Article 61 Performance studies on minors
A performance study on minors 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 minors have received the information referred to in Article 59(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children; (c) the explicit wish of a minor 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 intended to investigate treatments for a medical condition that only occurs in minors or the performance study is essential with respect to minors to validate data obtained in performance studies on persons able to give informed consent or by other research methods; (f) the performance study either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors; there are scientific grounds for expecting that participation in the performance study will produce: (i) a direct benefit to the minor subject outweighing the risks and burdens involved; or (ii) some benefit for the population represented by the minor concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard treatment of the minor's condition; there are scientific grounds for expecting that participation in the performance study will produce: (i) a direct benefit to the minor subject outweighing the risks and burdens involved; or (ii) some benefit for the population represented by the minor concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard treatment of the minor's condition; (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity; (i) if during a performance study the minor reaches the age of legal competence to give informed consent as defined in the national law, his or her express informed consent shall be obtained before that subject can continue to participate in the performance study. 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on minors, 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 61 Performance studies on minors):
2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on minors, 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.
Article 62 Performance studies on pregnant or breastfeeding women
A performance study on pregnant or breastfeeding women 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 performance study has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved; if such a performance study has no direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, it can be conducted only if: (i) a performance study of comparable effectiveness cannot be carried out on women who are not pregnant or breastfeeding; (ii) the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding women or other women in relation to reproduction or other embryos, foetuses or children; and (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding woman concerned, her embryo, foetus or child after birth; (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child; (d) no incentives or financial inducements are given to subjects, except for compensation for expenses and loss of earnings directly related to the participation in the 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 62 Performance studies on pregnant or breastfeeding women):
A performance study on pregnant or breastfeeding women 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 performance study has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved; (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child; (d) no incentives or financial inducements are given to subjects, except for compensation for expenses and loss of earnings directly related to the participation in the performance study.
Article 63 Additional national measures
Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance studies, or persons in residential care institutions.
Article 64 Performance studies in emergency situations
(a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the performance study; (b) there are scientific grounds to expect that participation of the subject in the performance study will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject, or in the diagnosis of its condition; (c) it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from his or her legally designated representative; (d) the investigator certifies that he or she is not aware of any objections to participate in the performance study previously expressed by the subject; (e) the performance study relates directly to the subject's medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the performance study is of such a nature that it may be conducted exclusively in emergency situations; (f) the performance study poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition. 2. Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with Article 59 shall be sought to continue the participation of the subject in the performance study, and information on the performance study shall be given, in accordance with the following requirements: (a) regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in Article 59(2) shall be given as soon as possible to the subject and to his or her legally designated representative; (b) regarding other subjects, the informed consent shall be sought by the investigator without undue delay from the subject or his or her legally designated representative, whichever can be done sooner, and the information referred to in Article 59(2) shall be given as soon as possible to the subject or his or her legally designated representative, as applicable. For the purposes of point (b) where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the performance study shall be obtained from the subject as soon as he or she is capable of giving informed consent. 3. If the subject or, where applicable, his or her legally designated representative does not give consent, he or she shall be informed of the right to object to the use of data obtained from the 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 64 Performance studies in emergency situations):
For the purposes of point (b) where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the performance study shall be obtained from the subject as soon as he or she is capable of giving informed consent. 3. If the subject or, where applicable, his or her legally designated representative does not give consent, he or she shall be informed of the right to object to the use of data obtained from the performance study.
Article 65 Damage compensation
1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a performance study conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk. 2. The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form appropriate for the Member State in which the performance study is conducted.
