MDCG guidance
MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745
MDCG guidance · Post-Market Surveillance and Vigilance (PMSV) · December 2022
Key facts
| Reference | MDCG 2022-21 |
|---|---|
| Title | Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 |
| Topic | Post-Market Surveillance and Vigilance (PMSV) |
| Published | December 2022 |
| Document | health.ec.europa.eu |
At a glance
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- MDCG 2022-21 (December 2022) 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.