The International Medical Device Regulators Forum (IMDRF) released two key documents related to medical device software: Good machine learning practice for medical device development: Guiding principles (IMDRF/AIML WG/N88 FINAL:2025); and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents are aimed at improving global harmonization and guiding medical device manufacturers in navigating compliance for software-based and AI-driven technologies.
Note: The IMDRF guidance documents are referred to by the N numbers.
IMDRF Releases Key Documents Governing Medical Device Software | Emergo by UL
IMDRF Releases Key Guidance Documents for Medical Device Software
The IMDRF has released two new key medical device software guidance documents.
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