Useful Documents
| Reference | Title | Link |
|---|---|---|
| MDR | 2017/745 - EN - Medical Device Regulation | Read more |
| Manual on Borderline | Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v4 | Read more |
| MDCG 2021-24 | Guidance on classification of medical devices | Read more |
| MDCG 2024-15 | Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED | Read more |
| MDCG 2024-3 | Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices | Read more |
| MDCG 2024-3 Appendix A | Clinical Investigation Plan Synopsis Template | Read more |