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Chapter III, Section 5 — Standards, conformity assessment, certificates, registrationArticle 47

Article 47: EU Declaration of Conformity

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

Article 47 requires providers of high-risk AI systems to draw up a written, machine-readable EU declaration of conformity for each system and keep it available for 10 years after market placement. The declaration must contain the information set out in Annex V, be updated as necessary, and be translated into the language(s) required by the Member State(s) where the system is made available. For dual-regulated products under Annex I legislation, a single declaration may cover both the AI Act and the sectoral requirements.

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Who does this apply to?

  • -Providers of high-risk AI systems issuing the declaration after conformity assessment
  • -Importers and distributors who must verify the declaration exists before making the system available
  • -Market surveillance authorities who may request the declaration during inspections
  • -Regulatory teams managing multi-language compliance documentation

Scenarios

A provider completes Annex VI internal control, issues an EU declaration per Annex V, and retains it in the compliance file for 10 years.

Correct Article 47 compliance — declaration ready for authority inspection at any time.
Ref. Art. 47 + Annex V + Annex VI

A medical device AI provider issues a single declaration covering both MDR and AI Act requirements.

Aligned with Article 47(3) — one declaration for dual-regulated products under Annex I.
Ref. Art. 47(3)

What Article 47 requires (plain terms)

The provider shall:

1. Draw up a written EU declaration of conformity for each high-risk AI system 2. Include the information set out in Annex V 3. Keep the declaration up to date as necessary 4. Make it available in machine-readable format 5. Retain the declaration for 10 years after market placement or putting into service 6. Translate the declaration into the language(s) required by each Member State where the system is available 7. Provide a copy to the market surveillance authority upon request

For products also covered by Annex I legislation, a single declaration may address both regimes.

How Article 47 connects to the rest of the Act

  • Annex V — Content requirements for the declaration.
  • Article 16(i) — Drawing up the declaration is a lettered provider obligation.
  • Article 43 — Conformity assessment must be completed before the declaration is issued.
  • Article 48 — CE marking is affixed after the declaration.
  • Annex VI / Annex VII — Assessment procedures that precede the declaration.
  • Article 18 — Documentation keeping (10-year retention).
  • Article 23 — Importer duties include verifying the declaration exists.

Compliance checklist

  • Map Annex V content requirements into a declaration template.
  • Issue the declaration only after successful conformity assessment (Annex VI or VII).
  • Ensure machine-readable format (structured data, not just PDF).
  • Translate into required languages for each target Member State.
  • Retain the declaration for 10 years from market placement.
  • Update the declaration when the system or its conformity status changes.
  • For dual-regulated products: combine AI Act and sectoral declaration per Article 47(3).
Read the official text on EUR-Lex

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Related annexes

  • Annex V — Content of the EU declaration of conformity

Frequently asked questions

Is a PDF declaration sufficient?

Article 47 requires machine-readable format. A PDF alone may not meet this — consider structured formats (XML, JSON) alongside human-readable versions.

Can one declaration cover multiple AI system versions?

Each materially different version should have its own declaration or a clearly versioned update. The declaration must accurately reflect the assessed system.

Must the EU declaration of conformity be kept accessible after market withdrawal?

Yes. The provider must keep the EU declaration of conformity at the disposal of market surveillance authorities for 10 years after the high-risk AI system has been placed on the market or put into service. The declaration must follow the template in Annex V and be updated if the system undergoes substantial modification.