MDCG guidance
MDCG 2025-5: Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746
MDCG guidance · Clinical investigation and evaluation, performance studies and evaluation · June 2025
Key facts
| Reference | MDCG 2025-5 |
|---|---|
| Title | Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 |
| Topic | Clinical investigation and evaluation, performance studies and evaluation |
| Published | June 2025 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- MDCG 2025-5 (June 2025) 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.