmonised application of the requirements relating to notified bodies.’;

(28)Article 36 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1.Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation in the public interest. They shall satisfy the organisational and general requirements and the quality management, resource and process requirements, as set out in further detail in Annex VII, that are necessary to fulfil those tasks in an effective, independent, diligent and expeditious manner.

Notified bodies designated for conformity assessment activities relating to devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689, or that use high-risk AI systems as safety components, shall also meet the requirements set out in Article 31(4), (5), (10) and (11) of that Regulation.’;

(b)the following paragraph 4 is added:

‘4.The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend Annex VII in order to adapt to technical or scientific progress regarding conformity assessment in the field of medical devices, including developments at international level.’;

(29)in Article 37, paragraph 4 is deleted;

(30)Article 39 is replaced by the following:

‘Article 39

Assessment of the application

1.The authority responsible for notified bodies shall within 30 days check that the application referred to in Article 38 is complete and shall request the applicant to provide any missing information. Once the application is complete, that authority shall send it to the Commission. 

2.Within 14 days of the receipt of the application referred to in paragraph 1 of this Article, the Commission, in consultation with the MCDG, shall appoint three experts, chosen from the list referred to in Article 40(2). In view of the specific circumstances of the application, a different number of experts may be appointed. 

At least one of the experts shall be an expert representing the Commission. The other experts shall be experts nominated by Member States other than the one in which the applicant conformity assessment body is established.

In order to be chosen in accordance with the first subparagraph, the experts shall be competent to assess the conformity assessment activities and the types of devices which are the subject of the application.

3.The experts appointed in accordance with paragraph 2 and the authority responsible for notified bodies shall form a joint assessment team that shall be coordinated by the expert representing the Commission. 

4.Within 90 days of the appointment of the experts in accordance with paragraph 3, the joint assessment team shall review the application and supporting documentation and shall draw up a preliminary assessment report. During that period, the joint assessment team may request any clarifications from the applicant conformity assessment body. The joint assessment team shall submit the preliminary assessment report to the applicant conformity assessment body. 

5.Where, based on the review of the application and supporting documentation referred to in this paragraph, the joint assessment team considers that the applicant body does not and, within a reasonable period of time, will not be able to meet the requirements of this Regulation and that any further assessment in accordance with paragraphs 6 to 9 is not appropriate, it shall draw up a final assessment report and the authority responsible for the notified bodies shall reject the application. 

6.Unless the application is rejected, the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located inside or outside the Union, that is to be involved in the conformity assessment process. 

Where an on-site assessment of the applicant body, a subsidiary or a subcontractor is temporarily impossible or impracticable due to exceptional circumstances, the joint assessment team may decide to carry out the assessment by other appropriate means.

At the end of the on-site assessment, the joint assessment team shall list for the applicant conformity assessment body any non-compliances resulting from the assessment and summarise the assessment by the joint assessment team. 

7.Within 30 days after the finalisation of the on-site assessment, the joint assessment team shall submit the assessment report to the applicant conformity assessment body and, where applicable, inform that body about any non-compliances resulting from the assessment. 

Where the joint assessment team has not identified any non-compliances, its assessment report shall be considered the final assessment report and paragraph 11 shall apply.

8.Where the joint assessment team has identified non-compliances, the applicant conformity assessment body shall submit to the joint assessment team a proposed corrective and preventive action plan to address the non-compliances effectively and in a timely manner.

That plan shall indicate the root cause of the identified non-compliances and shall include a timeframe for implementation of the actions therein.

9.Within 30 days of receipt of the proposed corrective and preventive action plan referred to in paragraph 8, the joint assessment team shall assess whether the non-compliances identified during the assessment have been appropriately addressed and, where necessary, provide any comments on it to the applicant conformity assessment body, including requests for further clarification and modifications.

The applicant conformity assessment body and the joint assessment team shall endeavour to agree on a final corrective and preventive action plan in due course.

10.Within 30 days of receipt of the final corrective and preventive action plan, or of the moment the joint assessment team concludes that no agreement on a final plan has been reached, the joint assessment team shall draw up its final assessment report. That report shall include the result of the assessment, conclusions regarding the corrective and preventive action plans and whether the non-compliances have been appropriately addressed and, where applicable, the recommended scope of designation. 

11.The joint assessment team shall submit its final assessment report to the MCDG without undue delay.

Based on the findings of the final assessment report, the authority responsible for notified bodies shall submit to the MDCG a draft decision on the designation of the notified body or reject the application. 

12.Within 21 days of receipt of the draft decision on the designation referred to in paragraph 11, the MDCG shall issue a recommendation with regard to the envisaged designation, which the authority responsible for notified bodies shall duly take into consideration for its final decision on the designation of the notified body. That 21-day period may be extended once for a further 21 days on justified grounds. 

13.Where the authority responsible for notified bodies does not agree with the recommendation of the MDCG, it shall submit to the MDCG a duly justified request to reconsider its recommendation. Within 30 days of receipt of that request, the MDCG shall either confirm its recommendation or issue a new recommendation.

14.Where no agreement can be reached between the MDCG and the authority responsible for notified bodies, either party may refer the matter to the Commission.

Within 180 days of receipt of the referral, the Commission shall, after consulting the MDCG, the authority responsible for notified bodies and, where necessary, the applicant conformity assessment body concerned, evaluate the draft decision on the designation and decide, by means of implementing act, whether or not the draft designation is justified. 

15.If, at any stage of the process, consensus cannot be reached within the joint assessment team on any issue, any member of the joint assessment team may refer the issue to the MDCG, which shall provide its views without undue delay and at the latest within 60 days from the referral. 

