| name | safety-md-mdr-triage |
| description | User-invoked skill for lightweight medical-device/SaMD triage and escalation from SAFETY.md documentation. |
| disable-model-invocation | true |
SAFETY.md MDR Triage
Use only when explicitly asked about medical-device, MDR, MHRA, SaMD, AIaMD, UKCA, CE, or regulatory classification uncertainty.
Boundary
This is triage, not regulatory advice and not a full MDR classification workflow. Escalate to qualified regulatory review where material.
Steps
- Extract intended purpose, claims, users, patient population, and clinical functionality. Completion: intended-purpose wording is quoted or pending.
- Identify red flags: diagnosis, monitoring, prediction, prognosis, treatment, decision support, dosing, alerts, AI/ML, patient-specific recommendations. Completion: red flags listed.
- Recommend one of: likely not medical device but record rationale; uncertain requires specialist classification; likely medical-device pathway requires regulatory review. Completion: no definitive legal claim unless already evidenced.
- Link to SAFETY.md hazards and evidence that may feed ISO 14971/MDR work.
Common Gotchas
- Small intended-purpose wording changes can alter classification.
- “Calculator” can be low-risk, but dose/risk-score/clinical recommendation calculators can be medical-device relevant.
- ArcKit has a broader MDR classifier; this skill should hand off rather than duplicate it.
