Article 47 Classification of devices
1. Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII. 2. Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision 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 the last indent of point (b) of the second paragraph of Section 2.2. of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body. The competent authority of the Member State in which the manufacturer has its registered place of business shall notify the MDCG and the Commission of its decision. The decision shall be made available upon request. 3. At the request of a Member State, the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices; (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. At the request of a Member State, the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices; (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. 4. The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3. 5. In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. 6. The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2017/745 (the ‘Medical Devices Regulation’ (MDR)) 1 and Regulation (EU) 2017/746 (the ‘ In Vitro Diagnostic Medical Devices Regulation’ (IVDR)) 2 of the European Parliament and of the Council set a strengthened regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs). Their objectives are a high level of protection of health for patients and users and the smooth functioning of the single market for these products. To achieve these objectives and to address issues identified with the previous regulatory framework, the Regulations set up a more robust system of conformity assessment to ensure the quality, safety and performance of devices placed on the EU market. The MDR has applied since 26 May 2021 3 . The transitional period provided for in Article 120 has been extended by Regulation (EU) 2023/607 4 and will end on either 31 December 2027 or 31 December 2028, depending on the device’s risk class and subject to certain conditions. The IVDR has applied since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions 5 . This extension was not subject to conditions similar to the ones laid down for medical devices by Regulation (EU) 2023/607. This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions. Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs. a) Transition of devices to the IVDR There is a wide variety of IVDs, including HIV tests for blood donation screening or individual diagnosis, cancer tests, pregnancy tests or SARS-CoV-2 tests. Around two thirds of all clinical decisions are based on information provided by IVDs 6 . It is paramount to ensure both a high level of safety and performance of IVDs and their availability to healthcare systems . The IVDR has introduced very substantial changes to the regulatory framework for IVDs with significant resource and capacity implications . According to the IVDR, IVDs are classified into different risk classes from class A (low risk) to class D (high risk). One of the most profound changes is the increased involvement of independent conformity assessment bodies (‘notified bodies’) in conformity assessment, in a way that is proportionate to the device’s risk class. Under the previous Directive 98/79/EC 7 , only a relatively small number of high-risk devices, i.e. about 8% of the more than 40 000 IVDs on the EU market covered by the Directive 8 , were subject to scrutiny by notified bodies. In October 2022, there were 1 551 valid certificates issued by notified bodies under Directive 98/79/EC 9 . Some of these have already expired (38 in 2022 and 165 in 2023); 482 certificates will expire in 2024 and 866 certificates will expire in 2025 (by 26 May) 10 . Under the IVDR, around 80% of IVDs will be subject to scrutiny by notified bodies, most of them for the first time 8 . As a consequence, the number of certificates under the IVDR is expected to be significantly higher than the number of certificates issued under Directive 98/79/EC . The relationship between the number of devices and the number of certificates covering them is complex, so no precise calculation can be made, but numbers in the order of 15 000 certificates and higher could reasonably be expected. M ore than 1 000 devices are in the highest risk class ( class D ) 11 . Under the IVDR , these devices require the issuance of both a quality management system certificate and an individual device technical documentation assessment certificate. Those figures are in stark contrast to the low number of certificates already issued and ongoing applications under the IVDR. In fact, the vast majority of IVDs have not yet transitioned to the IVDR. As of end of October 2023, manufacturers had submitted 1 378 applications for conformity assessment under the IVDR, resulting in 677 certificates issued by notified bodies across all risk classes. For class D IVDs, only 335 applications had been submitted and 117 certificates had been issued 12 . While there are still several years of transitional period remaining for classes C, B and A sterile, the transitional period for class D devices ends on 26 May 2025. Given the low number of certificates and applications for class D IVDs, and the long duration of the conformity assessment process as explained below, there is a high risk of shortages of many of these devices. Class D devices are used, for example, to test for infections in blood or organ donations, to test patients for life-threatening infectious diseases, or for blood grouping for transfusions. Therefore, there is a high risk of a public health crisis if there is a shortage of such devices. As explained above, in January 2022, the European Parliament and the Council adopted a staggered extension of the transitional period due to the impact of the COVID-19 pandemic. The slow rate of transition has made this extension insufficient. The reasons are multifaceted; however, they are underpinned by the far‑reaching nature of changes introduced by the IVDR and the resulting increased need for scientific, technical and regulatory expertise and capacity at all levels in the system, which require time to be built up. A t present, only 12 notified bodies 13 are designated under the IVDR, compared to 22 notified bodies designated under Directive 98/79/EC (18 after the UK’s withdrawal from the EU) . A f urther 8 applications for designation as notified body are currently in pro gress. The staggering of the transitional periods by risk class in 2022 meant that the workload on notified bodies could be distributed over time , and provided relief to the sector 14 . Nevertheless, access to notified bodies has remained an issue, especially for small to medium-sized enterprises (SMEs ) 11 . Notified bodies are also facing challenges due to the extensive changes introduced by the IVDR. They must apply new requirements for types of devices that they have not handled previously. The duration of the notified body’s assessment is affected by the often insufficient quality of manufacturers’ applications 15 . A s of July 2023 , t he average duration of the conformity assessment process combining quality management system and technical documentation assessment was around 18 months 15 . Thus, the overall notified body capacity in the EU is limited, due to both low numbers of notified bodies and challenges to their efficient and smooth operation. Additional transition time is needed to help address this persisting problem. More notified bodies will be designated over time and the efficiency in processing applications will improve as both manufacturers and notified bodies gain more experience with the IVDR. In the short term, it is also important to maintain the staggering of transitional periods by risk class to avoid a bottleneck at the level of notified bodies. Furthermore , it appears that many manufacturers are not sufficiently prepared to demonstrate compliance with the requirements of the IVDR. This may be due to various causes, including the complexity of these new requirements, lack of experience of interaction with notified bodies, and the continuous development of the IVDR framework, such as ongoing designation of notified bodies, and for class D IVDs adoption of common specifications and designation of EU reference laboratories. Around 90% of medical device companies are SMEs 16 , for which managing the transition can be especially challenging. More and more tools are being put in place to support manufacturers, with particular attention to SMEs, including : (i) guidance by the Medical Device Coordination Group (MDCG) and by notified bodies ; (ii) webinars and training by notified bodies ; (iii) structured dialogue with notified bodies 17 ; or (iv) EU-funded work to make notified body capacity more visible 18 . Additional transition time is necessary to allow manufacturers to make greater use of these tools and therefore support the transition of their devices to the IVDR . This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements. The need for additional time is most acute for mitigating shortages of class D devices. They constitute about 4% of the market 16 but their conformity assessment is intensive due to the requirement for individual technical documentation assessment and, where relevant, involvement of the scientific bodies (expert panel and EU reference laboratories). With only 12 notified bodies currently designated, capacity in the system to perform the required third party assessments remains limited, so an extension of the transitional period for class D IVDs should be combined with a shift in the transition deadlines for the other device groups as well to avoid a bottleneck in the certification process and to prevent shortages of these devices too. Class C and class B are large device groups (representing 26% and 49% of the market, respectively), and some of them are also subject to special requirements such as individual technical documentation assessment. It is also logical from the perspective of protection of public health that higher risk classes should be subject to the more stringent rules earlier than lower risk classes. The extension should be subject to conditions to support the transition to the IVDR, similar to the approach adopted in Regulation (EU) 2023/607, which extended the MDR transitional period. These conditions will ensure that only manufacturers that are actively taking the necessary steps to transition to the new rules and continue to place on the market devices meeting high safety standards will benefit from the additional time. In addition, at the latest by 26 May 2025, all manufacturers will have to put in place a quality management system in accordance with Article 10(8) IVDR. Such an approach respects the work of those manufacturers that have already taken the necessary steps to comply with the IVDR. Finally, it is clear that an extension of the transitional period will provide only a short-term solution to mitigate the risk of shortages. It will not solve certain underlying structural problems related to the implementation of the IVDR, notably with regard to the specific situation of SMEs. Moreover, the transition must be completed to ensure the credibility and robustness of the EU medical device regulatory system and to provide the necessary legal certainty for a stable, innovative and safe environment. It is necessary to analyse problems related to the implementation of the IVDR and the MDR, and their root causes, to identify shortcomings of the regulatory framework and remedy them in the medium term with a view to ensuring patient safety and access to safe and performant devices in a sustainable manner. b) European database on med ic al devices (E udamed ) In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). Eudamed must include seven electronic systems including the UDI database 19 . It is being developed in accordance with functional specifications drawn up by the Commission in collaboration with the MDCG and endorsed by the MDCG. Pursuant to these specifications, Eudamed will consist of six modules 20 , covering all the features specified by the Regulations: UDI/Devices, Actors, Notified bodies/Certificates, Post-Market Surveillance and Vigilance, Market Surveillance, and Clinical investigations/Performance studies . Three Eudamed modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further modules (Market Surveillance; Post-Market Surveillance and Vigilance) are expected to be completed in Q2/2024. The last module (Clinical investigations/Performance studies) will not be completed before Q3/2026. Pursuant to the current MDR rules, Eudamed can only be used mandatorily from a certain date after the Commission has verified that Eudamed is fully functional and has published a notice to that effect. Therefore, the delayed development of the last module holds back the mandatory use of the electronic systems that have been completed already. The mandatory use of all six modules thus cannot be expected before Q4/2027, with additional transitional periods not ending before Q2/2029. However, the use of Eudamed is key for effective and efficient implementation of the MDR and IVDR and of high value to the work of the competent authorities and the Commission in monitoring the market. Moreover, the deployment of Eudamed has profound and beneficial implications in terms of resource savings for manufacturers as it prevents multiple registrations or instances of communication of data at national level. This proposal aims to enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025. Consequently, also the specific transitional provisions in the MDR and IVDR related to Eudamed need to be amended to enable a smooth progressive transfer from multiple registrations in national databases to a single registration in Eudamed. In addition, having regard to the delay in the development of the module for clinical investigations / performance studies, the timelines for the application of the coordinated assessment of clinical investigations and performance studies need to be adapted. Keeping the approach provided for in the MDR and the IVDR, the coordinated assessment should first be applied by Member States on an ‘opt-in’ basis. Five years after its voluntary application, the coordinated assessment should become mandatory for all Member States. c) Prior notice if supply of certain medical devices and in vitro diagnostic medical devices is stopped Healthcare professionals, industry and competent authorities have reported that during the transitional period of the MDR and the IVDR, the supply of many medical devices and IVDs has or is likely to be stopped. In certain cases, especially if no or few alternative devices are available, the interruption of supply can result in serious harm or a risk of serious harm to patients or public health. This proposal aims to impose an obligation on manufacturers to inform their relevant competent authority and health institutions before they cease, temporarily or permanently, the supply of a critical device. If manufacturers do not supply directly to health institutions or healthcare professionals, they should inform the relevant economic operators in the supply chain, which then can inform the health institutions. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety. In accordance with Article 105 MDR, the MDCG may decide to provide guidance with the aim to ensure effective and harmonised implementation of this prior notice mechanism. 
