What Is the EU MDR (Regulation 2017/745)? A Complete Guide for Manufacturers

Short answer: The EU MDR — formally Regulation (EU) 2017/745 on medical devices — is the legal framework that governs how medical devices are placed on the market, made available, and monitored in the European Union. It was published on 5 May 2017, became applicable on 26 May 2021, and replaced the earlier Medical Devices Directive (93/42/EEC, MDD) and Active Implantable Medical Devices Directive (90/385/EEC, AIMDD). Any manufacturer selling a medical device into the EU must comply, regardless of where the company is located. Manufacturers based outside the EU — including in Türkiye — must also appoint an EU Authorised Representative.

Key takeaways

• What it is: Regulation (EU) 2017/745 — a single, directly binding regulation for medical devices across the EU (stricter than a directive, with no national transposition).
• Who it affects: Manufacturers, authorised representatives, importers and distributors (the four "economic operators"), plus notified bodies.
• Core obligations: an ISO 13485-based quality management system, conformity with the General Safety and Performance Requirements (Annex I), Annex II–III technical documentation, clinical evaluation, post-market surveillance (PMS), UDI and EUDAMED registration, and a designated PRRC.
• Classification: Classes I, IIa, IIb and III, determined by the 22 rules in Annex VIII; obligations rise with risk.
• Transition timeline: under Regulation (EU) 2023/607, valid MDD/AIMDD certificates are recognised — conditionally — until 31 December 2027 (Class III and implantable Class IIb) or 31 December 2028 (other Class IIb, Class IIa, sterile/measuring Class I).
• For Türkiye-based manufacturers: Türkiye's Medical Device Regulation mirrors the EU MDR; the competent authority is the TİTCK. To sell in the EU you still need an EU Authorised Representative and an EU notified body.