According to the announcement of the MDR, the transition period will end on May 26, 2024. However, the current Notified Body (NB)’s MDR certification capabilities are insufficient and manufacturers ‘lack of readiness still cannot be improved. The committee promises to submit a report to the EPSCO Council on December 9, 2022 and propose further solutions if necessary.
　　
At the special MDCG meeting on November 17, 2022 devoted to the transition to MDR, representatives of many member states spoke in support of extending the transition provisions related to certain conditions set out in MDR Article 120 to give manufacturers and notified bodies (NB) more time to conduct the compliance assessment process. NB also agreed that it was necessary to give them and manufacturers more time to transition to MDR, especially for some high-risk equipment (especially those requiring consultation procedures) that the extension to May 2026 may be too short.

The committee will present possible elements of a legislative proposal to target revisions to the MDR and IVDR at the EPSCO Health Council on December 9, 2022.
　　
MDR Extension Proposal Details
　　
1. The transition period for MDR Article 120 will be extended and the transition period will be staggered according to the risk category of the device. For Class III and Class IIb devices (i.e., higher-risk devices), the transition period deadline may be 2027, and for Class IIa and Class I devices (i.e., lower-risk devices), these deadlines may be 2028;
　　
2. If necessary for legal and practical reasons (including access to third country markets), MDR Article 120 can be revised, combining the extension of the transition period with the extension of the validity period of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC;
　　
3. Conditions that need to be met to ensure that the extension applies only to enterprises that do not pose any unacceptable risks to health and safety, that have not undergone significant changes in design or intended use, and that the manufacturer has taken the necessary steps to initiate the certification process under the MDR, such as adapting its quality management system to the MDR and having the notified body submit and/or accept the manufacturer’s conformity assessment application before a certain deadline (e.g. May 26, 2024);
　　
4. Delete the “sales after expiration” clause in MDR Article 120 and IVDR Article 110.
　　
European Commission opinion
　　
Given the urgency of the legislative initiative and the need for co-legislators to pass the changes quickly so that they can have the desired effect in a timely manner, the committee believes that changes should be kept at the current level in a timely manner.
　　
By May 2027, the committee will also conduct a comprehensive assessment of MDRs. If there is evidence that the new rules will fail to achieve their goals or have a negative impact on patient safety, public health or medical innovation, the committee will consider proposing amendments as appropriate.