EU MedTech Forum 2022: Regulatory Unpredictability Spurs Renewed Calls For Devices Agency

In the EU, lack of regulatory predictability is creating frustration, sending innovators across the Atlantic, and has been a factor in calls for a devices agency. MedTech Europe’s Oliver Bisazza and BVMed’s Marc Pierre Möll reviewed the top concerns aired at the MedTech Forum in early May.

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Despite the implementation date of the IVD Regulation looming on 26 May and the Medical Device Regulation having been applicable for nearly a year now, there are many key uncertainties surrounding the implementation of both regulations.

The current unpredictability within the system has industry seeking urgent answers. So it was hardly surprising that the two sessions...