Article 32 Summary of safety and clinical performance
1. For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance. The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed. The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available. The summary of safety and clinical performance shall include at least the following aspects: (a) the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN; (b) the intended purpose of the device and any indications, contraindications and target populations; (c) a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device; (d) possible diagnostic or therapeutic alternatives; (e) reference to any harmonised standards and CS applied; (f) the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up; (g) suggested profile and training for users; (h) information on any residual risks and any undesirable effects, warnings and precautions. 3. The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114(2).
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 32 Summary of safety and clinical performance):
1. For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance. The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed. The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available. 3. The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114(2).
Article 33 European database on medical devices
The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) for the following purposes: (a) to enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and about the relevant economic operators; (b) to enable unique identification of devices within the internal market and to facilitate their traceability; (c) to enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under Articles 62 to 80, Article 82, and any acts adopted pursuant to Article 81; (d) to enable manufacturers to comply with the information obligations laid down in Articles 87 to 90 or in any acts adopted pursuant to Article 91; (e) to enable the competent authorities of the Member States and the Commission to carry out their tasks relating to this Regulation on a well-informed basis and to enhance the cooperation between them. 2. Eudamed shall include the following electronic systems: (a) the electronic system for registration of devices referred to in Article 29(4); (b) the UDI-database referred to in Article 28; (c) the electronic system on registration of economic operators referred to in Article 30; (d) the electronic system on notified bodies and on certificates referred to in Article 57; (e) the electronic system on clinical investigations referred to in Article 73; (f) the electronic system on vigilance and post-market surveillance referred to in Article 92; (g) the electronic system on market surveillance referred to in Article 100. 3. When designing Eudamed the Commission shall give due consideration to compatibility with national databases and national web-interfaces to allow for import and export of data. 4. The data shall be entered into Eudamed by the Member States, notified bodies, economic operators and sponsors as specified in the provisions on the electronic systems referred to in paragraph 2. The Commission shall provide for technical and administrative support to users of Eudamed. 5. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2. The Commission shall ensure that public parts of Eudamed are presented in a user-friendly and easily-searchable format. 6. Eudamed shall contain personal data only insofar as necessary for the electronic systems referred to in paragraph 2 of this Article to collate and process information in accordance with this Regulation. Personal data shall be kept in a form which permits identification of data subjects for periods no longer than those referred to in Article 10(8). 7. The Commission and the Member States shall ensure that data subjects may effectively exercise their rights to information, of access, to rectification and to object in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall also ensure that data subjects may effectively exercise the right of access to data relating to them, and the right to have inaccurate or incomplete data corrected and erased. Within their respective responsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data are deleted, in accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as possible, but no later than 60 days after a request is made by a data subject. 8. The Commission shall, by means of implementing acts, lay down the detailed arrangements necessary for the setting up and maintenance of Eudamed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). When adopting those implementing acts, the Commission shall ensure that, as far as possible, the system is developed in such a way as to avoid having to enter the same information twice within the same module or in different modules of the system. 9. In relation to its responsibilities under this Article and the processing of personal data involved therein, the Commission shall be considered to be the controller of Eudamed and its electronic systems.
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 33 European database on medical devices):
3. When designing Eudamed the Commission shall give due consideration to compatibility with national databases and national web-interfaces to allow for import and export of data. 4. The data shall be entered into Eudamed by the Member States, notified bodies, economic operators and sponsors as specified in the provisions on the electronic systems referred to in paragraph 2. The Commission shall provide for technical and administrative support to users of Eudamed. 5. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2. The Commission shall ensure that public parts of Eudamed are presented in a user-friendly and easily-searchable format. 6. Eudamed shall contain personal data only insofar as necessary for the electronic systems referred to in paragraph 2 of this Article to collate and process information in accordance with this Regulation. Personal data shall be kept in a form which permits identification of data subjects for periods no longer than those referred to in Article 10(8). 7. The Commission and the Member States shall ensure that data subjects may effectively exercise their rights to information, of access, to rectification and to object in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall also ensure that data subjects may effectively exercise the right of access to data relating to them, and the right to have inaccurate or incomplete data corrected and erased. Within their respective responsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data are deleted, in accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as possible, but no later than 60 days after a request is made by a data subject. 8. The Commission shall, by means of implementing acts, lay down the detailed arrangements necessary for the setting up and maintenance of Eudamed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). When adopting those implementing acts, the Commission shall ensure that, as far as possible, the system is developed in such a way as to avoid having to enter the same information twice within the same module or in different modules of the system. 9. In relation to its responsibilities under this Article and the processing of personal data involved therein, the Commission shall be considered to be the controller of Eudamed and its electronic systems.
Article 34 Functionality of Eudamed
1. The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018. That plan shall seek to ensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2021 and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/746 are met. 2. The Commission shall, on the basis of an independent audit report, inform the MDCG when it has verified that Eudamed has achieved full functionality and Eudamed meets the functional specifications drawn up pursuant to paragraph 1. 3. The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European 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 34 Functionality of Eudamed):
1. The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018. 2. The Commission shall inform the MDCG when, on the basis of independent audit reports, it has verified that one or more of the electronic systems referred to in Article 33(2) are functional and meet the functional specifications drawn up pursuant to paragraph 1 of this Article. 3. The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union .
