Annex XIII Section 1.2.3 of the IVDR describes clinical performance in terms of diagnostic sensitivity and specificity, positive and negative predictive value, likelihood ratios, and expected values in normal and affected populations. Evidence can come from clinical performance studies, peer-reviewed literature, or routine diagnostic testing experience.

Why it matters

Clinical performance often requires prospective studies for higher-risk classes (C and D), particularly companion diagnostics and screening tests. Retrospective banked-sample studies are acceptable where justified by the intended use and population.

Common pitfalls

•Treating analytical performance as proof of clinical performance. Accurately measuring an analyte does not alone establish how well results identify or correlate with a clinical condition.
•Assuming predictive values transfer unchanged between populations. Differences in disease prevalence and patient selection can change the clinical meaning of a positive or negative result.
•Assuming every class C or D device requires a prospective study, or that banked samples are automatically sufficient. Study design and evidence must be justified against the intended purpose, population, and relevant risks.

Sources

Regulation (EU) 2017/746, Annex XIII · EUR-Lex
FDA - Medical Devices · FDA
European Commission - Medical Devices · European Commission

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