16.The Commission may, by means of implementing acts, adopt measures setting out detailed arrangements specifying the procedures and any relevant documentation for the following:

(a)the application for designation referred to in Article 38;

(b)the assessment of the application set out in this Article;

(c)the nomination and selection of experts referred to in Article 40;

(d)the monitoring of notified bodies pursuant to Article 44.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).’;

(31)Article 40 is amended as follows:

(a)the title is replaced by the following:

‘Nomination of experts for joint assessment’;

(b)paragraph 1 is replaced by the following:

‘1.All Member States that have appointed an authority responsible for notified bodies and the Commission shall nominate experts who are qualified in the assessment, designation or monitoring of conformity assessment bodies in the field of medical devices or in the assessment of manufacturers’ technical documentation and who will be available to participate in the activities referred to in Articles  39, 44 and 48. Member States that have not appointed an authority responsible for notified bodies may nominate experts who have those qualifications.

The nominated experts shall commit to participate in joint assessments.’;

(32)the following Article 40a is inserted:

‘Article 40a

Funding of activities related to designation and
monitoring of notified bodies

1.Conformity assessment bodies and notified bodies shall pay a fee for the assessment of their application for designation and their monitoring, including the costs for the involvement of experts nominated in accordance with Article 40 in those assessment and monitoring activities.

2.The structure and level of the fees and the scale and type of recoverable costs shall be established by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).’;

(33)the third paragraph of Article 41 is replaced by the following:

‘The applicant shall provide translations of the documentation pursuant to Articles 38 and 39, or parts thereof, into an official Union language, such as is necessary for that documentation to be readily understood by the joint assessment team referred to in Article 39(4).’;

(34)Article 42 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1.Member States may only designate conformity assessment bodies in accordance with the recommendation of the MDCG issued in accordance with Article 39(11) or (12) or in accordance with an implementing act adopted by the Commission in accordance with Article 39(14).’; 

(b)paragraph 4 is replaced by the following:

‘4.The notification shall be accompanied by the recommendation of the MDCG.’;

(c)paragraphs 6 to 9 are deleted;

(d)paragraph 10 is replaced by the following:

‘10.When publishing the notification in NANDO, the Commission shall add to the electronic system referred to in Article 57 the information relating to the notification of the notified body along with the documents referred to in paragraph 4 of this Article.’;

(35)Article 44 is amended as follows:

(a)the title is replaced by the following:

‘Monitoring of notified bodies’;

(b)in paragraph 2, the second sentence is replaced by the following:

‘Notified bodies shall, upon request by their authority responsible for notified bodies, supply all relevant information and documents required to enable the authority and the joint assessment team to verify compliance.’;

(c)the following paragraph 3a is inserted:

‘3a.The authority responsible for notified bodies shall conduct its monitoring and assessment activities in accordance with an assessment programme considering the full scope of the notified body’s activities. That programme shall ensure that the authority can effectively monitor the continued compliance of the notified body with the requirements of this Regulation and shall provide a reasoned schedule for the frequency of assessment of the notified body and, where applicable, its subsidiaries and/or subcontractors for a period of at least two years. The authority responsible for notified bodies shall submit the programme for monitoring or assessment for each notified body for which it is responsible to the MDCG and to the Commission. The authority shall address any request for clarification or modification made by the Commission or the MDCG.’; 

(d)paragraph 4 is replaced by the following:

‘4.At least once a year, the authorities responsible for notified bodies shall assess whether each notified body established on their respective territory and, where appropriate, the subsidiaries and subcontractors under the responsibility of those notified bodies still satisfy the requirements and fulfil their obligations set out in this Regulation, in particular Annex VII. 

Where necessary, the assessment shall include an on-site audit of the notified body, its subsidiaries or subcontractors.

The authority, the MDCG or the Commission may request the participation of experts from the Commission and other Member States in the annual assessment of a notified body.’;

(e)the following paragraphs 4a, 4b and 4c are inserted:

‘4a.At least every two years, the annual assessment of a notified body shall be carried out by a joint assessment team including the authority responsible for notified bodies and two experts from the list referred to in Article 40(2) appointed by the Commission in consultation with the MDCG. At least one of those experts shall be an expert representing the Commission. In light of the specific circumstances of the monitoring, the Commission may appoint a different number of experts. The joint assessment team shall be coordinated by the expert representing the Commission.

If, at any stage of the process, consensus cannot be reached within the joint assessment team on any issue, any member of the joint assessment team may refer the issue to the MDCG, which shall provide its views without undue delay and at the latest within 60 days from the referral. 

4b.At the end of any assessment carried out pursuant to paragraph 4 or 4a, the authority responsible for notified bodies or the joint assessment team, as applicable, shall inform the notified body about any non-compliances resulting from the assessment and summarise their assessment. 

Where non-compliances have been identified, the notified body shall submit a proposed corrective and preventive action plan to address the non-compliances. That plan shall indicate the root cause of the identified non-compliances and shall include a timeframe for implementation of the actions set out therein.

The authority responsible for notified bodies or the joint assessment team, as applicable, shall assess whether the non-compliances identified during the assessment have been appropriately addressed in the plan referred to in the second subparagraph and, where necessary, provide any comments on the plan to the notified body, including requests for further clarification and modifications. The notified body and the authority or the joint assessment team, as applicable, shall endeavour to agree on a final corrective and preventive action plan in due course.

4c.After receipt of the final corrective and preventive action plan, or where the authority responsible for notified bodies or the joint assessment team, as applicable, have not identified non-compliances or conclude that no agreement on a final plan has been reached, the authority or the joint assessment team, as applicable, shall draw up their final monitoring report which shall include the result of the assessment and, where applicable, conclusions regarding the corrective and preventive action plan and, where applicable, any recommendations regarding the notified body’s designation.

