GHTF · International guidance
GHTF/SG5/N6:2012
Clinical Evidence for IVD Medical Devices
International Medical Device Regulators ForumGHTF/IMDRFTechnical 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
- GHTF/IMDRF
- Reference
- GHTF/SG5/N6:2012
- Published (source metadata)
- November 2, 2012
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About this guidance
Clinical Evidence for IVD Medical Devices
Guidance on clinical evidence requirements for IVD medical devices. Addresses evidence generation, clinical performance data, and regulatory submission requirements.