Clinical Performance (IVDR)
The ability of an IVD to yield results correlated with a clinical condition in the target population and intended user.
Definition
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.What this means in practice
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.Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Continuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56.
IVD that identifies patients who will benefit from a specific drug.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2017/746, Annex XIIIVerifiedEUR-Lexeur-lex.europa.eu
- 2
FDA - Medical DevicesVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
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