Usability / Human Factors (IVDR)
Primary process standard: IEC 62366-1:2015+A1:2020
IVDR hooks: Annex I GSPR 5 (use error); self-testing / near-patient information requirements (GSPR 19–20 et al.); consistency with performance evaluation (Art. 56 / Annex XIII) and IFU
BPG reference: Team-NB BPG-IVDR V2 (Usability, approx. p. 23)
Checklist
- [ ] Usability Engineering File (UEF): use specification, hazard-related use scenarios, UI evaluation plan
- [ ] Use-error-related hazards identified and controlled (GSPR 5); results feed risk management
- [ ] Formative and summative evaluation records (or justified equivalent path)
- [ ] Intended users (lab professionals / HCPs / lay persons) and use environment defined in the UEF
- [ ] IFU, labels and training materials evaluated as part of the user interface
- [ ] Self-testing / near-patient testing: additional usability validation for lay or near-patient users
- [ ] Usability conclusions aligned with clinical performance evaluation and residual-risk acceptability
- [ ] Acceptance criteria predefined; missing data marked for manufacturer completion — never invented
Reguverse UEF Harness
Apply the Usability UEF harness in the evidence / V&V usability domain for structured protocol/report skeletons. Structure is code-assembled; AI fills product narrative only.