The MDR and IVDR are now in force for seven (7) years, and they are not in good shape.
I think it is safe to say that they did not deliver on their promise of a better, more streamlined and more SME and innovation friendly regulatory system.
Deadlines keep being moved, patchwork happens here and there. But it is still not a world-class regulatory system – essential parts like Eudamed are not even finished yet. Innovation is fleeing to other jurisdictions and hospitals complain about shorta [...]
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