The authority responsible for notified bodies or the joint assessment team, as applicable, shall submit their final monitoring report to the MDCG without undue delay. 

The authority responsible for notified bodies shall monitor the implementation of the corrective and preventive action plan by the notified body, as appropriate.

Where the final monitoring report concludes that the notified body no longer meets the requirements set out in this Regulation, or where the notified body fails to implement the corrective and preventive action plan, the authority responsible for notified bodies shall follow the procedure set out in Article 46(4).’;

(f)paragraph 5 is replaced by the following:

‘5.The monitoring of notified bodies shall include observed audits of notified body personnel, including where necessary any personnel from subsidiaries and subcontractors, as that personnel is in the process of conducting quality management system assessments at a manufacturer's facility.’;

(g)in paragraph 6, the first subparagraph is replaced by the following:

‘The monitoring of notified bodies shall consider data arising from market surveillance, vigilance and post-market surveillance.’;

(h)paragraph 8 is replaced by the following:

‘8.During the monitoring of a notified body, an appropriate number of the notified body’s assessments of manufacturers' quality management system and technical documentation, in particular the clinical evaluation documentation, shall be reviewed either off-site or on-site. The sampling of files shall be representative of the types and risk of devices certified by the notified body, in particular high-risk devices. ’;

(i)paragraphs 9, 10 and 11 are deleted;

(j)paragraph 12 is replaced by the following:

‘12.The authority responsible for notified bodies shall draw up an annual summary of their monitoring activities regarding notified bodies and, where applicable, subsidiaries and subcontractors. That summary shall be made publicly available through the electronic system referred to in Article 57.’;

(36)Article 45 is deleted;

(37)Article 46 is amended as follows:

(a)paragraphs 1 and 2 are replaced by the following:

‘1.The authority responsible for notified bodies shall notify the Commission and the MDCG of any application for relevant changes to the designation of a notified body.

The procedures set out in Articles 39 and 42 shall apply to significant extensions of the scope of the designation. By way of derogation from Article 39, an on-site assessment shall not be conducted where the Joint Assessment Team considers such assessment not to be necessary for the assessment of the requested scope extension.

For changes to the designation other than significant extensions of its scope, the procedures laid down in paragraphs 2 to 9 shall apply.

2.After having assessed the application for changes, the authority responsible for notified bodies shall notify the Commission of the relevant changes to the designation. The Commission shall without undue delay publish the amended notification in NANDO. The Commission shall also, without undue delay, enter information on the changes to the designation of the notified body in the electronic system referred to in Article 57.’;

(b)in paragraph 4, the first subparagraph is replaced by the following:

‘Where an authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in this Regulation or that it is failing to fulfil its obligations or has not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or partially withdraw the designation or impose conditions on the notified body, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same period.’;

(38)Article 47 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1.The Commission, in conjunction with the MDCG, shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body, or of one or more of its subsidiaries or subcontractors, of the requirements set out in this Regulation. It shall ensure that the relevant authority responsible for notified bodies is informed and is given an opportunity to investigate those concerns.’;

(b)paragraph 3 is replaced by the following:

‘3.The Commission, in consultation with the MDCG, may initiate the assessment by a joint assessment team as referred to in Article 39(2) to (10), where there is reasonable concern about the ongoing compliance of a notified body, or a subsidiary or subcontractor of the notified body, with the requirements set out in the Regulation and where the investigation by the authority responsible for notified bodies is not deemed to have fully addressed the concerns or upon request of the authority responsible for notified bodies. The reporting and outcome of that assessment shall follow the principles set out in Article 39.’;

(39)Article 48 is amended as follows:

(a)the title is replaced by the following:

‘Exchange of experience between authorities responsible for notified bodies’;

(b)paragraphs 2 to 5 are deleted;

(40)Articles 49 and 50 are replaced by the following:

‘Article 49

Coordination of notified bodies 

1.The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices. The coordination group shall meet on a regular basis, at least annually, and report to the MDCG. 

The Commission may establish the specific arrangements for the functioning of the coordination group.

2.Notified bodies shall ensure that their specialised personnel participate in the relevant activities of the coordination group. 

3.All bodies notified under this Regulation and under Regulation (EU) 2017/746 shall actively participate in the work of the coordination group to support the implementation of this Regulation and of Regulation (EU) 2017/746 by sharing experience and developing common templates and technical guidance to facilitate harmonisation and common approaches regarding conformity assessment activities. They shall cooperate with each other, with the Commission, with the relevant authorities of the Member States, with expert panels and, where applicable, expert laboratories or European Union reference laboratories to ensure a harmonised application of the requirements set out in this Regulation and in Regulation (EU) 2017/746. 

4.All bodies notified under this Regulation and under Regulation (EU) 2017/746 shall adhere to a code of conduct developed by the coordination group and approved by the MDCG. The code of conduct shall set out the principles of public interest, highest professional competence and integrity, impartiality, independence, transparency, proportionality, predictability and accountability to which notified bodies commit when exercising the rights and obligations conferred on them by this Regulation or Regulation (EU) 2017/746.

Article 50 

Access to notified bodies and fees

1.Notified bodies shall establish lists of their fees for the conformity assessment activities that they carry out and shall make those lists publicly available. They shall notify the lists to the Commission, which shall make references to them available to the public on a dedicated website. 

2.Notified bodies shall apply at least a 50 % fee reduction for manufacturers that are micro enterprises within the meaning of Recommendation 2003/361/EC and at least a 25 % fee reduction for small enterprises within the meaning of that Recommendation. They shall apply at least a 50 % fee reduction for manufacturers that apply for conformity assessment of an orphan device referred to in Article 52a(3). Notified bodies shall provide manufacturers that are micro or small enterprises within the meaning of Recommendation 2003/361/EC the possibility to defer the payment of fees until the relevant conformity assessment activity is finalised. 

