MDCG guidance
MDCG 2023-7: Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence
MDCG guidance · Clinical investigation and evaluation · December 2023
Key facts
| Reference | MDCG 2023-7 |
|---|---|
| Title | Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence |
| Topic | Clinical investigation and evaluation |
| Published | December 2023 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- MDCG 2023-7 (December 2023) Revisions on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.