The revised provisions provide medical device and in-vitro diagnostics manufacturers with additional time to bring their product into compliance with the new EU Regulations, subject to a number of conditions.

On March 20, 2023, Regulation (EU) no 2023/607 was published in the Official Journal of the European Union, following speedy adoption by the European Parliament and Council. The new Regulation amends Regulation (EU) no 2017/745 (MDR) and Regulation (EU) no 2017/746 (IVDR) and extends the transitional periods set out under these two regulations.