EU AI Act Article 47: The EU Declaration of Conformity for High-Risk AI

What Article 47 Covers

Article 47 of Regulation (EU) 2024/1689 governs the EU declaration of conformity, the document in which the provider of a high-risk AI system formally declares that the system meets the requirements of Section 2 of Chapter III, namely Articles 9 to 15. In the architecture of EU product law, the declaration is the legal pivot: testing, documentation and assessment all culminate in this signed statement, and the CE marking that follows is its visible expression.

Article 47(1) requires the provider to draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI system, and to keep it at the disposal of the national competent authorities for ten years after the system has been placed on the market or put into service. The declaration shall identify the high-risk AI system for which it has been drawn up, and a copy shall be submitted to the relevant national competent authorities upon request.

What the Declaration Must Contain

Article 47(2) requires the declaration to state that the high-risk AI system concerned meets the requirements of Section 2, and to contain the information set out in Annex V. Annex V requires, in essence:

• The AI system's name and type and any additional unambiguous reference allowing its identification and traceability.
• The name and address of the provider and, where applicable, of its authorised representative.
• A statement that the declaration is issued under the sole responsibility of the provider.
• A statement that the AI system is in conformity with the regulation and, where applicable, with any other relevant Union law that provides for the issuing of an EU declaration of conformity.
• Where the system involves the processing of personal data, a statement that it complies with the GDPR, the Law Enforcement Directive and the EUDPR, Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680.
• References to any relevant harmonised standards used or any other common specification in relation to which conformity is declared.
• Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed, and identification of the certificate issued.
• The place and date of issue of the declaration, the name and function of the signatory, an indication for or on whose behalf they signed, and a signature.

Language, Single Declarations and Continuous Responsibility

The declaration must be translated into a language that can be easily understood by the national competent authorities of the Member States in which the high-risk AI system is placed on the market or made available, so multi-country providers should plan for translations.

Article 47(3) handles overlap with other product law: where high-risk AI systems are subject to other Union harmonisation legislation that also requires an EU declaration of conformity, a single declaration shall be drawn up in respect of all Union law applicable to the system, containing all the information required to identify the legislation to which it relates. A medical device with an embedded high-risk AI system therefore carries one declaration covering both regimes.

Article 47(4) carries the legal weight: by drawing up the EU declaration of conformity, the provider assumes responsibility for compliance with the Section 2 requirements, and shall keep the declaration up to date as appropriate. The declaration is not a snapshot; it must continue to be true as the system evolves.

How to Implement Article 47 in Practice

1. Sequence correctly: complete the Article 43 conformity assessment first, then draw up the declaration, then affix the CE marking under Article 48, then register under Article 49, and only then place the system on the market.
2. Build the declaration from Annex V as a literal checklist, and generate it in a machine-readable format alongside the signed version, since Article 47(1) requires machine readability.
3. Bind the declaration to an exact system configuration: version identifiers in the declaration should match those in the technical documentation and registration data, or traceability breaks.
4. Decide signature authority in the quality management system: who in the organisation signs, after which internal verification steps, with the accountability framework of Article 17 naming the role.
5. Operate the update duty: define triggers, such as substantial modifications, new harmonised standards declared against, or changes of notified body details, that force a revised declaration.
6. Distribute copies where the law expects them: into the Article 11 technical documentation as required by Annex IV, to the authorised representative under Article 22, to importers under Article 23, and as the accompanying copy that distributors verify under Article 24.

A Concrete Example

A provider completing internal-control assessment of its high-risk educational proctoring system drafts a two-page declaration: system name, version 3.2 and build reference; provider identity and EU address; sole-responsibility statement; conformity statements for the AI Act and the GDPR given the personal data processing involved; references to the harmonised standards applied for risk management and logging; no notified body entry, since Annex VI internal control applied; place, date and the signature of its head of regulatory affairs. The same file, in machine-readable form, is attached to the technical documentation, stored for the ten-year period, sent to the authorised representative, and updated eight months later when a substantial model change triggers re-assessment.

How Article 47 Connects to Other Provisions

The declaration sits at the centre of a web: Article 16(g) makes drawing it up a core provider obligation; Article 43 produces the assessment it rests on; Annex V defines its content; Article 48 ties the CE marking to it; Annex IV includes a copy in the technical documentation; Article 18 sets its ten-year retention; Articles 22, 23 and 24 make representatives, importers and distributors hold or verify it. Supplying incorrect, incomplete or misleading information to authorities, including in declarations, is separately sanctionable under Article 99(5), with fines up to 7.5 million euros or 1 percent of worldwide annual turnover.

Actions to Take Before August 2, 2026

Providers should template their declaration against Annex V now, wire its generation into the release process, and dry-run the full sequence of assessment, declaration, marking and registration on one system before the obligations apply on August 2, 2026. The declaration itself is short; the discipline it formally declares on paper is the product of every other article, which is why late drafting so often exposes upstream gaps. This article provides general information about Regulation (EU) 2024/1689 and is not advice on any specific declaration.

This article is for informational purposes only and does not constitute legal advice. Regulatory requirements change frequently — verify current rules with official sources. Built by Sawai Gyoseishoshi Office, Hiroshima, Japan.