The European Commission accepted the proposal to extend the EU MDR transition period and removal of the sell-off period for MDR and IVDR. This is published on 20 March 2023 in the Official Journal of the EU. The extension gives manufacturers more time to complete the transition to EU MDR whilst allowing more time for the designation of Notified Bodies to ensure overall sufficient capacity for certification. For Class III and IIb implantables, the transition period is extended until 31 December 2027 while for IIb, IIa, Im, Is, and Ir devices the date is extended until 31 December 2028 being it subject to certain conditions to ensure patient safety. Only devices for which the manufacturer has already taken steps to transition to the EU MDR will benefit from the additional time.
The Medicines and Healthcare products Regulatory Agency (MHRA) took some time to consider what the implications of these revisions are for the acceptance of CE-marked devices on the UK market. Their official statement is published on 28 March 2023 and confirms the continued recognition of valid CE certificates subject to the extended transitional provisions of the EU . This mitigates the risk of medical device supply shortage and ensures safe access of devices on the market.
This decision has impact on the MHRA medical device/IVD database (DORS) because CE certificates are uploaded in the system with the expiration date. The MHRA will update the registration guidance to reflect this change and to provide insight in how manufacturers or UK Responsible Persons can update this in DORS.
Want to learn if your devices are subject to the specific conditions for extension of CE certificates?
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Q&A on practical aspects transitional provisions for certain medical devices
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Factsheet European Health Union: Supporting the transition to the new medical device framework
If you have additional questions please send them to globalreg@qservegroup.com
[1] Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
[2] Extension of CE certificates
[3] Register medical devices to place on the market