EU Medical Device Regulation (EU MDR 2017/745)
The EU MDR 2017/745 entered into full application on 26 May 2021, replacing MDD 93/42/EEC and AIMDD 90/385/EEC.
Structure
- Regulations — Full text and amendments
- Harmonised Standards — OJ-listed standards
- MDCG Guidance — Medical Device Coordination Group documents
- TEAM-NB Position Papers — Notified Body position papers
Key Articles and Annexes
| Article/Annex | Content | Sub-page |
|---|---|---|
| Article 10 | General Obligations of Manufacturers (QMS, clinical evaluation, PMS, PRRC) | View details |
| Article 52 | Conformity Assessment Procedures (by device class) | View details |
| Annex I | General Safety and Performance Requirements (GSPR) | View details |
| Annex II | Technical Documentation | View details |
| Annex III | Technical Documentation on Post-Market Surveillance (PMS) | View details |
| Annex XIV | Clinical Evaluation (CER + PMCF) | View details |
Harmonised Standards (by category, 48 standards total)
Based on Implementing Decision (EU) 2021/1182 (consolidated) + Amendment 2026/193
| Category | Key Standards | Count | Sub-page |
|---|---|---|---|
| Sterilization & Packaging | EN ISO 11135/11137/11607/17665/18562 etc. | 21 | View details |
| Biocompatibility | EN ISO 10993 series | 9 | View details |
| Non-Active Surgical Implants | EN ISO 14630/21535/21536 | 3 | View details |
| Surgical Clothing & Masks | EN 13795, EN 14683 | 3 | View details |
| Medical Gloves | EN 455 series | 2 | View details |
| Patient Handling Equipment | EN 1865 series | 2 | View details |
| Device Processing & Reprocessing | EN ISO 17664 series | 2 | View details |
| Quality Management | EN ISO 13485:2016 | 1 | View details |
| Risk Management | EN ISO 14971:2019 | 1 | View details |
| Electrical Safety & EMC | EN IEC 60601-2-83 | 1 | View details |
| Labelling & IFU | EN ISO 15223-1 | 1 | View details |
| Clinical Investigation | EN ISO 14155:2020 | 1 | View details |
| Small-Bore Connectors | EN ISO 80369-2 | 1 | View details |