AI SaMD Playbook
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    Back to AI SaMD PlaybookInteractive · 9 questions · ~3 min

    SaMD risk classification wizard

    Answer nine questions about intended use, autonomy, predicate, and deployment geography. Get a side-by-side estimate across IMDRF, FDA, EU AI Act, EU MDR/IVDR, UK MHRA, Health Canada, and China NMPA, with citations and a downloadable summary.

    Educational tool · not a regulatory determination

    Question 1 of 9

    What clinical role does the software play?

    Map to IMDRF SaMD categorisation: inform, drive, or treat/diagnose.