What is EUMDR?

The European Union Medical Device Regulation (EUMDR) is Regulation (EU) 2017/745 of the European Parliament and of the Council concerning medical devices. It aims to ensure the safety and performance of medical devices placed on the EU market, improving health protection for patients and users. It establishes a robust, transparent, and sustainable regulatory framework for medical devices, supplementing and replacing existing directives. The EUMDR covers a wide range of products, from bandages to pacemakers, and includes requirements for device classification, conformity assessment, clinical evaluation, post-market surveillance, and traceability through Unique Device Identification (UDI).