Revised version (Article 47 Classification of devices):
1. Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII. 2. Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision 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 the last indent of point (b) of the second paragraph of Section 2.2. of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body. The competent authority of the Member State in which the manufacturer has its registered place of business shall notify the MDCG and the Commission of its decision. The decision shall be made available upon request. 3. At the request of a Member State, the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices; (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. 4. The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3. 5. In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. 6. The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Article 48 Conformity assessment procedures
1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI. 2. Prior to putting into service a device that is not placed on the market, with the exception of in-house devices manufactured pursuant to Article 5(5), manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI. 3. Manufacturers of class D devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I, II except for Section 5, and in Chapter III of Annex IX. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX. In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics, the notified body shall consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council ( 4 ) or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX. 4. Manufacturers of class D devices, other than devices for performance study, may, instead of the conformity assessment procedure applicable pursuant to paragraph 3, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI. For companion diagnostics, the notified body shall in particular consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X. 5. In particular, and without prejudice to any of the obligations pursuant to the other procedures referred to in paragraphs 3 and 4, for devices for which one or more EU reference laboratories have been designated in accordance with Article 100, the notified body performing the conformity assessment shall request one of the EU reference laboratories to verify by laboratory testing the performance claimed by the manufacturer and the compliance of the device with the applicable CS, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in Section 4.9 of Annex IX and in point (j) of Section 3 of Annex X. Laboratory tests performed by an EU reference laboratory shall in particular focus on analytical and diagnostic sensitivity using the best available reference materials. 6. In addition to the procedure applicable pursuant to paragraphs 3 and 4, where no CS are available for class D devices and where it is also the first certification for that type of device, the notified body shall consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 on the performance evaluation report of the manufacturer. To that end, the notified body shall provide the performance evaluation report of the manufacturer to the expert panel within five days of receiving it from the manufacturer. The relevant experts shall, under the supervision of the Commission, provide their views, in accordance with Section 4.9 of Annex IX or point (j) of Section 3 of Annex X, as applicable, to the notified body within the deadline for delivery of the scientific opinion by the EU reference laboratory as specified therein. 7. Manufacturers of class C devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and, in addition, to an assessment of the technical documentation as specified in Section 4 of that Annex for at least one representative device per generic device group. In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified body shall for every device follow the procedure for technical documentation assessment laid down in Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX. 8. Manufacturers of class C devices, other than devices for performance study, may, instead of the conformity assessment procedure pursuant to paragraph 7, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI except its Section 5. For companion diagnostics the notified body shall in particular for every device consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X. 9. Manufacturers of class B devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and, in addition, to an assessment of the technical documentation as specified in Section 4 of that Annex for at least one representative device per category of devices. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for assessment of the technical documentation set out in Section 5.1 of Annex IX. 10. Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III. However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures set out in Annex IX or in Annex XI. Involvement of the notified body shall be limited to the aspects relating to establishing, securing and maintaining sterile conditions. 11. Devices for performance studies shall be subject to the requirements set out in Articles 57 to 77. 12. The Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 10 be made available in an official Union language(s) determined by that Member State. In the absence of such requirement, those documents shall be available in any official Union language acceptable to the notified body. The Commission may, by means of implementing acts, specify the detailed arrangements and procedural aspects with a view to ensuring the harmonised application of the conformity assessment procedures by the notified bodies, for any of the following aspects: (a) the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as set out in third paragraph of Section 2.3. and in Section 3.5 of Annex IX, in the case of class C devices; (b) the minimum frequency 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 frequency of samples of the manufactured devices or batches of class D devices to be sent to an EU reference laboratory designated under Article 100 in accordance with Section 4.12 of Annex IX and Section 5.1 of Annex XI; or (d) the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests, assessment of technical documentation and type examination in accordance with Sections 3.4 and 4.3 of Annex IX and points (f) and (g) of Section 3. of Annex X. The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2017/745 (the ‘Medical Devices Regulation’ (MDR)) 1 and Regulation (EU) 2017/746 (the ‘ In Vitro Diagnostic Medical Devices Regulation’ (IVDR)) 2 of the European Parliament and of the Council set a strengthened regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs). Their objectives are a high level of protection of health for patients and users and the smooth functioning of the single market for these products. To achieve these objectives and to address issues identified with the previous regulatory framework, the Regulations set up a more robust system of conformity assessment to ensure the quality, safety and performance of devices placed on the EU market. The MDR has applied since 26 May 2021 3 . The transitional period provided for in Article 120 has been extended by Regulation (EU) 2023/607 4 and will end on either 31 December 2027 or 31 December 2028, depending on the device’s risk class and subject to certain conditions. The IVDR has applied since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions 5 . This extension was not subject to conditions similar to the ones laid down for medical devices by Regulation (EU) 2023/607. This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions. Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs. a) Transition of devices to the IVDR There is a wide variety of IVDs, including HIV tests for blood donation screening or individual diagnosis, cancer tests, pregnancy tests or SARS-CoV-2 tests. Around two thirds of all clinical decisions are based on information provided by IVDs 6 . It is paramount to ensure both a high level of safety and performance of IVDs and their availability to healthcare systems . The IVDR has introduced very substantial changes to the regulatory framework for IVDs with significant resource and capacity implications . According to the IVDR, IVDs are classified into different risk classes from class A (low risk) to class D (high risk). One of the most profound changes is the increased involvement of independent conformity assessment bodies (‘notified bodies’) in conformity assessment, in a way that is proportionate to the device’s risk class. Under the previous Directive 98/79/EC 7 , only a relatively small number of high-risk devices, i.e. about 8% of the more than 40 000 IVDs on the EU market covered by the Directive 8 , were subject to scrutiny by notified bodies. In October 2022, there were 1 551 valid certificates issued by notified bodies under Directive 98/79/EC 9 . Some of these have already expired (38 in 2022 and 165 in 2023); 482 certificates will expire in 2024 and 866 certificates will expire in 2025 (by 26 May) 10 . Under the IVDR, around 80% of IVDs will be subject to scrutiny by notified bodies, most of them for the first time 8 . As a consequence, the number of certificates under the IVDR is expected to be significantly higher than the number of certificates issued under Directive 98/79/EC . The relationship between the number of devices and the number of certificates covering them is complex, so no precise calculation can be made, but numbers in the order of 15 000 certificates and higher could reasonably be expected. M ore than 1 000 devices are in the highest risk class ( class D ) 11 . Under the IVDR , these devices require the issuance of both a quality management system certificate and an individual device technical documentation assessment certificate. Those figures are in stark contrast to the low number of certificates already issued and ongoing applications under the IVDR. In fact, the vast majority of IVDs have not yet transitioned to the IVDR. As of end of October 2023, manufacturers had submitted 1 378 applications for conformity assessment under the IVDR, resulting in 677 certificates issued by notified bodies across all risk classes. For class D IVDs, only 335 applications had been submitted and 117 certificates had been issued 12 . While there are still several years of transitional period remaining for classes C, B and A sterile, the transitional period for class D devices ends on 26 May 2025. Given the low number of certificates and applications for class D IVDs, and the long duration of the conformity assessment process as explained below, there is a high risk of shortages of many of these devices. Class D devices are used, for example, to test for infections in blood or organ donations, to test patients for life-threatening infectious diseases, or for blood grouping for transfusions. Therefore, there is a high risk of a public health crisis if there is a shortage of such devices. As explained above, in January 2022, the European Parliament and the Council adopted a staggered extension of the transitional period due to the impact of the COVID-19 pandemic. The slow rate of transition has made this extension insufficient. The reasons are multifaceted; however, they are underpinned by the far‑reaching nature of changes introduced by the IVDR and the resulting increased need for scientific, technical and regulatory expertise and capacity at all levels in the system, which require time to be built up. A t present, only 12 notified bodies 13 are designated under the IVDR, compared to 22 notified bodies designated under Directive 98/79/EC (18 after the UK’s withdrawal from the EU) . A f urther 8 applications for designation as notified body are currently in pro gress. The staggering of the transitional periods by risk class in 2022 meant that the workload on notified bodies could be distributed over time , and provided relief to the sector 14 . Nevertheless, access to notified bodies has remained an issue, especially for small to medium-sized enterprises (SMEs ) 11 . Notified bodies are also facing challenges due to the extensive changes introduced by the IVDR. They must apply new requirements for types of devices that they have not handled previously. The duration of the notified body’s assessment is affected by the often insufficient quality of manufacturers’ applications 15 . A s of July 2023 , t he average duration of the conformity assessment process combining quality management system and technical documentation assessment was around 18 months 15 . Thus, the overall notified body capacity in the EU is limited, due to both low numbers of notified bodies and challenges to their efficient and smooth operation. Additional transition time is needed to help address this persisting problem. More notified bodies will be designated over time and the efficiency in processing applications will improve as both manufacturers and notified bodies gain more experience with the IVDR. In the short term, it is also important to maintain the staggering of transitional periods by risk class to avoid a bottleneck at the level of notified bodies. Furthermore , it appears that many manufacturers are not sufficiently prepared to demonstrate compliance with the requirements of the IVDR. This may be due to various causes, including the complexity of these new requirements, lack of experience of interaction with notified bodies, and the continuous development of the IVDR framework, such as ongoing designation of notified bodies, and for class D IVDs adoption of common specifications and designation of EU reference laboratories. Around 90% of medical device companies are SMEs 16 , for which managing the transition can be especially challenging. More and more tools are being put in place to support manufacturers, with particular attention to SMEs, including : (i) guidance by the Medical Device Coordination Group (MDCG) and by notified bodies ; (ii) webinars and training by notified bodies ; (iii) structured dialogue with notified bodies 17 ; or (iv) EU-funded work to make notified body capacity more visible 18 . Additional transition time is necessary to allow manufacturers to make greater use of these tools and therefore support the transition of their devices to the IVDR . This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements. The need for additional time is most acute for mitigating shortages of class D devices. They constitute about 4% of the market 16 but their conformity assessment is intensive due to the requirement for individual technical documentation assessment and, where relevant, involvement of the scientific bodies (expert panel and EU reference laboratories). With only 12 notified bodies currently designated, capacity in the system to perform the required third party assessments remains limited, so an extension of the transitional period for class D IVDs should be combined with a shift in the transition deadlines for the other device groups as well to avoid a bottleneck in the certification process and to prevent shortages of these devices too. Class C and class B are large device groups (representing 26% and 49% of the market, respectively), and some of them are also subject to special requirements such as individual technical documentation assessment. It is also logical from the perspective of protection of public health that higher risk classes should be subject to the more stringent rules earlier than lower risk classes. The extension should be subject to conditions to support the transition to the IVDR, similar to the approach adopted in Regulation (EU) 2023/607, which extended the MDR transitional period. These conditions will ensure that only manufacturers that are actively taking the necessary steps to transition to the new rules and continue to place on the market devices meeting high safety standards will benefit from the additional time. In addition, at the latest by 26 May 2025, all manufacturers will have to put in place a quality management system in accordance with Article 10(8) IVDR. Such an approach respects the work of those manufacturers that have already taken the necessary steps to comply with the IVDR. Finally, it is clear that an extension of the transitional period will provide only a short-term solution to mitigate the risk of shortages. It will not solve certain underlying structural problems related to the implementation of the IVDR, notably with regard to the specific situation of SMEs. Moreover, the transition must be completed to ensure the credibility and robustness of the EU medical device regulatory system and to provide the necessary legal certainty for a stable, innovative and safe environment. It is necessary to analyse problems related to the implementation of the IVDR and the MDR, and their root causes, to identify shortcomings of the regulatory framework and remedy them in the medium term with a view to ensuring patient safety and access to safe and performant devices in a sustainable manner. b) European database on med ic al devices (E udamed ) In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). Eudamed must include seven electronic systems including the UDI database 19 . It is being developed in accordance with functional specifications drawn up by the Commission in collaboration with the MDCG and endorsed by the MDCG. Pursuant to these specifications, Eudamed will consist of six modules 20 , covering all the features specified by the Regulations: UDI/Devices, Actors, Notified bodies/Certificates, Post-Market Surveillance and Vigilance, Market Surveillance, and Clinical investigations/Performance studies . Three Eudamed modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further modules (Market Surveillance; Post-Market Surveillance and Vigilance) are expected to be completed in Q2/2024. The last module (Clinical investigations/Performance studies) will not be completed before Q3/2026. Pursuant to the current MDR rules, Eudamed can only be used mandatorily from a certain date after the Commission has verified that Eudamed is fully functional and has published a notice to that effect. Therefore, the delayed development of the last module holds back the mandatory use of the electronic systems that have been completed already. The mandatory use of all six modules thus cannot be expected before Q4/2027, with additional transitional periods not ending before Q2/2029. However, the use of Eudamed is key for effective and efficient implementation of the MDR and IVDR and of high value to the work of the competent authorities and the Commission in monitoring the market. Moreover, the deployment of Eudamed has profound and beneficial implications in terms of resource savings for manufacturers as it prevents multiple registrations or instances of communication of data at national level. This proposal aims to enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025. Consequently, also the specific transitional provisions in the MDR and IVDR related to Eudamed need to be amended to enable a smooth progressive transfer from multiple registrations in national databases to a single registration in Eudamed. In addition, having regard to the delay in the development of the module for clinical investigations / performance studies, the timelines for the application of the coordinated assessment of clinical investigations and performance studies need to be adapted. Keeping the approach provided for in the MDR and the IVDR, the coordinated assessment should first be applied by Member States on an ‘opt-in’ basis. Five years after its voluntary application, the coordinated assessment should become mandatory for all Member States. c) Prior notice if supply of certain medical devices and in vitro diagnostic medical devices is stopped Healthcare professionals, industry and competent authorities have reported that during the transitional period of the MDR and the IVDR, the supply of many medical devices and IVDs has or is likely to be stopped. In certain cases, especially if no or few alternative devices are available, the interruption of supply can result in serious harm or a risk of serious harm to patients or public health. This proposal aims to impose an obligation on manufacturers to inform their relevant competent authority and health institutions before they cease, temporarily or permanently, the supply of a critical device. If manufacturers do not supply directly to health institutions or healthcare professionals, they should inform the relevant economic operators in the supply chain, which then can inform the health institutions. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety. In accordance with Article 105 MDR, the MDCG may decide to provide guidance with the aim to ensure effective and harmonised implementation of this prior notice mechanism. 
Revised version (Article 48 Conformity assessment procedures):
1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI. 2. Prior to putting into service a device that is not placed on the market, with the exception of in-house devices manufactured pursuant to Article 5(5), manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI. 3. Manufacturers of class D devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I, II except for Section 5, and in Chapter III of Annex IX. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX. In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics, the notified body shall consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council ( 4 ) or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX. 4. Manufacturers of class D devices, other than devices for performance study, may, instead of the conformity assessment procedure applicable pursuant to paragraph 3, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI. For companion diagnostics, the notified body shall in particular consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X. 5. In particular, and without prejudice to any of the obligations pursuant to the other procedures referred to in paragraphs 3 and 4, for devices for which one or more EU reference laboratories have been designated in accordance with Article 100, the notified body performing the conformity assessment shall request one of the EU reference laboratories to verify by laboratory testing the performance claimed by the manufacturer and the compliance of the device with the applicable CS, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in Section 4.9 of Annex IX and in point (j) of Section 3 of Annex X. Laboratory tests performed by an EU reference laboratory shall in particular focus on analytical and diagnostic sensitivity using the best available reference materials. 6. In addition to the procedure applicable pursuant to paragraphs 3 and 4, where no CS are available for class D devices and where it is also the first certification for that type of device, the notified body shall consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 on the performance evaluation report of the manufacturer. To that end, the notified body shall provide the performance evaluation report of the manufacturer to the expert panel within five days of receiving it from the manufacturer. The relevant experts shall, under the supervision of the Commission, provide their views, in accordance with Section 4.9 of Annex IX or point (j) of Section 3 of Annex X, as applicable, to the notified body within the deadline for delivery of the scientific opinion by the EU reference laboratory as specified therein. 7. Manufacturers of class C devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and, in addition, to an assessment of the technical documentation as specified in Section 4 of that Annex for at least one representative device per generic device group. In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified body shall for every device follow the procedure for technical documentation assessment laid down in Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX. 8. Manufacturers of class C devices, other than devices for performance study, may, instead of the conformity assessment procedure pursuant to paragraph 7, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI except its Section 5. For companion diagnostics the notified body shall in particular for every device consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X. 9. Manufacturers of class B devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and, in addition, to an assessment of the technical documentation as specified in Section 4 of that Annex for at least one representative device per category of devices. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for assessment of the technical documentation set out in Section 5.1 of Annex IX. 10. Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III. However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures set out in Annex IX or in Annex XI. Involvement of the notified body shall be limited to the aspects relating to establishing, securing and maintaining sterile conditions. 11. Devices for performance studies shall be subject to the requirements set out in Articles 57 to 77. 12. The Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 10 be made available in an official Union language(s) determined by that Member State. In the absence of such requirement, those documents shall be available in any official Union language acceptable to the notified body. The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Article 49 Involvement of notified bodies in conformity assessment procedures
1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for conformity assessment activities related to the types of devices concerned. The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure. 2. The notified body concerned shall, by means of the electronic system referred to in Article 52, inform the other notified bodies of any manufacturer that withdraws its application prior to the notified body's decision regarding the conformity assessment. 3. When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdrawn an application with another notified body prior to the decision of that notified body and provide information about any previous application for the same conformity assessment that has been refused by another notified body. 4. The notified body may require any information or data from the manufacturer, which is necessary in order to properly conduct the chosen conformity assessment procedure. 5. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of professional integrity and the requisite technical 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.
