--- title: "AI Act Technical Documentation (Annex IV)… | MedTech Terms" description: "The information set a provider must maintain to demonstrate a high-risk AI system's compliance with Articles 8 to 15." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-technical-documentation#term", "name": "AI Act Technical Documentation (Annex IV)", "description": "Article 11 and Annex IV require providers of high-risk AI systems to prepare and keep up to date technical documentation covering system description, design specification, monitoring and control, risk management, training and testing data (methodology, provenance, labelling, cleaning), validation and testing procedures, cybersecurity, and the post-market monitoring plan.", "url": "https://medtechterms.com/terms/ai-act-technical-documentation", "termCode": "ai-act-technical-documentation", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/ai-act-technical-documentation#article", "headline": "AI Act Technical Documentation (Annex IV)", "description": "The information set a provider must maintain to demonstrate a high-risk AI system's compliance with Articles 8 to 15.", "url": "https://medtechterms.com/terms/ai-act-technical-documentation", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/ai-act-technical-documentation" }, "about": { "@id": "https://medtechterms.com/terms/ai-act-technical-documentation#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "AI Act Technical Documentation (Annex IV), 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) 2024/1689, Article 11 and Annex IV", "url": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "IMDRF Documents", "url": "https://www.imdrf.org/documents", "publisher": { "@type": "Organization", "name": "IMDRF" } }, { "@type": "CreativeWork", "name": "RAPS Regulatory Focus", "url": "https://www.raps.org/news-and-articles/news-articles", "publisher": { "@type": "Organization", "name": "RAPS" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-high-risk-system#term", "name": "High-Risk AI System (EU AI Act)", "url": "https://medtechterms.com/terms/ai-act-high-risk-system" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-conformity-assessment#term", "name": "AI Act Conformity Assessment (Medical Devices)", "url": "https://medtechterms.com/terms/ai-act-conformity-assessment" } ] }, { "@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": "AI Act Technical Documentation (Annex IV)", "item": "https://medtechterms.com/terms/ai-act-technical-documentation" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. AI Act Technical Documentation (Annex IV) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Quality System](/ecosystems/quality-system) # AI Act Technical Documentation (Annex IV) The information set a provider must maintain to demonstrate a high-risk AI system's compliance with Articles 8 to 15. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 11 and Annex IV require providers of high-risk AI systems to prepare and keep up to date technical documentation covering system description, design specification, monitoring and control, risk management, training and testing data (methodology, provenance, labelling, cleaning), validation and testing procedures, cybersecurity, and the post-market monitoring plan. ## What this means in practice For medical devices, Annex IV elements fold into the [MDR](/terms/mdr-reporting) Annex II or [IVDR](/terms/ivdr) Annex II technical documentation rather than sitting in a separate file. Data-governance evidence (Article 10) is the section most often underdeveloped in existing device technical files. Common pitfalls - • Treating Annex IV as boilerplate. Notified bodies specifically probe training-data provenance and labelling processes. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory AI Act Conformity Assessment (Medical Devices) For AI-enabled medical devices, AI Act requirements are assessed through the MDR/IVDR notified-body procedure, not a separate CE route. ](/terms/ai-act-conformity-assessment)[ 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) ### 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 IMDRF· 1 RAPS· 1 1. [1 Regulation (EU) 2024/1689, Article 11 and Annex IV Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1689/oj) 2. [2 IMDRF Documents Verified IMDRF imdrf.org ](https://www.imdrf.org/documents) 3. [3 RAPS Regulatory Focus Verified RAPS raps.org ](https://www.raps.org/news-and-articles/news-articles) 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=ai-act-technical-documentation) Learn in 60 seconds Card Lesson Quiz The information set a provider must maintain to demonstrate a high-risk AI system's compliance with Articles 8 to 15. - · For medical devices, Annex IV elements fold into the MDR Annex II or IVDR Annex II technical documentation rather than sitting in a separate file. - · Data-governance evidence (Article 10) is the section most often underdeveloped in existing device technical files. Remember this Watch out: Treating Annex IV as boilerplate. Notified bodies specifically probe training-data provenance and labelling processes. Related terms - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) You may also need Auto-suggested from Regulatory and shared keywords. - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [General-Purpose AI Model(GPAI) ](/terms/ai-act-gpai) [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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