Article 66 Application for performance studies
The application shall be submitted by means of the electronic system referred to in Article 69, which shall generate a Union-wide unique single identification number for the performance study which shall be used for all relevant communication in relation to that performance study. Within 10 days of receiving the application, the Member State concerned shall notify the sponsor as to whether the performance study falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter I of Annex XIV. 2. Within one week of any change occurring in relation to the documentation referred to in Chapter I of Annex XIV, the sponsor shall update the relevant data in the electronic system referred to in Article 69 and make that change to the documentation clearly identifiable. The Member State concerned shall be notified of the update by means of that electronic system. 3. Where the Member State concerned finds that the performance study applied for does not fall within the scope of this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a time limit of maximum 10 days for the sponsor to comment or to complete the application by means of the electronic system referred to in Article 69. The Member State concerned may extend this period by a maximum of 20 days where appropriate. Where the sponsor has not provided comments nor completed the application within the time limit referred to in the first subparagraph, the application shall be deemed to have lapsed. Where the sponsor considers that the application falls under the scope of this Regulation and/or is complete but the Member State concerned does not agree, the application shall be considered to have been rejected. The Member State concerned shall provide for an appeal procedure in respect of such refusal. The Member State concerned shall notify the sponsor within five days of receipt of the comments or of the requested additional information, whether the performance study is considered as falling within the scope of this Regulation and the application is complete. 4. The Member State concerned may also extend the period referred to in paragraphs 1 and 3 each by a further five days. 5. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the periods referred to in paragraphs 1, 3 and 4 respectively. 6. During the period when the application is being assessed the Member State may request additional information from the sponsor. The expiry of the deadline pursuant to the point (b) of paragraph 7 shall be suspended from the date of the first request until such time as the additional information has been received. The sponsor may start the performance study in the following circumstances: in the case of performance studies carried out pursuant to point (a) of Article 58(1) and where the specimen collection does not represent a major clinical risk to the subject of the study, unless otherwise stated by national law, immediately after the validation date of application described in paragraph 5 of this Article, provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study; (b) in the case of performance studies carried out pursuant to points (b) and (c) of Article 58(1) and Article 58(2) or performance studies other than those referred to in point (a) of this paragraph, as soon as the Member State concerned has notified the sponsor of its authorisation and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date of the application referred to in paragraph 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts. 8. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of technical progress and global regulatory developments, the requirements laid down in Chapter I of Annex XIV. 9. In order to assure the uniform application of the requirements laid down in Chapter I of Annex XIV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and 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 66 Application for performance studies):
The application shall be submitted by means of the electronic system referred to in Article 69, which shall generate a Union-wide unique single identification number for the performance study which shall be used for all relevant communication in relation to that performance study. Within 10 days of receiving the application, the Member State concerned shall notify the sponsor as to whether the performance study falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter I of Annex XIV. 2. Within one week of any change occurring in relation to the documentation referred to in Chapter I of Annex XIV, the sponsor shall update the relevant data in the electronic system referred to in Article 69 and make that change to the documentation clearly identifiable. The Member State concerned shall be notified of the update by means of that electronic system. 3. Where the Member State concerned finds that the performance study applied for does not fall within the scope of this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a time limit of maximum 10 days for the sponsor to comment or to complete the application by means of the electronic system referred to in Article 69. The Member State concerned may extend this period by a maximum of 20 days where appropriate. Where the sponsor has not provided comments nor completed the application within the time limit referred to in the first subparagraph, the application shall be deemed to have lapsed. Where the sponsor considers that the application falls under the scope of this Regulation and/or is complete but the Member State concerned does not agree, the application shall be considered to have been rejected. The Member State concerned shall provide for an appeal procedure in respect of such refusal. The Member State concerned shall notify the sponsor within five days of receipt of the comments or of the requested additional information, whether the performance study is considered as falling within the scope of this Regulation and the application is complete. 4. The Member State concerned may also extend the period referred to in paragraphs 1 and 3 each by a further five days. 5. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the periods referred to in paragraphs 1, 3 and 4 respectively. 6. During the period when the application is being assessed the Member State may request additional information from the sponsor. The expiry of the deadline pursuant to the point (b) of paragraph 7 shall be suspended from the date of the first request until such time as the additional information has been received. 8. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of technical progress and global regulatory developments, the requirements laid down in Chapter I of Annex XIV. 9. In order to assure the uniform application of the requirements laid down in Chapter I of Annex XIV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Article 67 Assessment by Member States
1. Member States shall ensure that the persons validating and assessing the application, or deciding on it, do not have conflicts of interest, are independent of the sponsor, the investigators involved and of natural or legal persons financing the performance study, as well as free of any other undue influence. 2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. 3. Member States shall assess whether the performance study is designed in such a way that potential remaining risks to subjects or third persons, after risk minimization, are justified, when weighed against the clinical benefits to be expected. They shall, while taking into account applicable CS or harmonised standards, examine in particular: (a) the demonstration of compliance of the device(s) for performance study with the applicable general safety and performance requirements, apart from the aspects covered by the performance study, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, in case of performance studies, the evaluation of the analytical performance, and in case of interventional clinical performance studies, the evaluation of the analytical performance, clinical performance and scientific validity, taking into consideration the state of the art; (b) whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards and, in those cases where the sponsor does not use harmonised standards, whether the risk-minimisation solutions provide a level of protection that is equivalent to that provided by harmonised standards; (c) whether the measures planned for the safe installation, putting into service and maintenance of the device for performance study are adequate; (d) the reliability and robustness of the data generated in the performance study, taking account of statistical approaches, design of the performance study and methodological aspects, including sample size, comparator and endpoints; (e) whether the requirements of Annex XIV are met. 4. Member States shall refuse the authorisation of the performance study if: (a) the application dossier submitted pursuant to Article 66(3) remains incomplete; (b) the device or the submitted documents, especially the performance study plan and the investigator's brochure, do not correspond to the state of scientific knowledge, and the performance study, in particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the device on subjects or patients; (c) the requirements of Article 58 are not met; or (d) any assessment under paragraph 3 is negative. Member States shall provide for an appeal procedure in respect of a refusal pursuant to the first subparagraph.