Article 50 Mechanism for scrutiny of conformity assessments of class D devices
1. A notified body shall notify the competent authority of certificates it has granted for class D devices, with the exception of applications to supplement or renew existing certificates. Such notification shall take place through the electronic system referred to in Article 52 and shall include the instructions for use referred to in Section 20.4 of Annex I, the summary of safety and performance referred to in Article 29, the assessment report by the notified body, and, where applicable, the laboratory tests and the scientific opinion by the EU reference laboratory pursuant to the second subparagraph of Article 48(3), and where applicable the views expressed in accordance with Article 48(4) by the experts referred to in Article 106 of Regulation (EU) 2017/745. In the case of divergent views between the notified body and the experts, a full justification shall also be included. 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further procedures in accordance with Article 40, 41, 42, 43 or 89 and, where deemed necessary, take appropriate measures in accordance with to Articles 90 and 92. 3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice from the expert panels in relation to the safety and performance of any device.
Article 51 Certificates of conformity
1. The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates shall be as set out in Annex XII. 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid. 3. Notified bodies may impose restrictions to the intended purpose of a device to certain groups of patients or users or require manufacturers to undertake specific PMPF studies pursuant to Part B of Annex XIII. 4. 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 restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision. 5. The notified body shall enter in the electronic system referred to in Article 52 any information regarding certificates issued, including amendments and supplements thereto, and regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates. Such information shall be accessible to the public. 6. In the light of technical progress, the Commission is empowered to adopt delegated acts in accordance with Article 108 amending the minimum content of the certificates set out in Annex XII.
Article 52 Electronic system on notified bodies and on certificates of conformity
For the purposes of this Regulation, the following information shall be collated and processed pursuant to Article 57 of Regulation (EU) 2017/745 in the electronic system set up in accordance with that Article: (a) the list of subsidiaries referred to in Article 33(2); (b) the list of experts referred to in Article 36(2); the information relating to the notification referred to in Article 38(10) and the amended notifications referred to in Article 42(2); (d) the list of notified bodies referred to in Article 39(2); (e) the summary of the report referred to in Article 40(12); (f) the notifications for conformity assessments and certificates referred to in Article 50(1); (g) withdrawal or refusals of applications for the certificates as referred to in Article 49(2) and Section 4.3 of Annex VII; (h) the information regarding certificates referred to in Article 51(5); (i) the summary of safety and performance referred to in Article 29.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2017/745 (the ‘Medical Devices Regulation’ (MDR)) 1 and Regulation (EU) 2017/746 (the ‘ In Vitro Diagnostic Medical Devices Regulation’ (IVDR)) 2 of the European Parliament and of the Council set a strengthened regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs). Their objectives are a high level of protection of health for patients and users and the smooth functioning of the single market for these products. To achieve these objectives and to address issues identified with the previous regulatory framework, the Regulations set up a more robust system of conformity assessment to ensure the quality, safety and performance of devices placed on the EU market. The MDR has applied since 26 May 2021 3 . The transitional period provided for in Article 120 has been extended by Regulation (EU) 2023/607 4 and will end on either 31 December 2027 or 31 December 2028, depending on the device’s risk class and subject to certain conditions. The IVDR has applied since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions 5 . This extension was not subject to conditions similar to the ones laid down for medical devices by Regulation (EU) 2023/607. This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions. Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs. a) Transition of devices to the IVDR There is a wide variety of IVDs, including HIV tests for blood donation screening or individual diagnosis, cancer tests, pregnancy tests or SARS-CoV-2 tests. Around two thirds of all clinical decisions are based on information provided by IVDs 6 . It is paramount to ensure both a high level of safety and performance of IVDs and their availability to healthcare systems . The IVDR has introduced very substantial changes to the regulatory framework for IVDs with significant resource and capacity implications . According to the IVDR, IVDs are classified into different risk classes from class A (low risk) to class D (high risk). One of the most profound changes is the increased involvement of independent conformity assessment bodies (‘notified bodies’) in conformity assessment, in a way that is proportionate to the device’s risk class. Under the previous Directive 98/79/EC 7 , only a relatively small number of high-risk devices, i.e. about 8% of the more than 40 000 IVDs on the EU market covered by the Directive 8 , were subject to scrutiny by notified bodies. In October 2022, there were 1 551 valid certificates issued by notified bodies under Directive 98/79/EC 9 . Some of these have already expired (38 in 2022 and 165 in 2023); 482 certificates will expire in 2024 and 866 certificates will expire in 2025 (by 26 May) 10 . Under the IVDR, around 80% of IVDs will be subject to scrutiny by notified bodies, most of them for the first time 8 . As a consequence, the number of certificates under the IVDR is expected to be significantly higher than the number of certificates issued under Directive 98/79/EC . The relationship between the number of devices and the number of certificates covering them is complex, so no precise calculation can be made, but numbers in the order of 15 000 certificates and higher could reasonably be expected. M ore than 1 000 devices are in the highest risk class ( class D ) 11 . Under the IVDR , these devices require the issuance of both a quality management system certificate and an individual device technical documentation assessment certificate. Those figures are in stark contrast to the low number of certificates already issued and ongoing applications under the IVDR. In fact, the vast majority of IVDs have not yet transitioned to the IVDR. As of end of October 2023, manufacturers had submitted 1 378 applications for conformity assessment under the IVDR, resulting in 677 certificates issued by notified bodies across all risk classes. For class D IVDs, only 335 applications had been submitted and 117 certificates had been issued 12 . While there are still several years of transitional period remaining for classes C, B and A sterile, the transitional period for class D devices ends on 26 May 2025. Given the low number of certificates and applications for class D IVDs, and the long duration of the conformity assessment process as explained below, there is a high risk of shortages of many of these devices. Class D devices are used, for example, to test for infections in blood or organ donations, to test patients for life-threatening infectious diseases, or for blood grouping for transfusions. Therefore, there is a high risk of a public health crisis if there is a shortage of such devices. As explained above, in January 2022, the European Parliament and the Council adopted a staggered extension of the transitional period due to the impact of the COVID-19 pandemic. The slow rate of transition has made this extension insufficient. The reasons are multifaceted; however, they are underpinned by the far‑reaching nature of changes introduced by the IVDR and the resulting increased need for scientific, technical and regulatory expertise and capacity at all levels in the system, which require time to be built up. A t present, only 12 notified bodies 13 are designated under the IVDR, compared to 22 notified bodies designated under Directive 98/79/EC (18 after the UK’s withdrawal from the EU) . A f urther 8 applications for designation as notified body are currently in pro gress. The staggering of the transitional periods by risk class in 2022 meant that the workload on notified bodies could be distributed over time , and provided relief to the sector 14 . Nevertheless, access to notified bodies has remained an issue, especially for small to medium-sized enterprises (SMEs ) 11 . Notified bodies are also facing challenges due to the extensive changes introduced by the IVDR. They must apply new requirements for types of devices that they have not handled previously. The duration of the notified body’s assessment is affected by the often insufficient quality of manufacturers’ applications 15 . A s of July 2023 , t he average duration of the conformity assessment process combining quality management system and technical documentation assessment was around 18 months 15 . Thus, the overall notified body capacity in the EU is limited, due to both low numbers of notified bodies and challenges to their efficient and smooth operation. Additional transition time is needed to help address this persisting problem. More notified bodies will be designated over time and the efficiency in processing applications will improve as both manufacturers and notified bodies gain more experience with the IVDR. In the short term, it is also important to maintain the staggering of transitional periods by risk class to avoid a bottleneck at the level of notified bodies. Furthermore , it appears that many manufacturers are not sufficiently prepared to demonstrate compliance with the requirements of the IVDR. This may be due to various causes, including the complexity of these new requirements, lack of experience of interaction with notified bodies, and the continuous development of the IVDR framework, such as ongoing designation of notified bodies, and for class D IVDs adoption of common specifications and designation of EU reference laboratories. Around 90% of medical device companies are SMEs 16 , for which managing the transition can be especially challenging. More and more tools are being put in place to support manufacturers, with particular attention to SMEs, including : (i) guidance by the Medical Device Coordination Group (MDCG) and by notified bodies ; (ii) webinars and training by notified bodies ; (iii) structured dialogue with notified bodies 17 ; or (iv) EU-funded work to make notified body capacity more visible 18 . Additional transition time is necessary to allow manufacturers to make greater use of these tools and therefore support the transition of their devices to the IVDR . This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements. The need for additional time is most acute for mitigating shortages of class D devices. They constitute about 4% of the market 16 but their conformity assessment is intensive due to the requirement for individual technical documentation assessment and, where relevant, involvement of the scientific bodies (expert panel and EU reference laboratories). With only 12 notified bodies currently designated, capacity in the system to perform the required third party assessments remains limited, so an extension of the transitional period for class D IVDs should be combined with a shift in the transition deadlines for the other device groups as well to avoid a bottleneck in the certification process and to prevent shortages of these devices too. Class C and class B are large device groups (representing 26% and 49% of the market, respectively), and some of them are also subject to special requirements such as individual technical documentation assessment. It is also logical from the perspective of protection of public health that higher risk classes should be subject to the more stringent rules earlier than lower risk classes. The extension should be subject to conditions to support the transition to the IVDR, similar to the approach adopted in Regulation (EU) 2023/607, which extended the MDR transitional period. These conditions will ensure that only manufacturers that are actively taking the necessary steps to transition to the new rules and continue to place on the market devices meeting high safety standards will benefit from the additional time. In addition, at the latest by 26 May 2025, all manufacturers will have to put in place a quality management system in accordance with Article 10(8) IVDR. Such an approach respects the work of those manufacturers that have already taken the necessary steps to comply with the IVDR. Finally, it is clear that an extension of the transitional period will provide only a short-term solution to mitigate the risk of shortages. It will not solve certain underlying structural problems related to the implementation of the IVDR, notably with regard to the specific situation of SMEs. Moreover, the transition must be completed to ensure the credibility and robustness of the EU medical device regulatory system and to provide the necessary legal certainty for a stable, innovative and safe environment. It is necessary to analyse problems related to the implementation of the IVDR and the MDR, and their root causes, to identify shortcomings of the regulatory framework and remedy them in the medium term with a view to ensuring patient safety and access to safe and performant devices in a sustainable manner. b) European database on med ic al devices (E udamed ) In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). Eudamed must include seven electronic systems including the UDI database 19 . It is being developed in accordance with functional specifications drawn up by the Commission in collaboration with the MDCG and endorsed by the MDCG. Pursuant to these specifications, Eudamed will consist of six modules 20 , covering all the features specified by the Regulations: UDI/Devices, Actors, Notified bodies/Certificates, Post-Market Surveillance and Vigilance, Market Surveillance, and Clinical investigations/Performance studies . Three Eudamed modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further modules (Market Surveillance; Post-Market Surveillance and Vigilance) are expected to be completed in Q2/2024. The last module (Clinical investigations/Performance studies) will not be completed before Q3/2026. Pursuant to the current MDR rules, Eudamed can only be used mandatorily from a certain date after the Commission has verified that Eudamed is fully functional and has published a notice to that effect. Therefore, the delayed development of the last module holds back the mandatory use of the electronic systems that have been completed already. The mandatory use of all six modules thus cannot be expected before Q4/2027, with additional transitional periods not ending before Q2/2029. However, the use of Eudamed is key for effective and efficient implementation of the MDR and IVDR and of high value to the work of the competent authorities and the Commission in monitoring the market. Moreover, the deployment of Eudamed has profound and beneficial implications in terms of resource savings for manufacturers as it prevents multiple registrations or instances of communication of data at national level. This proposal aims to enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025. Consequently, also the specific transitional provisions in the MDR and IVDR related to Eudamed need to be amended to enable a smooth progressive transfer from multiple registrations in national databases to a single registration in Eudamed. In addition, having regard to the delay in the development of the module for clinical investigations / performance studies, the timelines for the application of the coordinated assessment of clinical investigations and performance studies need to be adapted. Keeping the approach provided for in the MDR and the IVDR, the coordinated assessment should first be applied by Member States on an ‘opt-in’ basis. Five years after its voluntary application, the coordinated assessment should become mandatory for all Member States. c) Prior notice if supply of certain medical devices and in vitro diagnostic medical devices is stopped Healthcare professionals, industry and competent authorities have reported that during the transitional period of the MDR and the IVDR, the supply of many medical devices and IVDs has or is likely to be stopped. In certain cases, especially if no or few alternative devices are available, the interruption of supply can result in serious harm or a risk of serious harm to patients or public health. This proposal aims to impose an obligation on manufacturers to inform their relevant competent authority and health institutions before they cease, temporarily or permanently, the supply of a critical device. If manufacturers do not supply directly to health institutions or healthcare professionals, they should inform the relevant economic operators in the supply chain, which then can inform the health institutions. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety. In accordance with Article 105 MDR, the MDCG may decide to provide guidance with the aim to ensure effective and harmonised implementation of this prior notice mechanism. 
