--- title: "Clinical Performance (IVDR), Definition | MedTech Terms" description: "The ability of an IVD to yield results correlated with a clinical condition in the target population and intended user." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-clinical-performance#term", "name": "Clinical Performance (IVDR)", "description": "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. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Clinical Performance (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Clinical Evidence](/ecosystems/clinical-evidence)[Global Markets](/ecosystems/global-markets) # Clinical Performance (IVDR) The ability of an IVD to yield results correlated with a clinical condition in the target population and intended user. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Annex XIII Section 1.2.3 of the [IVDR](/terms/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](/terms/intended-use) and population. ## 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)[ Market Segments Companion Diagnostic(CDx) IVD that identifies patients who will benefit from a specific drug. ](/terms/companion-diagnostic) ### 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 (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 FDA· 1 European Commission· 1 1. [1 Regulation (EU) 2017/746, Annex XIII Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 FDA - Medical Devices Verified FDA fda.gov ](https://www.fda.gov/medical-devices) 3. [3 European Commission - Medical Devices Verified European Commission health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 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-clinical-performance) Learn in 60 seconds Card Lesson Quiz The ability of an IVD to yield results correlated with a clinical condition in the target population and intended user. - · 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. - · Evidence can come from clinical performance studies, peer-reviewed literature, or routine diagnostic testing experience. Remember this The ability of an IVD to yield results correlated with a clinical condition in the target population and intended user. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [Companion Diagnostic(CDx) ](/terms/companion-diagnostic) You may also need Auto-suggested from Regulatory and shared keywords. - [Scientific Validity (IVDR) ](/terms/ivdr-scientific-validity) - [Analytical Performance (IVDR) ](/terms/ivdr-analytical-performance) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [ISO 20916 ](/terms/iso-20916) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) [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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