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 67 Assessment by Member States):
1. Member States shall ensure that the persons validating and assessing the application, or deciding on it, do not have conflicts of interest, are independent of the sponsor, the investigators involved and of natural or legal persons financing the performance study, as well as free of any other undue influence. 2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. 4. Member States shall provide for an appeal procedure in respect of a refusal pursuant to the first subparagraph.
Article 68 Conduct of a performance study
1. The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study plan. 2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the performance study including the following: (a) the objective and methodology of the performance study; and (b) the degree of deviation of the intervention from normal clinical practice. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the performance study including the following: (a) the objective and methodology of the performance study; and (b) the degree of deviation of the intervention from normal clinical practice. 3. All performance study information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection. 4. Appropriate technical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves transmission over a network. 5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan. 6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the 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 68 Conduct of a performance study):
1. The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study plan. 2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the performance study including the following: (a) the objective and methodology of the performance study; and (b) the degree of deviation of the intervention from normal clinical practice. 3. All performance study information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection. 4. Appropriate technical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves transmission over a network. 5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan. 6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the study.
Article 69 Electronic system on performance studies
The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system: (a) to create the single identification numbers for performance studies referred to in Article 66(1); (b) to be used as an entry point for the submission of all applications or notifications for performance studies referred to in Articles 66, 70, 71 and 74 and for all other submission of data, or processing of data in this context; (c) for the exchange of information relating to performance studies in accordance with this Regulation between the Member States and between them and the Commission including the exchange of information referred to in to Articles 72 and 74; (d) for information to be provided by the sponsor in accordance with Article 73, including the performance study report and its summary as required in paragraph 5 of that Article; (e) for reporting on serious adverse events and device deficiencies, and related updates referred to in Article 76. 2. When setting up the electronic system referred to in paragraph 1 of this Article, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of the Council ( 5 ) as concerns performance studies of companion diagnostics. The information referred to in point (c) of paragraph 1 shall only be accessible to the Member States and the Commission. The information referred to in the other points of that paragraph shall be accessible to the public, unless, for all or parts of that information, confidentiality of the information is justified on any of the following grounds: (a) protection of personal data in accordance with Regulation (EC) No 45/2001; (b) protection of commercially confidential information, especially in the investigators brochure, in particular through taking into account the status of the conformity assessment for the device, unless there is an overriding public interest in disclosure; (c) effective supervision of the conduct of the performance study by the Member State(s) concerned. 4. No personal data of subjects shall be publicly available. 5. The user interface of the electronic system referred to in paragraph 1 shall be available in all official languages of the Union.
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 69 Electronic system on performance studies):
2. When setting up the electronic system referred to in paragraph 1 of this Article, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of the Council ( 5 ) as concerns performance studies of companion diagnostics. 4. No personal data of subjects shall be publicly available. 5. The user interface of the electronic system referred to in paragraph 1 shall be available in all official languages of the Union.
Article 70 Performance studies regarding devices bearing the CE marking
1. Where a performance study is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 18(1) (‘PMPF study’), and where the performance study would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in Article 69. The sponsor shall include the documentation referred to in Section 2 of Part A of Annex XIII and in Annex XIV. Points (b) to (l) and (p) of Article 58(5), Articles 71, 72 and 73, and Article 76(5) and (6), and the relevant provisions of Annexes XIII and XIV shall apply to PMPF studies. 2. Where a performance study is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 18(1), Articles 58 to 77 shall apply.
