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art-5-en | en | Article 5 — Prohibited AI practices
1. The following AI practices shall be prohibited:
(a) the placing on the market, the putting into service or the use of an AI system that deploys subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective, or the e... | article_full | Art. 5 AI Act | art:5 | null | 2 | null | 5 | null | null | null | null | [
9,
27,
49
] | [] | [
"real-time remote biometric identification system",
"biometric identification",
"biometric categorisation",
"AI system",
"market surveillance authority",
"fundamental rights",
"placing on the market",
"putting into service"
] | 2025-02-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-5-par-1-en | en | The following AI practices shall be prohibited:
(a) the placing on the market, the putting into service or the use of an AI system that deploys subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective, or the effect of materially distorting the behav... | paragraph | Art. 5(1) AI Act | art:5/par:1 | null | 2 | null | 5 | 1 | null | null | null | [
9
] | [] | [
"biometric identification",
"biometric categorisation",
"AI system",
"placing on the market",
"putting into service"
] | 2025-02-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:5 |
art-5-par-2-en | en | The use of “real-time” remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement for any of the objectives referred to in paragraph 1, first subparagraph, point (h), shall be deployed for the purposes set out in that point only to confirm the identity of the specifically ... | paragraph | Art. 5(2) AI Act | art:5/par:2 | null | 2 | null | 5 | 2 | null | null | null | [
27,
49
] | [] | [
"biometric identification",
"fundamental rights"
] | 2025-02-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:5 |
art-5-par-3-en | en | For the purposes of paragraph 1, first subparagraph, point (h) and paragraph 2, each use for the purposes of law enforcement of a “real-time” remote biometric identification system in publicly accessible spaces shall be subject to a prior authorisation granted by a judicial authority or an independent administrative au... | paragraph | Art. 5(3) AI Act | art:5/par:3 | null | 2 | null | 5 | 3 | null | null | null | [] | [] | [
"biometric identification"
] | 2025-02-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:5 |
art-5-par-4-en | en | Without prejudice to paragraph 3, each use of a “real-time” remote biometric identification system in publicly accessible spaces for law enforcement purposes shall be notified to the relevant market surveillance authority and the national data protection authority in accordance with the national rules referred to in pa... | paragraph | Art. 5(4) AI Act | art:5/par:4 | null | 2 | null | 5 | 4 | null | null | null | [] | [] | [
"biometric identification",
"market surveillance authority"
] | 2025-02-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:5 |
art-5-par-5-en | en | A Member State may decide to provide for the possibility to fully or partially authorise the use of “real-time” remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement within the limits and under the conditions listed in paragraph 1, first subparagraph, point (h), and p... | paragraph | Art. 5(5) AI Act | art:5/par:5 | null | 2 | null | 5 | 5 | null | null | null | [] | [] | [
"biometric identification"
] | 2025-02-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:5 |
art-5-par-6-en | en | National market surveillance authorities and the national data protection authorities of Member States that have been notified of the use of “real-time” remote biometric identification systems in publicly accessible spaces for law enforcement purposes pursuant to paragraph 4 shall submit to the Commission annual report... | paragraph | Art. 5(6) AI Act | art:5/par:6 | null | 2 | null | 5 | 6 | null | null | null | [] | [] | [
"biometric identification"
] | 2025-02-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:5 |
art-5-par-7-en | en | The Commission shall publish annual reports on the use of real-time remote biometric identification systems in publicly accessible spaces for law enforcement purposes, based on aggregated data in Member States on the basis of the annual reports referred to in paragraph 6. Those annual reports shall not include sensitiv... | paragraph | Art. 5(7) AI Act | art:5/par:7 | null | 2 | null | 5 | 7 | null | null | null | [] | [] | [
"real-time remote biometric identification system",
"biometric identification"
] | 2025-02-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:5 |
art-5-par-8-en | en | This Article shall not affect the prohibitions that apply where an AI practice infringes other Union law. | paragraph | Art. 5(8) AI Act | art:5/par:8 | null | 2 | null | 5 | 8 | null | null | null | [] | [] | [] | 2025-02-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:5 |
art-6-en | en | Article 6 — Classification rules for high-risk AI systems
1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:
(a) the... | article_full | Art. 6 AI Act | art:6 | null | 3 | 1 | 6 | null | null | null | null | [
49,
96,
97,
7
] | [] | [
"high-risk AI system",
"AI system",
"fundamental rights",
"provider",
"placing on the market",
"putting into service",
"conformity assessment"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-6-par-1-en | en | Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:
(a) the AI system is intended to be used as a safety component of a p... | paragraph | Art. 6(1) AI Act | art:6/par:1 | null | 3 | 1 | 6 | 1 | null | null | null | [] | [] | [
"AI system",
"placing on the market",
"putting into service",
"conformity assessment"
] | 2027-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:6 |
art-6-par-2-en | en | In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be considered to be high-risk. | paragraph | Art. 6(2) AI Act | art:6/par:2 | null | 3 | 1 | 6 | 2 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:6 |