3.The Commission, in consultation with the MDCG, may adopt implementing acts to specify the structure and level of the fees referred to in paragraph 1, taking into account the need to:

(a)establish and maintain high standards of quality and safety of devices;

(b)ensure the availability of devices;

(c)protect the interests of micro, small or medium-sized enterprises within the meaning of Recommendation 2003/361/EC;

(d)support innovation and competitiveness. 

4.Notified bodies shall ensure that manufacturers, which are micro, small or medium-sized enterprises within the meaning of Recommendation 2003/361/EC, have access to their conformity assessment activities in a manner that is not less favourable than the manner in which access is provided to other manufacturers. 

5.Notified bodies shall deal with any request for conformity assessment activities from a manufacturer and, within 15 days of receipt of the request, inform the manufacturer accordingly.  

6.When duly justified in the interest of public health or patient health or safety, the authority responsible for notified bodies may instruct a notified body to accept a manufacturer’s request for conformity assessment activities falling within that notified body’s scope of designation.’;

(41)Article 51 is amended as follows:

(a)paragraph 2 is replaced by the following:

‘2.The competent authorities shall coordinate their activities when determining the classification of a device, or a category or group of devices. The results of the coordination activities of the competent authorities, including the results of any decision or measure adopted by a competent authority in accordance with Articles 51a or 51b and any opinion issued by an expert panel in relation to classification, shall be made publicly available, without disclosing any confidential information as referred to in Article 109.’;

(b)in paragraph 3, point (b) is replaced by the following:

‘(b)that a device, or category or group of devices, shall for reasons of public health based on new scientific evidence, or based on any information which becomes available in the course of the vigilance and market surveillance activities be reclassified, by way of derogation from Annex VIII, taking into consideration the principle of proportionality and classification of devices at international level.’;

(c)in paragraph 5, the first sentence is replaced by the following:

‘In order to ensure the uniform application of the rules set out in Annex VIII, and taking account of the relevant scientific opinions of the relevant scientific committees or expert panels, the Commission is empowered to adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application.’;

(d)the following paragraph 7 is added:

‘7.The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend Annex VIII in order to adapt it to technical or scientific progress or to take into account developments regarding classification of devices at international level.’;

(42)the following Articles 51a and 51b are inserted:

‘Article 51a

Classification in the event of a dispute between manufacturer and notified body

1.A manufacturer or a notified body may refer any dispute between them arising from the application of Annex VIII to the competent authority of the Member State in which the manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in Section 2.2, second paragraph, point (b), last indent, of Annex IX has its registered place of business.

2.Within 30 days of receipt of the referral referred to in paragraph 1, the competent authority shall consult the other Member States regarding its draft classification decision.

3.Where, within 30 days of receipt of the consultation referred to in the paragraph 2, no substantiated disagreement has been raised by a Member State, the competent authority shall adopt its decision within 90 days of receipt of the referral referred to in paragraph 1.

4.Where, within 30 days of receipt of the consultation referred to in paragraph 2, a substantiated disagreement has been raised by a Member State regarding the draft classification decision, the matter shall be referred to an expert panel as referred to in Article 106. That expert panel shall deliver an opinion on the classification of the device within 30 days. The competent authority may ask the expert panel for clarifications on its opinion. 

5.Within 30 days of receipt of the expert panel opinion, or any requested clarification, referred to in paragraph 4, the competent authority shall adopt its decision, giving utmost consideration to the expert panel opinion. It shall notify the other Member States and the Commission of its decision without undue delay. 

6.The Commission may, by means of implementing acts, lay down further details of the procedure for the application of this Article and of Article 51b. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Article 51b 

Challenges to the classification of CE marked devices

1.Where a competent authority, after having performed an evaluation in accordance with Article 94, considers that a device that is CE marked in accordance with Article 20, is not classified in accordance with Annex VIII, it shall consult the other Member States regarding its envisaged measure on the classification of the device. 

2.Where, within 30 days of receipt of the consultation referred to in paragraph 1, no substantiated disagreement is raised by a Member State, the competent authority may adopt the measure on the classification of the device in question and shall notify the other Member States and the Commission of its decision giving the reasons for the decision.

3.Where, within 30 days of receipt of the consultation referred to in paragraph 1, a substantiated disagreement is raised by a Member State regarding the envisaged measure on the classification, the matter shall be referred to an expert panel referred to in Article 106, which shall deliver an opinion on the classification of the device within 30 days. The competent authority may ask the expert panel for clarifications on its opinion. 

4.The competent authority shall give utmost consideration to the expert panel opinion. Where the competent authority adopts a measure on the classification, it shall notify the other Member States and the Commission of its measure without undue delay.’;

(43)Article 52 is amended as follows:

(a)in paragraph 3, the following subparagraph is added:

‘By way of derogation from the first subparagraph, class III devices that are well-established technology devices shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation of one representative device per generic device group.’;

(b)paragraph 4 is replaced by the following:

‘4.Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation of one representative device per generic device group or, in the case of non-implantable class IIb devices that are well-established technology devices, one representative device per each category of devices.  

By way of derogation from the first subparagraph, for class IIb implantable devices, except well-established technology devices, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device. Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI. ‘;

(c)paragraph 5 is deleted;

(d)paragraph 6 is replaced by the following:

‘6.Manufacturers of class IIa devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation of one representative device for each category of devices. 

Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Section 10 or Section 18 of Annex XI. The assessment of the technical documentation shall apply for one representative device for each category of devices.’;

(e)paragraph 7 is amended as follows:

(i)the second sentence is replaced by the following:

‘If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Section 10a of Annex XI’;

(ii)the following subparagraph is added:

‘Where the manufacturer of class I reusable surgical instruments has applied harmonised standards or CS covering all relevant aspects referred to in the first subparagraph, point (c), the involvement of a notified body is not required.’;

(f)paragraph 12 is replaced by the following:

‘12.The documents relating to the procedures referred to in paragraphs 1 to 7 shall be available in any official Union language acceptable to the notified body.’;

(g)in paragraph 14, the first subparagraph is replaced by the following:

‘The Commission may, by means of implementing acts, specify detailed arrangements and procedural aspects for any of the following aspects: 

(a)the basis for the selection of the representative device for the assessment of the technical documentation as referred to in paragraphs 3, 4 and 6; 

(b)the modalities of unannounced on-site audits and sample tests to be conducted by notified bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device,

(c)the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests, assessment of the technical documentation and type examination; 

(d)the modalities of the conformity assessment procedures regarding breakthrough devices and orphan devices set out in Article 52a;’;

(h)the following paragraph 15 is added:

‘15.The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend Annexes IX, X, XI and XIII in order to adapt to technical or scientific progress or to developments regarding conformity assessment of devices at international level and to take into account the needs of particular devices in view of their special characteristics.’;

(44)the following Articles 52a and 52b are inserted:

‘Article 52a 

Conformity assessment of breakthrough devices and of orphan devices

1.For the conformity assessment of breakthrough devices and orphan devices, for which a notified body is involved in the conformity assessment, the procedures laid down in Article 52 shall apply subject to the specific arrangements set out in this Article. 

2.A device shall be considered a breakthrough device if it meets the following criteria:

(a)it is expected to introduce in the Union a high degree of novelty with respect to the device technology, related clinical procedure or the application of the device in clinical practice;

(b)it is expected to provide a significant positive clinical impact on patients or public health, for a life-threatening or irreversibly debilitating disease or condition, by either of the following: 

(i)offering a significant positive clinical or health impact compared to available alternatives and the state of the art;

(ii)fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.

3.A device shall be considered an orphan device if it meets the following criteria: 

(a)it is intended for the treatment, diagnosis, or prevention of a disease or condition that presents in not more than 12 000 individuals in the Union per year;

(b)at least one of the following criteria is met:

(i)there are insufficient available alternatives;

(ii)the device is expected to provide a clinical benefit compared to available alternatives or the state of the art, taking into account both device-specific factors and patient population-specific factors.

4.Upon a duly substantiated request by a manufacturer or a notified body, an expert panel referred to in Article 106 shall provide an opinion as to whether the criteria set out in paragraph 2 or 3 of this Article, as applicable, are fulfilled. That opinion shall be published on a dedicated website without disclosing any confidential information as referred to in Article 109 and shall be duly taken into consideration by the manufacturer and the notified body.

5.Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device, as applicable, may request advice from the expert panels referred to in Article 106 regarding its clinical development strategy and appropriate preclinical or clinical data for the clinical evaluation of the device.

6.For a confirmed breakthrough device or an orphan device, as applicable, the notified body involved in the conformity assessment procedure set out in Article 52 shall prioritise the conformity assessment of that device and apply, where appropriate, a rolling review with a view to reduce assessment timelines.

The notified body shall give due consideration to an opinion or advice provided by the expert panels in accordance with paragraph 4 or 5 and, where it does not follow such opinion or advice, it shall provide duly justified reasons. The notified body may ask the expert panel to clarify the opinion it has provided.

7.The notified body shall issue a certificate pursuant to Article 56 where the pre-market clinical evidence, even if based on limited clinical data, is deemed adequate, provided that either of the following conditions is fulfilled:

(a)the benefit of the immediate availability on the market of the device outweighs the risk associated with the fact that additional clinical data are still required;

(b)the benefit-risk-ratio of the device is favourable and the manufacturer commits to providing additional data from post-market clinical follow-up activities. 

Where appropriate, the notified body shall limit the validity of the certificate and specify any conditions for or limitations to the certificate’s validity in accordance with Article 56, such as a requirement for the manufacturer to conduct specific post-market clinical follow-up activities within a specified period of time. 

8.The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend this Article to adapt to technical or scientific progress or to take into account developments regarding conformity assessment of breakthrough devices or orphan devices at international level.

9.The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices or orphan devices set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).

Article 52b 

Digitalisation of technical documentation, conformity assessment and reports

1.The manufacturer may draw up and make available in a digital format the technical documentation and any reports or other documents required pursuant to this Regulation. That digital format may be a structured machine-readable format, provided that it is possible to transform it into human-readable format, and that there is version-control to enable the conduct of retrospective conformity checks. Where the technical documentation, reports or other documents are to be submitted to and assessed by a notified body, the manufacturer shall agree with the notified body on the digital format.

2.Where necessary to ensure that the digital format referred to in paragraph 1 is reliable, interoperable and standardised, the Commission may establish minimum requirements or functional specifications for the digital format by means of common specifications as referred to in Article 9.’;

(45)in Article 53, paragraph 5 is replaced by the following:

‘5.Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities in the public interest and with the highest degree of professional integrity and the requisite technical and scientific competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities.’;

(46)Articles 54 and 55 are replaced by the following: 

‘Article 54

Clinical evaluation consultation procedure for certain high-risk devices

1.In addition to the procedures applicable pursuant to Article 52, a notified body shall follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of class III implantable devices, other than custom-made devices. 

Where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend paragraph 1 in order to add other types of devices to those devices that are subject to the clinical evaluation consultation procedure referred to in the first subparagraph. 

