What must the EU declaration of conformity contain?

The Annex V elements: system name and type, provider identification, a statement that it is issued under the provider's sole responsibility, the statement of conformity, references to standards or common specifications applied, notified body details where relevant, and the place and date of issue.

How long must the declaration be kept?

Ten years after the high-risk AI system has been placed on the market or put into service, at the disposal of the national competent authorities.

EU AI Act glossary · Documents & conformity· Art. 47

EU declaration of conformity

Article 47 requires the provider of a high-risk AI system to draw up a written EU declaration of conformity stating that the system meets the Act's requirements, and to keep it for ten years after the system is placed on the market.

The declaration must be machine-readable, physically or electronically signed, and contain the information in Annex V: the system's name and type, the provider's details, a statement that the declaration is issued under the sole responsibility of the provider, a statement of conformity with the Regulation and any other relevant Union legislation, references to the harmonised standards or common specifications applied, the notified body's details and certificate reference where applicable, and the place and date of issue. It must be kept at the disposal of national authorities for ten years, translated into the languages required by the member states where the system is made available, and kept up to date.

Where EU declaration of conformity sits in the Regulation

Art. 47
Annex V

Who it binds

EU declaration of conformity: why it matters

The declaration converts a technical file into a legal assertion by a named entity: it is issued under the provider's sole responsibility, and by drawing it up the provider assumes responsibility for compliance with all the requirements. That makes it the document enforcement actually turns on — an inaccurate declaration is a straightforward finding, whereas an incomplete technical file is an argument. It is also what importers and distributors ask for, so its absence stops the supply chain cold.

Worked example

EU declaration of conformity in practice

A provider ships the same high-risk system into Germany, France and Poland. One declaration covers the system, but it needs translating into the languages those member states require, it must reference every piece of Union legislation the system also falls under — such as machinery or medical device law where relevant — and it must be reissued when a substantial modification changes what was assessed. It is then retained for ten years past market placement.

Correction

EU declaration of conformity: the mistake people make

Confusing the declaration of conformity with the CE marking or with a notified-body certificate. The declaration is the provider's own signed statement; the CE marking is the visible sign that it exists; a certificate, where one is issued, comes from a notified body and is referenced inside the declaration rather than replacing it.

Questions

EU declaration of conformity: common questions

What must the EU declaration of conformity contain?: The Annex V elements: system name and type, provider identification, a statement that it is issued under the provider's sole responsibility, the statement of conformity, references to standards or common specifications applied, notified body details where relevant, and the place and date of issue.
How long must the declaration be kept?: Ten years after the high-risk AI system has been placed on the market or put into service, at the disposal of the national competent authorities.
Does one declaration cover the whole EU?: Yes, one declaration covers the system across the Union, but it must be translated into the languages required by the member states in which the system is placed on the market or made available.

Keep reading

EU declaration of conformity: terms that come up alongside it

Conformity assessmentArt. 43

The pre-market check that unlocks the declaration of conformity and the CE marking.

CE markingArt. 48

The visible mark that a high-risk AI system has completed the conformity route.

Technical documentation (Annex IV)Art. 11 / Annex IV

The Annex IV file that proves a high-risk system meets the requirements.

Notified bodyAnnex VII

The independent assessor required where AI Act self-assessment is not available.

See how EU declaration of conformity applies to your systems

Run the free 2-minute EU AI Act checker — no sign-up.

Run the free check