Two paths: (1) The AI is a safety component of a product covered by EU harmonisation legislation listed in Annex I (Article 6(1)), or (2) the AI falls into one of the use categories listed in Annex III (Article 6(2)).
5 questions answered with specific EU AI Act article references. 0 days until Annex III high-risk obligations apply on 2 December 2027 (Digital Omnibus on AI, Regulation (EU) 2026/1744); Article 50 transparency obligations have applied since 2 August 2026.
Not sure if your AI system is affected? Take the 5-minute diagnostic.Two paths: (1) The AI is a safety component of a product covered by EU harmonisation legislation listed in Annex I (Article 6(1)), or (2) the AI falls into one of the use categories listed in Annex III (Article 6(2)).
Eight categories: biometrics, critical infrastructure, education, employment, access to essential services, law enforcement, migration/border control, and justice/democratic processes.
Not automatically. AI systems that are medical devices under the MDR/IVDR are high-risk via Annex I. General health informatics tools without clinical decision-making may be lower risk.
Generally no. Chatbots typically fall under limited risk (Article 50 transparency obligations). However, if a chatbot makes or influences decisions about credit, insurance, employment, or healthcare, it may be high-risk.
The provider self-classifies based on Article 6 criteria. Market surveillance authorities can challenge the classification during inspection. For borderline cases, guidance from the European AI Office applies.
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