art-6-par-3-en | en | By derogation from paragraph 2, an AI system referred to in Annex III shall not be considered to be high-risk where it does not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not materially influencing the outcome of decision making. The first subparagraph s... | paragraph | Art. 6(3) AI Act | art:6/par:3 | null | 3 | 1 | 6 | 3 | null | null | null | [] | [] | [
"AI system",
"fundamental rights"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:6 |
art-6-par-4-en | en | A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment before that system is placed on the market or put into service. Such provider shall be subject to the registration obligation set out in Article 49(2). Upon request of national competent authorities, the p... | paragraph | Art. 6(4) AI Act | art:6/par:4 | null | 3 | 1 | 6 | 4 | null | null | null | [
49
] | [] | [
"AI system",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:6 |
art-6-par-5-en | en | The Commission shall, after consulting the European Artificial Intelligence Board (the “Board”), and no later than 2 February 2026, provide guidelines specifying the practical implementation of this Article in line with Article 96 together with a comprehensive list of practical examples of use cases of AI systems that ... | paragraph | Art. 6(5) AI Act | art:6/par:5 | null | 3 | 1 | 6 | 5 | null | null | null | [
96
] | [] | [
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:6 |
art-6-par-6-en | en | The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by adding new conditions to those laid down therein, or by modifying them, where there is concrete and reliable evidence of the existence of AI systems that fall under th... | paragraph | Art. 6(6) AI Act | art:6/par:6 | null | 3 | 1 | 6 | 6 | null | null | null | [
97
] | [] | [
"AI system",
"fundamental rights"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:6 |
art-6-par-7-en | en | The Commission shall adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by deleting any of the conditions laid down therein, where there is concrete and reliable evidence that this is necessary to maintain the level of protection of health, safety and ... | paragraph | Art. 6(7) AI Act | art:6/par:7 | null | 3 | 1 | 6 | 7 | null | null | null | [
97
] | [] | [
"fundamental rights"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:6 |
art-6-par-8-en | en | Any amendment to the conditions laid down in paragraph 3, second subparagraph, adopted in accordance with paragraphs 6 and 7 of this Article shall not decrease the overall level of protection of health, safety and fundamental rights provided for by this Regulation and shall ensure consistency with the delegated acts ad... | paragraph | Art. 6(8) AI Act | art:6/par:8 | null | 3 | 1 | 6 | 8 | null | null | null | [
7
] | [] | [
"fundamental rights"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:6 |
art-7-en | en | Article 7 — Amendments to Annex III
1. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:
(a) the AI systems are intended to be used in any of the areas liste... | article_full | Art. 7 AI Act | art:7 | null | 3 | 1 | 7 | null | null | null | null | [
97
] | [] | [
"high-risk AI system",
"AI system",
"fundamental rights",
"deployer",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-7-par-1-en | en | The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:
(a) the AI systems are intended to be used in any of the areas listed in Annex III;
(b) the AI systems pose ... | paragraph | Art. 7(1) AI Act | art:7/par:1 | null | 3 | 1 | 7 | 1 | null | null | null | [
97
] | [] | [
"high-risk AI system",
"AI system",
"fundamental rights"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:7 |
art-7-par-2-en | en | When assessing the condition under paragraph 1, point (b), the Commission shall take into account the following criteria:
(a) the intended purpose of the AI system;
(b) the extent to which an AI system has been used or is likely to be used;
(c) the nature and amount of the data processed and used by the AI system, in p... | paragraph | Art. 7(2) AI Act | art:7/par:2 | null | 3 | 1 | 7 | 2 | null | null | null | [] | [] | [
"AI system",
"fundamental rights",
"deployer",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:7 |
art-7-par-3-en | en | The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend the list in Annex III by removing high-risk AI systems where both of the following conditions are fulfilled:
(a) the high-risk AI system concerned no longer poses any significant risks to fundamental rights, health or safety, tak... | paragraph | Art. 7(3) AI Act | art:7/par:3 | null | 3 | 1 | 7 | 3 | null | null | null | [
97
] | [] | [
"high-risk AI system",
"AI system",
"fundamental rights"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:7 |
art-8-en | en | Article 8 — Compliance with the requirements
1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management system referred to in Article 9 sha... | article_full | Art. 8 AI Act | art:8 | null | 3 | 2 | 8 | null | null | null | null | [
9
] | [] | [
"high-risk AI system",
"AI system",
"provider",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-8-par-1-en | en | High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management system referred to in Article 9 shall be taken into account when ensuring compliance... | paragraph | Art. 8(1) AI Act | art:8/par:1 | null | 3 | 2 | 8 | 1 | null | null | null | [
9
] | [] | [
"AI system",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:8 |
art-8-par-2-en | en | Where a product contains an AI system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Section A of Annex I apply, providers shall be responsible for ensuring that their product is fully compliant with all applicable requirements under applicable Uni... | paragraph | Art. 8(2) AI Act | art:8/par:2 | null | 3 | 2 | 8 | 2 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:8 |
art-9-en | en | Article 9 — Risk management system
1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.
