--- title: "Analytical Performance (IVDR), Definition | MedTech Terms" description: "The ability of an IVD to correctly detect or measure a particular analyte. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Analytical Performance (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # Analytical Performance (IVDR) The ability of an IVD to correctly detect or measure a particular analyte. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Annex I Section 9.1(a) and Annex XIII of the [IVDR](/terms/ivdr) list the analytical performance characteristics: [analytical sensitivity](/terms/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](/terms/ivdr) obligations. Notified bodies expect pre-defined acceptance criteria linked back to the [intended use](/terms/intended-use) and clinical decision points, not just observed values. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory IVDR Performance Evaluation Continuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56. ](/terms/ivdr-performance-evaluation) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement 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. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 European Commission· 1 IMDRF· 1 1. [1 Regulation (EU) 2017/746, Annex I and Annex XIII Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 European Commission - Medical Devices Verified European Commission health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 3. [3 IMDRF Documents Verified IMDRF imdrf.org ](https://www.imdrf.org/documents) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-analytical-performance) Learn in 60 seconds Card Lesson Quiz The ability of an IVD to correctly detect or measure a particular analyte. - · 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. Remember this The ability of an IVD to correctly detect or measure a particular analyte. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) You may also need Auto-suggested from Regulatory and shared keywords. - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [Scientific Validity (IVDR) ](/terms/ivdr-scientific-validity) - [Analytical Sensitivity ](/terms/analytical-sensitivity) - [Limit of Detection / Limit of Quantitation(LoD / LoQ) ](/terms/lod-loq) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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