SaMD IMDRF category

Significance of the information the software provides × state of the healthcare situation. Based on the IMDRF SaMD risk framework (N12/N41), simplified.

What does the software do with the information?Inform clinical management (display, flag, trend — clinician still decides)Drive clinical management (prompts a specific next action or triage)Treat or diagnose (output is the diagnosis or the therapy decision)

Healthcare situation / conditionNon-serious (unlikely to produce irreversible harm if wrong)Serious (could produce serious harm if wrong)Critical (life-threatening, or time-critical intervention)

Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. SaMD IMDRF category does not submit to FDA, Notified Bodies, or IRBs.

Related tools

FDA pathway picker

510(k), De Novo, PMA or 510(k)-exempt — a structured first pass from class, predicates and novelty.

IEC 62304 software safety class

Walk harm scenarios to Class A, B or C for medical device software.

ISO 14971 risk matrix

Score severity × probability, see RPN bands, and keep a short hazard log in the browser.

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