What must an EU declaration of conformity contain?

What information does Annex V require?

Annex V sets the contents of the declaration, which in outline include the name and type of the system and an unambiguous reference allowing its identification, the name and address of the provider or its authorised representative, a statement that the declaration is issued under the provider's sole responsibility, a statement of conformity with the AI Act and any other relevant Union law, references to harmonised standards or common specifications applied, where applicable the notified body's details and certificate, and the place and date of issue with the name, function and signature of the person who signed it. Where personal data are processed, the declaration also addresses compliance with Union data protection law as Annex V provides. The provider should complete each element for the specific system and version, rather than copying a declaration from another system, and should check the consolidated Annex V text for the current wording, because a declaration that omits an element or states it incorrectly does not meet the article.

What does sole responsibility mean?

The declaration is issued under the provider's sole responsibility. That means the provider, not a notified body, not a supplier, and not a deployer, stands behind the statement that the system complies with the requirements. A notified-body certificate, a supplier's assurance, or a test report can support the declaration, but none of them replaces the provider's responsibility for it. The signatory should be a person with the authority to bind the provider and with access to the conformity file, and the signature should be dated and recorded. A declaration signed by a person who has not seen the file, or signed in advance of the assessment, does not carry the responsibility the article requires. The provider should record who signed, on what evidence, and when, in the conformity file.

For the broader regulatory framework, see Conformity assessment and CE marking overview.

How is the declaration kept and supplied?

The provider must keep the declaration at the disposal of national competent authorities for the period the Act sets, and must provide a copy on request, in the form and language the authority requires. The declaration should be stored in a controlled, retrievable form, linked to the system version, the assessment file, and any certificate. Where the system is supplied to deployers, the provider should consider how the declaration is made available in the supply chain, without treating a marketing summary as a substitute for the declaration itself. A declaration that cannot be produced when an authority asks for it, or that describes a different version from the one supplied, undermines the conformity conclusion it is meant to evidence.

What about translation and other Union law?

The declaration must be translated into the languages required by the Member States where the system is made available, as Article 47 provides, and the translation must accurately reflect the original. The declaration must also state conformity with other relevant Union harmonisation legislation where the system is subject to it, and must reference the legislation and any standards applied. A provider supplying a system in several Member States should plan translation and version control together, so that each translated declaration matches the same system version and the same conformity outcome. A translation that is outdated, or that omits a statement present in the original, creates a mismatch that can be treated as a failure to provide a correct declaration in that Member State.

When must a declaration be updated?

A declaration must be updated where a change affects the statements it contains, including a substantial modification that requires a new conformity assessment, a change in the standards or specifications applied, a change in the notified body or certificate, or a change in the provider or authorised representative details. The updated declaration should be issued as a new version, with the earlier version retained, and the change should be recorded with the date and the reason. Deployers and authorities who received the earlier declaration should be given the updated version where the change affects them. A provider should not amend a declaration silently, without a new date and signature, because the declaration is a dated legal statement and its history matters to anyone who relies on it.

Continue with CE marking under Article 48.

What does this guide not decide?

This guide does not decide whether a particular declaration meets Annex V, whether a signatory had authority, whether a translation is accurate, or whether an update was required. It does not draft a declaration for a specific system. Those questions depend on the system, the conformity file, the certificate where one exists, and the consolidated legal text. A provider should have its declaration checked against Annex V by a competent reviewer, keep it with the assessment file, and confirm the position with a competent authority, a notified body where involved, or a legal adviser where contested.

Frequently asked questions

Continue through this AI Act cluster

• Conformity assessment and CE marking overview
• CE marking under Article 48
• Conformity assessment routes under Article 43
• Registration linked to conformity
• Provider responsibilities
• How does internal control under Annex VI work?