IMDRF · International guidance
IMDRF/MDCE WG/N55:2019
Clinical Evidence - Key Definitions and Concepts
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/N55:2019
- Published (source metadata)
- October 10, 2019
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Clinical Evidence - Key Definitions and Concepts
Key definitions and concepts for clinical evidence in medical device regulation. Foundation terminology for clinical evaluation.