The organisation should establish a process for creating, managing, and maintaining an EU declaration of conformity for each high-risk AI system it provides. This declaration confirms that the system complies with the AI Act.
The process should ensure the declaration:
- Is created before the system is placed on the market.
- Contains all information specified in Annex V of the AI Act.
- Is kept for 10 years after the system is placed on the market and provided to authorities upon request.
- Is kept up to date with any changes to the system or regulations.
The declaration should be translated into a language understood by competent authorities of the Member States where the system is marketed. It should be structured to be provided as a single declaration where the AI system is also subject to other EU harmonisation legislation.