MDCG guidance
MDCG 2020-10/2, MDCG 2020-10/1: Guidance on safety reporting in clinical investigations, Appendix: Clinical investigation summary safety report form
MDCG guidance · Clinical investigation and evaluation · May 2020
Key facts
| Reference | MDCG 2020-10/2, MDCG 2020-10/1 |
|---|---|
| Title | Guidance on safety reporting in clinical investigations, Appendix: Clinical investigation summary safety report form |
| Topic | Clinical investigation and evaluation |
| Published | May 2020 |
| Document | ec.europa.eu |
At a glance
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- MDCG 2020-10/2, MDCG 2020-10/1 (May 2020) Revisions on file
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About MDCG guidance documents
The Medical Device Coordination Group (MDCG), made up of EU member-state experts, endorses guidance on applying the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Each page here covers one document and all of its revisions.