Impact of EU Medical Device Regulation (MDR) on Medical Device Innovation
The European Union (EU) Medical Device Regulation (MDR) has been in effect since May 2020 and has had a significant impact on medical device innovation. The MDR is a comprehensive regulatory framework that sets out the requirements for the safety, quality, and performance of medical devices sold in the EU. It replaces the previous Medical Device Directives (MDDs) and is designed to ensure that medical devices are safe and effective for use by patients and healthcare professionals. The MDR has had a major impact on medical device innovation, as it