MDR Amendment Proposal Likely To Be Adopted In Two Weeks’ Time

Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent. It looks like the EU is keeping its foot on the accelerator to adopt its latest proposal despite concerns raised about the text.

The European Parliament is likely to vote on the text of the European Commission proposal to amend the EU’s Medical Device Regulation (MDR) without making any changes at first reading. This is scheduled to be during the 13-16 February 2023 plenary session and done through an urgent procedure.

If so, the document will then be adopted after a first reading and not lose further time by needing to...