MDCG guidance
MDCG 2024-4: Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 Appendix - Performance Study Summary Safety Reporting Form
MDCG guidance · In Vitro Diagnostic medical devices (IVD) · April 2024
Key facts
| Reference | MDCG 2024-4 |
|---|---|
| Title | Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 Appendix - Performance Study Summary Safety Reporting Form |
| Topic | In Vitro Diagnostic medical devices (IVD) |
| Published | April 2024 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- MDCG 2024-4 (April 2024) 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.