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Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent.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.
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European Parliament Edges Closer To Adopting MDR Transition Proposal
The European Parliament voted in favor of using an accelerated process to adopt the European Commission’s proposed extension timelines for legacy devices in the context of the Medical Device Regulation and the removal of the “sell-off” date, which also applies to some IVDs.
Moves For Go Ahead For MDR Proposal To Be Discussed At European Parliament
The European Commission’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.
EU Regulatory Round-Up, March 2023: EU Deadlines Under MDR Amending Regulation Published And Clarified
This month’s round-up summarises the biggest EU medtech regulatory news in a year as legacy device transition periods are extended. A highly applauded commission summary of the new timelines under the EU’s MDR amending regulation provides key snapshot of the essential points.