GHTF · International guidance
GHTF/SG1/N77:2012
Principles of Medical Devices Classification
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/N77:2012
- Published (source metadata)
- November 2012
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About this guidance
Principles of Medical Devices Classification
Framework for medical device classification based on risk. Establishes harmonized classification rules considering intended use, duration of contact, and invasiveness.