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An IVD evidence package needs a clear link between the analyte, analytical behaviour and clinical use of the result.
IVDR performance evaluation — Define the regulatory scope
IVDR Article 56 and Annex XIII address scientific validity, analytical performance and clinical performance. MDCG 2022-2 explains the clinical evidence framework.
IVDR performance evaluation — Build the working record
Build one claim matrix with separate evidence for the analyte association, measurement characteristics and performance in the intended population. Identify specimen type, cut-off, comparator and limitations rather than treating a verification test as the entire evaluation.
IVDR performance evaluation — Check before release
- Check each intended specimen and setting.
- Distinguish analytical from clinical performance metrics.
- Explain gaps in scientific validity evidence.
IVDR performance evaluation — Record the decision and handover
Approve an integrated performance evaluation conclusion. Where one pillar is weak, assign targeted evidence generation or reconsider the claim; strength in analytical precision does not automatically establish clinical utility.
Frequently asked questions
- Can analytical validation replace clinical performance?
- Not automatically. Assess the evidence needed for the intended purpose and applicable requirements.
- Is scientific validity a one-time literature task?
- No. Maintain the evaluation as relevant knowledge and post-market evidence change.