What is Medical Device Regulation (MDR)?

Medical Device Regulation Definition

The medical device regulation (MDR) or European Union medical device regulation (EU MDR) is a new set of regulations that govern the clinical investigation, production and distribution of medical devices in Europe. Compliance with this regulation is mandatory for medical device companies that want to sell their products in the European marketplace. The MDR replaces the EU’s previous Medical Device Directive (MDD) and Active Implantable Medical Devices Directive. Under the new medical device regulation, manufacturers need to provide more in-depth clinical data to demonstrate their safety and performance claims.