Happy 26 May 2024!

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 [...] « Read the rest of this article on medicaldeviceslegal »