EU Declaration of Conformity: Article 47 and Annex V

The EU declaration of conformity is the document where the provider puts its name on the line. Under Article 47 of Regulation (EU) 2024/1689, the provider draws up a written declaration of conformity for each high-risk AI system and states, under its sole responsibility, that the system meets the requirements of the Regulation. It is short, it is signed, and it is the legal hinge between assessing a system and selling it: no valid declaration, no lawful CE marking.

People conflate three things — the technical documentation, the conformity assessment, and the declaration. They are different objects with different jobs. This page pins down the declaration: what Annex V says goes in it, how long you keep it, and where it sits in the sequence.

Stand-alone high-risk systems must carry a declaration from 2 December 2027 (Annex I product-embedded systems from 2 August 2028). Those dates are set by Regulation (EU) 2026/1744, the Digital Omnibus on AI, published in the Official Journal on 24 July 2026 and in force since 27 July 2026; the Annex III date was originally 2 August 2026.

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What the Declaration Must Contain — Annex V

Article 47 sets the duty; Annex V sets the content. The declaration must include:

• the AI system's name and type and any unambiguous reference allowing identification and traceability;
• the name and address of the provider (and, where applicable, the authorised representative);
• a statement that the EU declaration of conformity is issued under the sole responsibility of the provider;
• a statement that the system is in conformity with this Regulation and, where relevant, with any other Union legislation that provides for an EU declaration of conformity;
• where the system processes personal data, a statement that it complies with EU data-protection law (GDPR / Regulation (EU) 2018/1725);
• references to any harmonised standards or common specifications applied;
• where applicable, the name and identification number of the notified body, a description of the conformity-assessment procedure performed, and the identification of any certificate issued;
• the place and date of issue, and the name, function and signature of the person who signed it.

A single declaration can cover one system; where a system falls under several pieces of Union law that each demand a declaration, one combined declaration referencing all of them is permitted, so authorities see one document.

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Three Documents, Three Jobs — Don't Conflate Them

The Annex IV technical documentation is the body of evidence. The Article 43 conformity assessment is the act of checking that evidence against the requirements — for most Annex III categories an internal self-assessment (Annex VI route); for Annex III point 1 biometrics, the notified-body route (Annex VII). The Article 47 declaration is the one-page conclusion the provider signs once the assessment is done. The declaration is not the technical file and it is not the assessment — it is the attestation that both were done and that the system conforms.

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Retention and Sequence

The provider must keep the declaration for 10 years after the system is placed on the market or put into service (Article 18, alongside the technical documentation), and keep it at the disposal of national competent authorities — which ties straight into the Article 21 cooperation duty.

The sequence is fixed:

1. Build to the Chapter III, Section 2 requirements and assemble the Annex IV documentation (Article 11).
2. Run the conformity assessment (Article 43).
3. Draw up and sign the EU declaration of conformity (Article 47 / Annex V).
4. Affix the CE marking (Article 48).
5. Register in the EU database before placing on the market (Article 49).

You cannot legitimately CE-mark a high-risk AI system before the declaration exists — the mark is the public signal that the declaration has been made. Drawing up a declaration for a system that does not in fact conform is itself a breach.

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Worked Example

Lumvera AI BV (a fictional Dutch provider, ~60 employees, ~€9M turnover) builds a high-risk AI triage system used by a health insurer to price life-and-health cover (Annex III point 5(c)).

• Before the declaration: Lumvera assembles the Annex IV file (Article 11) and completes the internal-control conformity assessment (Article 43, Annex VI — not the biometrics route).
• The declaration: it draws up the Annex V declaration — system identification and version, Lumvera's name and address, the "sole responsibility" statement, conformity with Regulation (EU) 2024/1689 and applicable Union law, any harmonised standards or common specifications applied, place and date, and a signature from an authorised signatory.
• After: Lumvera affixes the CE marking (Article 48), registers the system (Article 49), and files the declaration for 10 years (Article 18), ready to produce on an Article 21 request.
• Exposure: issuing a declaration for a non-conforming system, or failing to draw one up, sits in the €15M or 3% provider-obligation tier (Article 99(4)). Supplying a misleading declaration to a notified body or authority can reach the separate €7.5M or 1% tier (Article 99(5)). Under Article 99(6), a company Lumvera's size pays the lower of the percentage or the fixed amount.

The verdict: the declaration is the shortest document in the high-risk file and the one with the sharpest teeth — a signature under "sole responsibility" is exactly what an authority points to when a system fails.

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How Confir Helps

For provider-role systems Confir generates the Article 47 / Annex V Declaration of Conformity alongside the Article 11 / Annex IV technical documentation, pre-populated from the structured assessment, and retains both with an immutable audit log so the 10-year obligation and any Article 21 request are covered. The engine is rule-based and deterministic — the declaration's contents map directly to the Annex V fields, and the same inputs reproduce the same document every time.

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Related guides

• Provider obligations checklist (Article 16)
• Conformity assessment explained (Article 43)
• Technical documentation and Annex IV
• CE marking for AI systems (Article 48)
• Cooperation with authorities (Article 21)