Revised version (Article 52 Electronic system on notified bodies and on certificates of conformity):
For the purposes of this Regulation, the following information shall be collated and processed pursuant to Article 57 of Regulation (EU) 2017/745 in the electronic system set up in accordance with that Article: (a) the list of subsidiaries referred to in Article 33(2); (b) the list of experts referred to in Article 36(2); (d) the list of notified bodies referred to in Article 39(2); (e) the summary of the report referred to in Article 40(12); (f) the notifications for conformity assessments and certificates referred to in Article 50(1); (g) withdrawal or refusals of applications for the certificates as referred to in Article 49(2) and Section 4.3 of Annex VII; (h) the information regarding certificates referred to in Article 51(5); (i) the summary of safety and performance referred to in Article 29.
Article 53 Voluntary change of notified body
In cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects: (a) the date on which the certificates issued by the outgoing notified body become invalid; (b) the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material; (c) the transfer of documents, including confidentiality aspects and property rights; (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body; (e) the last serial number or lot number for which the outgoing notified body is responsible. 2. The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2017/745 (the ‘Medical Devices Regulation’ (MDR)) 1 and Regulation (EU) 2017/746 (the ‘ In Vitro Diagnostic Medical Devices Regulation’ (IVDR)) 2 of the European Parliament and of the Council set a strengthened regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs). Their objectives are a high level of protection of health for patients and users and the smooth functioning of the single market for these products. To achieve these objectives and to address issues identified with the previous regulatory framework, the Regulations set up a more robust system of conformity assessment to ensure the quality, safety and performance of devices placed on the EU market. The MDR has applied since 26 May 2021 3 . The transitional period provided for in Article 120 has been extended by Regulation (EU) 2023/607 4 and will end on either 31 December 2027 or 31 December 2028, depending on the device’s risk class and subject to certain conditions. The IVDR has applied since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions 5 . This extension was not subject to conditions similar to the ones laid down for medical devices by Regulation (EU) 2023/607. This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions. Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs. a) Transition of devices to the IVDR There is a wide variety of IVDs, including HIV tests for blood donation screening or individual diagnosis, cancer tests, pregnancy tests or SARS-CoV-2 tests. Around two thirds of all clinical decisions are based on information provided by IVDs 6 . It is paramount to ensure both a high level of safety and performance of IVDs and their availability to healthcare systems . The IVDR has introduced very substantial changes to the regulatory framework for IVDs with significant resource and capacity implications . According to the IVDR, IVDs are classified into different risk classes from class A (low risk) to class D (high risk). One of the most profound changes is the increased involvement of independent conformity assessment bodies (‘notified bodies’) in conformity assessment, in a way that is proportionate to the device’s risk class. Under the previous Directive 98/79/EC 7 , only a relatively small number of high-risk devices, i.e. about 8% of the more than 40 000 IVDs on the EU market covered by the Directive 8 , were subject to scrutiny by notified bodies. In October 2022, there were 1 551 valid certificates issued by notified bodies under Directive 98/79/EC 9 . Some of these have already expired (38 in 2022 and 165 in 2023); 482 certificates will expire in 2024 and 866 certificates will expire in 2025 (by 26 May) 10 . Under the IVDR, around 80% of IVDs will be subject to scrutiny by notified bodies, most of them for the first time 8 . As a consequence, the number of certificates under the IVDR is expected to be significantly higher than the number of certificates issued under Directive 98/79/EC . The relationship between the number of devices and the number of certificates covering them is complex, so no precise calculation can be made, but numbers in the order of 15 000 certificates and higher could reasonably be expected. M ore than 1 000 devices are in the highest risk class ( class D ) 11 . Under the IVDR , these devices require the issuance of both a quality management system certificate and an individual device technical documentation assessment certificate. Those figures are in stark contrast to the low number of certificates already issued and ongoing applications under the IVDR. In fact, the vast majority of IVDs have not yet transitioned to the IVDR. As of end of October 2023, manufacturers had submitted 1 378 applications for conformity assessment under the IVDR, resulting in 677 certificates issued by notified bodies across all risk classes. For class D IVDs, only 335 applications had been submitted and 117 certificates had been issued 12 . While there are still several years of transitional period remaining for classes C, B and A sterile, the transitional period for class D devices ends on 26 May 2025. Given the low number of certificates and applications for class D IVDs, and the long duration of the conformity assessment process as explained below, there is a high risk of shortages of many of these devices. Class D devices are used, for example, to test for infections in blood or organ donations, to test patients for life-threatening infectious diseases, or for blood grouping for transfusions. Therefore, there is a high risk of a public health crisis if there is a shortage of such devices. As explained above, in January 2022, the European Parliament and the Council adopted a staggered extension of the transitional period due to the impact of the COVID-19 pandemic. The slow rate of transition has made this extension insufficient. The reasons are multifaceted; however, they are underpinned by the far‑reaching nature of changes introduced by the IVDR and the resulting increased need for scientific, technical and regulatory expertise and capacity at all levels in the system, which require time to be built up. A t present, only 12 notified bodies 13 are designated under the IVDR, compared to 22 notified bodies designated under Directive 98/79/EC (18 after the UK’s withdrawal from the EU) . A f urther 8 applications for designation as notified body are currently in pro gress. The staggering of the transitional periods by risk class in 2022 meant that the workload on notified bodies could be distributed over time , and provided relief to the sector 14 . Nevertheless, access to notified bodies has remained an issue, especially for small to medium-sized enterprises (SMEs ) 11 . Notified bodies are also facing challenges due to the extensive changes introduced by the IVDR. They must apply new requirements for types of devices that they have not handled previously. The duration of the notified body’s assessment is affected by the often insufficient quality of manufacturers’ applications 15 . A s of July 2023 , t he average duration of the conformity assessment process combining quality management system and technical documentation assessment was around 18 months 15 . Thus, the overall notified body capacity in the EU is limited, due to both low numbers of notified bodies and challenges to their efficient and smooth operation. Additional transition time is needed to help address this persisting problem. More notified bodies will be designated over time and the efficiency in processing applications will improve as both manufacturers and notified bodies gain more experience with the IVDR. In the short term, it is also important to maintain the staggering of transitional periods by risk class to avoid a bottleneck at the level of notified bodies. Furthermore , it appears that many manufacturers are not sufficiently prepared to demonstrate compliance with the requirements of the IVDR. This may be due to various causes, including the complexity of these new requirements, lack of experience of interaction with notified bodies, and the continuous development of the IVDR framework, such as ongoing designation of notified bodies, and for class D IVDs adoption of common specifications and designation of EU reference laboratories. Around 90% of medical device companies are SMEs 16 , for which managing the transition can be especially challenging. More and more tools are being put in place to support manufacturers, with particular attention to SMEs, including : (i) guidance by the Medical Device Coordination Group (MDCG) and by notified bodies ; (ii) webinars and training by notified bodies ; (iii) structured dialogue with notified bodies 17 ; or (iv) EU-funded work to make notified body capacity more visible 18 . Additional transition time is necessary to allow manufacturers to make greater use of these tools and therefore support the transition of their devices to the IVDR . This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements. The need for additional time is most acute for mitigating shortages of class D devices. They constitute about 4% of the market 16 but their conformity assessment is intensive due to the requirement for individual technical documentation assessment and, where relevant, involvement of the scientific bodies (expert panel and EU reference laboratories). With only 12 notified bodies currently designated, capacity in the system to perform the required third party assessments remains limited, so an extension of the transitional period for class D IVDs should be combined with a shift in the transition deadlines for the other device groups as well to avoid a bottleneck in the certification process and to prevent shortages of these devices too. Class C and class B are large device groups (representing 26% and 49% of the market, respectively), and some of them are also subject to special requirements such as individual technical documentation assessment. It is also logical from the perspective of protection of public health that higher risk classes should be subject to the more stringent rules earlier than lower risk classes. The extension should be subject to conditions to support the transition to the IVDR, similar to the approach adopted in Regulation (EU) 2023/607, which extended the MDR transitional period. These conditions will ensure that only manufacturers that are actively taking the necessary steps to transition to the new rules and continue to place on the market devices meeting high safety standards will benefit from the additional time. In addition, at the latest by 26 May 2025, all manufacturers will have to put in place a quality management system in accordance with Article 10(8) IVDR. Such an approach respects the work of those manufacturers that have already taken the necessary steps to comply with the IVDR. Finally, it is clear that an extension of the transitional period will provide only a short-term solution to mitigate the risk of shortages. It will not solve certain underlying structural problems related to the implementation of the IVDR, notably with regard to the specific situation of SMEs. Moreover, the transition must be completed to ensure the credibility and robustness of the EU medical device regulatory system and to provide the necessary legal certainty for a stable, innovative and safe environment. It is necessary to analyse problems related to the implementation of the IVDR and the MDR, and their root causes, to identify shortcomings of the regulatory framework and remedy them in the medium term with a view to ensuring patient safety and access to safe and performant devices in a sustainable manner. b) European database on med ic al devices (E udamed ) In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). Eudamed must include seven electronic systems including the UDI database 19 . It is being developed in accordance with functional specifications drawn up by the Commission in collaboration with the MDCG and endorsed by the MDCG. Pursuant to these specifications, Eudamed will consist of six modules 20 , covering all the features specified by the Regulations: UDI/Devices, Actors, Notified bodies/Certificates, Post-Market Surveillance and Vigilance, Market Surveillance, and Clinical investigations/Performance studies . Three Eudamed modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further modules (Market Surveillance; Post-Market Surveillance and Vigilance) are expected to be completed in Q2/2024. The last module (Clinical investigations/Performance studies) will not be completed before Q3/2026. Pursuant to the current MDR rules, Eudamed can only be used mandatorily from a certain date after the Commission has verified that Eudamed is fully functional and has published a notice to that effect. Therefore, the delayed development of the last module holds back the mandatory use of the electronic systems that have been completed already. The mandatory use of all six modules thus cannot be expected before Q4/2027, with additional transitional periods not ending before Q2/2029. However, the use of Eudamed is key for effective and efficient implementation of the MDR and IVDR and of high value to the work of the competent authorities and the Commission in monitoring the market. Moreover, the deployment of Eudamed has profound and beneficial implications in terms of resource savings for manufacturers as it prevents multiple registrations or instances of communication of data at national level. This proposal aims to enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025. Consequently, also the specific transitional provisions in the MDR and IVDR related to Eudamed need to be amended to enable a smooth progressive transfer from multiple registrations in national databases to a single registration in Eudamed. In addition, having regard to the delay in the development of the module for clinical investigations / performance studies, the timelines for the application of the coordinated assessment of clinical investigations and performance studies need to be adapted. Keeping the approach provided for in the MDR and the IVDR, the coordinated assessment should first be applied by Member States on an ‘opt-in’ basis. Five years after its voluntary application, the coordinated assessment should become mandatory for all Member States. c) Prior notice if supply of certain medical devices and in vitro diagnostic medical devices is stopped Healthcare professionals, industry and competent authorities have reported that during the transitional period of the MDR and the IVDR, the supply of many medical devices and IVDs has or is likely to be stopped. In certain cases, especially if no or few alternative devices are available, the interruption of supply can result in serious harm or a risk of serious harm to patients or public health. This proposal aims to impose an obligation on manufacturers to inform their relevant competent authority and health institutions before they cease, temporarily or permanently, the supply of a critical device. If manufacturers do not supply directly to health institutions or healthcare professionals, they should inform the relevant economic operators in the supply chain, which then can inform the health institutions. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety. In accordance with Article 105 MDR, the MDCG may decide to provide guidance with the aim to ensure effective and harmonised implementation of this prior notice mechanism. 
Revised version (Article 53 Voluntary change of notified body):
2. The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid.
Article 54 Derogation from the conformity assessment procedures
1. By way of derogation from Article 48, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service, within the territory of the Member State concerned, of a specific device for which the procedures referred to in that Article have not been carried out but use of which is in the interest of public health or patient safety or health. 2. The Member State shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient. 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or 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 of this Article to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 107(4).
Article 55 Certificate of free sale
1. For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE-marking in accordance with this Regulation may be marketed in the Union. The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 26. Where a notified body has issued a certificate pursuant to Article 51, the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body, as referred to in Section 3 of Chapter II of Annex XII. 2. The Commission may, by means of implementing acts, establish a model for certificates of free sale, taking into account international practice as regards the use of certificates of free sale. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2).
