--- title: "FRIA, Fundamental Rights Impact Assessment | MedTech Terms" description: "Assessment deployers of certain high-risk AI systems must complete before first use. Plain-English Regulatory definition for MedTech teams, with examples and re" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-fria#term", "name": "Fundamental Rights Impact Assessment", "alternateName": "FRIA", "description": "Article 27 requires deployers that are bodies governed by public law, private operators providing public services, or deployers of certain Annex III systems (creditworthiness, life and health insurance risk assessment) to perform a Fundamental Rights Impact Assessment. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Fundamental Rights Impact Assessment [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Quality System](/ecosystems/quality-system)FRIA # Fundamental Rights Impact Assessment Assessment deployers of certain high-risk AI systems must complete before first use. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 27 requires deployers that are bodies governed by public law, private operators providing public services, or deployers of certain Annex III systems (creditworthiness, life and health insurance risk assessment) to perform a Fundamental Rights Impact Assessment. It documents the deployment process, categories of persons affected, specific risks of harm, human-oversight measures, and mitigation actions. ## What this means in practice Public hospitals and health-service bodies deploying AI-enabled devices may qualify as deployers required to perform a FRIA, even though the manufacturer already performed the AI Act conformity assessment. MedTech commercial teams should be ready to support customers with the information needed for their FRIA. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory High-Risk AI System (EU AI Act) AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III. ](/terms/ai-act-high-risk-system)[ Regulatory Provider and Deployer (EU AI Act) The two primary role categories in the AI Act. Providers place systems on the market; deployers put them into use in a professional capacity. ](/terms/ai-act-provider-deployer) ### 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) - [AI / ML in Devices](/ecosystems/ai-ml) - [Quality System](/ecosystems/quality-system) ## 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) 2024/1689, Article 27 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1689/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 Acronym FRIA Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ai-act-fria) Learn in 60 seconds Card Lesson Quiz Assessment deployers of certain high-risk AI systems must complete before first use. - · MedTech commercial teams should be ready to support customers with the information needed for their FRIA. - · It documents the deployment process, categories of persons affected, specific risks of harm, human-oversight measures, and mitigation actions. Remember this Assessment deployers of certain high-risk AI systems must complete before first use. Related terms - [Provider and Deployer (EU AI Act) ](/terms/ai-act-provider-deployer) - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) You may also need Auto-suggested from Regulatory and shared keywords. - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) - [AI Act Transparency Obligations ](/terms/ai-act-transparency-obligations) - [Self-Test and Near-Patient Testing (IVDR) ](/terms/ivdr-self-test) - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) [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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