Article 35 Authorities responsible for notified bodies
1. Any Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an authority (‘authority responsible for notified bodies’), which may consist of separate constituent entities under national law and shall be responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, including subcontractors and subsidiaries of those bodies. 2. The authority responsible for notified bodies shall be established, organised and operated so as to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with conformity assessment bodies. 3. The authority responsible for notified bodies shall be organised in a manner such that each decision relating to designation or notification is taken by personnel different from those who carried out the assessment. 4. The authority responsible for notified bodies shall not perform any activities that notified bodies perform on a commercial or competitive basis. 5. The authority responsible for notified bodies shall safeguard the confidential aspects of the information it obtains. However, it shall exchange information on notified bodies with other Member States, the Commission and, when required, with other regulatory authorities. 6. The authority responsible for notified bodies shall have a sufficient number of competent personnel permanently available for the proper performance of its tasks. Where the authority responsible for notified bodies is a different authority from the national competent authority for medical devices, it shall ensure that the national authority responsible for medical devices is consulted on relevant matters. 7. Member States shall make publicly available general information on their measures governing the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and on changes which have a significant impact on such tasks. 8. The authority responsible for notified bodies shall participate in the peer-review activities provided for in Article 48.
Article 36 Requirements relating to notified bodies
1. Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation. They shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil those tasks. In particular, notified bodies shall comply with Annex VII. In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent availability of sufficient administrative, technical and scientific personnel in accordance with Section 3.1.1 of Annex VII and personnel with relevant clinical expertise in accordance with Section 3.2.4 of Annex VII, where possible employed by the notified body itself. The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified body itself and shall not be external experts or subcontractors. 2. Notified bodies shall make available and submit upon request all relevant documentation, including the manufacturer's documentation, to the authority responsible for notified bodies to allow it to conduct its assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined in this Chapter. 3. In order to ensure the uniform application of the requirements set out in Annex VII, the Commission may adopt implementing acts, to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 37 Subsidiaries and subcontracting
1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the authority responsible for notified bodies accordingly. 2. Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries. 3. Notified bodies shall make publicly available a list of their subsidiaries. 4. Conformity assessment activities may be subcontracted or carried out by a subsidiary provided that the legal or natural person that applied for conformity assessment has been informed accordingly. 5. Notified bodies shall keep at the disposal of the authority responsible for notified bodies all relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.
Article 38 Application by conformity assessment bodies for designation
1. Conformity assessment bodies shall submit an application for designation to the authority responsible for notified bodies. 2. The application shall specify the conformity assessment activities as defined in this Regulation, and the types of devices for which the body is applying to be designated, and shall be supported by documentation demonstrating compliance with Annex VII. In respect of the organisational and general requirements and the quality management requirements set out in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the corresponding evaluation report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008 may be submitted and shall be taken into consideration during the assessment described in Article 39. However, the applicant shall make available all the documentation referred to in the first subparagraph to demonstrate compliance with those requirements upon request. 3. The notified body shall update the documentation referred to in paragraph 2 whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements set out in Annex VII.
Article 39 Assessment of the application
1. The authority responsible for notified bodies shall within 30 days check that the application referred to in Article 38 is complete and shall request the applicant to provide any missing information. Once the application is complete that authority shall send it to the Commission. The authority responsible for notified bodies shall review the application and supporting documentation in accordance with its own procedures and shall draw up a preliminary assessment report. 2. The authority responsible for notified bodies shall submit the preliminary assessment report to the Commission which shall immediately transmit it to the MDCG. 3. Within 14 days of the submission referred to in paragraph 2 of this Article, the Commission, in conjunction with the MDCG, shall appoint a joint assessment team made up of three experts, unless the specific circumstances require a different number of experts, chosen from the list referred to in Article 40(2). One of the experts shall be a representative of the Commission who shall coordinate the activities of the joint assessment team. The other two experts shall come from Member States other than the one in which the applicant conformity assessment body is established. The joint assessment team shall be comprised of experts who are competent to assess the conformity assessment activities and the types of devices which are the subject of the application or, in particular when the assessment procedure is initiated in accordance with Article 47(3), to ensure that the specific concern can be appropriately assessed. 4. Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the application in accordance with Article 38. The joint assessment team may provide feedback to, or require clarification from, the authority responsible for notified bodies on the application and on the planned on-site assessment. The authority responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located inside or outside the Union, to be involved in the conformity assessment process. The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies. 5. Findings regarding non-compliance of an applicant conformity assessment body with the requirements set out in Annex VII shall be raised during the assessment process and discussed between the authority responsible for notified bodies and the joint assessment team with a view to reaching consensus and resolving any diverging opinions, with respect to the assessment of the application. At the end of the on-site assessment, the authority responsible for notified bodies shall list for the applicant conformity assessment body the non-compliances resulting from the assessment and summarise the assessment by the joint assessment team. Within a specified timeframe, the applicant conformity assessment body shall submit to the national authority a corrective and preventive action plan to address the non-compliances. 6. The joint assessment team shall document any remaining diverging opinions with respect to the assessment within 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies. 7. The authority responsible for notified bodies shall following receipt of a corrective and preventive action plan from the applicant body assess whether non-compliances identified during the assessment have been appropriately addressed. This plan shall indicate the root cause of the identified non-compliances and shall include a timeframe for implementation of the actions therein. The authority responsible for notified bodies shall having confirmed the corrective and preventive action plan forward it and its opinion thereon to the joint assessment team. The joint assessment team may request of the authority responsible for notified bodies further clarification and modifications. The authority responsible for notified bodies shall draw up its final assessment report which shall include: — the result of the assessment, — confirmation that the corrective and preventive actions have been appropriately addressed and, where required, implemented, — any remaining diverging opinion with the joint assessment team, and, where applicable, — the recommended scope of designation. 8. The authority responsible for notified bodies shall submit its final assessment report and, if applicable, the draft designation to the Commission, the MDCG and the joint assessment team. 9. The joint assessment team shall provide a final opinion regarding the assessment report prepared by the authority responsible for notified bodies and, if applicable, the draft designation within 21 days of receipt of those documents to the Commission, which shall immediately submit that final opinion to the MDCG. Within 42 days of receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft designation, which the authority responsible for notified bodies shall duly take into consideration for its decision on the designation of the notified body. 10. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements specifying procedures and reports for the application for designation referred to in Article 38 and the assessment of the application set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 40 Nomination of experts for joint assessment of applications for notification
1. The Member States and the Commission shall nominate experts qualified in the assessment of conformity assessment bodies in the field of medical devices to participate in the activities referred to in Articles 39 and 48. 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article, together with information on their specific field of competence and expertise. That list shall be made available to Member States competent authorities through the electronic system referred to in Article 57.
