EU’s Updated Plan Of Action To Plug The IVDR Gaps: All Hands To The Pump
There is still a long way to go to ensure all documents and structures needed for the implementation of the EU's IVD Regulation on 26 May 2022 are ready. An updated plan shows the steps and deadlines that the EU intends to take to arrive on time.
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The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.
Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent.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 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.