GHTF · International guidance
GHTF/SG5/N8:2012
Clinical Performance Studies 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/N8:2012
- Published (source metadata)
- November 2, 2012
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About this guidance
Clinical Performance Studies for IVD Medical Devices
Guidance on designing and conducting clinical performance studies for IVD devices. Covers study design, statistical considerations, and reporting requirements.