Article 41 Language requirements
All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages which shall be determined by the Member State concerned. Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in the medical field, for all or part of the documentation concerned. The Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or parts thereof into an official Union language, such as is necessary for that documentation to be readily understood by the joint assessment team appointed in accordance with Article 39(3).
Article 42 Designation and notification procedure
1. Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 39 was completed and which comply with Annex VII. 2. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they have designated, using the electronic notification tool within the database of notified bodies developed and managed by the Commission (NANDO). 3. The notification shall clearly specify, using the codes referred to in paragraph 13 of this Article, the scope of the designation indicating the conformity assessment activities as defined in this Regulation and the types of devices which the notified body is authorised to assess and, without prejudice to Article 44, any conditions associated with the designation. 4. The notification shall be accompanied by the final assessment report of the authority responsible for notified bodies, the final opinion of the joint assessment team referred to in Article 39(9) and the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it shall provide a duly substantiated justification. 5. The notifying Member State shall, without prejudice to Article 44, inform the Commission and the other Member States of any conditions associated with the designation and provide documentary evidence regarding the arrangements in place to ensure that the notified body will be monitored regularly and will continue to satisfy the requirements set out in Annex VII. 6. Within 28 days of the notification referred to in paragraph 2, a Member State or the Commission may raise written objections, setting out its arguments, with regard either to the notified body or to its monitoring by the authority responsible for notified bodies. Where no objection is raised, the Commission shall publish in NANDO the notification within 42 days of its having been notified as referred to in paragraph 2. 7. When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall bring the matter before the MDCG within 10 days of the expiry of the period referred to in paragraph 6. After consulting the parties involved, the MDCG shall give its opinion at the latest within 40 days of the matter having been brought before it. Where the MDCG is of the opinion that the notification can be accepted, the Commission shall publish in NANDO the notification within 14 days. 8. Where the MDCG, after having been consulted in accordance with paragraph 7, confirms the existing objection or raises another objection, the notifying Member State shall provide a written response to the MDCG opinion within 40 days of its receipt. The response shall address the objections raised in the opinion, and set out the reasons for the notifying Member State's decision to designate or not designate the conformity assessment body. 9. Where the notifying Member State decides to uphold its decision to designate the conformity assessment body, having given its reasons in accordance with paragraph 8, the Commission shall publish in NANDO the notification within 14 days of being informed thereof. 10. When publishing the notification in NANDO, the Commission shall also add to the electronic system referred to in Article 57 the information relating to the notification of the notified body along with the documents mentioned in paragraph 4 of this Article and the opinion and responses referred to in paragraphs 7 and 8 of this Article. 11. The designation shall become valid the day after the notification is published in NANDO. The published notification shall state the scope of lawful conformity assessment activity of the notified body. 12. The conformity assessment body concerned may perform the activities of a notified body only after the designation has become valid in accordance with paragraph 11. 13. The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). The Commission, after consulting the MDCG, may update this list based, inter alia , on information arising from the coordination activities described in Article 48.
Article 43 Identification number and list of notified bodies
1. The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 42(11). It shall assign a single identification number even when the body is notified under several Union acts. If they are successfully designated in accordance with this Regulation, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain the identification number assigned to them pursuant to those Directives. 2. The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO. It shall also make this list available on the electronic system referred to in Article 57. The Commission shall ensure that the list is kept up to date.
