Europe | Extension of the transition period for medical devices

Commission 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. The proposed Regulation aims at introducing a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions. It also aims at deleting in both MDR and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) the 'sell-off' deadline after which devices placed on the market before or during the transition periods that are still in the supply chain would have to be withdrawn.

In view of the expected adoption of the Commission proposal by the European Parliament and the Council through an accelerated ordinary legislative procedure, the feedback period is reduced until 18 January 2023.