On May 19, 2026, the European Commission published draft guidelines interpreting Article 6 of Regulation (EU) 2024/1689, the EU AI Act, on classifying high-risk AI systems. The guidelines are in draft form; the targeted consultation closes June 23, 2026. They do not carry binding legal force but will inform how national market surveillance authorities apply the classification rules in enforcement.
Article 6 AI Act establishes two classification tracks. Article 6(1) covers AI systems that are safety components of products regulated under Annex I sector legislation. Article 6(2) covers standalone AI systems listed in Annex III high-impact domains; those systems qualify as high-risk where they pose a significant risk of harm to health, safety, or fundamental rights. The draft guidelines, issued under Article 6(5), clarify the 'safety component' concept in Article 6(1) and the risk-of-harm threshold in Article 6(2). They also supply a catalogue of worked examples per Annex III sector; each example specifies whether a given AI application does or does not qualify as high-risk.
AI system providers and deployers operating in EU markets must classify their systems before deployment. Systems classified as high-risk under Article 6 require conformity assessments under Article 43, technical documentation per Annex IV, registration in the EU AI database under Article 71, and post-market monitoring. The worked examples directly affect AI developers active in healthcare, employment screening, credit scoring, biometrics, critical infrastructure management, and law enforcement, each of which is an Annex III domain.
The consultation closes June 23, 2026, after which the Commission will finalise the guidelines. Because the guidelines derive from a specific Article 6(5) delegation, they carry substantial practical weight in enforcement proceedings even before finalisation. Providers whose systems may qualify as high-risk should cross-reference the worked examples against their own AI system documentation during the consultation window and consider submitting feedback to shape the final text.
Licentium advises clients on EU AI Act compliance across the full product lifecycle, from initial classification analysis through conformity assessment and registration. Our partner network includes specialist AI Act counsel in multiple EU member states. Work we undertake includes AI Act classification reviews, high-risk AI compliance programs, technical documentation audits, and EU AI Act readiness assessments.