Commission Publishes Draft Implementing Regulation For Insufficiently Regulated Products
At last, common specifications for different groups of products that do not have an intended medical purpose but are covered in the scope of the EU’s Medical Device Regulation, are on the way.
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The European version of the international risk management standard, EN ISO 14971:2019, may have slipped through the net this January, but the European Commission has just published five new standards harmonized under the IVD Regulation.
Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent.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.