Product Verification & Validation (IVDR)
IVDR reference: Annex II interfaces; Annex I GSPRs; performance evaluation
BPG reference: Team-NB BPG-IVDR V2 (approx. pp. 19–30, including software)
Document code: AII-S6 (V&V set)
Overview requirements
- [ ] V&V evidence supports claimed analytical performance, safety and applicable GSPRs
- [ ] Controlled protocols/reports: objective, methods, acceptance criteria, results, deviations, conclusions
- [ ] Acceptance criteria predefined — never invented after the fact
- [ ] Consistency with risk management, IFU claims and performance evaluation claims
Topic pages
| Topic | Page |
|---|---|
| V&V overview | vv/ |
| Stability (reagents) | stability |
| Metrological traceability | metrological-traceability |
| Usability / human factors | usability |
| Chemical / physical / biological | chemical-physical-biological |
| Software & cybersecurity | software |