top of page
Glossary Term
EU MDR
Definition
The European Union Medical Device Regulation, also known as the EU MDR (Regulation (EU) 2017/745) is the regulatory framework for medical devices marketed in the European Union. It replaced the Medical Devices Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC) in May 2021, introducing stricter requirements for device safety, clinical evidence, post-market surveillance, and transparency.
Relevance to the MedTech Industry
The EU MDR ensures the safety, performance, and reliability of medical devices throughout their lifecycle. It focuses on patient safety, robust clinical data, and enhanced post-market monitoring to improve the quality and effectiveness of medical devices in the EU market.
Additional Information & Related Terms
bottom of page