The EU declaration of conformity under the AI Act (Article 47)

Short answer: The EU declaration of conformity is the document by which the provider of a high-risk AI system declares in writing that the system meets the requirements of the AI Act. Article 47 requires the provider to draw it up, sign it, keep it for ten years and supply it to the authorities on request. By drawing it up, the provider assumes full responsibility for compliance.

What is the declaration of conformity?

The declaration is the capstone of the conformity assessment: the formal evidence that the provider has been through that assessment and concludes the system is in conformity. It accompanies the CE marking and must exist before the system is placed on the market. The importer and distributor specifically check for the existence of this declaration.

What must it contain?

The declaration contains at least the information in Annex V, including:

• the name and type of the high-risk AI system, with identifiers allowing it to be traced;
• the name and address of the provider and, where applicable, of the authorised representative;
• the statement that the provider bears sole responsibility;
• a reference that the system complies with the AI Act and any other relevant Union law;
• references to the harmonised standards or specifications applied;
• where applicable, the name and number of the notified body and the certificate issued;
• the place, date and signature.

One system, possibly several rule sets

If the system also falls under other Union law requiring a declaration of conformity, the provider draws up a single declaration referring to all applicable acts. The authority then receives one coherent document instead of separate declarations.

Language, currency and retention

The declaration is drawn up in a language that can be easily understood by the authorities of the Member States concerned. The provider keeps it current: if the system or the relevant requirements change, the declaration is updated. The provider keeps the declaration for ten years after the system is placed on the market and makes it available to the national authorities on request.

What to do

• Draw up the declaration before market entry and link it to the technical documentation.
• Follow Annex V as a checklist for the mandatory content.
• Bundle multiple regimes into one declaration where possible.
• Set up version control and ten-year retention so you can produce current and past versions.
• Anchor the process in your AI governance framework, including who signs and updates it.

The declaration of conformity is not an afterthought formality but a personal promise by the provider: it puts its signature under the compliance of the whole system.