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 Annexes
| Annex | Content |
|---|---|
| Annex I | General Safety and Performance Requirements (GSPR) |
| Annex II | Technical Documentation |
| Annex III | Technical Documentation on Post-Market Surveillance |
| Annex XIV | Clinical Evaluation |
| Annex XV | Clinical Investigations |