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European Regulatory Roundup, July 2022: Threat Of Ongoing Hurdles Masks Progress

 
• By Amanda Maxwell

The first seven months of 2022 have seen significant progress on documents, tools and new structures needed for the MDR and IVDR implementation. But with major hurdles ahead, in July it was still the problems and not the successes taking centre stage

Top Stories EU

A significant amount of progress has been made in finalizing documents and processes needed for the implementation of the Medical Device Regulation (MDR) and IVD Regulation (IVDR), as the European Commission’s latest update to its rolling plan, issued in July, showed.

But despite this headway, the outcome of a recent extensive survey by MedTech Europe “clearly indicates an urgent need for immediate action” by decision-makers to help keep needed medical devices...

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