ISO/TS 24971-2:2026 – Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence

Summary
ISO has published Technical Specification ISO/TS 24971-2:2026, which addresses the application of the ISO 14971 risk management process to medical devices enabled by machine learning. The document provides guidance on the specific risks of AI/ML and should be used in conjunction with ISO 14971 and ISO/TR 24971. ISO specifies that the document does not apply to ML devices that use large language models or generative AI.

Practical Impact
High priority for manufacturers of medical software, SaMD, AIaMD, and devices with ML algorithms. Consider updating risk management files, software lifecycle documentation, cybersecurity files, clinical/performance evaluation documentation, algorithmic change control procedures, PMS/PMCF/PMPF documentation, and technical documentation for the EU, UK, U.S., Canada, and Australia markets.

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