Performance Evaluation (PEP / PER) (IVDR)
IVDR reference: Art. 56; Annex XIII; scientific validity, analytical performance, clinical performance
BPG reference: Team-NB BPG-IVDR V2 (Performance Evaluation, approx. pp. 31–36)
Service mode: Reguverse core workflow (including post-market Performance Evaluation Update)
General
- [ ] Controlled PEP and PER with clear versioning
- [ ] Scope consistent with intended purpose, classification and variants in the Device Description
- [ ] Scientific validity, analytical performance and clinical performance covered (or justified N/A)
- [ ] Transparent evidence sources; reproducible literature search strategy
- [ ] Benefit-risk aligned with RM; residual uncertainties feed PMPF
Scientific validity / analytical / clinical performance
- [ ] Scientific link between analyte and clinical condition/physiological state
- [ ] Analytical performance parameters as claimed (trueness/bias, precision, LoD, linearity/range, hook effect, interference, cross-reactivity, matrix effects, …)
- [ ] Protocols, acceptance criteria and specimen types aligned with claims; metrological traceability linked
- [ ] Clinical performance evidence for intended purpose and target population (sensitivity/specificity, predictive values, likelihood ratios as applicable)
- [ ] Self-testing / near-patient: performance under intended user conditions
- [ ] CDx: performance relevant to medicinal-product decision-making; consistency with drug authorisation information
Planning, reporting, updates
- [ ] PEP: objectives, methods, statistics, ethics/regulatory, milestones
- [ ] PER: evidence synthesis, gaps, conclusions, IFU impact
- [ ] Post-market: PE updates interfacing with PMPF/PMS
Reguverse notes
- Initial PE and performance_evaluation_update are both formal tasks; update is repeatable
- DD is a mandatory prerequisite — do not reinvent a conflicting intended purpose inside PE