--- title: "Scientific Validity (IVDR), Definition | MedTech Terms" description: "The association of an analyte with a clinical condition or physiological state. Plain-English Regulatory definition for MedTech teams, with examples and related" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-scientific-validity#term", "name": "Scientific Validity (IVDR)", "description": "Annex XIII Section 1.2.1 of the IVDR defines scientific validity as the association of an analyte with a clinical condition or a physiological state. Evidence can come from peer-reviewed literature, consensus expert opinions and guidelines, results from proof-of-concept studies, or clinical performance studies, weighted by strength.", "url": "https://medtechterms.com/terms/ivdr-scientific-validity", "termCode": "ivdr-scientific-validity", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/ivdr-scientific-validity#article", "headline": "Scientific Validity (IVDR)", "description": "The association of an analyte with a clinical condition or physiological state.", "url": "https://medtechterms.com/terms/ivdr-scientific-validity", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/ivdr-scientific-validity" }, "about": { "@id": "https://medtechterms.com/terms/ivdr-scientific-validity#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "Scientific Validity (IVDR), Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-07-25", "dateModified": "2026-07-25", "citation": [ { "@type": "CreativeWork", "name": "Regulation (EU) 2017/746, Annex XIII", "url": "https://eur-lex.europa.eu/eli/reg/2017/746/oj", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "FDA - Medical Devices", "url": "https://www.fda.gov/medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "European Commission - Medical Devices", "url": "https://health.ec.europa.eu/medical-devices-sector_en", "publisher": { "@type": "Organization", "name": "European Commission" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr#term", "name": "EU In Vitro Diagnostic Regulation", "alternateName": "IVDR", "url": "https://medtechterms.com/terms/ivdr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-performance-evaluation#term", "name": "IVDR Performance Evaluation", "url": "https://medtechterms.com/terms/ivdr-performance-evaluation" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "Scientific Validity (IVDR)", "item": "https://medtechterms.com/terms/ivdr-scientific-validity" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Scientific Validity (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Clinical Evidence](/ecosystems/clinical-evidence)[Global Markets](/ecosystems/global-markets)[Strategic Landscape](/ecosystems/strategic-landscape) # Scientific Validity (IVDR) The association of an analyte with a clinical condition or physiological state. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Annex XIII Section 1.2.1 of the [IVDR](/terms/ivdr) defines scientific validity as the association of an analyte with a clinical condition or a physiological state. Evidence can come from peer-reviewed literature, consensus expert opinions and guidelines, results from proof-of-concept studies, or clinical performance studies, weighted by strength. ## What this means in practice This pillar answers a foundational question: does measuring this thing tell us anything clinically meaningful? For long-established analytes (glucose, troponin) literature alone is usually sufficient; for novel biomarkers, dedicated studies are typically required. ## 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 (4) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Global Markets](/ecosystems/global-markets) - [Strategic Landscape](/ecosystems/strategic-landscape) ## 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-scientific-validity) Learn in 60 seconds Card Lesson Quiz The association of an analyte with a clinical condition or physiological state. - · This pillar answers a foundational question: does measuring this thing tell us anything clinically meaningful? - · For long-established analytes (glucose, troponin) literature alone is usually sufficient; for novel biomarkers, dedicated studies are typically required. - · Evidence can come from peer-reviewed literature, consensus expert opinions and guidelines, results from proof-of-concept studies, or clinical performance studies, weighted by strength. Remember this The association of an analyte with a clinical condition or physiological state. 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) - [ISO 20916 ](/terms/iso-20916) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) - [Analytical Performance (IVDR) ](/terms/ivdr-analytical-performance) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [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. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)