Article 56 Performance evaluation and clinical evidence
1. Confirmation of conformity with relevant general safety and performance requirements set out in Annex I, in particular those concerning the performance characteristics referred to in Chapter I and Section 9 of Annex I, under the normal conditions of the intended use of the device, and the evaluation of the interference(s) and cross-reaction(s) and of the acceptability of the benefit-risk ratio referred to in Sections 1 and 8 of Annex I, shall be based on scientific validity, analytical and clinical performance data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III. The manufacturer shall specify and justify the level of the clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose. To that end, manufacturers shall plan, conduct and document a performance evaluation in accordance with this Article and with Part A of Annex XIII. 2. The clinical evidence shall support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan. A performance evaluation shall follow a defined and methodologically sound procedure for the demonstration of the following, in accordance with this Article and with Part A of Annex XIII: (a) scientific validity; (b) analytical performance; (c) clinical performance. The data and conclusions drawn from the assessment of those elements shall constitute the clinical evidence for the device. The clinical evidence shall be such as to scientifically demonstrate, by reference to the state of the art in medicine, that the intended clinical benefit(s) will be achieved and that the device is safe. The clinical evidence derived from the performance evaluation shall provide scientifically valid assurance, that the relevant general safety and performance requirements set out in Annex I, are fulfilled, under normal conditions of use. 4. Clinical performance studies in accordance with Section 2 of Part A of Annex XIII shall be carried out unless it is duly justified to rely on other sources of clinical performance data. 5. The scientific validity data, the analytical performance data and the clinical performance data, their assessment and the clinical evidence derived therefrom, shall be documented in the performance evaluation report referred to in Section 1.3.2 of Part A of Annex XIII. The performance evaluation report shall be part of the technical documentation, referred to in Annex II, relating to the device concerned. 6. The performance evaluation and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from implementation of the manufacturer's PMPF plan in accordance with Part B of Annex XIII and the post-market surveillance plan referred to in Article 79. The performance evaluation report for class C and D devices shall be updated when necessary, but at least annually, with the data referred to in the first subparagraph. The summary of safety and performance referred to in Article 29(1) shall be updated as soon as possible, where necessary. 7. Where necessary to ensure the uniform application of Annex XIII, the Commission may, having due regard to technical and scientific progress, adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2017/745 (the ‘Medical Devices Regulation’ (MDR)) 1 and Regulation (EU) 2017/746 (the ‘ In Vitro Diagnostic Medical Devices Regulation’ (IVDR)) 2 of the European Parliament and of the Council set a strengthened regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs). Their objectives are a high level of protection of health for patients and users and the smooth functioning of the single market for these products. To achieve these objectives and to address issues identified with the previous regulatory framework, the Regulations set up a more robust system of conformity assessment to ensure the quality, safety and performance of devices placed on the EU market. The MDR has applied since 26 May 2021 3 . The transitional period provided for in Article 120 has been extended by Regulation (EU) 2023/607 4 and will end on either 31 December 2027 or 31 December 2028, depending on the device’s risk class and subject to certain conditions. The IVDR has applied since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions 5 . This extension was not subject to conditions similar to the ones laid down for medical devices by Regulation (EU) 2023/607. This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions. Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs. a) Transition of devices to the IVDR There is a wide variety of IVDs, including HIV tests for blood donation screening or individual diagnosis, cancer tests, pregnancy tests or SARS-CoV-2 tests. Around two thirds of all clinical decisions are based on information provided by IVDs 6 . It is paramount to ensure both a high level of safety and performance of IVDs and their availability to healthcare systems . The IVDR has introduced very substantial changes to the regulatory framework for IVDs with significant resource and capacity implications . According to the IVDR, IVDs are classified into different risk classes from class A (low risk) to class D (high risk). One of the most profound changes is the increased involvement of independent conformity assessment bodies (‘notified bodies’) in conformity assessment, in a way that is proportionate to the device’s risk class. Under the previous Directive 98/79/EC 7 , only a relatively small number of high-risk devices, i.e. about 8% of the more than 40 000 IVDs on the EU market covered by the Directive 8 , were subject to scrutiny by notified bodies. In October 2022, there were 1 551 valid certificates issued by notified bodies under Directive 98/79/EC 9 . Some of these have already expired (38 in 2022 and 165 in 2023); 482 certificates will expire in 2024 and 866 certificates will expire in 2025 (by 26 May) 10 . Under the IVDR, around 80% of IVDs will be subject to scrutiny by notified bodies, most of them for the first time 8 . As a consequence, the number of certificates under the IVDR is expected to be significantly higher than the number of certificates issued under Directive 98/79/EC . The relationship between the number of devices and the number of certificates covering them is complex, so no precise calculation can be made, but numbers in the order of 15 000 certificates and higher could reasonably be expected. M ore than 1 000 devices are in the highest risk class ( class D ) 11 . Under the IVDR , these devices require the issuance of both a quality management system certificate and an individual device technical documentation assessment certificate. Those figures are in stark contrast to the low number of certificates already issued and ongoing applications under the IVDR. In fact, the vast majority of IVDs have not yet transitioned to the IVDR. As of end of October 2023, manufacturers had submitted 1 378 applications for conformity assessment under the IVDR, resulting in 677 certificates issued by notified bodies across all risk classes. For class D IVDs, only 335 applications had been submitted and 117 certificates had been issued 12 . While there are still several years of transitional period remaining for classes C, B and A sterile, the transitional period for class D devices ends on 26 May 2025. Given the low number of certificates and applications for class D IVDs, and the long duration of the conformity assessment process as explained below, there is a high risk of shortages of many of these devices. Class D devices are used, for example, to test for infections in blood or organ donations, to test patients for life-threatening infectious diseases, or for blood grouping for transfusions. Therefore, there is a high risk of a public health crisis if there is a shortage of such devices. As explained above, in January 2022, the European Parliament and the Council adopted a staggered extension of the transitional period due to the impact of the COVID-19 pandemic. The slow rate of transition has made this extension insufficient. The reasons are multifaceted; however, they are underpinned by the far‑reaching nature of changes introduced by the IVDR and the resulting increased need for scientific, technical and regulatory expertise and capacity at all levels in the system, which require time to be built up. A t present, only 12 notified bodies 13 are designated under the IVDR, compared to 22 notified bodies designated under Directive 98/79/EC (18 after the UK’s withdrawal from the EU) . A f urther 8 applications for designation as notified body are currently in pro gress. The staggering of the transitional periods by risk class in 2022 meant that the workload on notified bodies could be distributed over time , and provided relief to the sector 14 . Nevertheless, access to notified bodies has remained an issue, especially for small to medium-sized enterprises (SMEs ) 11 . Notified bodies are also facing challenges due to the extensive changes introduced by the IVDR. They must apply new requirements for types of devices that they have not handled previously. The duration of the notified body’s assessment is affected by the often insufficient quality of manufacturers’ applications 15 . A s of July 2023 , t he average duration of the conformity assessment process combining quality management system and technical documentation assessment was around 18 months 15 . Thus, the overall notified body capacity in the EU is limited, due to both low numbers of notified bodies and challenges to their efficient and smooth operation. Additional transition time is needed to help address this persisting problem. More notified bodies will be designated over time and the efficiency in processing applications will improve as both manufacturers and notified bodies gain more experience with the IVDR. In the short term, it is also important to maintain the staggering of transitional periods by risk class to avoid a bottleneck at the level of notified bodies. Furthermore , it appears that many manufacturers are not sufficiently prepared to demonstrate compliance with the requirements of the IVDR. This may be due to various causes, including the complexity of these new requirements, lack of experience of interaction with notified bodies, and the continuous development of the IVDR framework, such as ongoing designation of notified bodies, and for class D IVDs adoption of common specifications and designation of EU reference laboratories. Around 90% of medical device companies are SMEs 16 , for which managing the transition can be especially challenging. More and more tools are being put in place to support manufacturers, with particular attention to SMEs, including : (i) guidance by the Medical Device Coordination Group (MDCG) and by notified bodies ; (ii) webinars and training by notified bodies ; (iii) structured dialogue with notified bodies 17 ; or (iv) EU-funded work to make notified body capacity more visible 18 . Additional transition time is necessary to allow manufacturers to make greater use of these tools and therefore support the transition of their devices to the IVDR . This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements. The need for additional time is most acute for mitigating shortages of class D devices. They constitute about 4% of the market 16 but their conformity assessment is intensive due to the requirement for individual technical documentation assessment and, where relevant, involvement of the scientific bodies (expert panel and EU reference laboratories). With only 12 notified bodies currently designated, capacity in the system to perform the required third party assessments remains limited, so an extension of the transitional period for class D IVDs should be combined with a shift in the transition deadlines for the other device groups as well to avoid a bottleneck in the certification process and to prevent shortages of these devices too. Class C and class B are large device groups (representing 26% and 49% of the market, respectively), and some of them are also subject to special requirements such as individual technical documentation assessment. It is also logical from the perspective of protection of public health that higher risk classes should be subject to the more stringent rules earlier than lower risk classes. The extension should be subject to conditions to support the transition to the IVDR, similar to the approach adopted in Regulation (EU) 2023/607, which extended the MDR transitional period. These conditions will ensure that only manufacturers that are actively taking the necessary steps to transition to the new rules and continue to place on the market devices meeting high safety standards will benefit from the additional time. In addition, at the latest by 26 May 2025, all manufacturers will have to put in place a quality management system in accordance with Article 10(8) IVDR. Such an approach respects the work of those manufacturers that have already taken the necessary steps to comply with the IVDR. Finally, it is clear that an extension of the transitional period will provide only a short-term solution to mitigate the risk of shortages. It will not solve certain underlying structural problems related to the implementation of the IVDR, notably with regard to the specific situation of SMEs. Moreover, the transition must be completed to ensure the credibility and robustness of the EU medical device regulatory system and to provide the necessary legal certainty for a stable, innovative and safe environment. It is necessary to analyse problems related to the implementation of the IVDR and the MDR, and their root causes, to identify shortcomings of the regulatory framework and remedy them in the medium term with a view to ensuring patient safety and access to safe and performant devices in a sustainable manner. b) European database on med ic al devices (E udamed ) In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). Eudamed must include seven electronic systems including the UDI database 19 . It is being developed in accordance with functional specifications drawn up by the Commission in collaboration with the MDCG and endorsed by the MDCG. Pursuant to these specifications, Eudamed will consist of six modules 20 , covering all the features specified by the Regulations: UDI/Devices, Actors, Notified bodies/Certificates, Post-Market Surveillance and Vigilance, Market Surveillance, and Clinical investigations/Performance studies . Three Eudamed modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further modules (Market Surveillance; Post-Market Surveillance and Vigilance) are expected to be completed in Q2/2024. The last module (Clinical investigations/Performance studies) will not be completed before Q3/2026. Pursuant to the current MDR rules, Eudamed can only be used mandatorily from a certain date after the Commission has verified that Eudamed is fully functional and has published a notice to that effect. Therefore, the delayed development of the last module holds back the mandatory use of the electronic systems that have been completed already. The mandatory use of all six modules thus cannot be expected before Q4/2027, with additional transitional periods not ending before Q2/2029. However, the use of Eudamed is key for effective and efficient implementation of the MDR and IVDR and of high value to the work of the competent authorities and the Commission in monitoring the market. Moreover, the deployment of Eudamed has profound and beneficial implications in terms of resource savings for manufacturers as it prevents multiple registrations or instances of communication of data at national level. This proposal aims to enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025. Consequently, also the specific transitional provisions in the MDR and IVDR related to Eudamed need to be amended to enable a smooth progressive transfer from multiple registrations in national databases to a single registration in Eudamed. In addition, having regard to the delay in the development of the module for clinical investigations / performance studies, the timelines for the application of the coordinated assessment of clinical investigations and performance studies need to be adapted. Keeping the approach provided for in the MDR and the IVDR, the coordinated assessment should first be applied by Member States on an ‘opt-in’ basis. Five years after its voluntary application, the coordinated assessment should become mandatory for all Member States. c) Prior notice if supply of certain medical devices and in vitro diagnostic medical devices is stopped Healthcare professionals, industry and competent authorities have reported that during the transitional period of the MDR and the IVDR, the supply of many medical devices and IVDs has or is likely to be stopped. In certain cases, especially if no or few alternative devices are available, the interruption of supply can result in serious harm or a risk of serious harm to patients or public health. This proposal aims to impose an obligation on manufacturers to inform their relevant competent authority and health institutions before they cease, temporarily or permanently, the supply of a critical device. If manufacturers do not supply directly to health institutions or healthcare professionals, they should inform the relevant economic operators in the supply chain, which then can inform the health institutions. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety. In accordance with Article 105 MDR, the MDCG may decide to provide guidance with the aim to ensure effective and harmonised implementation of this prior notice mechanism. 
