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European Health and Digital Executive Agency (HaDEA)
News article26 May 2021

Public health: Stronger rules on medical devices

As of today, new EU rules on medical devices (MDR) enter into application, establishing a modern and more robust regulatory framework to protect public health and patient safety. The new rules start applying after a one-year postponement due to the unprecedented challenges of the coronavirus pandemic, addressing the need for an increased availability of vitally important medical devices across the EU.

Questions & Answers: Application of Regulation on Medical Devices – EU rules to ensure safety of medical devices

Clinical investigation application/notification documents


Publication date
26 May 2021
Programme Sector
Public health