EU MDR Regulations
Primary Legislation
| Document | OJ Reference | Date |
|---|---|---|
| EU MDR 2017/745 | OJ L 117, 5.5.2017 | 2017 |
| EU IVDR 2017/746 | OJ L 117, 5.5.2017 | 2017 |
| Amendment 2020/561 | OJ L 130, 24.4.2020 | 2020 |
| Amendment 2023/607 | OJ L 80, 20.3.2023 | 2023 |
| Amendment 2024/1860 | OJ L, Jul 2024 | 2024 |
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 available at EUR-Lex. Source files in eu_mdr/regulations/.