EU Declaration of Conformity: What It Means Under the AI Act

Under Article 47 of Regulation (EU) 2024/1689, the EU declaration of conformity (DoC) is the written declaration a provider draws up for each high-risk AI system, stating that the system meets the requirements in Chapter III, Section 2 — Articles 8 to 15. It is a signed legal attestation, not a marketing claim: the provider thereby assumes sole responsibility for the system's compliance.

This page pins down the concept and its three legal levers — sole responsibility, ten-year retention, on-request availability — and separates it from CE marking and conformity assessment. It does not reproduce the full Annex V template; that lives on the template page.

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The EU AI Act definition

Article 47(1) requires the provider to draw up a written EU declaration of conformity for each high-risk AI system. The act carries weight: the provider thereby assumes sole responsibility for the system's compliance with the Regulation. There is no shared liability hidden in the document — the signature is the provider's alone.

The contents are fixed by Annex V. The declaration attests that the system meets the requirements set out in Chapter III, Section 2 (Articles 8 to 15) — risk management, data governance, technical documentation, logging, transparency to deployers, human oversight, accuracy and cybersecurity. It does not re-prove those requirements; it points to the conformity record that does.

Three obligations sit on the face of Article 47(2). The declaration must be kept for 10 years after the system is placed on the market or put into service. Throughout that period it must be made available to national competent authorities on request. And it must be drawn up in a language easily understood by the authorities of the member states where the system is made available. Failure to produce it on demand is itself a non-compliance event.

Under Article 47(3), where a high-risk AI system is also subject to other Union harmonisation legislation requiring a declaration, the provider may draw up one declaration covering all applicable acts.

Only providers draw it up. Under Article 16(a) and the definition in Article 3(3), the obligation falls on the entity that places the system on the market or puts it into service under its own name or trademark. Deployers, importers and distributors verify that a valid declaration exists — they do not produce it. The one exception is Article 25: a deployer or distributor that puts its name on the system, makes a substantial modification, or changes the intended purpose so the system becomes high-risk is treated as a provider and inherits the duty in full.

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What Annex V requires (in brief)

A glossary lists the categories, not a fill-in form. Annex V requires the declaration to:

• identify the AI system and the provider;
• state that it is issued under the provider's sole responsibility;
• declare conformity with Regulation (EU) 2024/1689 and any other applicable Union law;
• reference any harmonised standards or common specifications applied;
• give the notified body's details where the Annex VII route was used; and
• be dated and signed by a responsible person.

One practical reality shapes the reference to standards. As of mid-2026, no harmonised standards have been formally adopted under Article 40. Such standards confer a presumption of conformity, but until they exist most providers describe their internal testing methods instead. The absence does not suspend the obligation — it changes what you cite, not whether you sign.

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How it differs from CE marking and conformity assessment

The declaration is neither the assessment nor the marking. It sits between them in a fixed sequence — assess, declare, mark.

Declaration of conformity vs conformity assessment (Article 43)

Conformity assessment under Article 43 is the evaluation procedure that demonstrates the system meets Articles 8 to 15. For most Annex III categories it runs as internal control under Annex VI; for certain biometric systems it goes through the notified-body route under Annex VII. The declaration is the written attestation issued once that assessment is complete — you cannot sign a valid one without a finished assessment behind it. The assessment is the evidence, the declaration the cover statement that points to it.

Declaration of conformity vs CE marking (Article 48)

The CE marking under Article 48 is the visible mark affixed to the high-risk system, its packaging or its documentation, signalling conformity outwardly. It is affixed only after the declaration is drawn up — no CE marking without a declaration, no declaration without a completed assessment.

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How Confir helps

Confir assembles the EU declaration of conformity from the conformity record you have already built — pulling system identifiers, the Annex V fields, the standards or testing methods cited, and any notified-body details into one signed-ready document, or a single consolidated declaration where Article 47(3) lets several Union acts share a page. The engine is deterministic and rule-based — no model inference, no hallucination — so the output reflects your record exactly.

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Frequently asked questions

Is the declaration of conformity the same as the conformity assessment?

No. The conformity assessment under Article 43 is the evaluation procedure that demonstrates a high-risk AI system meets the Chapter III, Section 2 requirements — run as internal control (Annex VI) or via a notified body (Annex VII). The EU declaration of conformity under Article 47 is the written attestation drawn up once that assessment is complete. You cannot sign a valid declaration without a finished assessment behind it: the assessment record is the evidence, the declaration the signed cover statement that points to it.

How is the declaration of conformity different from CE marking?

The declaration (Article 47) is the written document stating the system conforms; the CE marking (Article 48) is the visible mark affixed to the system or its documentation to signal that conformity outwardly. The order is fixed: the conformity assessment comes first, the declaration is drawn up next, and only then is the CE marking affixed. There is no CE marking without a declaration, and no declaration without a completed conformity assessment. The marking is the public signal; the declaration is the underlying legal attestation.

Who has to draw up the EU declaration of conformity?

Only the provider — the entity that places the high-risk AI system on the market or puts it into service under its own name or trademark (Article 3(3), Article 16(a)). Deployers, importers and distributors verify that a valid declaration exists but do not produce it themselves. One exception: under Article 25, a deployer or distributor that puts its name on the system, makes a substantial modification, or changes the intended purpose so the system becomes high-risk is treated as a provider and must draw up its own declaration.

How long must the declaration be kept, and who can ask to see it?

Article 47(2) requires the provider to keep the EU declaration of conformity for 10 years after the high-risk AI system is placed on the market or put into service. Throughout that period it must be made available to national competent authorities on request, and failure to produce it on demand is itself a non-compliance event. The supporting technical documentation must be retained for the same period, since authorities examine that evidence base alongside the declaration.

Can one declaration cover the AI Act and other EU laws at once?

Yes. Article 47(3) allows a single EU declaration of conformity to cover all the Union harmonisation acts that apply to the system. If a high-risk AI system is also, for example, a medical device under Regulation (EU) 2017/745, the provider draws up one declaration listing each applicable instrument rather than separate documents. This keeps the paperwork consolidated where multiple acts overlap on the same product.

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Related terms

• Article 47 declaration of conformity — the full statutory walk-through of the drawing-up, retention and availability duties.
• Annex V declaration template and fields — the full template and a worked example you can build from.
• CE marking under the AI Act — the visible mark affixed after the declaration is drawn up.
• Article 43 conformity assessment — the internal-control and notified-body routes that precede the declaration.
• conformity assessment body — the notified body whose details appear on the declaration under the Annex VII route.