IMDRF · International guidance
IMDRF/MDCE WG/N56:2019
Clinical Evaluation
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/N56:2019
- Published (source metadata)
- October 10, 2019
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About this guidance
Clinical Evaluation
Guidance on clinical evaluation of medical devices. Covers evidence requirements, evaluation methodologies, and clinical evaluation reports.