Art. 47 EU declaration of conformity | AI act regulation | AI act

This article establishes the requirement for providers of high-risk AI systems to produce an EU declaration of conformity — a formal written document asserting that the system meets the requirements laid down in the regulation.

It connects directly to the conformity assessment process set out in Article 43, serving as the documentary output of that process.

The article covers what the declaration must contain, how long it must be retained, how it must be translated for relevant national authorities, and the principle that the act of drawing it up places responsibility for compliance squarely on the provider.

A practical streamlining provision is also included: where other EU harmonisation legislation requires its own declaration of conformity, a single combined declaration can be produced to cover all applicable Union law.

Important points:

Draw up a written EU declaration of conformity for each high-risk AI system and keep it available to national competent authorities for 10 years after the system is placed on the market or put into service.
By drawing up the declaration, providers formally assume responsibility for compliance with the requirements of Section 2, and must keep the declaration up-to-date.
The Commission has the power to amend the required content of the declaration via delegated acts in light of technical progress.

1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI system, and keep it at the disposal of the national competent authorities for 10 years after the high-risk AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the high-risk AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be submitted to the relevant national competent authorities upon request.
1. The EU declaration of conformity shall state that the high-risk AI system concerned meets the requirements set out in Section 2. The EU declaration of conformity shall contain the information set out in Annex V, and shall be translated into a language that can be easily understood by the national competent authorities of the Member States in which the high-risk AI system is placed on the market or made available.
1. Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union law applicable to the high-risk AI system. The declaration shall contain all the information required to identify the Union harmonisation legislation to which the declaration relates.
1. By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the requirements set out in Section 2. The provider shall keep the EU declaration of conformity up-to-date as appropriate.
1. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex V by updating the content of the EU declaration of conformity set out in that Annex, in order to introduce elements that become necessary in light of technical progress.