2. The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system,... | article_full | Art. 9 AI Act | art:9 | null | 3 | 2 | 9 | null | null | null | null | [
72,
13,
60
] | [] | [
"high-risk AI system",
"AI system",
"fundamental rights",
"provider",
"deployer",
"post-market monitoring system",
"intended purpose",
"reasonably foreseeable misuse"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-9-par-1-en | en | A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems. | paragraph | Art. 9(1) AI Act | art:9/par:1 | null | 3 | 2 | 9 | 1 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:9 |
art-9-par-2-en | en | The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following steps:
(a) the identification and analysis of the known and the reasonably foreseea... | paragraph | Art. 9(2) AI Act | art:9/par:2 | null | 3 | 2 | 9 | 2 | null | null | null | [
72
] | [] | [
"high-risk AI system",
"AI system",
"fundamental rights",
"post-market monitoring system",
"intended purpose",
"reasonably foreseeable misuse"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:9 |
art-9-par-3-en | en | The risks referred to in this Article shall concern only those which may be reasonably mitigated or eliminated through the development or design of the high-risk AI system, or the provision of adequate technical information. | paragraph | Art. 9(3) AI Act | art:9/par:3 | null | 3 | 2 | 9 | 3 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:9 |
art-9-par-4-en | en | The risk management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and possible interaction resulting from the combined application of the requirements set out in this Section, with a view to minimising risks more effectively while achieving an appropriate balance in impleme... | paragraph | Art. 9(4) AI Act | art:9/par:4 | null | 3 | 2 | 9 | 4 | null | null | null | [] | [] | [] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:9 |
art-9-par-5-en | en | The risk management measures referred to in paragraph 2, point (d), shall be such that the relevant residual risk associated with each hazard, as well as the overall residual risk of the high-risk AI systems is judged to be acceptable. In identifying the most appropriate risk management measures, the following shall be... | paragraph | Art. 9(5) AI Act | art:9/par:5 | null | 3 | 2 | 9 | 5 | null | null | null | [
13
] | [] | [
"high-risk AI system",
"AI system",
"deployer"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:9 |
art-9-par-6-en | en | High-risk AI systems shall be tested for the purpose of identifying the most appropriate and targeted risk management measures. Testing shall ensure that high-risk AI systems perform consistently for their intended purpose and that they are in compliance with the requirements set out in this Section. | paragraph | Art. 9(6) AI Act | art:9/par:6 | null | 3 | 2 | 9 | 6 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:9 |
art-9-par-7-en | en | Testing procedures may include testing in real-world conditions in accordance with Article 60. | paragraph | Art. 9(7) AI Act | art:9/par:7 | null | 3 | 2 | 9 | 7 | null | null | null | [
60
] | [] | [] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:9 |
art-9-par-8-en | en | The testing of high-risk AI systems shall be performed, as appropriate, at any time throughout the development process, and, in any event, prior to their being placed on the market or put into service. Testing shall be carried out against prior defined metrics and probabilistic thresholds that are appropriate to the in... | paragraph | Art. 9(8) AI Act | art:9/par:8 | null | 3 | 2 | 9 | 8 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:9 |
art-9-par-9-en | en | When implementing the risk management system as provided for in paragraphs 1 to 7, providers shall give consideration to whether in view of its intended purpose the high-risk AI system is likely to have an adverse impact on persons under the age of 18 and, as appropriate, other vulnerable groups. | paragraph | Art. 9(9) AI Act | art:9/par:9 | null | 3 | 2 | 9 | 9 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"provider",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:9 |
art-9-par-10-en | en | For providers of high-risk AI systems that are subject to requirements regarding internal risk management processes under other relevant provisions of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or combined with, the risk management procedures established pursuant to that law. | paragraph | Art. 9(10) AI Act | art:9/par:10 | null | 3 | 2 | 9 | 10 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:9 |
