MDCG guidance
MDCG 2021-28: Substantial modification of clinical investigation under Medical Device Regulation
MDCG guidance · Clinical investigation and evaluation · December 2021
Key facts
| Reference | MDCG 2021-28 |
|---|---|
| Title | Substantial modification of clinical investigation under Medical Device Regulation |
| Topic | Clinical investigation and evaluation |
| Published | December 2021 |
| Document | health.ec.europa.eu |
At a glance
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- MDCG 2021-28 (December 2021) 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.