--- title: "Article 16 — Obligations of providers of high-risk AI systems" type: regulation legal_status: in_force source: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02024R1689-20260727" source_retrieved: 2026-09-28 shortTitle: "Article 16 — Obligations of providers of high-risk AI systems" instrument_type: level1_regulation authority: Commission binding: true binding_character: binding mica_level2: false legal_basis: "Regulation (EU) 2024/1689" instrument: aiact celex: "32024R1689" regulation: AI Act regulation-full: "Regulation (EU) 2024/1689" article: 16 status: in_force object_id: eu.aiact.legal_text.article.16 text_version: "Consolidated version of 27 July 2026" source_url: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02024R1689-20260727" check_status: matched verified: true last_checked: 2026-10-26 --- *In force · applies from 2 Dec 2027 · Consolidated version of 27 July 2026 · Checked against EUR-Lex on 26 Oct 2026 · [Official source](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02024R1689-20260727)* 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](https://www.headlesslaw.com/definitions/ai-act/ai-system) or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted; **(c)** have a quality management system in place which complies with [Article 17](17.md); **(d)** keep the documentation referred to in [Article 18](18.md); **(e)** when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in [Article 19](19.md); **(f)** ensure that the high-risk AI system undergoes the relevant [conformity assessment](https://www.headlesslaw.com/definitions/ai-act/conformity-assessment) procedure as referred to in [Article 43](43.md), prior to its being placed on the market or put into service; **(g)** draw up an EU declaration of conformity in accordance with [Article 47](47.md); **(h)** affix the [CE marking](https://www.headlesslaw.com/definitions/ai-act/ce-marking) to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with [Article 48](48.md); **(i)** comply with the registration obligations referred to in [Article 49(1)](49.md); **(j)** take the necessary corrective actions and provide information as required in [Article 20](20.md); **(k)** upon a reasoned request of a [national competent authority](https://www.headlesslaw.com/definitions/ai-act/national-competent-authority), demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2; **(l)** ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882. *** [Chapter III — High-risk AI systems](../chapters/iii.md) · [← Article 15](15.md) · [Article 17 →](17.md)