Article 8: Compliance with the Requirements
Official Statutory Text
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 stateof the ar ton AI and AI-related tec hnologies. 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 Uni on 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 on harmonisation legislation. In ensuring the complianceof high-risk AI systems referred to in paragraph 1 with the requirements setout in this Section, and in order to ensure consistency , avoid duplication and minimise additional burdens, providers shall have achoiceof integrat ing, as appropr iate, 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 Uni on harmonisation legislation listed in Section A of Annex I.
European Parliament & Council (Regulation 2024/1689)
View Official EUR-Lex Publication- High-risk AI systems must comply with the requirements laid down in this Section (Chapter III, Section 2).
- Compliance must consider the AI system's intended purpose and the generally acknowledged state of the art in AI and AI-related technologies.
- The risk management system (Article 9) must be taken into account when ensuring compliance.
- For products containing AI systems that are also subject to other EU harmonisation legislation listed in Section A of Annex I, providers are responsible for ensuring full compliance with all applicable requirements.
- To ensure consistency, avoid duplication, and minimise burdens, providers may choose to integrate the necessary testing, reporting, information, and documentation for AI system compliance into existing documentation and procedures required under other EU harmonisation legislation.
Applies directly across all 27 EU Member States with phased entry into force from 2025 to 2026.