What EU Medical Devices Regulation (MDR) 2017/745 -- CE Marking and Market Surveillance for Medical Devices requires
Regulation (EU) 2017/745 (MDR) governs the placing on the EU market of medical devices and accessories. It replaced MDD 93/42/EEC and AIMD 90/385/EEC and applied fully from 26 May 2021 (with extended transition periods to 2027-2028 for legacy devices under Regulation 2023/607). Devices are classified into Classes I, IIa, IIb, and III under Annex VIII classification rules (1-22). Classes IIa and above require conformity assessment involving a Notified Body designated under Article 42. All devices must bear CE marking and comply with General Safety and Performance Requirements (GSPR) in Annex I. The Unique Device Identifier (UDI) system under Article 27 mandates labelling and registration in the EUDAMED database (Article 33). Serious incident reporting timelines under Article 87 are: immediately (life-threatening or death), 2 days (serious public health threat), 10 days (serious deterioration of health), and 15 days for trend reporting. Non-EU manufacturers must appoint an Authorised Representative in the EU under Article 11.
Pillar: Medical & Healthcare · Authority: European Parliament and the Council of the European Union · Version: 2024.1.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
SHA-256 integrity: 89e014ba244fffded82bf434ac084f2847c50d04b74ce0eadd3e2fc2cdc6e76d
Primary Citations — 6 traced to source
- {"title":"Regulation (EU) 2017/745 -- Medical Devices Regulation (MDR)","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745","section":"Article 11 (Authorised Representative); Article 27 (UDI); Article 29 (EUDAMED registration); Article 42 (Notified Body designation); Article 52 (conformity assessment procedures); Article 61 (clinical evaluation); Article 83-86 (PMS and PSUR); Article 87 (vigilance reporting: 2 days, 10 days, 15 days); Annex I (GSPR); Annex VIII (classification rules 1-22)","type":"primary_legislation"}
- {"title":"Regulation (EU) 2023/607 -- MDR Corrigendum Extending Transitional Timelines","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0607","section":"Article 1 (extended transition: Class III/IIb implantable to 31 December 2027; Class IIa/IIb non-implantable to 31 December 2028); submission deadlines 26 May 2026 and 26 May 2027","type":"primary_legislation"}
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