art-10-en | en | Article 10 — Data and data governance
1. High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5 whenever such data sets are used.
2. Tr... | article_full | Art. 10 AI Act | art:10 | null | 3 | 2 | 10 | null | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"AI model",
"fundamental rights",
"provider",
"testing data",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-10-par-1-en | en | High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5 whenever such data sets are used. | paragraph | Art. 10(1) AI Act | art:10/par:1 | null | 3 | 2 | 10 | 1 | null | null | null | [] | [] | [
"AI system",
"AI model",
"testing data"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:10 |
art-10-par-2-en | en | Training, validation and testing data sets shall be subject to data governance and management practices appropriate for the intended purpose of the high-risk AI system. Those practices shall concern in particular:
(a) the relevant design choices;
(b) data collection processes and the origin of data, and in the case of ... | paragraph | Art. 10(2) AI Act | art:10/par:2 | null | 3 | 2 | 10 | 2 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"fundamental rights",
"testing data",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:10 |
art-10-par-3-en | en | Training, validation and testing data sets shall be relevant, sufficiently representative, and to the best extent possible, free of errors and complete in view of the intended purpose. They shall have the appropriate statistical properties, including, where applicable, as regards the persons or groups of persons in rel... | paragraph | Art. 10(3) AI Act | art:10/par:3 | null | 3 | 2 | 10 | 3 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"testing data",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:10 |
art-10-par-4-en | en | Data sets shall take into account, to the extent required by the intended purpose, the characteristics or elements that are particular to the specific geographical, contextual, behavioural or functional setting within which the high-risk AI system is intended to be used. | paragraph | Art. 10(4) AI Act | art:10/par:4 | null | 3 | 2 | 10 | 4 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:10 |
art-10-par-5-en | en | To the extent that it is strictly necessary for the purpose of ensuring bias detection and correction in relation to the high-risk AI systems in accordance with paragraph (2), points (f) and (g) of this Article, the providers of such systems may exceptionally process special categories of personal data, subject to appr... | paragraph | Art. 10(5) AI Act | art:10/par:5 | null | 3 | 2 | 10 | 5 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"fundamental rights",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:10 |
art-10-par-6-en | en | For the development of high-risk AI systems not using techniques involving the training of AI models, paragraphs 2 to 5 apply only to the testing data sets. | paragraph | Art. 10(6) AI Act | art:10/par:6 | null | 3 | 2 | 10 | 6 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"AI model",
"testing data"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:10 |
art-11-en | en | Article 11 — Technical documentation
1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date. The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies... | article_full | Art. 11 AI Act | art:11 | null | 3 | 2 | 11 | null | null | null | null | [
97
] | [] | [
"high-risk AI system",
"AI system",
"conformity assessment"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-11-par-1-en | en | The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date. The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Se... | paragraph | Art. 11(1) AI Act | art:11/par:1 | null | 3 | 2 | 11 | 1 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"conformity assessment"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:11 |
art-11-par-2-en | en | Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section A of Annex I is placed on the market or put into service, a single set of technical documentation shall be drawn up containing all the information set out in paragraph 1, as well as the information required... | paragraph | Art. 11(2) AI Act | art:11/par:2 | null | 3 | 2 | 11 | 2 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:11 |
art-11-par-3-en | en | The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this S... | paragraph | Art. 11(3) AI Act | art:11/par:3 | null | 3 | 2 | 11 | 3 | null | null | null | [
97
] | [] | [] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:11 |
art-12-en | en | Article 12 — Record-keeping
1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system.
2. In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended purpose of the system, logging capabil... | article_full | Art. 12 AI Act | art:12 | null | 3 | 2 | 12 | null | null | null | null | [
79,
72,
26,
14
] | [] | [
"high-risk AI system",
"AI system",
"input data",
"substantial modification",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-12-par-1-en | en | High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system. | paragraph | Art. 12(1) AI Act | art:12/par:1 | null | 3 | 2 | 12 | 1 | null | null | null | [] | [] | [
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:12 |
art-12-par-2-en | en | In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended purpose of the system, logging capabilities shall enable the recording of events relevant for:
(a) identifying situations that may result in the high-risk AI system presenting a risk within the mea... | paragraph | Art. 12(2) AI Act | art:12/par:2 | null | 3 | 2 | 12 | 2 | null | null | null | [
79,
72,
26
] | [] | [
"high-risk AI system",
"AI system",
"substantial modification",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:12 |