Revised version (Article 56 Performance evaluation and clinical evidence):
1. Confirmation of conformity with relevant general safety and performance requirements set out in Annex I, in particular those concerning the performance characteristics referred to in Chapter I and Section 9 of Annex I, under the normal conditions of the intended use of the device, and the evaluation of the interference(s) and cross-reaction(s) and of the acceptability of the benefit-risk ratio referred to in Sections 1 and 8 of Annex I, shall be based on scientific validity, analytical and clinical performance data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III. The manufacturer shall specify and justify the level of the clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose. To that end, manufacturers shall plan, conduct and document a performance evaluation in accordance with this Article and with Part A of Annex XIII. 2. The clinical evidence shall support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan. The data and conclusions drawn from the assessment of those elements shall constitute the clinical evidence for the device. The clinical evidence shall be such as to scientifically demonstrate, by reference to the state of the art in medicine, that the intended clinical benefit(s) will be achieved and that the device is safe. The clinical evidence derived from the performance evaluation shall provide scientifically valid assurance, that the relevant general safety and performance requirements set out in Annex I, are fulfilled, under normal conditions of use. 4. Clinical performance studies in accordance with Section 2 of Part A of Annex XIII shall be carried out unless it is duly justified to rely on other sources of clinical performance data. 5. The scientific validity data, the analytical performance data and the clinical performance data, their assessment and the clinical evidence derived therefrom, shall be documented in the performance evaluation report referred to in Section 1.3.2 of Part A of Annex XIII. The performance evaluation report shall be part of the technical documentation, referred to in Annex II, relating to the device concerned. 6. The performance evaluation and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from implementation of the manufacturer's PMPF plan in accordance with Part B of Annex XIII and the post-market surveillance plan referred to in Article 79. The performance evaluation report for class C and D devices shall be updated when necessary, but at least annually, with the data referred to in the first subparagraph. The summary of safety and performance referred to in Article 29(1) shall be updated as soon as possible, where necessary. 7. Where necessary to ensure the uniform application of Annex XIII, the Commission may, having due regard to technical and scientific progress, adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Article 57 General requirements regarding performance studies
1. The manufacturer shall ensure that a device for performance study complies with the general safety and performance requirements set out in Annex I apart from the aspects covered by the performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient, user and other persons. 2. Where appropriate, performance studies shall be performed in circumstances similar to the normal conditions of use of the device. 3. Performance studies shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in such performance studies are protected and prevail over all other interests and the data generated are scientifically valid, reliable and robust. Performance studies, including performance studies that use left-over samples, shall be conducted in accordance with applicable law on data protection.
Article 58 Additional requirements for certain performance studies
Any performance study: (a) in which surgically invasive sample-taking is done only for the purpose of the performance study; (b) that is an interventional clinical performance study as defined in point (46) of Article 2; or (c) where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies, shall, in addition to meeting the requirements set out in Article 57 and Annex XIII, be designed, authorised, conducted, recorded and reported in accordance with this Article and Articles 59 to 77 and Annex XIV. 2. Performance studies involving companion diagnostics shall be subject to the same requirements as the performance studies listed in paragraph 1. This does not apply to performance studies involving companion diagnostics using only left-over samples. Such studies shall however be notified to the competent authority. 3. Performance studies shall be subject to scientific and ethical review. The ethical review shall be performed by an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a performance study. At least one lay person shall participate in the ethical review. 4. Where the sponsor of a performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor. Member States may choose not to apply the first subparagraph to performance studies to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that performance study who shall be the addressee for all communications with the sponsor provided for in this Regulation. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met: (a) the performance study is the subject of an authorisation by the Member State(s) in which the performance study is to be conducted, in accordance with this Regulation, unless otherwise stated; (b) an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the performance study, which is valid for that entire Member State under its national law; (c) the sponsor or its legal representative or a contact person pursuant to paragraph 4 is established in the Union; (d) vulnerable populations and subjects are appropriately protected in accordance with Articles 59 to 64; (e) the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored; (f) the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent, in accordance with Article 59; (g) the subject or, where the subject is not able to give informed consent, his or her legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need; (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded; (i) the performance study has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the performance study plan and constantly monitored; (j) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, any other person entitled by national law to provide the relevant patient care under performance study conditions; (k) no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his or her legally designated representatives, to participate in the performance study; (l) where appropriate, biological safety testing reflecting the latest scientific knowledge or any other test deemed necessary in the light of the device's intended purpose has been conducted; (m) in the case of clinical performance studies, the analytical performance has been demonstrated, taking into consideration the state of the art; (n) in the case of interventional clinical performance studies, the analytical performance and scientific validity has been demonstrated, taking into consideration the state of the art. Where, for companion diagnostics, the scientific validity is not established, the scientific rationale for the use of the biomarker shall be provided; (o) the technical safety of the device with regard to its use has been proven, taking into consideration the state of the art as well as provisions in the field of occupational safety and accident prevention; (p) the requirements of Annex XIV are fulfilled. 6. Any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the performance study at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC, the withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal. 7. The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care or laboratory medicine. Other personnel involved in conducting a performance study shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks. 8. Where appropriate, the facilities where the performance study involving subjects is to be conducted shall be suitable for the performance study and shall be similar to the facilities where the device is intended to be used.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2017/745 (the ‘Medical Devices Regulation’ (MDR)) 1 and Regulation (EU) 2017/746 (the ‘ In Vitro Diagnostic Medical Devices Regulation’ (IVDR)) 2 of the European Parliament and of the Council set a strengthened regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs). Their objectives are a high level of protection of health for patients and users and the smooth functioning of the single market for these products. To achieve these objectives and to address issues identified with the previous regulatory framework, the Regulations set up a more robust system of conformity assessment to ensure the quality, safety and performance of devices placed on the EU market. The MDR has applied since 26 May 2021 3 . The transitional period provided for in Article 120 has been extended by Regulation (EU) 2023/607 4 and will end on either 31 December 2027 or 31 December 2028, depending on the device’s risk class and subject to certain conditions. The IVDR has applied since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions 5 . This extension was not subject to conditions similar to the ones laid down for medical devices by Regulation (EU) 2023/607. This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions. Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs. a) Transition of devices to the IVDR There is a wide variety of IVDs, including HIV tests for blood donation screening or individual diagnosis, cancer tests, pregnancy tests or SARS-CoV-2 tests. Around two thirds of all clinical decisions are based on information provided by IVDs 6 . It is paramount to ensure both a high level of safety and performance of IVDs and their availability to healthcare systems . The IVDR has introduced very substantial changes to the regulatory framework for IVDs with significant resource and capacity implications . According to the IVDR, IVDs are classified into different risk classes from class A (low risk) to class D (high risk). One of the most profound changes is the increased involvement of independent conformity assessment bodies (‘notified bodies’) in conformity assessment, in a way that is proportionate to the device’s risk class. Under the previous Directive 98/79/EC 7 , only a relatively small number of high-risk devices, i.e. about 8% of the more than 40 000 IVDs on the EU market covered by the Directive 8 , were subject to scrutiny by notified bodies. In October 2022, there were 1 551 valid certificates issued by notified bodies under Directive 98/79/EC 9 . Some of these have already expired (38 in 2022 and 165 in 2023); 482 certificates will expire in 2024 and 866 certificates will expire in 2025 (by 26 May) 10 . Under the IVDR, around 80% of IVDs will be subject to scrutiny by notified bodies, most of them for the first time 8 . As a consequence, the number of certificates under the IVDR is expected to be significantly higher than the number of certificates issued under Directive 98/79/EC . The relationship between the number of devices and the number of certificates covering them is complex, so no precise calculation can be made, but numbers in the order of 15 000 certificates and higher could reasonably be expected. M ore than 1 000 devices are in the highest risk class ( class D ) 11 . Under the IVDR , these devices require the issuance of both a quality management system certificate and an individual device technical documentation assessment certificate. Those figures are in stark contrast to the low number of certificates already issued and ongoing applications under the IVDR. In fact, the vast majority of IVDs have not yet transitioned to the IVDR. As of end of October 2023, manufacturers had submitted 1 378 applications for conformity assessment under the IVDR, resulting in 677 certificates issued by notified bodies across all risk classes. For class D IVDs, only 335 applications had been submitted and 117 certificates had been issued 12 . While there are still several years of transitional period remaining for classes C, B and A sterile, the transitional period for class D devices ends on 26 May 2025. Given the low number of certificates and applications for class D IVDs, and the long duration of the conformity assessment process as explained below, there is a high risk of shortages of many of these devices. Class D devices are used, for example, to test for infections in blood or organ donations, to test patients for life-threatening infectious diseases, or for blood grouping for transfusions. Therefore, there is a high risk of a public health crisis if there is a shortage of such devices. As explained above, in January 2022, the European Parliament and the Council adopted a staggered extension of the transitional period due to the impact of the COVID-19 pandemic. The slow rate of transition has made this extension insufficient. The reasons are multifaceted; however, they are underpinned by the far‑reaching nature of changes introduced by the IVDR and the resulting increased need for scientific, technical and regulatory expertise and capacity at all levels in the system, which require time to be built up. A t present, only 12 notified bodies 13 are designated under the IVDR, compared to 22 notified bodies designated under Directive 98/79/EC (18 after the UK’s withdrawal from the EU) . A f urther 8 applications for designation as notified body are currently in pro gress. The staggering of the transitional periods by risk class in 2022 meant that the workload on notified bodies could be distributed over time , and provided relief to the sector 14 . Nevertheless, access to notified bodies has remained an issue, especially for small to medium-sized enterprises (SMEs ) 11 . Notified bodies are also facing challenges due to the extensive changes introduced by the IVDR. They must apply new requirements for types of devices that they have not handled previously. The duration of the notified body’s assessment is affected by the often insufficient quality of manufacturers’ applications 15 . A s of July 2023 , t he average duration of the conformity assessment process combining quality management system and technical documentation assessment was around 18 months 15 . Thus, the overall notified body capacity in the EU is limited, due to both low numbers of notified bodies and challenges to their efficient and smooth operation. Additional transition time is needed to help address this persisting problem. More notified bodies will be designated over time and the efficiency in processing applications will improve as both manufacturers and notified bodies gain more experience with the IVDR. In the short term, it is also important to maintain the staggering of transitional periods by risk class to avoid a bottleneck at the level of notified bodies. Furthermore , it appears that many manufacturers are not sufficiently prepared to demonstrate compliance with the requirements of the IVDR. This may be due to various causes, including the complexity of these new requirements, lack of experience of interaction with notified bodies, and the continuous development of the IVDR framework, such as ongoing designation of notified bodies, and for class D IVDs adoption of common specifications and designation of EU reference laboratories. Around 90% of medical device companies are SMEs 16 , for which managing the transition can be especially challenging. More and more tools are being put in place to support manufacturers, with particular attention to SMEs, including : (i) guidance by the Medical Device Coordination Group (MDCG) and by notified bodies ; (ii) webinars and training by notified bodies ; (iii) structured dialogue with notified bodies 17 ; or (iv) EU-funded work to make notified body capacity more visible 18 . Additional transition time is necessary to allow manufacturers to make greater use of these tools and therefore support the transition of their devices to the IVDR . This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements. The need for additional time is most acute for mitigating shortages of class D devices. They constitute about 4% of the market 16 but their conformity assessment is intensive due to the requirement for individual technical documentation assessment and, where relevant, involvement of the scientific bodies (expert panel and EU reference laboratories). With only 12 notified bodies currently designated, capacity in the system to perform the required third party assessments remains limited, so an extension of the transitional period for class D IVDs should be combined with a shift in the transition deadlines for the other device groups as well to avoid a bottleneck in the certification process and to prevent shortages of these devices too. Class C and class B are large device groups (representing 26% and 49% of the market, respectively), and some of them are also subject to special requirements such as individual technical documentation assessment. It is also logical from the perspective of protection of public health that higher risk classes should be subject to the more stringent rules earlier than lower risk classes. The extension should be subject to conditions to support the transition to the IVDR, similar to the approach adopted in Regulation (EU) 2023/607, which extended the MDR transitional period. These conditions will ensure that only manufacturers that are actively taking the necessary steps to transition to the new rules and continue to place on the market devices meeting high safety standards will benefit from the additional time. In addition, at the latest by 26 May 2025, all manufacturers will have to put in place a quality management system in accordance with Article 10(8) IVDR. Such an approach respects the work of those manufacturers that have already taken the necessary steps to comply with the IVDR. Finally, it is clear that an extension of the transitional period will provide only a short-term solution to mitigate the risk of shortages. It will not solve certain underlying structural problems related to the implementation of the IVDR, notably with regard to the specific situation of SMEs. Moreover, the transition must be completed to ensure the credibility and robustness of the EU medical device regulatory system and to provide the necessary legal certainty for a stable, innovative and safe environment. It is necessary to analyse problems related to the implementation of the IVDR and the MDR, and their root causes, to identify shortcomings of the regulatory framework and remedy them in the medium term with a view to ensuring patient safety and access to safe and performant devices in a sustainable manner. b) European database on med ic al devices (E udamed ) In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). Eudamed must include seven electronic systems including the UDI database 19 . It is being developed in accordance with functional specifications drawn up by the Commission in collaboration with the MDCG and endorsed by the MDCG. Pursuant to these specifications, Eudamed will consist of six modules 20 , covering all the features specified by the Regulations: UDI/Devices, Actors, Notified bodies/Certificates, Post-Market Surveillance and Vigilance, Market Surveillance, and Clinical investigations/Performance studies . Three Eudamed modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further modules (Market Surveillance; Post-Market Surveillance and Vigilance) are expected to be completed in Q2/2024. The last module (Clinical investigations/Performance studies) will not be completed before Q3/2026. Pursuant to the current MDR rules, Eudamed can only be used mandatorily from a certain date after the Commission has verified that Eudamed is fully functional and has published a notice to that effect. Therefore, the delayed development of the last module holds back the mandatory use of the electronic systems that have been completed already. The mandatory use of all six modules thus cannot be expected before Q4/2027, with additional transitional periods not ending before Q2/2029. However, the use of Eudamed is key for effective and efficient implementation of the MDR and IVDR and of high value to the work of the competent authorities and the Commission in monitoring the market. Moreover, the deployment of Eudamed has profound and beneficial implications in terms of resource savings for manufacturers as it prevents multiple registrations or instances of communication of data at national level. This proposal aims to enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025. Consequently, also the specific transitional provisions in the MDR and IVDR related to Eudamed need to be amended to enable a smooth progressive transfer from multiple registrations in national databases to a single registration in Eudamed. In addition, having regard to the delay in the development of the module for clinical investigations / performance studies, the timelines for the application of the coordinated assessment of clinical investigations and performance studies need to be adapted. Keeping the approach provided for in the MDR and the IVDR, the coordinated assessment should first be applied by Member States on an ‘opt-in’ basis. Five years after its voluntary application, the coordinated assessment should become mandatory for all Member States. c) Prior notice if supply of certain medical devices and in vitro diagnostic medical devices is stopped Healthcare professionals, industry and competent authorities have reported that during the transitional period of the MDR and the IVDR, the supply of many medical devices and IVDs has or is likely to be stopped. In certain cases, especially if no or few alternative devices are available, the interruption of supply can result in serious harm or a risk of serious harm to patients or public health. This proposal aims to impose an obligation on manufacturers to inform their relevant competent authority and health institutions before they cease, temporarily or permanently, the supply of a critical device. If manufacturers do not supply directly to health institutions or healthcare professionals, they should inform the relevant economic operators in the supply chain, which then can inform the health institutions. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety. In accordance with Article 105 MDR, the MDCG may decide to provide guidance with the aim to ensure effective and harmonised implementation of this prior notice mechanism. 
