Article 3 of 1133%
Article 3: Definitions
EU Official:
Title I: General Provisions
According to Article 3, an AI system is a machine-based system designed to operate with varying levels of autonomy, that may exhibit adaptiveness, and infers from input how to generate outputs such as predictions, recommendations or decisions.
Official text
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Source: EUR-Lex, Regulation (EU) 2024/1689. Text reproduced verbatim.
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7- Guidelines on transparency obligations for providers and deployers of certain AI systems under Article 50 of the AI ActSpecifies the concepts of provider, deployer and deepfake that determine who in a chain bears which transparency obligation.PublishedGuidelinesEuropean Commission20 Jul 2026
- Guidelines on the scope of obligations for providers of general-purpose AI models under the AI ActSpecifies the definition of a general-purpose AI model in Article 3, point 63, with an indicative threshold based on training compute.PublishedGuidelinesEuropean Commission18 Jul 2025
- AIB 2025-1 / MDCG 2025-6 Interplay between the Medical Devices Regulation (MDR) and In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)Specifies that the deployer under the AI Regulation does not coincide with the user under the Medical Devices Regulation and in vitro Diagnostic Medical Devices Regulation, which determines who bears which obligation.PublishedGuidelinesAI Board (AIB) and Medical Device Coordination Group (MDCG), European Commission
- Commission Guidelines on the definition of an artificial intelligence system established by Regulation (EU) 2024/1689 (AI Act)Works through the definition of AI system in Article 3, paragraph 1, element by element so that organisations can classify their software portfolio as in scope or out of scope.PublishedGuidelinesEuropean Commission (DG CONNECT / AI Office)6 Feb 2025
- AI Literacy - Questions & AnswersClarifies who falls within the definition of staff, including contractors and third parties who work with AI on behalf of the organisationPublishedQ&AEuropean Commission, DG CONNECT27 Jul 2026
- Draft guidance and reporting template on serious AI incidents (Article 73)Clarifies the definition of serious incident from Article 3, paragraph 49, with examples of harm to health, property, environment and fundamental rightsConsultationTemplateEuropean Commission26 Sept 2025
- EU AI Act Compliance CheckerHelps determine what role an organisation has, provider or deployer, because the entire package of obligations depends on itDraftQ&AEuropean Commission (AI Act Service Desk)
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Frequently asked questions
How does Article 3 AI Act define an AI system?+
According to Article 3, an AI system is a machine-based system designed to operate with varying levels of autonomy, that may exhibit adaptiveness, and infers from input how to generate outputs such as predictions, recommendations or decisions.
What is a provider under the AI Act?+
Article 3(3) defines a provider as a person or organisation that develops an AI system or general-purpose AI model and places it on the market or puts it into service under its own name or trademark.
What is a deployer under Article 3 of the AI Act?+
Article 3(4) defines a deployer as a person or organisation using an AI system under its authority, except where the AI system is used in the course of a personal non-professional activity.