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European Commission Issues Draft Guidelines on High-Risk AI System Classification, EU, May 2026

On 19 May 2026, the European Commission published draft guidelines on the classification of high-risk AI systems under Article 6 of Regulation (EU) 2024/1689, the EU AI Act. A targeted public consultation is open until 23 July 2026. The guidelines aim to assist providers, deployers, and market surveillance authorities in determining which AI systems trigger the Act's most onerous compliance obligations. Final guidelines are expected before end of 2026.

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On 19 May 2026, the European Commission published draft guidelines on the classification of high-risk AI systems and opened a targeted public consultation. The consultation deadline was subsequently extended to 23 July 2026. The guidelines are non-binding at this stage and will not take effect until the Commission adopts them in final form, which is expected before the end of 2026.

The draft guidelines interpret Article 6 of Regulation (EU) 2024/1689, the EU AI Act. Article 6(1) covers AI systems embedded in products subject to Union harmonised product safety legislation. Article 6(2) covers AI systems whose use can significantly affect the health, safety, or fundamental rights of natural persons in the use cases listed in Annex III. Annex III sectors include biometric identification, critical infrastructure, education, employment, essential private and public services, law enforcement, migration, and administration of justice. The draft guidelines set out general classification principles and a non-exhaustive list of examples across each Annex III sector.

Providers of AI systems operating in Annex III sectors must assess whether their products meet the Article 6 classification threshold. A positive classification triggers the full set of high-risk obligations in Chapter III of the EU AI Act, including conformity assessments, technical documentation, logging requirements, human oversight measures, and registration in the EU database. Deployers of high-risk AI systems face parallel requirements covering monitoring, incident reporting, and data governance. Market surveillance authorities in each Member State will apply the final guidelines when deciding whether to open enforcement proceedings.

Article 6(3) of the EU AI Act exempts from high-risk classification AI systems that perform a narrow procedural task, improve the outcome of a previously completed human activity, detect decision-making patterns without influencing individual decisions, or prepare tasks for human assessment. The draft guidelines do not fully define the boundaries of these exclusions, creating scope for divergent interpretations among national market surveillance authorities before the final text is adopted. Consultation responses are accepted until 23 July 2026.

Licentium advises AI system providers and deployers on EU AI Act classification and compliance. If you are assessing whether your AI product is high-risk under Article 6, we can assist with classification analysis and readiness planning. Work we undertake includes EU AI Act conformity assessment support, Annex III classification analysis, technical documentation review, and regulatory consultation strategy.

Source: European Commission, Draft Commission Guidelines on the Classification of High-Risk AI Systems, 19 May 2026

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