--- title: "Performance Study Application (IVDR)… | MedTech Terms" description: "Formal submission via EUDAMED required before commencing certain performance studies under IVDR Annex XIII and XIV." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-performance-study-application#term", "name": "Performance Study Application (IVDR)", "description": "Article 58 and Annex XIV set out the application procedure for performance studies. Interventional clinical performance studies, studies involving invasive sample-taking done only for the purpose of the study, and studies of companion diagnostics using leftover samples with additional testing must be authorised by the competent authorities of the Member States in which the study is conducted. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Performance Study Application (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # Performance Study Application (IVDR) Formal submission via EUDAMED required before commencing certain performance studies under IVDR Annex XIII and XIV. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 58 and Annex XIV set out the application procedure for performance studies. Interventional clinical performance studies, studies involving invasive sample-taking done only for the purpose of the study, and studies of companion diagnostics using leftover samples with additional testing must be authorised by the competent authorities of the Member States in which the study is conducted. Applications are submitted through [EUDAMED](/terms/eudamed) using a single identification number (SIN). What the regulation says Article 66 defines the substantive assessment procedure and timelines; Article 70 governs substantial modifications to authorised studies. ## What this means in practice The [IVDR](/terms/ivdr) harmonises the performance-study route across Member States, replacing the fragmented national procedures of the IVDD era. Timelines mirror [MDR](/terms/mdr-reporting) clinical investigations: 10 days for validation, then 45 days (extendable) for substantive review. ## 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)[ Regulatory EUDAMED European Database on Medical Devices. ](/terms/eudamed)[ Clinical & Trials Performance Study (IVDR) A study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77. ](/terms/ivdr-performance-study) ### 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: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 1 MDCG· 1 European Commission· 1 1. [1 Regulation (EU) 2017/746, Articles 58 and 66 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 MDCG 2022-19 Performance Study Application Unchecked MDCG health.ec.europa.eu ](https://health.ec.europa.eu/document/download/9a35eabb-6a3e-4f0e-9e5f-96f1f1a8f8b3_en) 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-performance-study-application) Learn in 60 seconds Card Lesson Quiz Formal submission via EUDAMED required before commencing certain performance studies under IVDR Annex XIII and XIV. - · The IVDR harmonises the performance-study route across Member States, replacing the fragmented national procedures of the IVDD era. - · Timelines mirror MDR clinical investigations: 10 days for validation, then 45 days (extendable) for substantive review. - · Applications are submitted through EUDAMED using a single identification number (SIN). Remember this Article 66 defines the substantive assessment procedure and timelines; Article 70 governs substantial modifications to authorised studies. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [EUDAMED ](/terms/eudamed) You may also need Auto-suggested from Regulatory and shared keywords. - [ISO 20916 ](/terms/iso-20916) - [Modular PMA ](/terms/pma-modular) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [Summary of Safety and Clinical Performance(SSCP) ](/terms/sscp) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) [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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