| 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.
- For SaMD/software cases, distinguish whether the software is embedded in a physical medical device, SaMD implemented within or forming part of a health IT system, or standalone SaMD not forming part of a health IT system. Completion: DCB0129/DCB0160 implications are stated as triage, not legal conclusion.
- 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, and note any DCB0129/DCB0160 evidence that remains separately required.
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.
- ISO 14971 completion does not automatically mean DCB0129/DCB0160 obligations are complete where DCB standards apply.
- SaMD forming part of a health IT system can need both MDR/ISO and DCB clinical-safety evidence paths.
