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EU Regulatory Roundup, November 2023: Notified Body Advances But Sector Still Demands System Rethink
There is currently a melting pot of ideas concerning the future of the EU’s medtech regulatory system due to its shortfalls. All the while progress is being made, especially in the area notified bodies.
EU medtech industry association, MedTech Europe, published a position paper calling for reform of the medtech regulatory system during November.
The document is part of a growing crescendo of calls for remedying problems associated with the MDR and IVDR.