Updated on May 21^st 2024 based on the version and article numbering approved by the EU Parliament on May 14^th 2024.

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 shall be taken into account when ensuring compliance with those requirements.

2. 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 Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order to ensure consistency, avoid duplication and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist and are required under the Union harmonisation legislation listed in Section A of Annex I.

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[Previous version]

Updated on May 8^th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19^th 2024.

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 shall be taken into account when ensuring compliance with those requirements.

2. 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 Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order to ensure consistency, avoid duplication and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist and are required under the Union harmonisation legislation listed in Section A of Annex I.

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Updated on April 10^th 2024 based on the version and article numbering approved by the EU Parliament on March 13^th 2024.

1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purposes 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 with those requirements.

2. 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 required under applicable Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist and are required under the Union harmonisation legislation listed in Section A of Annex I.