--- title: "ISO 20916, Definition | MedTech Terms" description: "International standard for Good Study Practice for clinical performance studies of IVDs using specimens from human subjects." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-20916#term", "name": "ISO 20916", "description": "ISO 20916 is the IVD analogue to ISO 14155 - defining responsibilities, design, conduct, recording, and reporting of IVD clinical performance studies. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. ISO 20916 [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Clinical Evidence](/ecosystems/clinical-evidence) # ISO 20916 International standard for Good Study Practice for clinical performance studies of IVDs using specimens from human subjects. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO 20916 is the [IVD](/terms/ivd) analogue to [ISO 14155](/terms/iso-14155) - defining responsibilities, design, conduct, recording, and reporting of IVD clinical performance studies. EU [IVDR](/terms/ivdr) Annex XIII references it as state of the art. What the regulation says ISO 20916:2019 specifies general requirements for the design, conduct, recording, and reporting of clinical performance studies for in vitro diagnostic medical devices (IVDs). This standard is harmonized under the EU [IVDR](/terms/ivdr), with Annex XIII, Part A, Section 1 referencing it as a recognized state of the art for performance studies. It provides a framework for ensuring the scientific validity and ethical conduct of [IVD](/terms/ivd) performance studies, aligning with principles found in other [good clinical practice](/terms/gcp) (GCP) standards. ## What this means in practice Required reading for any [IVD](/terms/ivd) sponsor designing performance studies under [IVDR](/terms/ivdr); closes a long-standing gap in IVD-specific [GCP](/terms/gcp) guidance. ## Examples - A manufacturer of a new immunoassay for a disease biomarker designs a clinical performance study following ISO 20916 to gather data on diagnostic sensitivity and specificity. - An IVD company developing a molecular diagnostic test for an infectious agent uses ISO 20916 as a guide to establish ethical considerations and informed consent processes for their study participants. - A regulatory body reviews a manufacturer's clinical performance study report for a novel IVD device, specifically assessing adherence to the data integrity and reporting requirements outlined in ISO 20916 clause 7. Common pitfalls - • Confusing ISO 20916 requirements with those of ISO 14155, which applies to non-IVD medical devices. - • Failing to establish a comprehensive clinical performance study plan as required by ISO 20916 clause 5.2. - • Neglecting to appoint a qualified principal investigator and clearly define their responsibilities according to ISO 20916 clause 4.2. - • Not adequately documenting adverse events and their causality assessment during an IVD clinical performance study. - • Applying ISO 20916 retrospectively to studies initiated before its publication without a clear justification or transition plan. ## Frequently asked questions What is the primary objective of ISO 20916? The primary objective of ISO 20916 is to protect the rights, safety, and well-being of study participants while ensuring the scientific validity and reliability of clinical performance data for in vitro diagnostic ( [IVD](/terms/ivd)) medical devices. How does ISO 20916 relate to the EU IVDR? Who is responsible for ensuring compliance with ISO 20916? Does ISO 20916 apply to all types of IVD performance studies? ## 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)[ Standards ISO 14155 Good clinical practice for clinical investigations of medical devices. ](/terms/iso-14155) ### 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) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 1 FDA· 1 European Commission· 1 1. [1 ISO 20916 Verified ISO · iso.org ](https://www.iso.org/standard/69455.html) 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 5/5/2026 [Compare with another term](/compare?a=iso-20916) Learn in 60 seconds Card Lesson Quiz International standard for Good Study Practice for clinical performance studies of IVDs using specimens from human subjects. - · Required reading for any IVD sponsor designing performance studies under IVDR; closes a long-standing gap in IVD-specific GCP guidance. - · EU IVDR Annex XIII references it as state of the art. Remember this Watch out: Confusing ISO 20916 requirements with those of ISO 14155, which applies to non-IVD medical devices. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [ISO 14155 ](/terms/iso-14155) You may also need Auto-suggested from Regulatory and shared keywords. - [ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [Scientific Validity (IVDR) ](/terms/ivdr-scientific-validity) - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) [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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