Medical Device Regulation 2017/745

The Medical Device Regulation (MDR) 2017/745, which became fully enforceable on May 26, 2021, is a comprehensive legislative framework established by the European Union to ensure the safety and efficacy of medical devices being placed on the market. This regulation replaces the previous Medical Device Directive (MDD), with the aim of providing a more robust, transparent, and sustainable regulatory framework.

MDR 2017/745 details, from classification to conformity assessment and post-market surveillance, have significant implications for the entire lifecycle of a medical device. Read the full text of the Medical Device Regulation (MDR) 2017/745 to ensure compliance and uphold the highest standards of patient safety and device efficacy.

Our library contains more information regarding the Medical Device Regulation 2017/745.