In May 2021, the EU MDR replaced the EU's Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC). Manufacturers selling medical devices within the EU must adhere to these new regulations to ensure their products are safe to use.
After a one-year delay due to the pandemic, the European Medical Devices Regulation 2017/745 (EU MDR) is now in effect. The EU MDR is a regulatory framework for medical devices produced in or supplied to Europe. It replaces the Medical Device Directive (MDD), which has been in effect since the 1990s; the Active Implantable Medical Devices (AIMD); and the In-vitro Diagnostic Directive (IVDD). It also ushers in major changes in how medical device manufacturers obtain CE Marking and maintain access to the European market