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Article 8: compliance with the requirements for high-risk AI systems

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obligation

Article 8: compliance with the requirements for high-risk AI systems

High-risk AI systems comply with the requirements of Chapter III, Section 2, and that is assessed taking into account the intended purpose and the generally acknowledged state of the art on AI and AI-related technologies, with the risk management system of Article 9 as the instrument. Where the system sits in a product also covered by the Union harmonisation legislation of Section A of Annex I, the provider is responsible for full compliance with all applicable requirements of that legislation, and may integrate the testing and reporting processes and the information and documentation on the product into the documentation and procedures that already exist there.

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Article 8 on EUR-Lexguidance

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obligation

Article 8: compliance with the requirements for high-risk AI systems

Applies from 2027-12-02

The legal path

Source ·: Article 8 on EUR-Lex
Condition ·: Applies to every AI system that qualifies as high-risk under Article 6, along both routes: the system that falls under the Union harmonisation legislation of Annex I as a safety component of a product or as a product in its own right, and the system that falls within one of the areas of Annex III. For the Annex I route there is a limit that this Article does not state itself: Article 2(2), as replaced by Article 1, point (2)(a), of Regulation (EU) 2026/1744, makes only Article 6(1), Article 60a and Articles 102 to 112 applicable to systems related to products covered by Section B of Annex I. Article 8 is not in that list, so for Section B products, machinery among them since 27 July 2026, this provision does not bear. In addition, Article 2(13), inserted by Article 1, point (3), can limit the application of the requirements in Articles 9 to 15 and 17 to 25 for Section A products, but only once the delegated act it prescribes exists. Article 8 sets no additional threshold of its own: what is high-risk is the subject of Article 6 and not of this provision.
Condition ·: Compliance is not assessed in the abstract but against two measures at once: the intended purpose of the system, and the generally acknowledged state of the art on AI and AI-related technologies. The second measure lies outside the Regulation and has no fixed content, so what suffices changes without the text changing.
Exception ·: The integration in paragraph 2 is a choice and not a duty: 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. Anyone who does not integrate breaches nothing. What the provision does not permit is doing less: the responsibility for full compliance with all applicable requirements under the sectoral harmonisation legislation stands undiminished.

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Checked on 2026-08-08T00:00:00.000Z · praxikon:eu:ai-act:obligation:article-8-compliance-with-requirements

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Article 8: compliance with the requirements for high-risk AI systems

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