EU MDCG Paper Sheds Some Light On Hybrid Audit Rules, But Questions Remain
How much time do auditors need to spend on a manufacturer’s premises? A new EU document aims to clarify this and other issues, but questions remain
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All eyes were on the European Commission in January as it edged closer to adopting new legislation that will see the Medical Device Regulation transition deadlines extended.
Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent.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.