Analytical Performance (IVDR)
The ability of an IVD to correctly detect or measure a particular analyte.
Definition
Annex I Section 9.1(a) and Annex XIII of the IVDR list the analytical performance characteristics: analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy, limits of detection and quantitation, measuring range, linearity, cut-off, and interference from endogenous and exogenous substances plus cross-reactivity.What this means in practice
Analytical performance is where CLSI protocols map directly to IVDR obligations. Notified bodies expect pre-defined acceptance criteria linked back to the intended use and clinical decision points, not just observed values.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.
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 I and Annex XIIIVerifiedEUR-Lexeur-lex.europa.eu
- 2
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
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