IMDRF · International guidance
IMDRF/MDCE WG/N57:2019
Clinical Investigation
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/N57:2019
- Published (source metadata)
- October 10, 2019
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About this guidance
Clinical Investigation
Guidance on clinical investigations for medical devices. Covers study design, conduct, and regulatory requirements.