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AnnexesArticle Annex V

Annex V: EU Declaration of Conformity — Content Requirements

Applies from 2 Aug 20264 min readEUR-Lex verified Apr 2026

Annex V prescribes the content of the EU declaration of conformity that providers must draw up under Article 47 for each high-risk AI system. The declaration is a structured document containing: the AI system and provider identification, the statement of conformity, the conformity assessment procedure used, references to applicable harmonised standards or common specifications, the notified body details (where applicable), the date, and the signatory. For products also covered by Annex I Union harmonisation legislation, a single declaration may address all applicable EU acts.

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Who does this apply to?

  • -Providers drafting the EU declaration of conformity for high-risk AI systems
  • -Legal and compliance teams creating declaration templates
  • -Importers and distributors verifying declaration content
  • -Market surveillance authorities checking conformity documentation

Scenarios

A provider creates a declaration template listing the AI system name, unique ID, Annex VI procedure reference, applied harmonised standards, and signs it with date and role.

Declaration meets Annex V content requirements — ready for Article 47 compliance.
Ref. Annex V + Art. 47

A medical device AI provider combines the MDR and AI Act declarations into a single document covering both regimes.

Aligned with Annex V and Article 47(3) — one document referencing all applicable Union harmonisation acts.
Ref. Annex V + Art. 47(3)

What Annex V requires (the declaration content)

The EU declaration of conformity must contain:

1. AI system name and type, and any additional unambiguous reference for identification 2. Name and address of the provider (and authorised representative, if applicable) 3. A statement that the declaration is issued under the sole responsibility of the provider 4. A statement that the AI system is in conformity with the AI Act and, where applicable, other Union legislation providing for the issuing of an EU DoC 5. References to any relevant harmonised standards or common specifications used 6. Where applicable: name and identification number of the notified body, the conformity assessment procedure performed, and certificate identification 7. Place and date of issue 8. Name, function, and signature of the person signing on behalf of the provider

The full numbered text appears on EUR-Lex Annex V.

Combined declarations for dual-regulated products

Article 47(3) allows providers whose AI systems are also covered by Annex I legislation (medical devices, machinery, toys, etc.) to issue a single EU declaration of conformity covering both the AI Act and the sectoral product law.

In this case, the declaration lists the requirements of each applicable act, references the harmonised standards or common specifications for each, and identifies the notified bodies involved for each assessment. This reduces administrative burden while ensuring transparency.

How Annex V connects to the rest of the Act

  • Article 47 — The obligation to draw up the declaration that Annex V structures.
  • Article 48 — CE marking, which presupposes a valid declaration.
  • Annex VI / Annex VII — The conformity assessment procedure referenced in the declaration.
  • Article 43 — Decision tree for which procedure to reference.
  • Annex VIII — EU database registration references the declaration.
  • Annex I — Product-safety legislation for combined declarations.

Compliance checklist

  • Create a declaration template covering all 8 Annex V content items.
  • Pre-populate with provider identity, AI system identification, and Annex III category.
  • Reference the correct conformity assessment procedure (Annex VI or VII).
  • List applied harmonised standards or common specifications with version numbers.
  • Include notified body details if Annex VII assessment was used.
  • For dual-regulated products: list all applicable EU acts in one declaration.
  • Ensure the declaration is machine-readable (Article 47 requirement).
  • Sign with date, name, and function of the responsible person.
Read the official text on EUR-Lex

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Related annexes

  • Annex VI — Internal control conformity assessment
  • Annex VII — Notified body conformity assessment
  • Annex VIII — Registration information

Frequently asked questions

Is the declaration a one-time document?

No. Article 47 requires it to be kept up to date as necessary — update when the system, conformity status, or applied standards change.

Must the declaration be in every EU language?

It must be translated into the language(s) required by Member States where the system is made available (Article 47).

Can I use a digital-only declaration?

Yes — Article 47 actually requires a machine-readable format. A digital structured document (e.g., XML) alongside a human-readable version is best practice.