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    EU AI Act

    EU regulation establishing risk-based requirements for AI systems, including most medical AI.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast 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/IVDR.

    What this means in practice

    Conformity assessment for medical AI is integrated with the existing Notified Body process. Phased application runs through 2027; manufacturers should align technical documentation now.

    Cross-references

    Governs

    Things this term applies rules or requirements to.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1IMDRF·1MDCG·1
    1. 1
      EU AI Act (Reg. 2024/1689)
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      IMDRF - Software as a Medical Device
      Verified
      IMDRFimdrf.org
    3. 3
      MDCG Software Guidance
      Verified
      MDCGhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.