How the EU Medical Device Regulation is Affecting Medical Device Innovation
The European Union Medical Device Regulation (EU MDR) is a major piece of legislation that has been implemented to ensure the safety and efficacy of medical devices. This regulation has been in effect since May 2020, and it is having a significant impact on medical device innovation. The EU MDR requires medical device manufacturers to provide detailed information about their products, including clinical data, safety and performance data, and post-market surveillance data. This information must be submitted to the European Commission for review and approval. The EU MDR also requires