Clinical decision support / triage

Context

An AI system supporting clinical triage and decision-making. Beyond the Act, patient-affecting output on health data can make it a regulated medical device (SaMD) — a separate, heavier regulatory pathway with clinical-validation obligations.

The decision

Two regimes at once: classify it under the Act and against medical-device rules, because clinical-validation studies and a device regulatory pathway may govern before the Act's obligations even apply.

What most miss

Teams run the AI-Act checklist and miss that clinical decision support can be a regulated medical device — the device pathway (validation studies, CE-MDR/SaMD) is the binding constraint, not the Act.

Stakes

Treat it as software-only and you skip the clinical-validation study that legally gates patient use.