--- title: "AI Act Conformity Assessment (Medical Devic… | MedTech Terms" description: "For AI-enabled medical devices, AI Act requirements are assessed through the MDR/IVDR notified-body procedure, not a separate CE route." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-conformity-assessment#term", "name": "AI Act Conformity Assessment (Medical Devices)", "description": "Article 43(3) provides that where an AI system is a safety component of, or is itself, a product covered by Annex I legislation such as the MDR or IVDR, the AI Act requirements are checked as part of the conformity assessment procedure under that legislation. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. AI Act Conformity Assessment (Medical Devices) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Global Markets](/ecosystems/global-markets) # 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. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 43(3) provides that where an AI system is a safety component of, or is itself, a product covered by Annex I legislation such as the [MDR](/terms/mdr-reporting) or [IVDR](/terms/ivdr), the AI Act requirements are checked as part of the conformity assessment procedure under that legislation. The [notified body](/terms/notified-body) performing the MDR/IVDR assessment therefore extends its scope to cover the relevant AI Act articles. ## What this means in practice Practically, manufacturers must ensure their [notified body](/terms/notified-body) is designated for the AI Act scope relevant to the device. Technical documentation under [MDR](/terms/mdr-reporting) Annex II or [IVDR](/terms/ivdr) Annex II must be extended to include the AI Act Annex IV elements (data governance, training methodology, evaluation, cybersecurity, human oversight). Common pitfalls - • Selecting a notified body designated only under MDR without confirming AI Act scope designation. - • Duplicating documentation instead of integrating AI Act evidence into the existing technical file. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 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. ](/terms/ai-act-technical-documentation)[ 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 Notified Body(NB) EU-designated organization that assesses conformity of medical devices under MDR and IVDR. ](/terms/notified-body) ### 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) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 RAPS· 1 FDA· 1 1. [1 Regulation (EU) 2024/1689, Article 43 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1689/oj) 2. [2 RAPS Regulatory Focus Verified RAPS raps.org ](https://www.raps.org/news-and-articles/news-articles) 3. [3 FDA - Medical Devices Verified FDA fda.gov ](https://www.fda.gov/medical-devices) 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-conformity-assessment) Learn in 60 seconds Card Lesson Quiz For AI-enabled medical devices, AI Act requirements are assessed through the MDR/IVDR notified-body procedure, not a separate CE route. - · Practically, manufacturers must ensure their notified body is designated for the AI Act scope relevant to the device. - · The notified body performing the MDR/IVDR assessment therefore extends its scope to cover the relevant AI Act articles. Remember this Watch out: Selecting a notified body designated only under MDR without confirming AI Act scope designation. Related terms - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [Notified Body(NB) ](/terms/notified-body) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) You may also need Auto-suggested from Regulatory and shared keywords. - [CE Mark ](/terms/ce-mark) - [MDR Article 117 ](/terms/mdr-article-117) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) [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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