2.By way of derogation from paragraph 1, the procedure referred to in that paragraph is not required in the following cases: 

(a)for a renewal of a certificate issued under this Regulation; 

(b)where the device has been designed by modifying a device already marketed for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device;

(c)where the principles of the clinical evaluation of the device type or category have been addressed in a harmonised standard referred to in Article 8 or in CS referred to in Article 9 and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant harmonised standard or CS for clinical evaluation of that kind of device. 

3.The notified body shall notify the competent authorities, the authority responsible for notified bodies and the Commission through the electronic system referred to in Article 57 of whether or not the procedure referred to in paragraph 1 of this Article is to be applied. That notification shall be accompanied by the clinical evaluation assessment report. 

4.The notified body shall give utmost consideration to the opinion issued by the expert panel in the framework of the clinical evaluation consultation procedure. Where the notified body has not followed the views and recommendations expressed in that opinion, it shall provide a substantiated justification of the reasons therefore and its final clinical evaluation assessment report to the authority responsible for notified bodies of the Member State in which it is established, to the expert panel that issued the opinion and to the Commission. 

Article 55

Mechanism for scrutiny of conformity assessments

1.The MDCG or the Commission may, based on reasonable concerns, request advice from an expert panel in relation to the safety and performance of any device. For that purpose, the MDCG or the Commission may request the notified body that issued the certificate for the device in question to submit to the expert panel its clinical evaluation assessment report and any subsequent surveillance assessment reports regarding that device. The expert panel may request the notified body or the manufacturer to submit additional information needed for its assessment. 

2.The MDCG or the Commission may, based on reasonable concerns, request advice from one or more expert laboratories, based on laboratory testing, in relation to the safety and performance of any device, provided that the device falls within the scope of designation of those expert laboratories. For that purpose, the MDCG or the Commission may request the notified body that issued the certificate for the device in question to submit to the expert laboratories its clinical evaluation assessment report and any subsequent surveillance assessment reports regarding that device. The expert laboratories may request the notified body or the manufacturer to submit samples of the device or any additional information needed for their assessment.

3.The notified body shall give utmost consideration to the advice provided by the expert panel or the expert laboratory and, where needed, take any appropriate measures, including those referred to in Article 56(3) and (4).’;

(47)Article 56 is amended as follows:

(a)paragraphs 1 and 2 are replaced by the following:

‘1.The notified bodies shall issue certificates in accordance with Annexes IX, X and XI in an official Union language and immediately upload them in Eudamed. The minimum content of the certificates shall be as set out in Annex XII.

2.The validity of certificates shall not be limited in time, unless in exceptional cases where the notified body considers it necessary to limit the period of validity based on duly justified grounds. In those cases, the notified body shall indicate the period of validity on the certificate. If the period of validity of the certificate is limited, on application by the manufacturer, the notified body may, following an assessment performed in accordance with Annex VII, Section 4.11, extend the validity of the certificate. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.’

(b)the following paragraph 2a is inserted:

‘2a.During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device.’;

(c)paragraph 3 is replaced by the following:

‘3.Notified bodies may impose conditions on the validity of the certificate, such as limiting the intended purpose of a device to certain groups of patients or requiring the manufacturer to undertake specific PMCF studies pursuant to Part B of Annex XIV.’;

(d)in paragraph 4, the first sentence is replaced by the following:

‘Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any conditions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body.’;

(e)in paragraph 5, the first sentence is replaced by the following:

‘The notified body shall enter in the electronic system referred to in Article 57 any information regarding certificates issued, including amendments and supplements thereto, and regarding suspended, reinstated, withdrawn or refused certificates and conditions imposed on certificates.’;

(48)Article 57 is amended as follows:

(a)paragraph 1 is amended as follows:

(i)point (f) is replaced by the following:

‘(f)the notifications for conformity assessments and information or documents referred to in Article 54(3) and (3a);’;

(ii)point (i) is deleted;

(49)Article 59 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1.By way of derogation from Article 52 and on a duly justified request, any competent authority may authorise for a limited period of time the placing on the market or putting into service within the territory of the Member State concerned of a specific device for which the applicable conformity assessment procedures have not been carried out, provided that the use of that device is in the interest of public health, patient safety or patient health.’;

(b)the following paragraph 1a is inserted:

‘1a.By way of derogation from Article 6(2) and on a duly justified request, any competent authority may authorise for a limited period of time the provision of a diagnostic or therapeutic service referred to in that Article to a natural or legal person established within the territory of the Member State concerned using a device for which the applicable conformity assessment procedures set out in this Regulation have not been carried out, provided that the provision of that service is in the interest of public health, patient safety or patient health.’;

(c)paragraph 2 is replaced by the following:

‘2.The Member State shall inform the Commission, the other Member States and the relevant expert panels referred to in Article 106 of any decision to authorise the placing on the market or putting into service of a device, or the provision of a service, in accordance with paragraph 1 or 1a, where such authorisation is granted for use other than for a single patient.

The Member State shall also make information about such authorisations publicly available.’;

(d)in paragraph 3, the first subparagraph is replaced by the following:

‘3.Where a request pursuant to paragraph 1 or paragraph 1a has been submitted to competent authorities in more than one Member State and based on an opinion of an expert panel referred to in Article 106, the Commission, in exceptional cases relating to public health, patient safety or patient health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 or paragraph 1a to the territory of the Union, or provide an authorisation referred to in paragraph 1 or paragraph 1a for the territory of the Union. The Commission may set out the conditions under which the device may be placed on the market or put into service, or under which the diagnostic or therapeutic service may be provided. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).’;

(e)the following paragraphs 4 and 5 are added:

‘4.In the event of a public health emergency at Union level recognised in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council*****, the Commission may, by means of implementing acts, on its own initiative after consulting the MDCG, authorise the placing on the market or putting into service of a device in accordance with paragraph 3. The authorisation shall cease to apply at the latest when the recognition of the public health emergency is terminated pursuant to Article 23(2) of Regulation (EU) 2022/2371. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). 

On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission may adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 114(4).

5.The Commission may, by means of implementing acts, lay down rules further specifying the procedure set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).’;

____________________

*****Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj ).’;

(50)the following Articles 59a, 59b and 59c are inserted:

‘Article 59a

Derogations from certain requirements in the event of a serious cross-border threat to health, disaster or crisis

1.Upon a duly justified request by the manufacturer, a competent authority may authorise for a limited period of time, by way of derogation from the relevant provisions in Annexes II, III, IX, X and XI, an exemption from the requirements related to changes to the manufacturing, design or intended purpose of a CE marked device, where it is in the interest of public health, patient safety or patient health, in either of the following circumstances:

(a)a serious cross-border threat to health as defined in Article 3, point (1), of Regulation (EU) 2022/2371;

(b)a disaster or a crisis within the meaning of Regulation (EU) …/… of the European Parliament and of the Council****** 52 .

2.The manufacturer shall ensure that the manufactured devices remain in conformity with the relevant general safety and performance requirements set out in Annex I. 

3.The competent authority may request the notified body that issued a certificate for the device in question, to assist it in the assessment of a request referred to in paragraph 1.

4.Where applicable, the manufacturer shall keep the notified body that issued a certificate for the device in question, informed about any changes made regarding the manufacturing, design or intended purpose of a CE marked device in accordance with the authorisation referred to in paragraph 1. 

5.Where a request pursuant to paragraph 1 has been submitted to competent authorities in more than one Member State, the Commission, in exceptional cases relating to public health, patient safety or patient health, may, by means of implementing acts, extend for a limited period of time the validity of an exemption granted by a Member State in accordance with paragraph 1 to the territory of the Union, or provide an exemption referred to in paragraph 1 for the territory of the Union. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).  

On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission may adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 114(4).    

___________________

****** Regulation (EU) .../... of the European Parliament and of the Council of ... on ... (OJ ..., ELI ).

Article 59b

Regulatory sandboxes at national level

1.Member States, on their own initiative or upon a substantiated request by a manufacturer or a prospective manufacturer, may establish one or more regulatory sandboxes to which the application of certain requirements of Chapters V or VI or of Annexes I, VIII IX, X, XI, XIV or XV would not be appropriate. The Member States shall designate the competent authority that is responsible for the supervision of the regulatory sandbox.

Member States may also establish regulatory sandboxes jointly with other Member States.

2.The activities within a regulatory sandbox shall take place pursuant to a specific sandbox plan that shall clearly identify the requirements of this Regulation referred to in paragraph 1, which, by way of derogation from this Regulation, are temporarily adapted or waived in the regulatory sandbox, a justification that the application of those requirements is considered not appropriate and an explanation as to how potential risks related to the adaptation or waiver are controlled and mitigated. The plan shall also identify the reasonable duration of the regulatory sandbox necessary to achieve its objectives and the participants in the regulatory sandbox and their respective roles.

3.A regulatory sandbox shall be set up only if the following conditions are met:

(a)the device is expected to address unmet medical needs or to provide a significant clinical benefit to patients or to the health system compared with similar existing alternatives or the state of the art;

(b)the application of the requirements of this Regulation referred to in paragraph 1 would impede or significantly delay the development of the device and access by healthcare professionals or lay users to such device.

4.The Member State may request an expert panel referred to in Article 106 to provide scientific, technical or regulatory advice on the draft sandbox plan. 

5.Any participant in the regulatory sandbox shall, without undue delay, inform the competent authority that is responsible for the supervision of the regulatory sandbox about any harm occurred in relation to the implementation of the regulatory sandbox. The competent authority shall take immediate and adequate corrective measures, including to suspend, revoke or restrict the scope of the regulatory sandbox.

6.Manufacturers and prospective manufacturers participating in a regulatory sandbox shall remain liable under applicable Union and national law for any damage inflicted on third parties as a result of their activities taking place in the regulatory sandbox.

7.The Member State shall inform the Commission and the MDCG about the establishment of a regulatory sandbox and keep them informed about its implementation and outcome. 

Article 59c

Union regulatory sandboxes

1.The Commission, on its own initiative or upon a substantiated request by a Member State, may establish, by means of implementing acts for a limited time and pursuant to a specific plan, Union regulatory sandboxes, which shall inform whether the existing requirements appropriately regulate a specific type of device with particular characteristics or emerging technologies, and there is a risk that the existing requirements:

(a)would impede or significantly delay the development of such devices and access by healthcare professionals or lay users to those devices; or 

(b)would not adequately protect the health and safety of patients, users or other persons or other aspects of public health.

Union regulatory sandboxes shall not involve the placing on the market or putting into service of devices which do not comply with this Regulation. 

2.The Commission shall request an expert panel as referred to in Article 106 to provide scientific, technical or regulatory advice on the design of a Union regulatory sandbox. 

3.The Commission shall inform the MDCG about the establishment of a regulatory sandbox and keep it informed about its outcome. 

4.The Commission may, by means of implementing acts, specify common principles or the detailed arrangements for the establishment, operation and supervision of regulatory sandboxes pursuant to Article 59b or of Union regulatory sandboxes pursuant to this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). 

