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Analytical Performance (IVDR)
The ability of an IVD to correctly detect or measure a particular analyte.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026
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 the regulation says
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), adopted on 5 April 2017 and applicable from 26 May 2022, sets analytical performance requirements in Annex I, Section 9.1(a). Manufacturers must demonstrate performance appropriate to the device’s intended purpose. The listed characteristics include analytical sensitivity and specificity, trueness (bias), precision (repeatability and reproducibility), accuracy, limits of detection and quantitation, measuring range, linearity, and cut-off. They also cover interference from endogenous and exogenous substances and cross-reactivity. These characteristics must be considered in relation to the specimens, users, and conditions specified for the device.
Article 56 and Annex XIII establish the performance evaluation framework, combining scientific validity, analytical performance, and clinical performance. Annex XIII, Part A, requires analytical performance to be demonstrated and documented in an analytical performance report; any omission of an applicable characteristic requires justification. For MedTech manufacturers, study methods and acceptance criteria should support the intended purpose, with evidence incorporated into the performance evaluation and technical documentation. Analytical performance alone does not establish clinical performance or complete conformity assessment. Performance evaluation must remain current throughout the device lifecycle, including relevant post-market performance follow-up findings under Annex XIII, Part B.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.Examples
- A manufacturer establishes the analytical sensitivity of a glucose monitor, demonstrating its ability to detect glucose levels as low as 0.5 mmol/L, with acceptance criteria defined based on critical hypoglycemic thresholds.
- For a rapid diagnostic test for a specific pathogen, the analytical specificity is verified by testing against a panel of closely related non-target pathogens and common commensals to confirm no false positives occur.
- The precision (repeatability and reproducibility) of an immunoassay is determined across different batches, operators, and instruments, ensuring consistent results within a predefined acceptable range for disease monitoring.
Common pitfalls
- •Manufacturers often define analytical performance characteristics but fail to establish pre-defined acceptance criteria, instead relying on observed values which may not align with clinical needs.
- •Not adequately considering the impact of endogenous and exogenous interfering substances, or cross-reactivity, can lead to inaccurate results and compromise patient safety.
- •Failing to link acceptance criteria for analytical performance directly to the intended use and specific clinical decision points can result in data that lacks clinical relevance.
Frequently asked questions
Annex I Section 9.1(a) and Annex XIII list 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. Each characteristic must be studied with a protocol appropriate to the intended use, not simply reported as a summary value.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulatory
EU In Vitro Diagnostic Regulation(IVDR)
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Regulatory
IVDR Performance Evaluation
Continuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56.
Industry Bodies
Clinical and Laboratory Standards Institute(CLSI)
US-based consensus standards organization whose documents establish widely used analytical and clinical laboratory performance evaluation protocols for IVDs.
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FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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513(g) Request for Information(513(g))
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3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2
Link health: 3 verified· last checked 2026-06-20
EUR-Lex·1European Commission·1IMDRF·1
- 1Regulation (EU) 2017/746, Annex I and Annex XIIITier 1 VerifiedEUR-Lexeur-lex.europa.eu
- 2European Commission - Medical DevicesTier 2 VerifiedEuropean Commissionhealth.ec.europa.eu
- 3IMDRF DocumentsTier 2 VerifiedIMDRFimdrf.org
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