IMDRF · International guidance
IMDRF/MDCE WG/N65:2021
Post-Market Clinical Follow-Up (PMCF) Studies
International Medical Device Regulators ForumIMDRFTechnical guidance
International guidance
This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.
Source identity
- Issuing body
- IMDRF
- Reference
- IMDRF/MDCE WG/N65:2021
- Published (source metadata)
- May 20, 2021
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About this guidance
Post-Market Clinical Follow-Up (PMCF) Studies
Guidance on post-market clinical follow-up studies for medical devices. Covers PMCF planning, execution, and reporting.