MDCG guidance
MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies
MDCG guidance · Annex XVI products · December 2023
Key facts
| Reference | MDCG 2023-6 |
|---|---|
| Title | Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies |
| Topic | Annex XVI products |
| Published | December 2023 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- MDCG 2023-6 (December 2023) 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.