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.