How to Prepare the EU Declaration of Conformity for AI Act 2026

What is the EU Declaration of Conformity?

The EU Declaration of Conformity is the written statement by which the provider of a high-risk AI system declares that the system complies with all applicable requirements of the EU AI Act. It is one of the mandatory steps before placing a high-risk AI system on the market or putting it into service in the European Union.

Source: Regulation (EU) 2024/1689 – EU AI Act (eur-lex.europa.eu)

When is the Declaration of Conformity required?

The EU Declaration of Conformity is required for all high-risk AI systems (Article 6). The provider must draw up and sign the declaration after having completed the applicable conformity assessment procedure (e.g. internal control under Annex VI, EU-type examination, or full quality assurance). Without a valid declaration, the high-risk AI system must not be placed on the market.

Source: European Commission – Regulatory framework on AI

What must the Declaration of Conformity contain?

The EU AI Act specifies the mandatory content of the EU Declaration of Conformity. To be compliant, the declaration must include at least the following elements:

The declaration must be drawn up in a language required by the Member State in which the system is placed on the market, and it must be translated if so required by that Member State.

How to prepare the EU Declaration of Conformity?

To prepare the EU Declaration of Conformity, the provider must complete the following steps in order:

• Complete the conformity assessment: Carry out the applicable conformity assessment procedure (internal control, EU-type examination, or full quality assurance) and obtain a positive result.
• Prepare and maintain Technical documentation: Ensure that the Technical documentation (Annex IV) is complete, up to date, and available to authorities.
• Draft the declaration: Include all mandatory elements required by the EU AI Act for the EU Declaration of Conformity.
• Sign and date: Have the declaration signed by a person authorised to bind the provider, and add the date of issue.
• Keep the declaration available: The declaration must be available to market surveillance authorities upon request, together with the Technical documentation.

ActProof supports the generation of compliance documentation, including elements that feed into the Technical documentation and the preparation of the EU Declaration of Conformity. Explore ActProof.

What is the link with CE marking?

Where a high-risk AI system is a product or component of a product covered by EU harmonisation legislation that provides for CE marking, the CE marking must be affixed. In that case, a single EU Declaration of Conformity may cover both the EU AI Act and the other legislation, provided that all applicable requirements are stated. The EU AI Act itself does not introduce a standalone CE mark for AI-only systems not covered by other product legislation; the declaration of conformity remains mandatory in all cases for high-risk AI systems.

Next steps and resources

To meet the August 2, 2026 deadline, providers of high-risk AI systems must complete the conformity assessment, prepare the Technical documentation (Annex IV), draw up and sign the EU Declaration of Conformity, and keep both available for authorities. Use official sources for the full wording and any implementing acts.

• Regulation (EU) 2024/1689 – EU AI Act (eur-lex.europa.eu)
• European Commission – Regulatory framework on AI
• EU AI Act Conformity Assessment & Certification – ActProof Blog
• Annex IV Technical Documentation for EU AI Act – ActProof Blog