Why Many MDD Certificates Will Be Invalid Before Their MDR Replacements Can Be Issued
The initial virtual audit ban is just one obstacle to timely EU MDR compliance. Another is that many companies have seriously underestimated how much time they need, even with the grace period.
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Almost half of companies polled on extra resources needed to comply with the EU Medical Device Regulation are preparing for considerable outlay. Manufacturers are also falling short in digital readiness.
Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent.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.