New transitional arrangements for the MDR and IVDR

Following the European Commission's proposal (explained here), Regulation 2023/607 of the European Parliament and of the Council of 15 March 2023 on transitional provisions for certain medical devices and in vitro diagnostic medical devices was published on 20 March 2023. The new Regulation amends Regulation (EU) 2017/745 of 5 April 2017 (“MDR”) and Regulation (EU) 2017/746 of 5 April 2017 (“IVDR”). 

Regulation 2023/607 extended the validity of certificates issued under the previous legislation. It also extended the transitional period during which devices complying with the previous legislation may be lawfully placed on the market.

The length of the transition period depends on the risk class of the medical devices concerned. Therefore, the period is shorter for devices belonging to a higher risk class and longer for devices belonging to a lower risk class, as we will explain below.

Get to know the new transitional arrangements on this Informative Note.