Crunch Time: Will EU Allow Article 97 Solution To MDR Bottlenecks Or Will MDR Be Delayed?

Do all roads lead back to the reopening of the Medical Device Regulation and risk-based staggered delays as was introduced with the IVD Regulation? Medtech Insight spoke to TÜV SÜD’s Dr Royth von Hahn and BSI’s Graeme Tunbridge, about how potential solutions to MDR delays are being received.

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What Is The Best Way To Solve The MDR Crisis?

The European Commission has long made it seem that any proposal to officially further extend the compliance deadlines laid out in the Medical Device Regulation (MDR) was off the table, despite the growing bottlenecks at notified bodies.

Some are hopeful the commission may yet change its mind as it did with the IVD Regulation to avoid products having to be removed from the market due to being...

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