art-12-par-3-en | en | For high-risk AI systems referred to in point 1 (a), of Annex III, the logging capabilities shall provide, at a minimum:
(a) recording of the period of each use of the system (start date and time and end date and time of each use);
(b) the reference database against which input data has been checked by the system;
(c) ... | paragraph | Art. 12(3) AI Act | art:12/par:3 | null | 3 | 2 | 12 | 3 | null | null | null | [
14
] | [] | [
"high-risk AI system",
"AI system",
"input data"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:12 |
art-13-en | en | Article 13 — Transparency and provision of information to deployers
1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of transpar... | article_full | Art. 13 AI Act | art:13 | null | 3 | 2 | 13 | null | null | null | null | [
14,
12,
15,
9
] | [] | [
"high-risk AI system",
"AI system",
"authorised representative",
"fundamental rights",
"provider",
"deployer",
"conformity assessment",
"input data",
"testing data",
"intended purpose",
"reasonably foreseeable misuse"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-13-par-1-en | en | High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of transparency shall be ensured with a view to achieving compliance with the relev... | paragraph | Art. 13(1) AI Act | art:13/par:1 | null | 3 | 2 | 13 | 1 | null | null | null | [] | [] | [
"AI system",
"provider",
"deployer"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:13 |
art-13-par-2-en | en | High-risk AI systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that include concise, complete, correct and clear information that is relevant, accessible and comprehensible to deployers. | paragraph | Art. 13(2) AI Act | art:13/par:2 | null | 3 | 2 | 13 | 2 | null | null | null | [] | [] | [
"AI system",
"deployer"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:13 |
art-13-par-3-en | en | The instructions for use shall contain at least the following information:
(a) the identity and the contact details of the provider and, where applicable, of its authorised representative;
(b) the characteristics, capabilities and limitations of performance of the high-risk AI system, including:
(c) the changes to the ... | paragraph | Art. 13(3) AI Act | art:13/par:3 | null | 3 | 2 | 13 | 3 | null | null | null | [
14,
12,
15,
9
] | [] | [
"high-risk AI system",
"AI system",
"authorised representative",
"fundamental rights",
"provider",
"deployer",
"conformity assessment",
"input data",
"testing data",
"intended purpose",
"reasonably foreseeable misuse"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:13 |
art-14-en | en | Article 14 — Human oversight
1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons during the period in which they are in use.
2. Human oversight shall aim to prevent or minimise the ris... | article_full | Art. 14 AI Act | art:14 | null | 3 | 2 | 14 | null | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"fundamental rights",
"provider",
"deployer",
"intended purpose",
"reasonably foreseeable misuse"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-14-par-1-en | en | High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons during the period in which they are in use. | paragraph | Art. 14(1) AI Act | art:14/par:1 | null | 3 | 2 | 14 | 1 | null | null | null | [] | [] | [
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:14 |
art-14-par-2-en | en | Human oversight shall aim to prevent or minimise the risks to health, safety or fundamental rights that may emerge when a high-risk AI system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, in particular where such risks persist despite the application of other requ... | paragraph | Art. 14(2) AI Act | art:14/par:2 | null | 3 | 2 | 14 | 2 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"fundamental rights",
"intended purpose",
"reasonably foreseeable misuse"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:14 |
art-14-par-3-en | en | The oversight measures shall be commensurate with the risks, level of autonomy and context of use of the high-risk AI system, and shall be ensured through either one or both of the following types of measures:
(a) measures identified and built, when technically feasible, into the high-risk AI system by the provider bef... | paragraph | Art. 14(3) AI Act | art:14/par:3 | null | 3 | 2 | 14 | 3 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"provider",
"deployer"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:14 |
art-14-par-4-en | en | For the purpose of implementing paragraphs 1, 2 and 3, the high-risk AI system shall be provided to the deployer in such a way that natural persons to whom human oversight is assigned are enabled, as appropriate and proportionate:
(a) to properly understand the relevant capacities and limitations of the high-risk AI sy... | paragraph | Art. 14(4) AI Act | art:14/par:4 | null | 3 | 2 | 14 | 4 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"deployer"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:14 |
art-14-par-5-en | en | For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to in paragraph 3 of this Article shall be such as to ensure that, in addition, no action or decision is taken by the deployer on the basis of the identification resulting from the system unless that identification has been separatel... | paragraph | Art. 14(5) AI Act | art:14/par:5 | null | 3 | 2 | 14 | 5 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"deployer"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:14 |
art-15-en | en | Article 15 — Accuracy, robustness and cybersecurity
1. High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy, robustness, and cybersecurity, and that they perform consistently in those respects throughout their lifecycle.
