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

 
• By Amanda Maxwell

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.

Business questions (TierneyMJ/Shutterstock.com)

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

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