Article 44 Monitoring and re-assessment of notified bodies
1. Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they have been designated. 2. The authorities responsible for notified bodies shall monitor the notified bodies established on their territory and their subsidiaries and subcontractors to ensure ongoing compliance with the requirements and the fulfilment of its obligations set out in this Regulation. Notified bodies shall, upon request by their authority responsible for notified bodies, supply all relevant information and documents, required to enable the authority, the Commission and other Member States to verify compliance. 3. Where the Commission or the authority of a Member State submits a request to a notified body established on the territory of another Member State relating to a conformity assessment carried out by that notified body, it shall send a copy of that request to the authority responsible for notified bodies of that other Member State. The notified body concerned shall respond without delay and within 15 days at the latest to the request. The authority responsible for notified bodies of the Member State in which the body is established shall ensure that requests submitted by authorities of any other Member State or by the Commission are resolved by the notified body unless there is a legitimate reason for not doing so in which case the matter may be referred to the MDCG. 4. At least once a year, the authorities responsible for notified bodies shall re-assess whether the notified bodies established on their respective territory and, where appropriate, the subsidiaries and subcontractors under the responsibility of those notified bodies still satisfy the requirements and fulfil their obligations set out in Annex VII. That review shall include an on-site audit of each notified body and, where necessary, of its subsidiaries and subcontractors. The authority responsible for notified bodies shall conduct its monitoring and assessment activities according to an annual assessment plan to ensure that it can effectively monitor the continued compliance of the notified body with the requirements of this Regulation. That plan shall provide a reasoned schedule for the frequency of assessment of the notified body and, in particular, associated subsidiaries and subcontractors. The authority shall submit its annual plan for monitoring or assessment for each notified body for which it is responsible to the MDCG and to the Commission. 5. The monitoring of notified bodies by the authority responsible for notified bodies shall include observed audits of notified body personnel, including where necessary any personnel from subsidiaries and subcontractors, as that personnel is in the process of conducting quality management system assessments at a manufacturer's facility. 6. The monitoring of notified bodies conducted by the authority responsible for notified bodies shall consider data arising from market surveillance, vigilance and post-market surveillance to help guide its activities. The authority responsible for notified bodies shall provide for a systematic follow-up of complaints and other information, including from other Member States, which may indicate non-fulfilment of the obligations by a notified body or its deviation from common or best practice. 7. The authority responsible for notified bodies may in addition to regular monitoring or on-site assessments conduct short-notice, unannounced or ‘for-cause’ reviews if needed to address a particular issue or to verify compliance. 8. The authority responsible for notified bodies shall review the assessments by notified bodies of manufacturers' technical documentation, in particular the clinical evaluation documentation as further outlined in Article 45. 9. The authority responsible for notified bodies shall document and record any findings regarding non-compliance of the notified body with the requirements set out in Annex VII and shall monitor the timely implementation of corrective and preventive actions. 10. 5 years after notification of a notified body, and again every 5 years thereafter, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be conducted by the authority responsible for notified bodies of the Member State in which the body is established and by a joint assessment team in accordance with the procedure described in Article 39. 5 years after notification of a notified body, and again every 5 years thereafter, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be conducted by the authority responsible for notified bodies of the Member State in which the body is established and by a joint assessment team in accordance with the procedure described in Article 39. The authority responsible for notified bodies of the Member State in which the notified body is established may conduct a complete re-assessment prior to the dates referred to in the first subparagraph, upon request by the notified body or where, based on the results of the annual assessments conducted in accordance with paragraph 4 of this Article, it has concerns regarding the continued fulfilment by the notified body of the requirements set out in Annex VII. Complete re-assessments that have already started prior to 11 March 2023 shall continue to be conducted, unless the authority responsible for notified bodies of the Member State in which the notified body is established decides to suspend or terminate the ongoing complete re-assessment, taking into account its own resources and the resources of the notified body already spent on the re-assessment, as well as the results of the annual assessments conducted in accordance with paragraph 4 of this Article. Before suspending or terminating an ongoing complete re-assessment, the authority responsible for notified bodies shall hear the notified body concerned. 11. The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend paragraph 10 to modify the frequency at which the complete re-assessment referred to in that paragraph is to be carried out. 12. The Member States shall report to the Commission and to the MDCG, at least once a year, on their monitoring and on-site assessment activities regarding notified bodies and, where applicable, subsidiaries and subcontractors. The report shall provide details of the outcome of those activities, including activities pursuant to paragraph 7, and shall be treated as confidential by the MDCG and the Commission; however it shall contain a summary which shall be made publicly available. The summary of the report shall be uploaded to the electronic system referred to in Article 57.
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 44 Monitoring and re-assessment of notified bodies):
1. Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they have been designated. 2. The authorities responsible for notified bodies shall monitor the notified bodies established on their territory and their subsidiaries and subcontractors to ensure ongoing compliance with the requirements and the fulfilment of its obligations set out in this Regulation. Notified bodies shall, upon request by their authority responsible for notified bodies, supply all relevant information and documents, required to enable the authority, the Commission and other Member States to verify compliance. 3. Where the Commission or the authority of a Member State submits a request to a notified body established on the territory of another Member State relating to a conformity assessment carried out by that notified body, it shall send a copy of that request to the authority responsible for notified bodies of that other Member State. The notified body concerned shall respond without delay and within 15 days at the latest to the request. The authority responsible for notified bodies of the Member State in which the body is established shall ensure that requests submitted by authorities of any other Member State or by the Commission are resolved by the notified body unless there is a legitimate reason for not doing so in which case the matter may be referred to the MDCG. 4. At least once a year, the authorities responsible for notified bodies shall re-assess whether the notified bodies established on their respective territory and, where appropriate, the subsidiaries and subcontractors under the responsibility of those notified bodies still satisfy the requirements and fulfil their obligations set out in Annex VII. That review shall include an on-site audit of each notified body and, where necessary, of its subsidiaries and subcontractors. The authority responsible for notified bodies shall conduct its monitoring and assessment activities according to an annual assessment plan to ensure that it can effectively monitor the continued compliance of the notified body with the requirements of this Regulation. That plan shall provide a reasoned schedule for the frequency of assessment of the notified body and, in particular, associated subsidiaries and subcontractors. The authority shall submit its annual plan for monitoring or assessment for each notified body for which it is responsible to the MDCG and to the Commission. 