--- title: "High-Risk AI System (EU AI Act), Definition | MedTech Terms" description: "AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-high-risk-system#term", "name": "High-Risk AI System (EU AI Act)", "description": "Under Article 6 of Regulation (EU) 2024/1689, an AI system is high-risk if it is a safety component of, or itself is, a product covered by Union harmonisation legislation listed in Annex I (which includes medical devices under the MDR and IVDR) and requires third-party conformity assessment, or if it is listed in Annex III. 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Self-declared Class I MDR software is not automatically high-risk." } }, { "@type": "Question", "name": "When do the high-risk obligations start applying?", "acceptedAnswer": { "@type": "Answer", "text": "The high-risk provisions for products listed in Annex I (including medical devices) apply from 2 August 2027 per Article 113(c)." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. High-Risk AI System (EU AI Act) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Quality System](/ecosystems/quality-system)[Global Markets](/ecosystems/global-markets)[Startup Lifecycle](/ecosystems/startup-lifecycle) # 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. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Under Article 6 of Regulation (EU) 2024/1689, an AI system is high-risk if it is a safety component of, or itself is, a product covered by Union harmonisation legislation listed in Annex I (which includes medical devices under the [MDR](/terms/mdr-reporting) and [IVDR](/terms/ivdr)) and requires third-party conformity assessment, or if it is listed in Annex III. Nearly all AI-enabled Class IIa and above medical devices fall into the first branch. What the regulation says Article 6(1) states an AI system is high-risk where it is intended to be used as a safety component of a product, or is itself a product, covered by Annex I Union harmonisation legislation and is required to undergo a third-party conformity assessment. ## What this means in practice For MedTech, this means the AI Act does not create a separate [CE mark](/terms/ce-mark): obligations layer on top of the [MDR](/terms/mdr-reporting)/ [IVDR](/terms/ivdr) conformity assessment through the [notified body](/terms/notified-body). Manufacturers must satisfy Articles 8 to 15 (risk management, data governance, technical documentation, record-keeping, transparency, human oversight, accuracy, robustness, and cybersecurity) in addition to the underlying device regulation. Common pitfalls - • Assuming Class I MDR devices with AI escape the AI Act. Many still do, but only where no third-party conformity assessment is required. - • Treating the AI Act as a replacement for MDR Annex XVI clinical evaluation. It is additive, not substitutive. - • Confusing Annex III (standalone high-risk use cases) with the MedTech route through Annex I. ## Frequently asked questions Does every AI/ML SaMD count as high-risk? Any AI-enabled medical device that requires notified-body involvement under [MDR](/terms/mdr-reporting) or [IVDR](/terms/ivdr) is high-risk under the AI Act. Self-declared Class I MDR software is not automatically high-risk. When do the high-risk obligations start applying? ## 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)[ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr)[ Regulatory Notified Body(NB) EU-designated organization that assesses conformity of medical devices under MDR and IVDR. ](/terms/notified-body)[ Software & AI EU AI Act EU regulation establishing risk-based requirements for AI systems, including most medical AI. ](/terms/eu-ai-act) ### 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 (5) - [Regulated Pathways](/ecosystems/regulated-pathways) - [AI / ML in Devices](/ecosystems/ai-ml) - [Quality System](/ecosystems/quality-system) - [Global Markets](/ecosystems/global-markets) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 1 European Commission· 1 IMDRF· 1 1. [1 Regulation (EU) 2024/1689, Article 6 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1689/oj) 2. [2 Commission Q&A on the AI Act Unchecked European Commission digital-strategy.ec.europa.eu ](https://digital-strategy.ec.europa.eu/en/faqs/artificial-intelligence-act) 3. [3 IMDRF Documents Verified IMDRF imdrf.org ](https://www.imdrf.org/documents) 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-high-risk-system) Learn in 60 seconds Card Lesson Quiz AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III. - · For MedTech, this means the AI Act does not create a separate CE mark: obligations layer on top of the MDR/IVDR conformity assessment through the notified body. - · Nearly all AI-enabled Class IIa and above medical devices fall into the first branch. Remember this Watch out: Assuming Class I MDR devices with AI escape the AI Act. Many still do, but only where no third-party conformity assessment is required. Related terms - [EU AI Act ](/terms/eu-ai-act) - [Software as a Medical Device(SaMD) ](/terms/samd) - [Notified Body(NB) ](/terms/notified-body) - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) You may also need Auto-suggested from Regulatory and shared keywords. - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [CE Mark ](/terms/ce-mark) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) [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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