Draft Commission guidelines on the classification of high-risk AI systems | Shaping Europe’s digital future

https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems
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2026-05-19 12:35:52 · adavies@vixio.com
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These Guidelines aim to support providers and deployers of AI systems, as well as competent market surveillance authorities, in assessing whether an AI system should be classified as high-risk, thereby facilitating the uniform application and effective enforcement of Article 6 AI Act.

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TITLE: European Commission Publishes Draft Guidelines on Classification of High-Risk Artificial Intelligence Systems BODY: On May 19, 2026, the European Commission published draft guidelines to support the uniform application and effective enforcement of Article 6 of the Artificial Intelligence Act (AI Act). The guidelines aim to assist AI system providers, deployers, and competent market surveillance authorities in determining whether an AI system should be classified as high-risk. The draft guidelines interpret key concepts relevant to classification and provide practical examples of AI systems that should or should not be classified as high-risk across all areas and use cases. The guidelines are structured around two scenarios under Article 6 of the AI Act. The first scenario covers AI systems intended as safety components of products covered by EU harmonisation legislation listed in Annex I of the AI Act, where the product or AI system itself requires third-party conformity assessment. The second scenario addresses AI systems falling into specific use cases listed under areas in Annex III of the AI Act. The guidelines acknowledge that the examples provided are not exhaustive and may be updated over time. The Commission has divided the draft guidelines into sections following the structure of Article 6 of the AI Act. Section III addresses the first category of high-risk AI systems, while Section IV addresses the second category. The guidelines are available for download in separate sections covering general principles, Annex I of the AI Act, and Annex III of the AI Act, enabling stakeholders to access specific areas of interest. The European Commission is conducting a targeted stakeholder consultation on these draft guidelines. Stakeholders are encouraged to review the guidelines and provide feedback to support the development of final guidance on high-risk AI system classification.
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  • By:adavies@vixio.com (41)