Revised version (Article 58 Additional requirements for certain performance studies):
2. Performance studies involving companion diagnostics shall be subject to the same requirements as the performance studies listed in paragraph 1. This does not apply to performance studies involving companion diagnostics using only left-over samples. Such studies shall however be notified to the competent authority. 3. Performance studies shall be subject to scientific and ethical review. The ethical review shall be performed by an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a performance study. At least one lay person shall participate in the ethical review. 4. Where the sponsor of a performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor. Member States may choose not to apply the first subparagraph to performance studies to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that performance study who shall be the addressee for all communications with the sponsor provided for in this Regulation. 6. Any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the performance study at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC, the withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal. 7. The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care or laboratory medicine. Other personnel involved in conducting a performance study shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks. 8. Where appropriate, the facilities where the performance study involving subjects is to be conducted shall be suitable for the performance study and shall be similar to the facilities where the device is intended to be used.
Article 59 Informed consent
1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not able to give informed consent, his or her legally designated representative after having been duly informed in accordance with paragraph 2. Where the subject is unable to write, consent may be given and recorded through appropriate alternative means in the presence of at least one impartial witness. In that case, the witness shall sign and date the informed consent document. The subject or, where the subject is not able to give informed consent, his or her legally designated representative shall be provided with a copy of the document or the record, as appropriate, by which informed consent has been given. The informed consent shall be documented. Adequate time shall be given for the subject or his or her legally designated representative to consider his or her decision to participate in the performance study. 2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall: enable the subject or his or her legally designated representative to understand: (i) the nature, objectives, benefits, implications, risks and inconveniences of the performance study; (ii) the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the performance study at any time without any resulting detriment and without having to provide any justification; (iii) the conditions under which the performance study is to be conducted, including the expected duration of the subject's participation in the performance study; and (iv) the possible treatment alternatives, including the follow-up measures if the participation of the subject in the performance study is discontinued; (b) be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative; (c) be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law; and (d) include information about the applicable damage compensation system referred to in Article 65; (e) include the Union-wide unique single identification number for the performance study referred to in Article 66(1) and information about the availability of the performance study results in accordance with paragraph 6 of this Article. 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative. 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information. 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information. 6. The subject shall be informed that a report of the performance study and a summary presented in terms understandable to the intended user will be made available pursuant to Article 73(5) in the electronic system on performance studies referred to in Article 69, irrespective of the outcome of the performance study, and shall be informed, to the extent possible, when they have become available. 7. This Regulation is without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, shall also assent in order to participate in a performance study.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2017/745 (the ‘Medical Devices Regulation’ (MDR)) 1 and Regulation (EU) 2017/746 (the ‘ In Vitro Diagnostic Medical Devices Regulation’ (IVDR)) 2 of the European Parliament and of the Council set a strengthened regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs). Their objectives are a high level of protection of health for patients and users and the smooth functioning of the single market for these products. To achieve these objectives and to address issues identified with the previous regulatory framework, the Regulations set up a more robust system of conformity assessment to ensure the quality, safety and performance of devices placed on the EU market. The MDR has applied since 26 May 2021 3 . The transitional period provided for in Article 120 has been extended by Regulation (EU) 2023/607 4 and will end on either 31 December 2027 or 31 December 2028, depending on the device’s risk class and subject to certain conditions. The IVDR has applied since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions 5 . This extension was not subject to conditions similar to the ones laid down for medical devices by Regulation (EU) 2023/607. This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions. Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs. a) Transition of devices to the IVDR There is a wide variety of IVDs, including HIV tests for blood donation screening or individual diagnosis, cancer tests, pregnancy tests or SARS-CoV-2 tests. Around two thirds of all clinical decisions are based on information provided by IVDs 6 . It is paramount to ensure both a high level of safety and performance of IVDs and their availability to healthcare systems . The IVDR has introduced very substantial changes to the regulatory framework for IVDs with significant resource and capacity implications . According to the IVDR, IVDs are classified into different risk classes from class A (low risk) to class D (high risk). One of the most profound changes is the increased involvement of independent conformity assessment bodies (‘notified bodies’) in conformity assessment, in a way that is proportionate to the device’s risk class. Under the previous Directive 98/79/EC 7 , only a relatively small number of high-risk devices, i.e. about 8% of the more than 40 000 IVDs on the EU market covered by the Directive 8 , were subject to scrutiny by notified bodies. In October 2022, there were 1 551 valid certificates issued by notified bodies under Directive 98/79/EC 9 . Some of these have already expired (38 in 2022 and 165 in 2023); 482 certificates will expire in 2024 and 866 certificates will expire in 2025 (by 26 May) 10 . Under the IVDR, around 80% of IVDs will be subject to scrutiny by notified bodies, most of them for the first time 8 . As a consequence, the number of certificates under the IVDR is expected to be significantly higher than the number of certificates issued under Directive 98/79/EC . The relationship between the number of devices and the number of certificates covering them is complex, so no precise calculation can be made, but numbers in the order of 15 000 certificates and higher could reasonably be expected. M ore than 1 000 devices are in the highest risk class ( class D ) 11 . Under the IVDR , these devices require the issuance of both a quality management system certificate and an individual device technical documentation assessment certificate. Those figures are in stark contrast to the low number of certificates already issued and ongoing applications under the IVDR. In fact, the vast majority of IVDs have not yet transitioned to the IVDR. As of end of October 2023, manufacturers had submitted 1 378 applications for conformity assessment under the IVDR, resulting in 677 certificates issued by notified bodies across all risk classes. For class D IVDs, only 335 applications had been submitted and 117 certificates had been issued 12 . While there are still several years of transitional period remaining for classes C, B and A sterile, the transitional period for class D devices ends on 26 May 2025. Given the low number of certificates and applications for class D IVDs, and the long duration of the conformity assessment process as explained below, there is a high risk of shortages of many of these devices. Class D devices are used, for example, to test for infections in blood or organ donations, to test patients for life-threatening infectious diseases, or for blood grouping for transfusions. Therefore, there is a high risk of a public health crisis if there is a shortage of such devices. As explained above, in January 2022, the European Parliament and the Council adopted a staggered extension of the transitional period due to the impact of the COVID-19 pandemic. The slow rate of transition has made this extension insufficient. The reasons are multifaceted; however, they are underpinned by the far‑reaching nature of changes introduced by the IVDR and the resulting increased need for scientific, technical and regulatory expertise and capacity at all levels in the system, which require time to be built up. A t present, only 12 notified bodies 13 are designated under the IVDR, compared to 22 notified bodies designated under Directive 98/79/EC (18 after the UK’s withdrawal from the EU) . A f urther 8 applications for designation as notified body are currently in pro gress. The staggering of the transitional periods by risk class in 2022 meant that the workload on notified bodies could be distributed over time , and provided relief to the sector 14 . Nevertheless, access to notified bodies has remained an issue, especially for small to medium-sized enterprises (SMEs ) 11 . Notified bodies are also facing challenges due to the extensive changes introduced by the IVDR. They must apply new requirements for types of devices that they have not handled previously. The duration of the notified body’s assessment is affected by the often insufficient quality of manufacturers’ applications 15 . A s of July 2023 , t he average duration of the conformity assessment process combining quality management system and technical documentation assessment was around 18 months 15 . Thus, the overall notified body capacity in the EU is limited, due to both low numbers of notified bodies and challenges to their efficient and smooth operation. Additional transition time is needed to help address this persisting problem. More notified bodies will be designated over time and the efficiency in processing applications will improve as both manufacturers and notified bodies gain more experience with the IVDR. In the short term, it is also important to maintain the staggering of transitional periods by risk class to avoid a bottleneck at the level of notified bodies. Furthermore , it appears that many manufacturers are not sufficiently prepared to demonstrate compliance with the requirements of the IVDR. This may be due to various causes, including the complexity of these new requirements, lack of experience of interaction with notified bodies, and the continuous development of the IVDR framework, such as ongoing designation of notified bodies, and for class D IVDs adoption of common specifications and designation of EU reference laboratories. Around 90% of medical device companies are SMEs 16 , for which managing the transition can be especially challenging. More and more tools are being put in place to support manufacturers, with particular attention to SMEs, including : (i) guidance by the Medical Device Coordination Group (MDCG) and by notified bodies ; (ii) webinars and training by notified bodies ; (iii) structured dialogue with notified bodies 17 ; or (iv) EU-funded work to make notified body capacity more visible 18 . Additional transition time is necessary to allow manufacturers to make greater use of these tools and therefore support the transition of their devices to the IVDR . This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements. The need for additional time is most acute for mitigating shortages of class D devices. They constitute about 4% of the market 16 but their conformity assessment is intensive due to the requirement for individual technical documentation assessment and, where relevant, involvement of the scientific bodies (expert panel and EU reference laboratories). With only 12 notified bodies currently designated, capacity in the system to perform the required third party assessments remains limited, so an extension of the transitional period for class D IVDs should be combined with a shift in the transition deadlines for the other device groups as well to avoid a bottleneck in the certification process and to prevent shortages of these devices too. Class C and class B are large device groups (representing 26% and 49% of the market, respectively), and some of them are also subject to special requirements such as individual technical documentation assessment. It is also logical from the perspective of protection of public health that higher risk classes should be subject to the more stringent rules earlier than lower risk classes. The extension should be subject to conditions to support the transition to the IVDR, similar to the approach adopted in Regulation (EU) 2023/607, which extended the MDR transitional period. These conditions will ensure that only manufacturers that are actively taking the necessary steps to transition to the new rules and continue to place on the market devices meeting high safety standards will benefit from the additional time. In addition, at the latest by 26 May 2025, all manufacturers will have to put in place a quality management system in accordance with Article 10(8) IVDR. Such an approach respects the work of those manufacturers that have already taken the necessary steps to comply with the IVDR. Finally, it is clear that an extension of the transitional period will provide only a short-term solution to mitigate the risk of shortages. It will not solve certain underlying structural problems related to the implementation of the IVDR, notably with regard to the specific situation of SMEs. Moreover, the transition must be completed to ensure the credibility and robustness of the EU medical device regulatory system and to provide the necessary legal certainty for a stable, innovative and safe environment. It is necessary to analyse problems related to the implementation of the IVDR and the MDR, and their root causes, to identify shortcomings of the regulatory framework and remedy them in the medium term with a view to ensuring patient safety and access to safe and performant devices in a sustainable manner. b) European database on med ic al devices (E udamed ) In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). Eudamed must include seven electronic systems including the UDI database 19 . It is being developed in accordance with functional specifications drawn up by the Commission in collaboration with the MDCG and endorsed by the MDCG. Pursuant to these specifications, Eudamed will consist of six modules 20 , covering all the features specified by the Regulations: UDI/Devices, Actors, Notified bodies/Certificates, Post-Market Surveillance and Vigilance, Market Surveillance, and Clinical investigations/Performance studies . Three Eudamed modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further modules (Market Surveillance; Post-Market Surveillance and Vigilance) are expected to be completed in Q2/2024. The last module (Clinical investigations/Performance studies) will not be completed before Q3/2026. Pursuant to the current MDR rules, Eudamed can only be used mandatorily from a certain date after the Commission has verified that Eudamed is fully functional and has published a notice to that effect. Therefore, the delayed development of the last module holds back the mandatory use of the electronic systems that have been completed already. The mandatory use of all six modules thus cannot be expected before Q4/2027, with additional transitional periods not ending before Q2/2029. However, the use of Eudamed is key for effective and efficient implementation of the MDR and IVDR and of high value to the work of the competent authorities and the Commission in monitoring the market. Moreover, the deployment of Eudamed has profound and beneficial implications in terms of resource savings for manufacturers as it prevents multiple registrations or instances of communication of data at national level. This proposal aims to enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025. Consequently, also the specific transitional provisions in the MDR and IVDR related to Eudamed need to be amended to enable a smooth progressive transfer from multiple registrations in national databases to a single registration in Eudamed. In addition, having regard to the delay in the development of the module for clinical investigations / performance studies, the timelines for the application of the coordinated assessment of clinical investigations and performance studies need to be adapted. Keeping the approach provided for in the MDR and the IVDR, the coordinated assessment should first be applied by Member States on an ‘opt-in’ basis. Five years after its voluntary application, the coordinated assessment should become mandatory for all Member States. c) Prior notice if supply of certain medical devices and in vitro diagnostic medical devices is stopped Healthcare professionals, industry and competent authorities have reported that during the transitional period of the MDR and the IVDR, the supply of many medical devices and IVDs has or is likely to be stopped. In certain cases, especially if no or few alternative devices are available, the interruption of supply can result in serious harm or a risk of serious harm to patients or public health. This proposal aims to impose an obligation on manufacturers to inform their relevant competent authority and health institutions before they cease, temporarily or permanently, the supply of a critical device. If manufacturers do not supply directly to health institutions or healthcare professionals, they should inform the relevant economic operators in the supply chain, which then can inform the health institutions. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety. In accordance with Article 105 MDR, the MDCG may decide to provide guidance with the aim to ensure effective and harmonised implementation of this prior notice mechanism. 