5.The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this Article or Article 59b in order to adapt it to scientific, technical or regulatory progress and to take into account developments regarding regulatory sandboxes, including in areas other than medical devices.’;

(51)in Article 60, the following paragraphs 1a and 1b are inserted:

‘1a.The person referred to in Article 22(1) or (3) may request the competent authority of the Member State where it is established to issue a certificate of free sale for a system or procedure pack for which it has drawn up a statement in accordance with Article 22.

1b.The competent authority shall make the certificates of free sale issued in accordance with paragraphs 1 and 1a publicly available in Eudamed.’;

(52)Article 61 is amended as follows:

(a)paragraphs 1 and 2 are replaced by the following:

‘1.Manufacturers shall plan, conduct and document a clinical evaluation in accordance with this Article and with Part A of Annex XIV to confirm the safety and performance of the device under normal conditions of use in accordance with the intended purpose of the device, and shall evaluate any undesirable side-effects and the acceptability of the benefit-risk ratio referred to in Sections 1 and 8 of Annex I.

The manufacturer shall specify and justify the level of clinical evidence necessary to confirm the safety and performance of the device. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose, taking into consideration paragraph 10. 

The clinical evaluation, its results and the clinical evidence derived from it shall be documented in a clinical evaluation report as referred to in Section 4 of Annex XIV, which, except for custom-made devices, shall be part of the technical documentation referred to in Annex II relating to the device concerned. 

2.For class IIb and class III devices, a manufacturer may, prior to its clinical investigation or clinical evaluation, consult an expert panel as referred to in Article 106, with the aim of reviewing the manufacturer's intended clinical development strategy or proposals for clinical investigation. The manufacturer and the notified body involved in any future conformity assessment procedure shall, in the clinical evaluation report and the clinical evaluation assessment report, give due consideration to the advice of the expert panel and where they do not follow the advice, they shall provide duly justified reasons.’;

(b)in paragraph 4, first subparagraph, the introductory wording is replaced by the following:

‘In the case of implantable class IIb devices and class III devices, other than custom-made devices, clinical investigations shall be performed, except if:’;

(c)paragraph 5 is replaced by the following:

‘5.A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by it, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the original clinical evaluation has been performed in compliance with the requirements of this Regulation and the manufacturer provides clear evidence thereof to the notified body.’;

(d)paragraph 6 is amended as follows:

(i)the introductory wording is replaced by the following:

‘The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable class IIb devices and class III devices:’;

(ii)point (b) is replaced by the following:

‘(b)that are well-established technology devices for which the clinical evaluation is based on sufficient clinical evidence and is in compliance with the relevant product-specific CS, where such CS are available.’;

(e)paragraph 8 is deleted;

(f)paragraphs 10 and 11 are replaced by the following:

’10.Without prejudice to paragraph 4, where the confirmation of safety and performance based on clinical data is not deemed appropriate, adequate justification shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer and the data available for the generic device group. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing, in vitro, ex vivo, in silico testing, computational modeling or simulation and pre-clinical evaluation, to be adequate.

11.The clinical evaluation, its documentation and, where applicable and needed, the summary of safety and performance referred to in Article 32 shall be updated throughout the life cycle of the device concerned with data and findings obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84, whenever those data and findings obtained from PMCF provide information relevant for the confirmation of safety and performance of the device.’ 

(g)paragraph 12 is deleted;

(h)the following paragraph 14 is added:

‘14.The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend Annex XIV in order to adapt it to technical and scientific progress and developments at international level, having due regard to the protection of the health and safety of patients, users or other persons and other aspects of public health.’;

(53)in Article 62, the introductory wording is replaced by the following:

‘Clinical investigations shall be designed, authorised, conducted, recorded and reported in accordance with the provisions of this Article, of Articles 63 to 73 and of Articles 75 to 80, the acts adopted pursuant to Article 81, and Annex XV, where they are carried out to assess an investigational device that has not been placed on the market or put into service in accordance with this Regulation and where carried out for one or more of the following purposes:’;

(54)in Article 64(1), point (g) is replaced by the following:

‘(g)there are scientific grounds for expecting that participation in the clinical investigation will produce either of the following:

(i)a direct benefit to the incapacitated subject outweighing the risks and burdens involved;  

(ii)a benefit for the population represented by the incapacitated subject provided that the clinical investigation poses only minimal risk to, and imposes minimal burden on, the incapacitated subject in comparison with the standard treatment of the subject's condition.’;

(55)in Article 65, point (g) is replaced by the following:

‘(g)there are scientific grounds for expecting that participation in the clinical investigation will produce either of the following:

(i)a direct benefit to the minor subject outweighing the risks and burdens involved;

(ii)a benefit for the population represented by the minor subject provided that the clinical investigation will pose only minimal risk to, and will impose minimal burden on, the minor subject in comparison with the standard treatment of the subject's condition.’;

(56)in Article 66, point (a) is replaced by the following:

‘(a)the clinical investigation has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved, or if the clinical investigation has not the potential to produce such direct, the following conditions are met:

(i)a clinical investigation of comparable effectiveness cannot be carried out on women who are not pregnant or breastfeeding; 

(ii)the clinical investigation contributes to the attainment of results capable of benefitting pregnant or breastfeeding women or other women in relation to reproduction, or other embryos, foetuses or children; 

(iii)the clinical investigation poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding woman concerned, her embryo, foetus or child after birth;’;

(57)in Article 68(1), point (b) is replaced by the following:

‘(b)there are scientific grounds to expect that participation of the subject in the clinical investigation will have the potential to produce either of the following: 

(i)a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject, or in the diagnosis of its condition;

(ii)a benefit for the population represented by the subject provided that the clinical investigation will pose only minimal risk to, and will impose minimal burden on, the subject in comparison with the standard treatment of the subject's condition;’;