5. The monitoring of notified bodies by the authority responsible for notified bodies shall include observed audits of notified body personnel, including where necessary any personnel from subsidiaries and subcontractors, as that personnel is in the process of conducting quality management system assessments at a manufacturer's facility. 6. The monitoring of notified bodies conducted by the authority responsible for notified bodies shall consider data arising from market surveillance, vigilance and post-market surveillance to help guide its activities. The authority responsible for notified bodies shall provide for a systematic follow-up of complaints and other information, including from other Member States, which may indicate non-fulfilment of the obligations by a notified body or its deviation from common or best practice. 7. The authority responsible for notified bodies may in addition to regular monitoring or on-site assessments conduct short-notice, unannounced or ‘for-cause’ reviews if needed to address a particular issue or to verify compliance. 8. The authority responsible for notified bodies shall review the assessments by notified bodies of manufacturers' technical documentation, in particular the clinical evaluation documentation as further outlined in Article 45. 9. The authority responsible for notified bodies shall document and record any findings regarding non-compliance of the notified body with the requirements set out in Annex VII and shall monitor the timely implementation of corrective and preventive actions. 10. 5 years after notification of a notified body, and again every 5 years thereafter, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be conducted by the authority responsible for notified bodies of the Member State in which the body is established and by a joint assessment team in accordance with the procedure described in Article 39. The authority responsible for notified bodies of the Member State in which the notified body is established may conduct a complete re-assessment prior to the dates referred to in the first subparagraph, upon request by the notified body or where, based on the results of the annual assessments conducted in accordance with paragraph 4 of this Article, it has concerns regarding the continued fulfilment by the notified body of the requirements set out in Annex VII. Complete re-assessments that have already started prior to 11 March 2023 shall continue to be conducted, unless the authority responsible for notified bodies of the Member State in which the notified body is established decides to suspend or terminate the ongoing complete re-assessment, taking into account its own resources and the resources of the notified body already spent on the re-assessment, as well as the results of the annual assessments conducted in accordance with paragraph 4 of this Article. Before suspending or terminating an ongoing complete re-assessment, the authority responsible for notified bodies shall hear the notified body concerned. 11. The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend paragraph 10 to modify the frequency at which the complete re-assessment referred to in that paragraph is to be carried out. 12. The Member States shall report to the Commission and to the MDCG, at least once a year, on their monitoring and on-site assessment activities regarding notified bodies and, where applicable, subsidiaries and subcontractors. The report shall provide details of the outcome of those activities, including activities pursuant to paragraph 7, and shall be treated as confidential by the MDCG and the Commission; however it shall contain a summary which shall be made publicly available. The summary of the report shall be uploaded to the electronic system referred to in Article 57.
Article 45 Review of notified body assessment of technical documentation and clinical evaluation documentation
1. The authority responsible for notified bodies, as part of its ongoing monitoring of notified bodies, shall review an appropriate number of notified body assessments of manufacturers' technical documentation, in particular the clinical evaluation documentation as referred to in points (c) and (d) of Section 6.1 of Annex II to verify the conclusions drawn by the notified body based on the information presented by the manufacturer. The reviews by the authority responsible for notified bodies shall be conducted both off-site and on-site. 2. The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and representative of the types and risk of devices certified by the notified body, in particular high-risk devices, and be appropriately justified and documented in a sampling plan, which shall be made available by the authority responsible for notified bodies to the MDCG upon request. 3. The authority responsible for notified bodies shall review whether the assessment by the notified body was conducted appropriately and shall check the procedures used, associated documentation and the conclusions drawn by the notified body. Such checking shall include the technical documentation and clinical evaluation documentation of the manufacturer upon which the notified body has based its assessment. Such reviews shall be conducted utilising CS. 4. Those reviews shall also form part of the re-assessment of notified bodies in accordance with Article 44(10) and the joint assessment activities referred to in Article 47(3). The reviews shall be conducted utilising appropriate expertise. 5. Based on the reports of the reviews and assessments by the authority responsible for notified bodies or joint assessment teams, on input from the market surveillance, vigilance and post-market surveillance activities described in Chapter VII, on the continuous monitoring of technical progress, or on the identification of concerns and emerging issues concerning the safety and performance of devices, the MDCG may recommend that the sampling, carried out under this Article, cover a greater or lesser proportion of the technical documentation and clinical evaluation documentation assessed by a notified body. 6. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements, associated documents for, and coordination of, the review of assessments of technical documentation and clinical evaluation documentation, as referred to in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 46 Changes to designations and notifications
1. The authority responsible for notified bodies shall notify the Commission and the other Member States of any relevant changes to the designation of a notified body. The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation. For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply. 2. The Commission shall immediately publish the amended notification in NANDO. The Commission shall immediately enter information on the changes to the designation of the notified body in the electronic system referred to in Article 57. 3. Where a notified body decides to cease its conformity assessment activities it shall inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of the notified body's activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new notified body shall complete a full assessment of the devices affected by the end of that period before issuing new certificates for those devices. Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation. 4. Where a authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same period. The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a designation. 5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days. 6. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to authorities in other Member States responsible for notified bodies and to authorities responsible for market surveillance at their request. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall: (a) assess the impact on the certificates issued by the notified body; (b) submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation; (c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued to ensure the safety of devices on the market; (d) enter into the electronic system referred to in Article 57 information in relation to certificates of which it has required their suspension or withdrawal; (e) inform the competent authority for medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 57 of the certificates for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or others. 