2. To address the technical aspe... | article_full | Art. 15 AI Act | art:15 | null | 3 | 2 | 15 | null | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"AI model",
"training data"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-15-par-1-en | en | High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy, robustness, and cybersecurity, and that they perform consistently in those respects throughout their lifecycle. | paragraph | Art. 15(1) AI Act | art:15/par:1 | null | 3 | 2 | 15 | 1 | null | null | null | [] | [] | [
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:15 |
art-15-par-2-en | en | To address the technical aspects of how to measure the appropriate levels of accuracy and robustness set out in paragraph 1 and any other relevant performance metrics, the Commission shall, in cooperation with relevant stakeholders and organisations such as metrology and benchmarking authorities, encourage, as appropri... | paragraph | Art. 15(2) AI Act | art:15/par:2 | null | 3 | 2 | 15 | 2 | null | null | null | [] | [] | [] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:15 |
art-15-par-3-en | en | The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be declared in the accompanying instructions of use. | paragraph | Art. 15(3) AI Act | art:15/par:3 | null | 3 | 2 | 15 | 3 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:15 |
art-15-par-4-en | en | High-risk AI systems shall be as resilient as possible regarding errors, faults or inconsistencies that may occur within the system or the environment in which the system operates, in particular due to their interaction with natural persons or other systems. Technical and organisational measures shall be taken in this ... | paragraph | Art. 15(4) AI Act | art:15/par:4 | null | 3 | 2 | 15 | 4 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:15 |
art-15-par-5-en | en | High-risk AI systems shall be resilient against attempts by unauthorised third parties to alter their use, outputs or performance by exploiting system vulnerabilities. The technical solutions aiming to ensure the cybersecurity of high-risk AI systems shall be appropriate to the relevant circumstances and the risks. The... | paragraph | Art. 15(5) AI Act | art:15/par:5 | null | 3 | 2 | 15 | 5 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"AI model",
"training data"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:15 |
art-16-en | en | Article 16 — Obligations of providers of high-risk AI systems
Providers of high-risk AI systems shall:
(a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
(b) indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying docume... | article_full | Art. 16 AI Act | art:16 | null | 3 | 3 | 16 | null | null | null | null | [
17,
18,
19,
43,
47,
48,
49,
20
] | [] | [
"high-risk AI system",
"AI system",
"provider",
"conformity assessment",
"CE marking"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-16-par-0.1-en | en | Providers of high-risk AI systems shall:
(a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
(b) indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or re... | paragraph | Art. 16 AI Act | art:16/par:0.1 | null | 3 | 3 | 16 | null | null | null | null | [
17,
18,
19,
43,
47,
48,
49,
20
] | [] | [
"high-risk AI system",
"AI system",
"conformity assessment",
"CE marking"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:16 |
art-17-en | en | Article 17 — Quality management system
1. Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at ... | article_full | Art. 17 AI Act | art:17 | null | 3 | 3 | 17 | null | null | null | null | [
9,
72,
73,
40
] | [] | [
"high-risk AI system",
"AI system",
"provider",
"operator",
"placing on the market",
"putting into service",
"conformity assessment",
"post-market monitoring system",
"serious incident"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-17-par-1-en | en | Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at least the following aspects:
(a) a strategy... | paragraph | Art. 17(1) AI Act | art:17/par:1 | null | 3 | 3 | 17 | 1 | null | null | null | [
9,
72,
73
] | [] | [
"high-risk AI system",
"AI system",
"operator",
"placing on the market",
"putting into service",
"conformity assessment",
"post-market monitoring system",
"serious incident"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:17 |
art-17-par-2-en | en | The implementation of the aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s organisation. Providers shall, in any event, respect the degree of rigour and the level of protection required to ensure the compliance of their high-risk AI systems with this Regulation. | paragraph | Art. 17(2) AI Act | art:17/par:2 | null | 3 | 3 | 17 | 2 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:17 |
art-17-par-3-en | en | Providers of high-risk AI systems that are subject to obligations regarding quality management systems or an equivalent function under relevant sectoral Union law may include the aspects listed in paragraph 1 as part of the quality management systems pursuant to that law. | paragraph | Art. 17(3) AI Act | art:17/par:3 | null | 3 | 3 | 17 | 3 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:17 |
art-17-par-4-en | en | For providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law, the obligation to put in place a quality management system, with the exception of paragraph 1, points (g), (h) and (i) of this Article, shall be deemed... | paragraph | Art. 17(4) AI Act | art:17/par:4 | null | 3 | 3 | 17 | 4 | null | null | null | [
40
] | [] | [
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:17 |
art-18-en | en | Article 18 — Documentation keeping
1. The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities:
(a) the technical documentation referred to in Article 11;
(b) the documentation concerning... | article_full | Art. 18 AI Act | art:18 | null | 3 | 3 | 18 | null | null | null | null | [
11,
17,
47
] | [] | [
"high-risk AI system",
"AI system",
"authorised representative",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-18-par-1-en | en | The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities:
