The terms, as the law defines them

AI system

Article 3, point (1) — the Regulation as adopted; this point was not amended

(1) ‘AI system’ means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;

provider

Article 3, point (3) — the Regulation as adopted; this point was not amended

(3) ‘provider’ means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge;

deployer

Article 3, point (4) — the Regulation as adopted; this point was not amended

(4) ‘deployer’ means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;

authorised representative

Article 3, point (5) — the Regulation as adopted; this point was not amended

(5) ‘authorised representative’ means a natural or legal person located or established in the Union who has received and accepted a written mandate from a provider of an AI system or a general-purpose AI model to, respectively, perform and carry out on its behalf the obligations and procedures established by this Regulation;

importer

Article 3, point (6) — the Regulation as adopted; this point was not amended

(6) ‘importer’ means a natural or legal person located or established in the Union that places on the market an AI system that bears the name or trademark of a natural or legal person established in a third country;

distributor

Article 3, point (7) — the Regulation as adopted; this point was not amended

(7) ‘distributor’ means a natural or legal person in the supply chain, other than the provider or the importer, that makes an AI system available on the Union market;

operator

Article 3, point (8) — the Regulation as adopted; this point was not amended

(8) ‘operator’ means a provider, product manufacturer, deployer, authorised representative, importer or distributor;

putting into service

Article 3, point (11) — the Regulation as adopted; this point was not amended

(11) ‘putting into service’ means the supply of an AI system for first use directly to the deployer or for own use in the Union for its intended purpose;

intended purpose

Article 3, point (12) — the Regulation as adopted; this point was not amended

(12) ‘intended purpose’ means the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;

substantial modification

Article 3, point (23) — the Regulation as adopted; this point was not amended

(23) ‘substantial modification’ means a change to an AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the compliance of the AI system with the requirements set out in Chapter III, Section 2 is affected or results in a modification to the intended purpose for which the AI system has been assessed;

AI literacy

Article 3, point (56) — the Regulation as adopted; this point was not amended

(56) ‘AI literacy’ means skills, knowledge and understanding that allow providers, deployers and affected persons, taking into account their respective rights and obligations in the context of this Regulation, to make an informed deployment of AI systems, as well as to gain awareness about the opportunities and risks of AI and possible harm it can cause;

general-purpose AI model

Article 3, point (63) — the Regulation as adopted; this point was not amended

(63) ‘general-purpose AI model’ means an AI model, including where such an AI model is trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable of competently performing a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into a variety of downstream systems or applications, except AI models that are used for research, development or prototyping activities before they are placed on the market;

micro, small and medium-sized enterprise

Article 3, point (14a) — inserted by Regulation (EU) 2026/1744, point (4)(b) — the point did not exist in the 2024 text

(14a) “micro, small and medium-sized enterprise” or “SME” means a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Recommendation 2003/361/EC;

small mid-cap enterprise

Article 3, point (14b) — inserted by Regulation (EU) 2026/1744, point (4)(b) — the point did not exist in the 2024 text

(14b) “small mid-cap enterprise” or “SMC” means a small mid-cap enterprise as defined in point (2) of the Annex to Recommendation (EU) 2025/1099;