EU MDR Regulations
Primary Legislation
| Document | OJ Reference | Date | Status |
|---|---|---|---|
| EU MDR 2017/745 | OJ L 117, 5.5.2017 | 2017 | In force |
| EU IVDR 2017/746 | OJ L 117, 5.5.2017 | 2017 | In force |
| Amendment 2020/561 | OJ L 130, 24.4.2020 | 2020 | MDR transition extension |
| Amendment 2023/607 | OJ L 80, 20.3.2023 | 2023 | Legacy device transition |
| Regulation 2024/1860 | OJ L, 2024/1860, 9.7.2024 | 2024 | Gradual Eudamed roll-out, supply interruption notification, IVDR transition extension |
Implementation Timeline
| Date | Milestone |
|---|---|
| 26 May 2021 | EU MDR 2017/745 fully applicable |
| 26 May 2024 | Class IIb implantable legacy devices deadline |
| 31 Dec 2027 | Class IIb non-implantable + Class IIa legacy devices deadline |
| 31 Dec 2028 | Class I legacy devices deadline |
| 26 May 2022 | EU IVDR 2017/746 fully applicable (Class D IVDs) |
| 26 May 2025 | Class C IVDs deadline |
| 26 May 2026 | Class B + Class A sterile IVDs deadline |
| 31 Dec 2030 | Class A non-sterile IVD legacy devices deadline (extended by 2024/1860) |
Key Articles
Article 10 — General Obligations of Manufacturers
Manufacturers must:
- Establish, document, implement and maintain a Quality Management System (QMS)
- Conduct clinical evaluation in accordance with Annex XIV
- Establish a post-market surveillance (PMS) system per Annex III
- Register in EUDAMED and assign a UDI
- Designate an Authorized Representative (if outside EU)
- Appoint a Person Responsible for Regulatory Compliance (PRRC)
Article 52 — Conformity Assessment Procedures
| Device Class | Procedure |
|---|---|
| Class I (non-sterile, non-measuring) | Self-declaration (Annex IV) |
| Class I sterile / measuring | QMS (Annex IX) or Type Examination (Annex X) + Verification (Annex XI) |
| Class IIa | QMS (Annex IX) or Type Examination (Annex X) + Verification (Annex XI) |
| Class IIb | QMS (Annex IX) or Type Examination (Annex X) + Verification (Annex XI) |
| Class III | QMS (Annex IX) + Design Dossier, or Type Examination (Annex X) + Conformity (Annex XI) |
Annex I — General Safety and Performance Requirements (GSPR)
Annex I contains requirements across 3 parts:
Part I — General Requirements (GSPR 1–9)
- GSPR 1: Devices shall achieve intended purpose, not compromise safety
- GSPR 2: Risk management — reduce risks as far as possible (ALARP)
- GSPR 3: Known and foreseeable risks minimized
- GSPR 6: Benefits shall outweigh risks
Part II — Requirements for Design and Manufacture (GSPR 10–22)
- GSPR 10: Chemical, physical, biological properties
- GSPR 11: Infection and microbial contamination
- GSPR 17: Electronic programmable systems — software
- GSPR 18: Active devices and devices connected to them
Part III — Requirements for Information Supplied with the Device (GSPR 23)
- GSPR 23: Label and instructions for use requirements
Quality Management
- ISO 13485:2016 — Medical devices QMS (harmonised under EU MDR)
- EN ISO 13485:2016 — European adoption
Related Legislation
| Regulation | Topic |
|---|---|
| Regulation (EU) 2022/123 | EUDAMED and Notified Bodies |
| Directive 2006/42/EC | Machinery Directive |
| Regulation (EU) 2016/679 | GDPR (data protection) |
TIP
Full regulation texts at EUR-Lex. Source files in eu_mdr/regulations/.