IVDR demands a robust Performance Evaluation Report (PER) built on scientific validity, analytical performance, and clinical performance. Use this checklist to validate your package before NB review.
1) Scientific validity
- Intended purpose, specimen types, user profile, and target population.
- State-of-the-art analysis and references supporting clinical background.
- Trace scientific validity claims to evidence and labeling.
2) Analytical performance
- Sensitivity/specificity, LoD/LoQ, precision, reproducibility, linearity.
- Inclusivity/exclusivity, interfering substances, hook/prozone effects.
- Stability, transport, storage, and sample handling studies.
- Software/algorithm validation (if applicable) and version control.
3) Clinical performance
- Study design, endpoints, comparators, and statistical analysis plan.
- Cohort representativeness, bias mitigation, and missing data handling.
- Usability/human factors for near-patient tests.
- Post-market clinical performance follow-up (PMPF) triggers and design.
4) Risk management and labeling linkage
- Hazards and mitigations linked to analytical/clinical evidence.
- IFU/label claims aligned to proven performance and limitations.
- Residual risk evaluation and benefit-risk conclusions.
How MedReg AI helps
- Map your PER to IVDR Annex XIII and MDCG expectations.
- Flag evidence gaps across analytical, clinical, and labeling claims.
- Produce a concise IVDR gap report for internal reviews or NB submissions.
Check IVDR coverage on /solutions and start a trial at /pricing.
