IMDRF · International guidance
IMDRF/IVD WG/N64:2021
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
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/IVD WG/N64:2021
- Published (source metadata)
- January 21, 2021
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About this guidance
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
Classification principles for IVD medical devices based on risk. Harmonized framework for global IVD classification.