(a) the technical documentation referred to in Article 11;
(b) the documentation concerning the quality management system referred... | paragraph | Art. 18(1) AI Act | art:18/par:1 | null | 3 | 3 | 18 | 1 | null | null | null | [
11,
17,
47
] | [] | [
"high-risk AI system",
"AI system",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:18 |
art-18-par-2-en | en | Each Member State shall determine conditions under which the documentation referred to in paragraph 1 remains at the disposal of the national competent authorities for the period indicated in that paragraph for the cases when a provider or its authorised representative established on its territory goes bankrupt or ceas... | paragraph | Art. 18(2) AI Act | art:18/par:2 | null | 3 | 3 | 18 | 2 | null | null | null | [] | [] | [
"authorised representative",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:18 |
art-18-par-3-en | en | Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the technical documentation as part of the documentation kept under the relevant Union financial services law. | paragraph | Art. 18(3) AI Act | art:18/par:3 | null | 3 | 3 | 18 | 3 | null | null | null | [] | [] | [] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:18 |
art-19-en | en | Article 19 — Automatically generated logs
1. Providers of high-risk AI systems shall keep the logs referred to in Article 12(1), automatically generated by their high-risk AI systems, to the extent such logs are under their control. Without prejudice to applicable Union or national law, the logs shall be kept for a pe... | article_full | Art. 19 AI Act | art:19 | null | 3 | 3 | 19 | null | null | null | null | [
12
] | [] | [
"high-risk AI system",
"AI system",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-19-par-1-en | en | Providers of high-risk AI systems shall keep the logs referred to in Article 12(1), automatically generated by their high-risk AI systems, to the extent such logs are under their control. Without prejudice to applicable Union or national law, the logs shall be kept for a period appropriate to the intended purpose of th... | paragraph | Art. 19(1) AI Act | art:19/par:1 | null | 3 | 3 | 19 | 1 | null | null | null | [
12
] | [] | [
"high-risk AI system",
"AI system",
"intended purpose"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:19 |
art-19-par-2-en | en | Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the logs automatically generated by their high-risk AI systems as part of the documentation kept under the relevant financial services law. | paragraph | Art. 19(2) AI Act | art:19/par:2 | null | 3 | 3 | 19 | 2 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:19 |
art-20-en | en | Article 20 — Corrective actions and duty of information
1. Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective actions to ... | article_full | Art. 20 AI Act | art:20 | null | 3 | 3 | 20 | null | null | null | null | [
79,
44
] | [] | [
"high-risk AI system",
"AI system",
"authorised representative",
"notified body",
"provider",
"deployer",
"importer",
"distributor"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-20-par-1-en | en | Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective actions to bring that system into conformity, to withdraw it, to disabl... | paragraph | Art. 20(1) AI Act | art:20/par:1 | null | 3 | 3 | 20 | 1 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"authorised representative",
"deployer",
"importer",
"distributor"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:20 |
art-20-par-2-en | en | Where the high-risk AI system presents a risk within the meaning of Article 79(1) and the provider becomes aware of that risk, it shall immediately investigate the causes, in collaboration with the reporting deployer, where applicable, and inform the market surveillance authorities competent for the high-risk AI system... | paragraph | Art. 20(2) AI Act | art:20/par:2 | null | 3 | 3 | 20 | 2 | null | null | null | [
79,
44
] | [] | [
"high-risk AI system",
"AI system",
"notified body",
"provider",
"deployer"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:20 |
art-21-en | en | Article 21 — Cooperation with competent authorities
1. Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all the information and documentation necessary to demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2, i... | article_full | Art. 21 AI Act | art:21 | null | 3 | 3 | 21 | null | null | null | null | [
12,
78
] | [] | [
"high-risk AI system",
"AI system",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-21-par-1-en | en | Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all the information and documentation necessary to demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2, in a language which can be easily understood by the autho... | paragraph | Art. 21(1) AI Act | art:21/par:1 | null | 3 | 3 | 21 | 1 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:21 |
art-21-par-2-en | en | Upon a reasoned request by a competent authority, providers shall also give the requesting competent authority, as applicable, access to the automatically generated logs of the high-risk AI system referred to in Article 12(1), to the extent such logs are under their control. | paragraph | Art. 21(2) AI Act | art:21/par:2 | null | 3 | 3 | 21 | 2 | null | null | null | [
12
] | [] | [
"high-risk AI system",
"AI system",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:21 |
art-21-par-3-en | en | Any information obtained by a competent authority pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78. | paragraph | Art. 21(3) AI Act | art:21/par:3 | null | 3 | 3 | 21 | 3 | null | null | null | [
78
] | [] | [] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:21 |
art-22-en | en | Article 22 — Authorised representatives of providers of high-risk AI systems
1. Prior to making their high-risk AI systems available on the Union market, providers established in third countries shall, by written mandate, appoint an authorised representative which is established in the Union.
