--- title: "EU AI Act, Definition | MedTech Terms" description: "EU regulation establishing risk-based requirements for AI systems, including most medical AI. Plain-English Software & AI definition for MedTech teams, with exa" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/eu-ai-act#term", "name": "EU AI Act", "description": "Regulation (EU) 2024/1689 classifies AI systems by risk. 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Medical devices incorporating AI must satisfy both the specific requirements of the AI Act and all applicable requirements of the MDR or IVDR, with conformity assessment integrated into the Notified Body process." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Software & AI](/terms?cat=Software%20%26%20AI) 6. / 7. EU AI Act [All terms](/terms) Software & AI [AI / ML in Devices](/ecosystems/ai-ml)[Software Lifecycle](/ecosystems/software-lifecycle)[Quality System](/ecosystems/quality-system)[Global Markets](/ecosystems/global-markets) # EU AI Act EU regulation establishing risk-based requirements for AI systems, including most medical AI. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Regulation (EU) 2024/1689 classifies AI systems by risk. Medical-device AI is generally treated as 'high-risk' and must meet AI Act requirements (data governance, transparency, human oversight, robustness, post-market monitoring) in addition to [MDR](/terms/mdr-reporting)/ [IVDR](/terms/ivdr). What the regulation says The EU AI Act, specifically Regulation (EU) 2024/1689, categorizes AI systems based on their risk level, with AI in medical devices generally falling under the "high-risk" classification. This necessitates adherence to the Act's stringent requirements, covering aspects like data governance, transparency, human oversight, robustness, and post-market monitoring, in addition to existing [EU Medical Device Regulation](/terms/mdr) ( [MDR](/terms/mdr-reporting)) or In Vitro Diagnostic Regulation ( [IVDR](/terms/ivdr)) obligations. The Act explicitly aims to ensure that AI systems placed on the Union market and used in the Union are [safe](/terms/safe-note) and respect existing fundamental rights and Union values. ## What this means in practice Conformity assessment for medical AI is integrated with the existing [Notified Body](/terms/notified-body) process. Phased application runs through 2027; manufacturers should align technical documentation now. ## Examples - A manufacturer developing an AI-powered diagnostic imaging system must demonstrate robust data governance practices for the AI model's training data, as per AI Act requirements. - An AI-enabled surgical robot requires clear human oversight mechanisms, allowing medical professionals to intervene or override AI decisions, in line with the EU AI Act. - A company marketing an AI algorithm for disease prediction must establish a comprehensive post-market monitoring system to track the AI's performance and address any emerging risks or biases. Common pitfalls - • Failing to integrate AI Act requirements into technical documentation early will lead to significant delays in market access. - • Assuming that MDR/IVDR compliance alone is sufficient for AI-powered medical devices is a critical error. - • Neglecting to establish robust post-market monitoring for AI systems will result in non-compliance and potential regulatory action. - • Misinterpreting the "high-risk" classification criteria for AI in medical devices can lead to inadequate conformity assessment. - • Overlooking the need for human oversight mechanisms in AI-driven medical devices will result in non-adherence to the Act. ## Frequently asked questions When does the EU AI Act apply to medical devices? The phased application of the EU AI Act runs through 2027. Manufacturers should proactively align their technical documentation now to meet the upcoming requirements, integrating them with existing [MDR](/terms/mdr-reporting)/ [IVDR](/terms/ivdr) processes. What specific requirements does the EU AI Act introduce for high-risk AI in MedTech? How does the EU AI Act interact with the MDR/IVDR? ## Cross-references ### Governs Things this term applies rules or requirements to. - [ AI/ML-Enabled Medical Device Most medical AI is high-risk under the AI Act. ](/terms/ai-ml-device) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI AI/ML-Enabled Medical Device Medical device that uses artificial intelligence or machine learning to perform its intended use. ](/terms/ai-ml-device)[ 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) ### More in Software & AI · Same category [ Software & AI AAMI TIR45(TIR45) AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle. ](/terms/aami-tir45)[ Software & AI Adversarial Robustness Resilience of an ML model to inputs deliberately crafted to cause misclassification. ](/terms/adversarial-robustness)[ Software & AI Algorithm Change Protocol(ACP) The detailed procedural section of a PCCP that specifies how planned modifications to an AI/ML model will be developed, validated, and implemented. ](/terms/algorithm-change-protocol)[ Software & AI Algorithmic Bias and Fairness Systematic differences in model performance across demographic or clinical subgroups. ](/terms/ai-bias-fairness) Cited by Where this term appears across MedTech Terms. Ecosystems (4) - [AI / ML in Devices](/ecosystems/ai-ml) - [Software Lifecycle](/ecosystems/software-lifecycle) - [Quality System](/ecosystems/quality-system) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 IMDRF· 1 MDCG· 1 1. [1 EU AI Act (Reg. 2024/1689) Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1689/oj) 2. [2 IMDRF - Software as a Medical Device Verified IMDRF · imdrf.org ](https://www.imdrf.org/working-groups/software-medical-device-samd) 3. [3 MDCG Software Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building software-as-a-medical-device? We help SaMD and AI/ML device teams meet IEC 62304 and the FDA's evolving expectations for software cybersecurity. [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 Software & AI Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=eu-ai-act) Learn in 60 seconds Card Lesson Quiz EU regulation establishing risk-based requirements for AI systems, including most medical AI. - · Conformity assessment for medical AI is integrated with the existing Notified Body process. - · Phased application runs through 2027; manufacturers should align technical documentation now. - · Medical-device AI is generally treated as 'high-risk' and must meet AI Act requirements (data governance, transparency, human oversight, robustness, post-market monitoring) in addition to MDR/IVDR. Remember this Watch out: Failing to integrate AI Act requirements into technical documentation early will lead to significant delays in market access. Related terms - [AI/ML-Enabled Medical Device ](/terms/ai-ml-device) - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Notified Body(NB) ](/terms/notified-body) You may also need Auto-suggested from Software & AI and shared keywords. - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [Data Governance (AI/ML) ](/terms/data-governance) - [ONC HTI-1 / HTI-2 ](/terms/onc-hti) - [AAMI SW96 ](/terms/aami-sw96) - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) [All Software & AI terms](/terms?cat=Software%20%26%20AI) From the Blue Goat network Related resources and services on this topic. - [ AI SaMD Insights How AI is changing SaMD - risk, regulation, and good machine-learning practice. ](https://ai-samd.com) - [ Med Device Cyber Podcast Conversations with medical device cybersecurity practitioners. ](https://mdcpodcast.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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