GHTF · International guidance
GHTF/SG1/N046:2008
Principles of Conformity Assessment 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/SG1/N046:2008
- Published (source metadata)
- July 2008
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About this guidance
Principles of Conformity Assessment for IVD Medical Devices
Conformity assessment principles specific to in vitro diagnostic devices. Addresses IVD-specific evaluation requirements and compliance pathways.