On 9 December 2022, the EU Council decided to support a proposal to postpone the MDR deadline of 26 May 2024 until 2027 for Class III and IIb devices and May 2028 for Class IIa and I devices. The EU Commission and the EU Council will move forward with an amendment in the beginning of 2023 to extend the MDR deadline.
The EU Medical Devices Regulation (MDR) entered into force on 26 May 2021 and sets the framework for the authorisation process of all medical devices on the European market. According to the new rules, all medical devices must by 26 May 2024 be authorised under the new regulation to remain on the European market. However, by the end of 2024, it is estimated that around 22,000 certificates will expire, of which 4,000 will expire during 2023.
The MDR provides a transitional period as laid down in Article 120(3), and the current deadlines have sparked concern that widespread shortages of medical devices could be the result if the deadlines are left in place. The main reason for the major challenges is the work involved in obtaining certification from an accredited body and the lack of capacity in this regard. In addition, recent evaluations have shown that a considerable number of applications are rejected because they are insufficient.
During 2022, there has been a lot of policy work around the alignment of the MDR and, among other things, several guidelines have been set by the Medical Device Coordination Group (MDCG). This has proved not to be enough, and member states, on behalf of relevant stakeholders including both the public health organisations and the industry, have made calls for postponement.
In the interest of continued medical device availability and patient safety in the EU, France, Germany and Ireland have proposed the following:
- Extension of the transition period to 2027 for Class III and IIb, and to 2028 for Class IIa and I
- Extension of validity of MDD and AIMDD certificates to suit the aforementioned
- Extensions only apply if:
- No safety signals from PMS data
- Notified body application for conformity assessment in place before May 2024 and/or
- QMS certified to MDD by May 2024
The recommendation to postpone
In light of the above, the Commission presented the likely elements of a legislative proposal for a targeted amendment of the MDR and the IVDR during a session of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in Brussels on 9 December 2022. The Note of 6 December 2022 from the General Secretariat of the Council serves as the basis for the proposal (read here).
The Commission's outline of possible proposals for a revision of the MDR has three elements:
- an extension of the transitional period in Article 120(3) MDR with staggered deadlines depending on the risk class of the device. Those deadlines could be 2027 for class III and class IIb devices (i.e. devices with a higher risk) and 2028 for class IIa and class I devices (i.e. lower risk devices) that need the involvement of a notified body in the conformity assessment;
- if needed for legal and practical reasons (including for access to third country markets), the extension of the transitional period could be combined with an extension of the validity of certificates issued under Council Directives 90/385/EEC and 93/42/EEC by amending Article 120(2) MDR;
- conditions to be fulfilled in order to ensure that the extension applies only to devices that do not present any unacceptable risk to health and safety, have not undergone significant changes in design or intended purpose and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a certain deadline (e.g. 26 May 2024);
All EU member states agreed that the proposals presented by the European Commission should be pursued. The grounds for voting in favor of the proposal were, in essence, to ensure the continued availability of medical devices on the market and thus to ensure patient safety.
The EU Commission together with the Council will move forward with an amendment in the beginning of 2023 to extend the MDR deadline. According to the EU Commission, by May 2027, a comprehensive evaluation of the MDR will also be undertaken.
The purpose behind the increased safety requirements for medical devices in the MDR is patient safety. Several stakeholders are now asking the pertinent question, is the MDR even relevant when a proposal to postpone has been endorsed? The implementation challenges around MDR are, however, so critical in the eyes of both healthcare organisations and the industry that too much is at stake for patients and the healthcare system if action is not taken.
Certificates are still expiring on a daily basis and shortly after the EPSCO meeting, the MDCG published its Position Paper (MDCG 2022-18) to act as a bridging mechanism for devices with certificates expiring before the legislative amendment is implemented. MDCG 2022-18 outlines options for MDD/AIMDD devices with expired CE certificates and without MDR CE marking but which are still considered safe for use under MDR Article 97(1).
We will await a proposal for amending legislation, which may of course be different from that set out in the Note from the General Secretariat of the Council and as presented at the EPSCO meeting.