2. The provider shall en... | article_full | Art. 22 AI Act | art:22 | null | 3 | 3 | 22 | null | null | null | null | [
47,
11,
74,
12,
49
] | [] | [
"high-risk AI system",
"AI system",
"authorised representative",
"notified body",
"market surveillance authority",
"provider",
"conformity assessment"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-22-par-1-en | en | Prior to making their high-risk AI systems available on the Union market, providers established in third countries shall, by written mandate, appoint an authorised representative which is established in the Union. | paragraph | Art. 22(1) AI Act | art:22/par:1 | null | 3 | 3 | 22 | 1 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system",
"authorised representative",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:22 |
art-22-par-2-en | en | The provider shall enable its authorised representative to perform the tasks specified in the mandate received from the provider. | paragraph | Art. 22(2) AI Act | art:22/par:2 | null | 3 | 3 | 22 | 2 | null | null | null | [] | [] | [
"authorised representative",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:22 |
art-22-par-3-en | en | The authorised representative shall perform the tasks specified in the mandate received from the provider. It shall provide a copy of the mandate to the market surveillance authorities upon request, in one of the official languages of the institutions of the Union, as indicated by the competent authority. For the purpo... | paragraph | Art. 22(3) AI Act | art:22/par:3 | null | 3 | 3 | 22 | 3 | null | null | null | [
47,
11,
74,
12,
49
] | [] | [
"high-risk AI system",
"AI system",
"authorised representative",
"notified body",
"provider",
"conformity assessment"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:22 |
art-22-par-4-en | en | The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be acting contrary to its obligations pursuant to this Regulation. In such a case, it shall immediately inform the relevant market surveillance authority, as well as, where applicable, the relevant notifi... | paragraph | Art. 22(4) AI Act | art:22/par:4 | null | 3 | 3 | 22 | 4 | null | null | null | [] | [] | [
"authorised representative",
"notified body",
"market surveillance authority",
"provider"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:22 |
art-23-en | en | Article 23 — Obligations of importers
1. Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that:
(a) the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk A... | article_full | Art. 23 AI Act | art:23 | null | 3 | 3 | 23 | null | null | null | null | [
43,
11,
47,
22,
79
] | [] | [
"high-risk AI system",
"AI system",
"authorised representative",
"notified body",
"provider",
"importer",
"conformity assessment",
"CE marking"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | null |
art-23-par-1-en | en | Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that:
(a) the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk AI system;
(b) the provider has drawn up th... | paragraph | Art. 23(1) AI Act | art:23/par:1 | null | 3 | 3 | 23 | 1 | null | null | null | [
43,
11,
47,
22
] | [] | [
"high-risk AI system",
"AI system",
"authorised representative",
"provider",
"importer",
"conformity assessment",
"CE marking"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:23 |
art-23-par-2-en | en | Where an importer has sufficient reason to consider that a high-risk AI system is not in conformity with this Regulation, or is falsified, or accompanied by falsified documentation, it shall not place the system on the market until it has been brought into conformity. Where the high-risk AI system presents a risk withi... | paragraph | Art. 23(2) AI Act | art:23/par:2 | null | 3 | 3 | 23 | 2 | null | null | null | [
79
] | [] | [
"high-risk AI system",
"AI system",
"authorised representative",
"provider",
"importer"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:23 |
art-23-par-3-en | en | Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can be contacted on the high-risk AI system and on its packaging or its accompanying documentation, where applicable. | paragraph | Art. 23(3) AI Act | art:23/par:3 | null | 3 | 3 | 23 | 3 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:23 |
art-23-par-4-en | en | Importers shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise its compliance with the requirements set out in Section 2. | paragraph | Art. 23(4) AI Act | art:23/par:4 | null | 3 | 3 | 23 | 4 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:23 |
art-23-par-5-en | en | Importers shall keep, for a period of 10 years after the high-risk AI system has been placed on the market or put into service, a copy of the certificate issued by the notified body, where applicable, of the instructions for use, and of the EU declaration of conformity referred to in Article 47. | paragraph | Art. 23(5) AI Act | art:23/par:5 | null | 3 | 3 | 23 | 5 | null | null | null | [
47
] | [] | [
"high-risk AI system",
"AI system",
"notified body"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:23 |
art-23-par-6-en | en | Importers shall provide the relevant competent authorities, upon a reasoned request, with all the necessary information and documentation, including that referred to in paragraph 5, to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2 in a language which can be easily unders... | paragraph | Art. 23(6) AI Act | art:23/par:6 | null | 3 | 3 | 23 | 6 | null | null | null | [] | [] | [
"high-risk AI system",
"AI system"
] | 2026-08-02 | false | reg_2024_1689 | 32024R1689 | https://eur-lex.europa.eu/eli/reg/2024/1689/oj | European Union | CC BY 4.0 | v2026-07-20 | e8625a71f3895c72ed7244465f5222b9f25ea12d71f1a094369aef6ef456fc38 | 2026-07-20 | art:23 |
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