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title: "SaMD Risk Classification Wizard · AI SaMD Playbook"
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[Back to AI SaMD Playbook](/)Interactive · 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.

Inform clinical management

Aggregates or displays information for a clinician to interpret.

Drive clinical management

Triages, flags, or prioritises, clinician still decides.

Treat or diagnose

Outputs a diagnosis or directly drives a therapeutic action.

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Editorial reference only. Not legal or regulatory advice.