Benefit-Risk Analysis & Risk Management (IVDR)
IVDR reference: Annex I GSPR 1–8 et al.; aligned with performance evaluation conclusions
BPG reference: Team-NB BPG-IVDR V2 (approx. pp. 16–18)
Document code: AII-S5
Process standard: EN ISO 14971 (and ISO/TR 24971 where used)
Procedures and lifecycle
- [ ] Risk management procedure(s) including rating system definitions
- [ ] Evidence of continuous iterative lifecycle risk management
- [ ] Coverage of all parts/components of the device
- [ ] Lifecycle management (post-market information feeds updates)
Risk management plan
- [ ] Device-specific RMP: scope, responsibilities, acceptability criteria, control strategy
- [ ] Interfaces to usability, performance evaluation, PMS/PMPF
Safety concept and use error
- [ ] Safety concept per Annex I Section 4
- [ ] Use-error risk reduction covers Annex I Section 5
- [ ] Use flow-chart recommended for reviewability
Analysis, controls, benefit-risk
- [ ] All known and reasonably foreseeable hazards addressed (IVD examples: false negative/positive consequences, specimen handling, cross-contamination, calibration failure, software failure, self-test misuse, CDx treatment decision errors, …)
- [ ] Risk controls implemented per hazard with document references
- [ ] Effectiveness of controls verified with document references
- [ ] Design changes assessed for new hazards / benefit-risk impact
- [ ] RMR: residual risks acceptable; benefit-risk aligned with performance evaluation