Article 71 Substantial modifications to performance studies
1. If a sponsor intends to introduce modifications to a performance study that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the study, it shall notify, within one week, by means of the electronic system referred to in Article 69, the Member State(s) in which the performance study is being or is to be conducted of the reasons for and the nature of those modifications. The sponsor shall include an updated version of the relevant documentation referred to in Annex XIV as part of the notification. Changes to the relevant documentation shall be clearly identifiable. 2. The Member State shall assess any substantial modification to the performance study in accordance with the procedure laid down in Article 67. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in paragraph 1, unless: (a) the Member State in which the performance study is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 67(4) or on considerations of public health, of subject and user safety or health, or of public policy; or (b) an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the performance study, which, in accordance with national law, is valid for that entire Member State. 4. The Member State(s) concerned may extend the period referred to in paragraph 3 by a further seven days, for the purpose of consulting with experts.
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 71 Substantial modifications to performance studies):
1. If a sponsor intends to introduce modifications to a performance study that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the study, it shall notify, within one week, by means of the electronic system referred to in Article 69, the Member State(s) in which the performance study is being or is to be conducted of the reasons for and the nature of those modifications. The sponsor shall include an updated version of the relevant documentation referred to in Annex XIV as part of the notification. Changes to the relevant documentation shall be clearly identifiable. 2. The Member State shall assess any substantial modification to the performance study in accordance with the procedure laid down in Article 67. 4. The Member State(s) concerned may extend the period referred to in paragraph 3 by a further seven days, for the purpose of consulting with experts.
Article 72 Corrective measures to be taken by Member States and information exchange between Member States on performance studies
1. Where a Member State in which a performance study is being or is to be conducted has grounds for considering that the requirements set out in this Regulation are not met, it may take at least any of the following measures on its territory: (a) revoke the authorisation for the performance study; (b) suspend or terminate the performance study; (c) require the sponsor to modify any aspect of the performance study. 2. Before the Member State concerned takes any of the measures referred to in paragraph 1 it shall, except where immediate action is required, ask the sponsor or the investigator or both for their opinion. That opinion shall be delivered within seven days. 3. Where a Member State has taken a measure referred to in paragraph 1 of this Article, or has refused a performance study, or has been notified by the sponsor of the early termination of a performance study on safety grounds, that Member State shall communicate the corresponding decision and the grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 69. 4. Where an application is withdrawn by the sponsor prior to a decision by a Member State, that information shall be made available through the electronic system referred to in Article 69 to all Member States and the Commission.
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 72 Corrective measures to be taken by Member States and information exchange between Member States on performance studies):
2. Before the Member State concerned takes any of the measures referred to in paragraph 1 it shall, except where immediate action is required, ask the sponsor or the investigator or both for their opinion. That opinion shall be delivered within seven days. 3. Where a Member State has taken a measure referred to in paragraph 1 of this Article, or has refused a performance study, or has been notified by the sponsor of the early termination of a performance study on safety grounds, that Member State shall communicate the corresponding decision and the grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 69. 4. Where an application is withdrawn by the sponsor prior to a decision by a Member State, that information shall be made available through the electronic system referred to in Article 69 to all Member States and the Commission.
Article 73 Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination
1. If the sponsor has temporarily halted a performance study or has terminated a performance study early, it shall inform within 15 days the Member States in which that performance study has been temporarily halted or terminated early, through the electronic system referred to in Article 69, of the temporary halt or early termination. In the event that the sponsor has temporarily halted or terminated early the performance study on safety grounds, it shall inform all Member States in which that performance study is being conducted thereof within 24 hours. 2. The end of a performance study shall be deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the performance study plan. 3. The sponsor shall notify each Member State in which that performance study was being conducted of the end of that performance study in that Member State. That notification shall be made within 15 days of the end of the performance study in relation to that Member State. 4. If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that performance study was conducted of the end of the performance study in all Member States. That notification shall be made within 15 days of that end of the performance study. 5. Irrespective of the outcome of the performance study, within one year of the end of the performance study or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a performance study was conducted a performance study report as referred to in Section 2.3.3. of Part A of Annex XIII. The performance study report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. Both the report and summary shall be submitted by the sponsor by means of the electronic system referred to in Article 69. Where, for scientific reasons, it is not possible to submit the performance study report within one year of the end of the study, it shall be submitted as soon as it is available. In such case, the clinical performance study plan referred to in Section 2.3.2. of Part A of Annex XIII shall specify when the results of the performance study are going to be available, together with a justification. 6. The Commission shall issue guidelines regarding the content and structure of the summary of the performance study report. In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of performance studies. 7. The summary and the performance study report referred to in paragraph 5 of this Article shall become publicly accessible through the electronic system referred to in Article 69, at the latest when the device is registered in accordance with Article 26 and before it is placed on the market. In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission. If the device is not registered in accordance with Article 26 within one year of the summary and the performance study report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at that point in time.