Commission proposes extension for certification period for medical devices in accordance with MDR
On Friday, 6 January 2023 the European Commission issued a proposal to extend transition periods to ensure sufficient time for devices that are on the market to be certified in accordance with the MD Regulation. The proposal includes longer transition periods for making evaluations by registered institutions, and the length of the new transition period would depend on the risk classification of the medical device in question.
The key elements of the proposal are:
- The transition period for medical devices put on the market before 26 May 2021 is to be extended under MDR, tiered according to risk classification. In the expanded transition period conditions would be applied that would benefit only those devices that are safe, and whose manufacturers have already taken measures to accommodate MDR.
- The “sell-off” date of MDR and the IVD Regulation would be removed.
Fimea reported already on 25 November 2022 on the Commission's plans to propose the change, and the content of the proposal that was announced on 6 January 2023 corresponds to what was reported in November.
Next the European Commission's proposal will go to the European Parliament and the Council for approval under expedited codecision procedure.
European Commission press release 6 January 2023:
Public health: more time to certify medical devices to mitigate risks of shortages (europa.eu)
(Folkhälsa: medicintekniska produkter (europa.eu))
European Health Union: Supporting the transition to the new medical device framework
Questions and Answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation (europa.eu)
European Commission proposal COM(2023) 10 final, 2023/0005 (COD):
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
European Commission website on MDR: New Regulations (europa.eu)
Fimea news item 25 November 2022: The Commission is preparing a legislative amendment to address MDR implementation challenges (in Finnish)
MD Regulation: Regulation of the European Parliament and of the Council on medical devices (EU) 2017/745
IVD Regulation: Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices (EU) 2017/746
Fimea news item 02/09/2022:
Guideline of the Medical Device Coordination Group MDCG 2022-14 published on solving challenges of implementing MD and IVD regulations (in Finnish)
- Susanna Peltoniemi, Head of Unit, Medical Devices, Tel. +358 29 522 3270
- Jari Knuuttila, Chief Specialist, Medical Devices, Tel. +358 29 522 3274
- E-mails take the format firstname.lastname@example.org