EU MDR — Medical Device Regulation (EU) 2017/745 — Official Full Text

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.

Overview

The MDR establishes a modernised and robust EU regulatory framework for medical devices, replacing the previous Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC). It introduces stricter pre-market requirements, enhanced clinical evidence obligations, a comprehensive traceability system through Unique Device Identification (UDI), and the European Database on Medical Devices (EUDAMED).

Key Areas

• Classification of medical devices (Classes I, IIa, IIb, III)
• Conformity assessment procedures and Notified Body requirements
• Clinical evaluation and clinical investigations
• Post-market surveillance (PMS) and vigilance reporting
• Unique Device Identification (UDI) system
• EUDAMED (European Database on Medical Devices)
• Technical documentation requirements
• Economic operator obligations
• Transparency and traceability requirements
• Special rules for implantable devices (Implant Card)

Key Dates

• Published: 5 May 2017 (Official Journal L 117)
• Date of Application: 26 May 2021
• Replaces: Directive 93/42/EEC (MDD) and Directive 90/385/EEC (AIMDD)