Regulation (EU) 2017/745/EU Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Publication Year
2017
Document Status
Current
Abstract
Known as the Medical Device Regulation (MDR), this regulation replaces previous directives to enhance patient safety and market transparency. Introducing stricter requirements for clinical evaluation, post-market surveillance, and notified bodies, it harmonizes EU regulations for better oversight and innovation.
Document History
Source: Office for Official Publications of the European Communities. Only European Community's legislation printed in the Official Journal of the European Communities is deemed to be authentic. Consolidated version dated 10-01-2025. Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
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