If the organisation is established outside the European Union, it should appoint an authorised representative located within the Union. This appointment must be formalised through a written mandate before making any high-risk AI system available on the EU market.
The responsibilities of the authorised representative should be defined by the organisation of the provider of high-risk AI systems when the representative is appointed. The authorised representative should act within the scope of these responsibilities and be able to provide a copy of them to market surveillance authorities upon request in an official language of the EU as indicated by the competent authority.
The authorised representative should be empowered to:
- verify that the EU declaration of conformity and the required technical documentation have been prepared and that the appropriate conformity assessment procedure has been carried out by the provider
- retain, for 10 years after the high-risk AI system has been placed on the market or put into service, the provider’s contact details, the EU declaration of conformity, the technical documentation and any applicable notified body certificate, and make them available to competent authorities upon request
- provide competent authorities, upon a reasoned request, with the information and documentation necessary to demonstrate conformity, including access to automatically generated logs where such logs are under the provider’s control
- cooperate with competent authorities in actions taken to address or mitigate risks related to the high-risk AI system
- comply with applicable registration obligations, or ensure the correctness of registration information where registration is carried out by the provider
Competent authorities should be able to address the authorised representative, in addition to or instead of the provider of the high-risk AI system, on matters related to compliance with the AI Act.
The organization should maintain documented evidence covering the full spectrum of these responsibilities.