--- title: "Performance Study (IVDR), Definition | MedTech Terms" description: "A study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-performance-study#term", "name": "Performance Study (IVDR)", "description": "Article 2(42) of the IVDR defines a performance study as a study undertaken to establish or confirm the analytical or clinical performance of a device. Articles 57 to 77 and Annex XIII Part A Section 2 set out study design, sponsor obligations, ethics review, informed consent, and adverse-event reporting, with additional obligations for interventional studies and studies involving companion diagnostics.", "url": "https://medtechterms.com/terms/ivdr-performance-study", "termCode": "ivdr-performance-study", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/ivdr-performance-study#article", "headline": "Performance Study (IVDR)", "description": "A study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77.", "url": "https://medtechterms.com/terms/ivdr-performance-study", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/ivdr-performance-study" }, "about": { "@id": "https://medtechterms.com/terms/ivdr-performance-study#term" }, "articleSection": "Clinical & Trials", "inLanguage": "en", "keywords": "Performance Study (IVDR), Clinical & Trials, 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, Articles 57 to 77", "url": "https://eur-lex.europa.eu/eli/reg/2017/746/oj", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "ISO 14155 Standard Page", "url": "https://www.iso.org/standard/71690.html", "publisher": { "@type": "Organization", "name": "ISO" } }, { "@type": "CreativeWork", "name": "FDA - Clinical Trials and Human Subject Protection", "url": "https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection", "publisher": { "@type": "Organization", "name": "FDA" } } ], "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-clinical-performance#term", "name": "Clinical Performance (IVDR)", "url": "https://medtechterms.com/terms/ivdr-clinical-performance" } ] }, { "@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": "Clinical & Trials", "item": "https://medtechterms.com/terms?cat=Clinical%20%26%20Trials" }, { "@type": "ListItem", "position": 4, "name": "Performance Study (IVDR)", "item": "https://medtechterms.com/terms/ivdr-performance-study" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. [Terms](/terms) 3. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 4. Performance Study (IVDR) [All terms](/terms) Clinical & Trials [Regulated Pathways](/ecosystems/regulated-pathways)[Clinical Evidence](/ecosystems/clinical-evidence)[Global Markets](/ecosystems/global-markets) # Performance Study (IVDR) A study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 2(42) of the [IVDR](/terms/ivdr) defines a performance study as a study undertaken to establish or confirm the analytical or clinical performance of a device. Articles 57 to 77 and Annex XIII Part A Section 2 set out study design, sponsor obligations, ethics review, [informed consent](/terms/informed-consent), and adverse-event reporting, with additional obligations for interventional studies and studies involving companion diagnostics. ## What this means in practice Performance studies are the [IVDR](/terms/ivdr) analogue of [MDR](/terms/mdr-reporting) clinical investigations but with categories tied to invasiveness of sampling and use of results in patient management. Interventional studies (Article 58(2)) require prior authorisation by Member States, similar to MDR clinical investigations. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Clinical Performance (IVDR) The ability of an IVD to yield results correlated with a clinical condition in the target population and intended user. ](/terms/ivdr-clinical-performance)[ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr) ### More in Clinical & Trials · Same category [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event)[ Clinical & Trials ALCOA+ Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available). ](/terms/alcoa-plus)[ Clinical & Trials Analytical Sensitivity An IVD's ability to detect small quantities of an analyte. ](/terms/analytical-sensitivity) 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 ISO· 1 FDA· 1 1. [1 Regulation (EU) 2017/746, Articles 57 to 77 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 ISO 14155 Standard Page Verified ISO iso.org ](https://www.iso.org/standard/71690.html) 3. [3 FDA - Clinical Trials and Human Subject Protection Verified FDA fda.gov ](https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [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 Clinical & Trials Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-performance-study) Learn in 60 seconds Card Lesson Quiz A study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77. - · Performance studies are the IVDR analogue of MDR clinical investigations but with categories tied to invasiveness of sampling and use of results in patient management. - · Interventional studies (Article 58(2)) require prior authorisation by Member States, similar to MDR clinical investigations. Remember this A study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [ISO 20916 ](/terms/iso-20916) - [Scientific Validity (IVDR) ](/terms/ivdr-scientific-validity) - [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ 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)