The European Commission published draft guidelines on 19 May 2026 for determining when an AI system qualifies as high-risk under Article 6 of Regulation (EU) 2024/1689. The targeted consultation closes on 23 July 2026. Final guidelines are expected before the end of 2026. The guidelines are not legally binding but reflect the Commission's interpretive position and will inform enforcement decisions taken by National Market Surveillance Authorities across the European Union.
Article 6 of the AI Act establishes two classification pathways. Under Article 6(1), an AI system is automatically high-risk if it functions as a safety component in an Annex I product and requires third-party conformity assessment. Annex I products include machinery, radio equipment, and medical devices. Under Article 6(2), a system is high-risk if it falls within one of the nine Annex III use cases: biometric identification, critical infrastructure management, AI in education and vocational training, employment and worker management decisions, access to essential private services including credit scoring and insurance, law enforcement, migration and border control, administration of justice, and management of democratic processes. The draft guidelines provide worked examples for each category and clarify the threshold at which a system's risk level triggers the high-risk designation.
Classification as high-risk matters most for banks and fintech lenders applying AI to credit decisions, HR platforms using AI for recruitment screening, insurers running automated underwriting models, and financial institutions using AI-assisted AML or fraud detection systems. A system classified as high-risk under Article 6(2) must meet obligations covering risk management (Article 9), technical documentation (Article 11), automatic logging (Article 12), transparency for deployers (Article 13), human oversight (Article 14), accuracy and robustness (Article 15), conformity assessment (Article 43), and registration in the EU AI Act database (Articles 49 and 71). These obligations apply before the system is placed on the market or put into service.
Article 6(3) allows providers to self-assess that their Annex III AI system does not pose significant risk and therefore falls outside the high-risk designation. The draft guidelines address the criteria and procedure for this exemption. Providers that invoke Article 6(3) incorrectly face retroactive enforcement by National Market Surveillance Authorities. The consultation specifically invites input on where the boundaries of this exemption should sit, making a submission before 23 July 2026 a direct opportunity to shape the final guidelines.
Licentium advises AI providers and deployers on EU AI Act classification obligations, conformity assessment procedures, and technical documentation requirements. If your system may qualify as high-risk under Annex III, or if you are assessing the Article 6(3) exemption, we can support that analysis. Work we undertake includes AI Act readiness assessments, Article 6 classification analysis, Annex III mapping, documentation support, and regulatory engagement with national supervisory authorities.