EU Declaration of Conformity Under the AI Act (Article 47): Definition
The EU Declaration of Conformity (Article 47) is where a provider declares a high-risk AI system conforms. Content is set by Annex V; kept 10 years.
The EU Declaration of Conformity is the formal document in which the provider of a high-risk AI system declares, on its own responsibility, that the system meets the requirements of the EU AI Act, Regulation (EU) 2024/1689. It is required by Article 47, and its content is set by Annex V. Drawing it up is one of the final steps a provider takes before placing a high-risk system on the market.
What it is — and is not
The Declaration is a statement of result, not the assessment itself. The provider first runs the conformity assessment under Article 43, compiles the technical documentation (Article 11, Annex IV), and then issues the Declaration of Conformity to attest that the system conforms. It precedes and underpins the CE marking (Article 48): you affix the CE marking because you have drawn up the Declaration.
Keep three documents distinct: the technical documentation (Annex IV — the evidence), the conformity assessment (Article 43 — the procedure), and the Declaration of Conformity (Article 47, Annex V — the signed result).
What Annex V requires it to contain
Under Annex V, the Declaration must include, among other elements: the system's name and identifying details; the name and address of the provider (or authorised representative); a statement that the Declaration is issued under the provider's sole responsibility; a statement that the system conforms to the AI Act and, where relevant, other EU law; references to any harmonised standards or common specifications applied; and the place, date and signature.
The provider must keep the Declaration for 10 years after the system is placed on the market and make it available to national authorities on request. It must also be kept up to date as the system changes.
Who draws it up, and when
The duty falls on the provider of the high-risk system. Where a downstream actor becomes the provider under Article 25 — by rebranding or substantially modifying a system — that new provider takes on the Article 47 duty. The Declaration is drawn up before the system is placed on the market or put into service.
How Confir helps
Confir assembles the inputs the Declaration depends on — the Article 11 / Annex IV technical documentation and the conformity-assessment record — and generates the Article 47 / Annex V Declaration of Conformity from them, kept current as the system changes and retained with the rest of the technical file. The engine is deterministic and rule-based, so the Declaration reflects the recorded findings rather than a manual re-keying.
Frequently asked questions
What is the EU Declaration of Conformity under the AI Act?
It is the Article 47 document in which the provider of a high-risk AI system declares, on its own responsibility, that the system meets the AI Act's requirements. Its content is set by Annex V. It is issued before the system is placed on the market and underpins the CE marking.
Is the Declaration of Conformity the same as the conformity assessment?
No. The conformity assessment (Article 43) is the procedure that checks the system against the requirements; the technical documentation (Annex IV) is the evidence; the Declaration of Conformity (Article 47, Annex V) is the signed statement of the result. They are three distinct things.
What must the Declaration contain?
Under Annex V: the system's identifying details, the provider's name and address, a statement that it is issued under the provider's sole responsibility, a statement of conformity with the AI Act and other relevant EU law, references to standards applied, and the place, date and signature.
How long must we keep it?
Ten years after the system is placed on the market, available to national competent authorities on request, and kept up to date as the system changes.
Who is responsible for it?
The provider of the high-risk system. If a downstream actor becomes the provider under Article 25 — by rebranding or substantially modifying the system — that party takes on the Article 47 duty.
Related guides
- Conformity assessment, defined
- CE marking under the AI Act
- EU database registration
- Annex III high-risk use cases
- Provider versus deployer roles
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