How Has the EU Medical Device Regulation Impacted Medical Device Innovation?
The European Union (EU) Medical Device Regulation (MDR) has had a significant impact on medical device innovation since it was implemented in 2017. The MDR is a set of regulations that govern the safety and performance of medical devices sold in the EU. It replaces the previous Medical Device Directive (MDD) and is designed to ensure that medical devices are safe and effective for use by patients. The MDR has had a positive impact on medical device innovation in a number of ways. Firstly, it has increased the safety and