The European Commission published draft guidelines on the classification of high-risk AI systems under the AI Act, Regulation (EU) 2024/1689, and opened a targeted consultation for stakeholder feedback. The guidelines are in draft form and not yet final: the Commission extended the consultation deadline to 23 July 2026, after which it will finalise and publish the guidelines, with final adoption expected by end of 2026. The guidelines are intended to support providers and deployers in self-classifying AI systems and to assist national market surveillance authorities in enforcement.
Article 6 of Regulation (EU) 2024/1689 sets the criteria for classifying an AI system as high-risk. The draft guidelines address two categories: first, AI systems intended as safety components of products covered by EU harmonisation legislation listed in Annex I that must undergo third-party conformity assessment; second, AI systems falling into one of the use-case areas listed in Annex III, which covers biometric identification, critical infrastructure, education, employment, essential services, law enforcement, migration, and administration of justice. The guidelines also address the Article 6(3) exclusion allowing providers to self-determine that a listed AI system does not pose a significant risk of harm.
AI system providers, deployers, importers, and distributors placing AI systems on the EU market must determine whether their systems qualify as high-risk, as that classification triggers mandatory conformity assessment, registration in the EU database under Article 71, and ongoing post-market monitoring obligations. The draft guidelines affect developers of systems in healthcare, HR, education technology, credit scoring, biometrics, border control, and critical infrastructure, all of which are Annex III areas. Providers that incorrectly classify a high-risk system as non-high-risk face enforcement action by national market surveillance authorities.
The draft guidelines note that not all AI systems listed under an Annex III area automatically qualify as high-risk: Article 6(3) permits providers to self-determine that their system does not pose a significant risk, provided specified conditions are met and the determination is documented in the technical file. The Commission has indicated that these guidelines will be supplemented by additional guidance on obligations applying to providers and deployers of confirmed high-risk systems. Consultation responses submitted by 23 July 2026 will be published and considered before finalisation.
Licentium advises AI system providers and deployers on AI Act compliance, including high-risk classification assessments and conformity procedure preparation. Organisations seeking to respond to the consultation or to assess their products against the draft guidelines are welcome to contact us. Work we undertake includes AI Act readiness assessments, high-risk classification analysis, conformity assessment preparation, technical documentation review, and EU AI regulatory strategy.