> For the complete documentation index, see [llms.txt](https://www.mica.wtf/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://www.mica.wtf/cra/chapter-ii-obligations-of-economic-operators-and-provisions-in-relation-to-free-and-open-source-soft/12.md). # Art. 12 — High-risk AI systems CRA Article 12 — High-risk AI systems. Regulation (EU) 2024/2847, Chapter II — Obligations of economic operators and provisions in relation to free and open-source software. 1. Without prejudice to the requirements relating to accuracy and robustness set out in Article 15 of Regulation (EU) 2024/1689, products with digital elements which fall within the scope of this Regulation and which are classified as high-risk AI systems pursuant to Article 6 of that Regulation shall be deemed to comply with the [cybersecurity](https://headlesslaw.com/definitions/cra/cybersecurity/) requirements set out in Article 15 of that Regulation where: 1. those products fulfil the essential cybersecurity requirements set out in Part I of Annex I; 2. the processes put in place by the [manufacturer](https://headlesslaw.com/definitions/cra/manufacturer/) comply with the essential cybersecurity requirements set out in Part II of Annex I; and 3. the achievement of the level of cybersecurity protection required under Article 15 of Regulation (EU) 2024/1689 is demonstrated in the EU declaration of conformity issued under this Regulation. 2. For the products with digital elements and cybersecurity requirements referred to in paragraph 1 of this Article, the relevant [conformity assessment](https://headlesslaw.com/definitions/cra/conformity-assessment/) procedure provided for in Article 43 of Regulation (EU) 2024/1689 shall apply. For the purposes of that assessment, notified bodies which are competent to control the conformity of the high-risk AI systems under Regulation (EU) 2024/1689 shall also be competent to control the conformity of high-risk AI systems which fall within the scope of this Regulation with the requirements set out in Annex I to this Regulation, provided that the compliance of those notified bodies with the requirements laid down in [Article 39](/cra/chapter-iv-notification-of-conformity-assessment-bodies-art.-35-51/39.md) of this Regulation has been assessed in the context of the notification procedure under Regulation (EU) 2024/1689. 3. By way of derogation from paragraph 2 of this Article, important products with digital elements as listed in Annex III to this Regulation, which are subject to the conformity assessment procedures referred to in [Article 32(2)](/cra/chapter-iii-conformity-of-the-product-with-digital-elements-art.-27-34/32.md), points (a) and (b), and [Article 32(3)](/cra/chapter-iii-conformity-of-the-product-with-digital-elements-art.-27-34/32.md) of this Regulation and critical products with digital elements as listed in Annex IV to this Regulation which are required to obtain a European cybersecurity certificate pursuant to [Article 8(1)](/cra/chapter-ii-obligations-of-economic-operators-and-provisions-in-relation-to-free-and-open-source-soft/8.md) of this Regulation or, absent that, which are subject to the conformity assessment procedures referred to in [Article 32(3)](/cra/chapter-iii-conformity-of-the-product-with-digital-elements-art.-27-34/32.md) of this Regulation, and which are classified as high-risk AI systems pursuant to Article 6 of Regulation (EU) 2024/1689, and to which the conformity assessment procedure based on internal control as referred to in Annex VI to Regulation (EU) 2024/1689 applies, shall be subject to the conformity assessment procedures provided for in this Regulation in so far as the essential cybersecurity requirements set out in this Regulation are concerned. 4. Manufacturers of products with digital elements as referred to in paragraph 1 of this Article may participate in the AI regulatory sandboxes referred to in Article 57 of Regulation (EU) 2024/1689. --- # Agent Instructions This documentation is published with GitBook. GitBook is the documentation platform designed so that both humans and AI agents can read, navigate, and reason over technical content effectively. Learn more at gitbook.com. ## Querying This Documentation If you need additional information that is not directly available in this page, you can query the documentation dynamically by asking a question. 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