The AI Act enters into force on the twentieth day after publication in the EU Official Journal and fully applies from 2 August 2026.
Entry into force and application This Regulation shall enter into force on the twentieth day follow… +
1. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and … +
2. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of … +
3. Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreation… +
4. Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmon… +
5. Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmon… +
6. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisa… +
7. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisati… +
8. Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway i… +
9. Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal p… +
10. Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances… +
11. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical de… +
12. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro d… +
13. Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common… +
14. Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the … +
15. Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the … +
16. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipme… +
17. Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interope… +
18. Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approva… +
19. Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-… +
20. Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rul… +
1. Biometrics, in so far as their use is permitted under relevant Union or national law: (a) remote b… +
2. Critical infrastructure: AI systems intended to be used as safety components in the management and o… +
3. Education and vocational training: (a) AI systems intended to be used to determine access or admis… +
4. Employment, workers’ management and access to self-employment: (a) AI systems intended to be used … +
5. Access to and enjoyment of essential private services and essential public services and benefits: (… +
6. Law enforcement, in so far as their use is permitted under relevant Union or national law: (a) AI … +
7. Migration, asylum and border control management, in so far as their use is permitted under relevant … +
8. Administration of justice and democratic processes: (a) AI systems intended to be used by a judici… +
1. A general description of the AI system including: (a) its intended purpose, the name of the provid… +
2. A detailed description of the elements of the AI system and of the process for its development, incl… +
3. Detailed information about the monitoring, functioning and control of the AI system, in particular w… +
4. A description of the appropriateness of the performance metrics for the specific AI system; +
5. A detailed description of the risk management system in accordance with Article 9; +
6. A description of relevant changes made by the provider to the system through its lifecycle; +
7. A list of the harmonised standards applied in full or in part the references of which have been publ… +
8. A copy of the EU declaration of conformity referred to in Article 47; +
9. A detailed description of the system in place to evaluate the AI system performance in the post-mark… +
1. AI system name and type and any additional unambiguous reference allowing the identification and tra… +
2. The name and address of the provider or, where applicable, of their authorised representative; +
3. A statement that the EU declaration of conformity referred to in Article 47 is issued under the sole… +
4. A statement that the AI system is in conformity with this Regulation and, if applicable, with any ot… +
5. Where an AI system involves the processing of personal data, a statement that that AI system complie… +
6. References to any relevant harmonised standards used or any other common specification in relation t… +
7. Where applicable, the name and identification number of the notified body, a description of the conf… +
8. The place and date of issue of the declaration, the name and function of the person who signed it, a… +
1. The conformity assessment procedure based on internal control is the conformity assessment procedure… +
2. The provider verifies that the established quality management system is in compliance with the requi… +
3. The provider examines the information contained in the technical documentation in order to assess th… +
4. The provider also verifies that the design and development process of the AI system and its post-mar… +
1. Introduction Conformity based on an assessment of the quality management system and an assessment of… +
2. Overview The approved quality management system for the design, development and testing of AI system… +
3. Quality management system 3.1. The application of the provider shall include: (a) the name and a… +
4. Control of the technical documentation. 4.1. In addition to the application referred to in point 3… +
5. Surveillance of the approved quality management system. 5.1. The purpose of the surveillance carri… +
1. The name, address and contact details of the provider; +
2. Where submission of information is carried out by another person on behalf of the provider, the name… +
3. The name, address and contact details of the authorised representative, where applicable; +
4. The AI system trade name and any additional unambiguous reference allowing the identification and tr… +
5. A description of the intended purpose of the AI system and of the components and functions supported… +
6. A basic and concise description of the information used by the system (data, inputs) and its operati… +
7. The status of the AI system (on the market, or in service; no longer placed on the market/in service… +
8. The type, number and expiry date of the certificate issued by the notified body and the name or iden… +
9. A scanned copy of the certificate referred to in point 8, where applicable; +
10. Any Member States in which the AI system has been placed on the market, put into service or made ava… +
11. A copy of the EU declaration of conformity referred to in Article 47; +
12. Electronic instructions for use; this information shall not be provided for high-risk AI systems in … +
13. A URL for additional information (optional). Section B — Information to be submitted by providers o… +
1. The name, address and contact details of the provider; +
2. Where submission of information is carried out by another person on behalf of the provider, the name… +
3. The name, address and contact details of the authorised representative, where applicable; +
4. The AI system trade name and any additional unambiguous reference allowing the identification and tr… +
5. A description of the intended purpose of the AI system; +
6. The condition or conditions under Article 6(3)based on which the AI system is considered to be not-h… +
7. A short summary of the grounds on which the AI system is considered to be not-high-risk in applicati… +
8. The status of the AI system (on the market, or in service; no longer placed on the market/in service… +
9. Any Member States in which the AI system has been placed on the market, put into service or made ava… +
1. The name, address and contact details of the deployer; +
2. The name, address and contact details of the person submitting information on behalf of the deployer… +
3. The URL of the entry of the AI system in the EU database by its provider; +
4. A summary of the findings of the fundamental rights impact assessment conducted in accordance with A… +
5. A summary of the data protection impact assessment carried out in accordance with Article 35 of Regu… +
1. A Union-wide unique single identification number of the testing in real world conditions; +
2. The name and contact details of the provider or prospective provider and of the deployers involved i… +
3. A brief description of the AI system, its intended purpose, and other information necessary for the … +
4. A summary of the main characteristics of the plan for testing in real world conditions; +
5. Information on the suspension or termination of the testing in real world conditions. ANNEX X Union… +
1. Schengen Information System (a) Regulation (EU) 2018/1860 of the European Parliament and of the Co… +
2. Visa Information System (a) Regulation (EU) 2021/1133 of the European Parliament and of the Counci… +
3. Eurodac Regulation (EU) 2024/1358 of the European Parliament and of the Council of 14 May 2024 on th… +
4. Entry/Exit System Regulation (EU) 2017/2226 of the European Parliament and of the Council of 30 Nove… +
5. European Travel Information and Authorisation System (a) Regulation (EU) 2018/1240 of the European… +
6. European Criminal Records Information System on third-country nationals and stateless persons Regula… +
7. Interoperability (a) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 … +
1. A general description of the general-purpose AI model including: (a) the tasks that the model is i… +
2. A detailed description of the elements of the model referred to in point 1, and relevant information… +
1. A detailed description of the evaluation strategies, including evaluation results, on the basis of a… +
2. Where applicable, a detailed description of the measures put in place for the purpose of conducting … +
3. Where applicable, a detailed description of the system architecture explaining how software componen… +
1. A general description of the general-purpose AI model including: (a) the tasks that the model is i… +
2. A description of the elements of the model and of the process for its development, including: (a) … +