IMDRF · International guidance
IMDRF/AIMD WG/N67:2022
Machine Learning-enabled Medical Devices: Key Terms and Definitions
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/AIMD WG/N67:2022
- Published (source metadata)
- May 9, 2022
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Machine Learning-enabled Medical Devices: Key Terms and Definitions
Key terms and definitions for machine learning-enabled medical devices. Foundation terminology document for AI/ML device regulation.