The MDR/IVDR amendment is published in the EU’s Official Journal and has entered into force

The extension of the MDR transitional period and the deletion of the MDR/IVDR 'sell-off' dates has entered into force.

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.

The Commission's DG SANTE will publish soon a Q&A on the practical aspects related to the implementation of this amending Regulation.