Article 47 — EU declaration of conformity (EU AI Act)

Article 47 of Regulation (EU) 2024/1689 — EU declaration of conformity. Official text, practical interpretation, key obligations and compliance implications.

Official Text Summary

Article 47 of Regulation (EU) 2024/1689 establishes the obligation for providers of high-risk AI systems to draw up an EU declaration of conformity before placing their system on the market or putting it into service. The declaration must attest, on the exclusive responsibility of the provider, that the high-risk AI system in question complies with all requirements set out in Chapter 2 of Title III of the Regulation.

The Article specifies the minimum content of the declaration: the identity and contact details of the provider; a description of the AI system including its name, version, and intended purpose; a statement of conformity with the applicable requirements; references to any relevant harmonised standards applied or common specifications used; where applicable, the identification of the notified body that carried out the conformity assessment, along with the number and date of the EU type-examination certificate or any other relevant certificate issued; the place and date of issue; and the signature and name of the responsible person authorised to bind the provider.

Providers are required to keep the declaration up to date, ensuring it reflects any modifications made to the system that could affect conformity. The declaration must be made available to national competent authorities upon request, and providers must retain it for ten years following market placement or entry into service. Where a high-risk AI system is also subject to other Union harmonisation legislation requiring a declaration of conformity, a single EU declaration of conformity may cover all applicable Union acts, provided all required information is included.

What This Means in Practice

Article 47 places a concrete documentation obligation on every provider bringing a high-risk AI system to the EU market. In practical terms, this means that before a product can lawfully be placed on the market or put into service — and before the CE marking required by Article 48 can be affixed — the provider must have a signed, complete, and accurate EU declaration of conformity on file.

For providers of AI systems that are safety components of regulated products (such as medical devices, machinery, or vehicles under Annex I legislation), Article 47 integrates with existing product compliance workflows. A single consolidated declaration can be used to cover the AI Act and the sectoral legislation simultaneously, reducing administrative duplication — but only if all required information for each applicable act is present in that single document.

For providers of standalone high-risk AI systems listed in Annex III — such as AI used in recruitment, credit scoring, education, or biometric categorisation — the declaration is a standalone document drawn up internally by the provider after completing the appropriate conformity assessment procedure under Article 43.

Concretely, a provider building an AI-assisted CV screening tool classified as high-risk under Annex III, Point 2, must: complete the conformity assessment, compile the technical documentation required by Article 11 and Annex IV, and then draw up and sign the EU declaration of conformity before commercial deployment. Any subsequent update to the model that meaningfully affects its intended purpose or performance must trigger a review and update of the declaration. The declaration is the provider's legally binding attestation and forms part of the audit trail inspected by market surveillance authorities.

Key Obligations

• Draw up the declaration before market placement: Providers must prepare the EU declaration of conformity as a prerequisite to placing the high-risk AI system on the market or putting it into service — it cannot be completed retroactively.
• Include all mandatory content elements: The declaration must contain the provider's identity, a full description of the system, a statement of conformity, references to applied harmonised standards or common specifications, and notified body details where third-party assessment was conducted.
• Sign by an authorised representative: The declaration must be signed by a named individual with authority to legally bind the provider, establishing clear personal and organisational accountability.
• Keep the declaration updated: If a high-risk AI system is modified in ways that affect its conformity with the applicable requirements, the provider must update the declaration accordingly before the modified system is deployed or made available.
• Retain for ten years: The declaration must be preserved and made available to national competent authorities on request for ten years from the date the system was placed on the market or put into service.
• Consolidation with other Union acts: Where multiple Union harmonisation acts apply to the same product, a single combined declaration of conformity is permitted, provided all legally required information for each applicable act is comprehensively included.

Relationship to Other Articles

Article 47 sits at the centre of the conformity infrastructure established by Chapter 5 of Title III. It is directly preceded by Article 43, which defines the conformity assessment procedures that must be completed before the declaration can be validly drawn up. The content of the technical documentation that underpins the declaration is governed by Article 11 and detailed in Annex IV. Article 48 is immediately dependent on Article 47: providers may only affix the CE marking once the EU declaration of conformity has been drawn up. Article 16 lists the declaration as one of the core obligations of providers of high-risk AI systems, anchoring it within the general obligations framework.

The declaration should also be read alongside Article 46, which governs the conformity assessment bodies (notified bodies) whose assessments may be referenced within the declaration, and Article 72, which establishes market surveillance authority powers to request and verify the declaration. For AI systems embedded in regulated products, the relevant sectoral Union harmonisation legislation cross-referenced in Annex I must be consulted to determine whether a consolidated declaration is appropriate.

Compliance Timeline

The EU AI Act entered into force on 1 August 2024 (twenty days after publication in the Official Journal on 12 July 2024). The Regulation applies in a phased manner:

• February 2, 2025: Prohibitions on unacceptable-risk AI practices (Title II, Article 5) became applicable.
• August 2, 2025: Rules applying to general-purpose AI models (Title VIII) became applicable; governance provisions and obligations for notified bodies and market surveillance authorities also apply from this date.
• August 2, 2026: Obligations for high-risk AI systems listed in Annex III (excluding those already covered by Union harmonisation legislation) become fully applicable. Article 47 obligations — including the requirement to draw up and maintain the EU declaration of conformity — apply in full from this date for those systems.
• August 2, 2027: Obligations for high-risk AI systems that are safety components of products regulated under the sectoral Union harmonisation legislation listed in Annex I become applicable. Providers of such embedded AI systems must have their EU declaration of conformity in place by this date.

Providers subject to the December 2026 or August 2027 deadlines should begin conformity assessment procedures well in advance — typically 12 to 18 months before the applicable deadline — to ensure technical documentation, conformity assessments, and the EU declaration of conformity are complete and accurate at the moment of market placement.