Revised version (Article 59 Informed consent):
1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not able to give informed consent, his or her legally designated representative after having been duly informed in accordance with paragraph 2. Where the subject is unable to write, consent may be given and recorded through appropriate alternative means in the presence of at least one impartial witness. In that case, the witness shall sign and date the informed consent document. The subject or, where the subject is not able to give informed consent, his or her legally designated representative shall be provided with a copy of the document or the record, as appropriate, by which informed consent has been given. The informed consent shall be documented. Adequate time shall be given for the subject or his or her legally designated representative to consider his or her decision to participate in the performance study. 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative. 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information. 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information. 6. The subject shall be informed that a report of the performance study and a summary presented in terms understandable to the intended user will be made available pursuant to Article 73(5) in the electronic system on performance studies referred to in Article 69, irrespective of the outcome of the performance study, and shall be informed, to the extent possible, when they have become available. 7. This Regulation is without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, shall also assent in order to participate in a performance study.
Article 60 Performance studies on incapacitated subjects
In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a performance study may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met: (a) the informed consent of their legally designated representative has been obtained; (b) the incapacitated subjects have received the information referred to in Article 59(2) in a way that is adequate in view of their capacity to understand it; (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator; (d) no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the performance study; (e) the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in performance studies on persons able to give informed consent, or by other research methods; (f) the performance study relates directly to a medical condition from which the subject suffers; there are scientific grounds for expecting that participation in the performance study will produce: (i) a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or (ii) some benefit for the population represented by the incapacitated subject concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned in comparison with the standard treatment of the incapacitated subject's condition. there are scientific grounds for expecting that participation in the performance study will produce: (i) a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or (ii) some benefit for the population represented by the incapacitated subject concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned in comparison with the standard treatment of the incapacitated subject's condition. 2. The subject shall as far as possible take part in the informed consent procedure. 3. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2017/745 (the ‘Medical Devices Regulation’ (MDR)) 1 and Regulation (EU) 2017/746 (the ‘ In Vitro Diagnostic Medical Devices Regulation’ (IVDR)) 2 of the European Parliament and of the Council set a strengthened regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs). Their objectives are a high level of protection of health for patients and users and the smooth functioning of the single market for these products. To achieve these objectives and to address issues identified with the previous regulatory framework, the Regulations set up a more robust system of conformity assessment to ensure the quality, safety and performance of devices placed on the EU market. The MDR has applied since 26 May 2021 3 . The transitional period provided for in Article 120 has been extended by Regulation (EU) 2023/607 4 and will end on either 31 December 2027 or 31 December 2028, depending on the device’s risk class and subject to certain conditions. The IVDR has applied since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions 5 . This extension was not subject to conditions similar to the ones laid down for medical devices by Regulation (EU) 2023/607. This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions. Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs. a) Transition of devices to the IVDR There is a wide variety of IVDs, including HIV tests for blood donation screening or individual diagnosis, cancer tests, pregnancy tests or SARS-CoV-2 tests. Around two thirds of all clinical decisions are based on information provided by IVDs 6 . It is paramount to ensure both a high level of safety and performance of IVDs and their availability to healthcare systems . The IVDR has introduced very substantial changes to the regulatory framework for IVDs with significant resource and capacity implications . According to the IVDR, IVDs are classified into different risk classes from class A (low risk) to class D (high risk). One of the most profound changes is the increased involvement of independent conformity assessment bodies (‘notified bodies’) in conformity assessment, in a way that is proportionate to the device’s risk class. Under the previous Directive 98/79/EC 7 , only a relatively small number of high-risk devices, i.e. about 8% of the more than 40 000 IVDs on the EU market covered by the Directive 8 , were subject to scrutiny by notified bodies. In October 2022, there were 1 551 valid certificates issued by notified bodies under Directive 98/79/EC 9 . Some of these have already expired (38 in 2022 and 165 in 2023); 482 certificates will expire in 2024 and 866 certificates will expire in 2025 (by 26 May) 10 . Under the IVDR, around 80% of IVDs will be subject to scrutiny by notified bodies, most of them for the first time 8 . As a consequence, the number of certificates under the IVDR is expected to be significantly higher than the number of certificates issued under Directive 98/79/EC . The relationship between the number of devices and the number of certificates covering them is complex, so no precise calculation can be made, but numbers in the order of 15 000 certificates and higher could reasonably be expected. M ore than 1 000 devices are in the highest risk class ( class D ) 11 . Under the IVDR , these devices require the issuance of both a quality management system certificate and an individual device technical documentation assessment certificate. Those figures are in stark contrast to the low number of certificates already issued and ongoing applications under the IVDR. In fact, the vast majority of IVDs have not yet transitioned to the IVDR. As of end of October 2023, manufacturers had submitted 1 378 applications for conformity assessment under the IVDR, resulting in 677 certificates issued by notified bodies across all risk classes. For class D IVDs, only 335 applications had been submitted and 117 certificates had been issued 12 . While there are still several years of transitional period remaining for classes C, B and A sterile, the transitional period for class D devices ends on 26 May 2025. Given the low number of certificates and applications for class D IVDs, and the long duration of the conformity assessment process as explained below, there is a high risk of shortages of many of these devices. Class D devices are used, for example, to test for infections in blood or organ donations, to test patients for life-threatening infectious diseases, or for blood grouping for transfusions. Therefore, there is a high risk of a public health crisis if there is a shortage of such devices. As explained above, in January 2022, the European Parliament and the Council adopted a staggered extension of the transitional period due to the impact of the COVID-19 pandemic. The slow rate of transition has made this extension insufficient. The reasons are multifaceted; however, they are underpinned by the far‑reaching nature of changes introduced by the IVDR and the resulting increased need for scientific, technical and regulatory expertise and capacity at all levels in the system, which require time to be built up. A t present, only 12 notified bodies 13 are designated under the IVDR, compared to 22 notified bodies designated under Directive 98/79/EC (18 after the UK’s withdrawal from the EU) . A f urther 8 applications for designation as notified body are currently in pro gress. The staggering of the transitional periods by risk class in 2022 meant that the workload on notified bodies could be distributed over time , and provided relief to the sector 14 . Nevertheless, access to notified bodies has remained an issue, especially for small to medium-sized enterprises (SMEs ) 11 . Notified bodies are also facing challenges due to the extensive changes introduced by the IVDR. They must apply new requirements for types of devices that they have not handled previously. The duration of the notified body’s assessment is affected by the often insufficient quality of manufacturers’ applications 15 . A s of July 2023 , t he average duration of the conformity assessment process combining quality management system and technical documentation assessment was around 18 months 15 . Thus, the overall notified body capacity in the EU is limited, due to both low numbers of notified bodies and challenges to their efficient and smooth operation. Additional transition time is needed to help address this persisting problem. More notified bodies will be designated over time and the efficiency in processing applications will improve as both manufacturers and notified bodies gain more experience with the IVDR. In the short term, it is also important to maintain the staggering of transitional periods by risk class to avoid a bottleneck at the level of notified bodies. Furthermore , it appears that many manufacturers are not sufficiently prepared to demonstrate compliance with the requirements of the IVDR. This may be due to various causes, including the complexity of these new requirements, lack of experience of interaction with notified bodies, and the continuous development of the IVDR framework, such as ongoing designation of notified bodies, and for class D IVDs adoption of common specifications and designation of EU reference laboratories. Around 90% of medical device companies are SMEs 16 , for which managing the transition can be especially challenging. More and more tools are being put in place to support manufacturers, with particular attention to SMEs, including : (i) guidance by the Medical Device Coordination Group (MDCG) and by notified bodies ; (ii) webinars and training by notified bodies ; (iii) structured dialogue with notified bodies 17 ; or (iv) EU-funded work to make notified body capacity more visible 18 . Additional transition time is necessary to allow manufacturers to make greater use of these tools and therefore support the transition of their devices to the IVDR . This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements. The need for additional time is most acute for mitigating shortages of class D devices. They constitute about 4% of the market 16 but their conformity assessment is intensive due to the requirement for individual technical documentation assessment and, where relevant, involvement of the scientific bodies (expert panel and EU reference laboratories). With only 12 notified bodies currently designated, capacity in the system to perform the required third party assessments remains limited, so an extension of the transitional period for class D IVDs should be combined with a shift in the transition deadlines for the other device groups as well to avoid a bottleneck in the certification process and to prevent shortages of these devices too. Class C and class B are large device groups (representing 26% and 49% of the market, respectively), and some of them are also subject to special requirements such as individual technical documentation assessment. It is also logical from the perspective of protection of public health that higher risk classes should be subject to the more stringent rules earlier than lower risk classes. The extension should be subject to conditions to support the transition to the IVDR, similar to the approach adopted in Regulation (EU) 2023/607, which extended the MDR transitional period. These conditions will ensure that only manufacturers that are actively taking the necessary steps to transition to the new rules and continue to place on the market devices meeting high safety standards will benefit from the additional time. In addition, at the latest by 26 May 2025, all manufacturers will have to put in place a quality management system in accordance with Article 10(8) IVDR. Such an approach respects the work of those manufacturers that have already taken the necessary steps to comply with the IVDR. Finally, it is clear that an extension of the transitional period will provide only a short-term solution to mitigate the risk of shortages. It will not solve certain underlying structural problems related to the implementation of the IVDR, notably with regard to the specific situation of SMEs. Moreover, the transition must be completed to ensure the credibility and robustness of the EU medical device regulatory system and to provide the necessary legal certainty for a stable, innovative and safe environment. It is necessary to analyse problems related to the implementation of the IVDR and the MDR, and their root causes, to identify shortcomings of the regulatory framework and remedy them in the medium term with a view to ensuring patient safety and access to safe and performant devices in a sustainable manner. b) European database on med ic al devices (E udamed ) In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). Eudamed must include seven electronic systems including the UDI database 19 . It is being developed in accordance with functional specifications drawn up by the Commission in collaboration with the MDCG and endorsed by the MDCG. Pursuant to these specifications, Eudamed will consist of six modules 20 , covering all the features specified by the Regulations: UDI/Devices, Actors, Notified bodies/Certificates, Post-Market Surveillance and Vigilance, Market Surveillance, and Clinical investigations/Performance studies . Three Eudamed modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further modules (Market Surveillance; Post-Market Surveillance and Vigilance) are expected to be completed in Q2/2024. The last module (Clinical investigations/Performance studies) will not be completed before Q3/2026. Pursuant to the current MDR rules, Eudamed can only be used mandatorily from a certain date after the Commission has verified that Eudamed is fully functional and has published a notice to that effect. Therefore, the delayed development of the last module holds back the mandatory use of the electronic systems that have been completed already. The mandatory use of all six modules thus cannot be expected before Q4/2027, with additional transitional periods not ending before Q2/2029. However, the use of Eudamed is key for effective and efficient implementation of the MDR and IVDR and of high value to the work of the competent authorities and the Commission in monitoring the market. Moreover, the deployment of Eudamed has profound and beneficial implications in terms of resource savings for manufacturers as it prevents multiple registrations or instances of communication of data at national level. This proposal aims to enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025. Consequently, also the specific transitional provisions in the MDR and IVDR related to Eudamed need to be amended to enable a smooth progressive transfer from multiple registrations in national databases to a single registration in Eudamed. In addition, having regard to the delay in the development of the module for clinical investigations / performance studies, the timelines for the application of the coordinated assessment of clinical investigations and performance studies need to be adapted. Keeping the approach provided for in the MDR and the IVDR, the coordinated assessment should first be applied by Member States on an ‘opt-in’ basis. Five years after its voluntary application, the coordinated assessment should become mandatory for all Member States. c) Prior notice if supply of certain medical devices and in vitro diagnostic medical devices is stopped Healthcare professionals, industry and competent authorities have reported that during the transitional period of the MDR and the IVDR, the supply of many medical devices and IVDs has or is likely to be stopped. In certain cases, especially if no or few alternative devices are available, the interruption of supply can result in serious harm or a risk of serious harm to patients or public health. This proposal aims to impose an obligation on manufacturers to inform their relevant competent authority and health institutions before they cease, temporarily or permanently, the supply of a critical device. If manufacturers do not supply directly to health institutions or healthcare professionals, they should inform the relevant economic operators in the supply chain, which then can inform the health institutions. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety. In accordance with Article 105 MDR, the MDCG may decide to provide guidance with the aim to ensure effective and harmonised implementation of this prior notice mechanism. 
Revised version (Article 60 Performance studies on incapacitated subjects):
2. The subject shall as far as possible take part in the informed consent procedure. 3. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved.