The days when the EU medtech regulatory system was favored by medtech innovators over its US Food and Drug Administration counterpart are long gone. That is not a new contention, in the era of the EU Medical Device Regulation, but the fact that increasing numbers of German medtech firms are voicing this view is sobering indeed.
The recent annual survey of market sentiment and business confidence by Germany’s BVMed shows that 67% of firms rate the FDA regulatory system above the EU’s MDR
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