1. This Regulation applies to:

(a) providers placing on the marketplacing on the marketmeans the first making available of an AI systemAI systemmeans 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 environmentsArticle 3(1) or a general-purpose AI model on the Union marketArticle 3(9) or putting into serviceputting into servicemeans the supply of an AI systemAI systemmeans 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 environmentsArticle 3(1) for first use directly to the deployerdeployermeans 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 activityArticle 3(4) or for own use in the Union for its intended purposeintended purposemeans the use for which an AI systemAI systemmeans 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 environmentsArticle 3(1) is intended by the providerprovidermeans 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 chargeArticle 3(3), including the specific context and conditions of use, as specified in the information supplied by the providerprovidermeans 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 chargeArticle 3(3) in the instructions for use, promotional or sales materials and statements, as well as in the technical documentationArticle 3(12)Article 3(11) AI systems or placing on the marketplacing on the marketmeans the first making available of an AI systemAI systemmeans 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 environmentsArticle 3(1) or a general-purpose AI model on the Union marketArticle 3(9) general-purpose AI models in the Union, irrespective of whether those providers are established or located within the Union or in a third country;

(b) deployers of AI systems that have their place of establishment or are located within the Union;

(c) providers and deployers of AI systems that have their place of establishment or are located in a third country, where the output produced by the AI systemAI systemmeans 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 environmentsArticle 3(1) is used in the Union;

(d) importers and distributors of AI systems;

(e) product manufacturers placing on the marketplacing on the marketmeans the first making available of an AI systemAI systemmeans 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 environmentsArticle 3(1) or a general-purpose AI model on the Union marketArticle 3(9) or putting into serviceputting into servicemeans the supply of an AI systemAI systemmeans 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 environmentsArticle 3(1) for first use directly to the deployerdeployermeans 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 activityArticle 3(4) or for own use in the Union for its intended purposeintended purposemeans the use for which an AI systemAI systemmeans 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 environmentsArticle 3(1) is intended by the providerprovidermeans 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 chargeArticle 3(3), including the specific context and conditions of use, as specified in the information supplied by the providerprovidermeans 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 chargeArticle 3(3) in the instructions for use, promotional or sales materials and statements, as well as in the technical documentationArticle 3(12)Article 3(11) an AI systemAI systemmeans 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 environmentsArticle 3(1) together with their product and under their own name or trademark;

(f) authorised representatives of providers, which are not established in the Union;

(g) affected persons that are located in the Union.

3. This Regulation does not apply to areas outside the scope of Union law, and shall not, in any event, affect the competences of the Member States concerning national security, regardless of the type of entity entrusted by the Member States with carrying out tasks in relation to those competences.

4. This Regulation applies neither to public authorities in a third country nor to international organisations falling within the scope of this Regulation pursuant to paragraph 1, where those authorities or organisations use AI systems in the framework of international cooperation or agreements for law enforcementlaw enforcementmeans activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public securityArticle 3(46) and judicial cooperation with the Union or with one or more Member States, provided that such a third country or international organisation provides adequate safeguards with respect to the protection of fundamental rightsfundamental rightsIncludes human dignity, right to life, prohibition of torture, protection of personal datapersonal dataAny information relating to an identified or identifiable natural person ('data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)An identified or identifiable natural person to whom personal data relateGDPR Art. 4(1)'). Includes name, ID number, location data, online identifiers, or factors specific to physical, physiological, genetic, mental, economic, cultural or social identityGDPR Art. 4(1), freedom of expression, non-discrimination, equality between women and men, rights of the child, right to an effective remedy and fair trialCharter of Fundamental Rights Art. 1–54 and freedoms of individuals.

5. This Regulation shall not affect the application of the provisions on the liability of providers of intermediary services as set out in Chapter II of Regulation (EU) 2022/2065.

6. This Regulation does not apply to AI systems or AI models, including their output, specifically developed and put into service for the sole purpose of scientific research and development.

8. This Regulation does not apply to any research, testing or development activity regarding AI systems or AI models prior to their being placed on the market or put into service. Such activities shall be conducted in accordance with applicable Union law. Testing in real world conditions shall not be covered by that exclusion.

9. This Regulation is without prejudice to the rules laid down by other Union legal acts related to consumer protection and product safety.

10. This Regulation does not apply to obligations of deployers who are natural persons using AI systems in the course of a purely personal non-professional activity.

11. This Regulation does not preclude the Union or Member States from maintaining or introducing laws, regulations or administrative provisions which are more favourable to workers in terms of protecting their rights in respect of the use of AI systems by employers, or from encouraging or allowing the application of collective agreements which are more favourable to workers.

12. This Regulation does not apply to AI systems released under free and open-source licences, unless they are placed on the market or put into service as high-risk AI systems or as an AI systemAI systemmeans 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 environmentsArticle 3(1) that falls under Article 5 or 50.