8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances: (a) the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction, and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction. In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances: (a) the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction, and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction. In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction. 9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances: (a) where the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and (b) another notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the withdrawal of the designation. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances: (a) where the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and (b) another notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the withdrawal of the designation. In the circumstances referred to in the first subparagraph, the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months. The authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
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 46 Changes to designations and notifications):
1. The authority responsible for notified bodies shall notify the Commission and the other Member States of any relevant changes to the designation of a notified body. The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation. For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply. 2. The Commission shall immediately publish the amended notification in NANDO. The Commission shall immediately enter information on the changes to the designation of the notified body in the electronic system referred to in Article 57. 3. Where a notified body decides to cease its conformity assessment activities it shall inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of the notified body's activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new notified body shall complete a full assessment of the devices affected by the end of that period before issuing new certificates for those devices. Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation. 4. Where a authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same period. The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a designation. 5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days. 6. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to authorities in other Member States responsible for notified bodies and to authorities responsible for market surveillance at their request. 8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances: (a) the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction, and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction. In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction. 9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances: (a) where the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and (b) another notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the withdrawal of the designation. In the circumstances referred to in the first subparagraph, the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months. The authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
Article 47 Challenge to the competence of notified bodies
1. The Commission, in conjunction with the MDCG, shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body, or of one or more of its subsidiaries or subcontractors, of the requirements set out in Annex VII or the obligations to which they are subject. It shall ensure that the relevant authority responsible for notified bodies is informed and is given an opportunity to investigate those concerns. 2. The notifying Member State shall provide the Commission, on request, with all information regarding the designation of the notified body concerned. 3. The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure described in Article 39(3) and (4), where there is reasonable concern about the ongoing compliance of a notified body or a subsidiary or subcontractor of the notified body with the requirements set out in Annex VII and where the investigation by the authority responsible for notified bodies is not deemed to have fully addressed the concerns or upon request of the authority responsible for notified bodies. The reporting and outcome of that assessment shall follow the principles of Article 39. Alternatively, depending on the severity of the issue, the Commission, in conjunction with the MDCG, may request that the authority responsible for notified bodies allow the participation of up to two experts from the list established pursuant to Article 40 in an on-site assessment as part of the planned monitoring and assessment activities in accordance with Article 44 and as outlined in the annual assessment plan described in Article 44(4). 4. Where the Commission ascertains that a notified body no longer meets the requirements for its designation, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the designation if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of implementing acts, suspend, restrict or withdraw the designation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). It shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in Article 57. 5. The Commission shall ensure that all confidential information obtained in the course of its investigations is treated accordingly.
Article 48 Peer review and exchange of experience between authorities responsible for notified bodies
The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the authorities responsible for notified bodies. Such exchange shall cover elements including: (a) development of best practice documents relating to the activities of the authorities responsible for notified bodies; (b) development of guidance documents for notified bodies in relation to the implementation of this Regulation; (c) training and qualification of the experts referred to in Article 40; (d) monitoring of trends relating to changes to notified body designations and notifications and trends in certificate withdrawals and transfers between notified bodies; (e) monitoring of the application and applicability of scope codes referred to in Article 42(13); (f) development of a mechanism for peer reviews between authorities and the Commission; (g) methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies. 2. The authorities responsible for notified bodies shall participate in a peer review every third year through the mechanism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be conducted in parallel with the on-site joint assessments described in Article 39. Alternatively, an authority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 44. 3. The Commission shall participate in the organisation and provide support to the implementation of the peer review mechanism. 4. The Commission shall compile an annual summary report of the peer review activities, which shall be made publicly available. 5. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and related documents for the peer review mechanism and training and qualification as referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2017/745 (the ‘Medical Devices Regulation’ (MDR)) 1 and Regulation (EU) 2017/746 (the ‘ In Vitro Diagnostic Medical Devices Regulation’ (IVDR)) 2 of the European Parliament and of the Council set a strengthened regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs). Their objectives are a high level of protection of health for patients and users and the smooth functioning of the single market for these products. To achieve these objectives and to address issues identified with the previous regulatory framework, the Regulations set up a more robust system of conformity assessment to ensure the quality, safety and performance of devices placed on the EU market. The MDR has applied since 26 May 2021 3 . The transitional period provided for in Article 120 has been extended by Regulation (EU) 2023/607 4 and will end on either 31 December 2027 or 31 December 2028, depending on the device’s risk class and subject to certain conditions. The IVDR has applied since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions 5 . This extension was not subject to conditions similar to the ones laid down for medical devices by Regulation (EU) 2023/607. This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions. Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs. a) Transition of devices to the IVDR There is a wide variety of IVDs, including HIV tests for blood donation screening or individual diagnosis, cancer tests, pregnancy tests or SARS-CoV-2 tests. Around two thirds of all clinical decisions are based on information provided by IVDs 6 . It is paramount to ensure both a high level of safety and performance of IVDs and their availability to healthcare systems . The IVDR has introduced very substantial changes to the regulatory framework for IVDs with significant resource and capacity implications . According to the IVDR, IVDs are classified into different risk classes from class A (low risk) to class D (high risk). One of the most profound changes is the increased involvement of independent conformity assessment bodies (‘notified bodies’) in conformity assessment, in a way that is proportionate to the device’s risk class. Under the previous Directive 98/79/EC 7 , only a relatively small number of high-risk devices, i.e. about 8% of the more than 40 000 IVDs on the EU market covered by the Directive 8 , were subject to scrutiny by notified bodies. In October 2022, there were 1 551 valid certificates issued by notified bodies under Directive 98/79/EC 9 . Some of these have already expired (38 in 2022 and 165 in 2023); 482 certificates will expire in 2024 and 866 certificates will expire in 2025 (by 26 May) 10 . Under the IVDR, around 80% of IVDs will be subject to scrutiny by notified bodies, most of them for the first time 8 . As a consequence, the number of certificates under the IVDR is expected to be significantly higher than the number of certificates issued under Directive 98/79/EC . The relationship between the number of devices and the number of certificates covering them is complex, so no precise calculation can be made, but numbers in the order of 15 000 certificates and higher could reasonably be expected. M ore than 1 000 devices are in the highest risk class ( class D ) 11 . Under the IVDR , these devices require the issuance of both a quality management system certificate and an individual device technical documentation assessment certificate. Those figures are in stark contrast to the low number of certificates already issued and ongoing applications under the IVDR. In fact, the vast majority of IVDs have not yet transitioned to the IVDR. As of end of October 2023, manufacturers had submitted 1 378 applications for conformity assessment under the IVDR, resulting in 677 certificates issued by notified bodies across all risk classes. For class D IVDs, only 335 applications had been submitted and 117 certificates had been issued 12 . While there are still several years of transitional period remaining for classes C, B and A sterile, the transitional period for class D devices ends on 26 May 2025. Given the low number of certificates and applications for class D IVDs, and the long duration of the conformity assessment process as explained below, there is a high risk of shortages of many of these devices. Class D devices are used, for example, to test for infections in blood or organ donations, to test patients for life-threatening infectious diseases, or for blood grouping for transfusions. Therefore, there is a high risk of a public health crisis if there is a shortage of such devices. As explained above, in January 2022, the European Parliament and the Council adopted a staggered extension of the transitional period due to the impact of the COVID-19 pandemic. The slow rate of transition has made this extension insufficient. The reasons are multifaceted; however, they are underpinned by the far‑reaching nature of changes introduced by the IVDR and the resulting increased need for scientific, technical and regulatory expertise and capacity at all levels in the system, which require time to be built up. A t present, only 12 notified bodies 13 are designated under the IVDR, compared to 22 notified bodies designated under Directive 98/79/EC (18 after the UK’s withdrawal from the EU) . A f urther 8 applications for designation as notified body are currently in pro gress. The staggering of the transitional periods by risk class in 2022 meant that the workload on notified bodies could be distributed over time , and provided relief to the sector 14 . Nevertheless, access to notified bodies has remained an issue, especially for small to medium-sized enterprises (SMEs ) 11 . Notified bodies are also facing challenges due to the extensive changes introduced by the IVDR. They must apply new requirements for types of devices that they have not handled previously. The duration of the notified body’s assessment is affected by the often insufficient quality of manufacturers’ applications 15 . A s of July 2023 , t he average duration of the conformity assessment process combining quality management system and technical documentation assessment was around 18 months 15 . Thus, the overall notified body capacity in the EU is limited, due to both low numbers of notified bodies and challenges to their efficient and smooth operation. Additional transition time is needed to help address this persisting problem. More notified bodies will be designated over time and the efficiency in processing applications will improve as both manufacturers and notified bodies gain more experience with the IVDR. In the short term, it is also important to maintain the staggering of transitional periods by risk class to avoid a bottleneck at the level of notified bodies. Furthermore , it appears that many manufacturers are not sufficiently prepared to demonstrate compliance with the requirements of the IVDR. This may be due to various causes, including the complexity of these new requirements, lack of experience of interaction with notified bodies, and the continuous development of the IVDR framework, such as ongoing designation of notified bodies, and for class D IVDs adoption of common specifications and designation of EU reference laboratories. Around 90% of medical device companies are SMEs 16 , for which managing the transition can be especially challenging. More and more tools are being put in place to support manufacturers, with particular attention to SMEs, including : (i) guidance by the Medical Device Coordination Group (MDCG) and by notified bodies ; (ii) webinars and training by notified bodies ; (iii) structured dialogue with notified bodies 17 ; or (iv) EU-funded work to make notified body capacity more visible 18 . Additional transition time is necessary to allow manufacturers to make greater use of these tools and therefore support the transition of their devices to the IVDR . This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements. The need for additional time is most acute for mitigating shortages of class D devices. They constitute about 4% of the market 16 but their conformity assessment is intensive due to the requirement for individual technical documentation assessment and, where relevant, involvement of the scientific bodies (expert panel and EU reference laboratories). With only 12 notified bodies currently designated, capacity in the system to perform the required third party assessments remains limited, so an extension of the transitional period for class D IVDs should be combined with a shift in the transition deadlines for the other device groups as well to avoid a bottleneck in the certification process and to prevent shortages of these devices too. Class C and class B are large device groups (representing 26% and 49% of the market, respectively), and some of them are also subject to special requirements such as individual technical documentation assessment. It is also logical from the perspective of protection of public health that higher risk classes should be subject to the more stringent rules earlier than lower risk classes. The extension should be subject to conditions to support the transition to the IVDR, similar to the approach adopted in Regulation (EU) 2023/607, which extended the MDR transitional period. These conditions will ensure that only manufacturers that are actively taking the necessary steps to transition to the new rules and continue to place on the market devices meeting high safety standards will benefit from the additional time. In addition, at the latest by 26 May 2025, all manufacturers will have to put in place a quality management system in accordance with Article 10(8) IVDR. Such an approach respects the work of those manufacturers that have already taken the necessary steps to comply with the IVDR. Finally, it is clear that an extension of the transitional period will provide only a short-term solution to mitigate the risk of shortages. It will not solve certain underlying structural problems related to the implementation of the IVDR, notably with regard to the specific situation of SMEs. Moreover, the transition must be completed to ensure the credibility and robustness of the EU medical device regulatory system and to provide the necessary legal certainty for a stable, innovative and safe environment. It is necessary to analyse problems related to the implementation of the IVDR and the MDR, and their root causes, to identify shortcomings of the regulatory framework and remedy them in the medium term with a view to ensuring patient safety and access to safe and performant devices in a sustainable manner. b) European database on med ic al devices (E udamed ) In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). Eudamed must include seven electronic systems including the UDI database 19 . It is being developed in accordance with functional specifications drawn up by the Commission in collaboration with the MDCG and endorsed by the MDCG. Pursuant to these specifications, Eudamed will consist of six modules 20 , covering all the features specified by the Regulations: UDI/Devices, Actors, Notified bodies/Certificates, Post-Market Surveillance and Vigilance, Market Surveillance, and Clinical investigations/Performance studies . Three Eudamed modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further modules (Market Surveillance; Post-Market Surveillance and Vigilance) are expected to be completed in Q2/2024. The last module (Clinical investigations/Performance studies) will not be completed before Q3/2026. Pursuant to the current MDR rules, Eudamed can only be used mandatorily from a certain date after the Commission has verified that Eudamed is fully functional and has published a notice to that effect. Therefore, the delayed development of the last module holds back the mandatory use of the electronic systems that have been completed already. The mandatory use of all six modules thus cannot be expected before Q4/2027, with additional transitional periods not ending before Q2/2029. However, the use of Eudamed is key for effective and efficient implementation of the MDR and IVDR and of high value to the work of the competent authorities and the Commission in monitoring the market. Moreover, the deployment of Eudamed has profound and beneficial implications in terms of resource savings for manufacturers as it prevents multiple registrations or instances of communication of data at national level. This proposal aims to enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025. Consequently, also the specific transitional provisions in the MDR and IVDR related to Eudamed need to be amended to enable a smooth progressive transfer from multiple registrations in national databases to a single registration in Eudamed. In addition, having regard to the delay in the development of the module for clinical investigations / performance studies, the timelines for the application of the coordinated assessment of clinical investigations and performance studies need to be adapted. Keeping the approach provided for in the MDR and the IVDR, the coordinated assessment should first be applied by Member States on an ‘opt-in’ basis. Five years after its voluntary application, the coordinated assessment should become mandatory for all Member States. c) Prior notice if supply of certain medical devices and in vitro diagnostic medical devices is stopped Healthcare professionals, industry and competent authorities have reported that during the transitional period of the MDR and the IVDR, the supply of many medical devices and IVDs has or is likely to be stopped. In certain cases, especially if no or few alternative devices are available, the interruption of supply can result in serious harm or a risk of serious harm to patients or public health. This proposal aims to impose an obligation on manufacturers to inform their relevant competent authority and health institutions before they cease, temporarily or permanently, the supply of a critical device. If manufacturers do not supply directly to health institutions or healthcare professionals, they should inform the relevant economic operators in the supply chain, which then can inform the health institutions. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety. In accordance with Article 105 MDR, the MDCG may decide to provide guidance with the aim to ensure effective and harmonised implementation of this prior notice mechanism. 
Revised version (Article 48 Peer review and exchange of experience between authorities responsible for notified bodies):
2. The authorities responsible for notified bodies shall participate in a peer review every third year through the mechanism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be conducted in parallel with the on-site joint assessments described in Article 39. Alternatively, an authority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 44. 3. The Commission shall participate in the organisation and provide support to the implementation of the peer review mechanism. 4. The Commission shall compile an annual summary report of the peer review activities, which shall be made publicly available. 5. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and related documents for the peer review mechanism and training and qualification as referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 49 Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices. This group shall meet on a regular basis and at least annually. The bodies notified under this Regulation shall participate in the work of that group. The Commission may establish the specific arrangements for the functioning of the coordination group of notified bodies.
Article 50 List of standard fees
Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available.
Article 51 Classification of devices
1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII. 2. Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in the last indent of point (b) of the second paragraph of Section 2.2 of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body. The competent authority of the Member State in which the manufacturer has its registered place of business shall notify the MDCG and the Commission of its decision. The decision shall be made available upon request. 3. At the request of a Member State the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices; (b) that a device, or category or group of devices, shall for reasons of public health based on new scientific evidence, or based on any information which becomes available in the course of the vigilance and market surveillance activities be reclassified, by way of derogation from Annex VIII. At the request of a Member State the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices; (b) that a device, or category or group of devices, shall for reasons of public health based on new scientific evidence, or based on any information which becomes available in the course of the vigilance and market surveillance activities be reclassified, by way of derogation from Annex VIII. 4. The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3. 5. In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. 6. The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with the examination procedure referred to in Article 114(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 51 Classification of devices):
1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII. 2. Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in the last indent of point (b) of the second paragraph of Section 2.2 of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body. The competent authority of the Member State in which the manufacturer has its registered place of business shall notify the MDCG and the Commission of its decision. The decision shall be made available upon request. 3. At the request of a Member State the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices; (b) that a device, or category or group of devices, shall for reasons of public health based on new scientific evidence, or based on any information which becomes available in the course of the vigilance and market surveillance activities be reclassified, by way of derogation from Annex VIII. 4. The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3. 5. In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. 6. The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with the examination procedure referred to in Article 114(3).