Article 18
Obligation to draw up technical documentation Document keeping [The Council amended this heading, and it has been provisionally agreed on subject to final check by the EP.]

 

1. Providers of high-risk AI systems shall draw up the technical documentation referred to in Article 11 in accordance with Annex IV. The provider shall, for a period ending 10 years after the AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities:

(a) the technical documentation referred to in Article 11;

(b) the documentation concerning the quality management system referred to in Article 17;

(c) the documentation concerning the changes approved by notified bodies where applicable;

d) the decisions and other documents issued by the notified bodies where applicable;

(e) the EU declaration of conformity referred to in Article 48.

1a. Each Member State shall determine conditions under which the documentation referred to in paragraph 1 remains at the disposal of the national competent authorities for the period indicated in that paragraph for the cases when a provider or its authorised representative established on its territory goes bankrupt or ceases its activity prior to the end of that period. [The Council added these clauses, and they have been provisionally agreed on subject to final checks by the EP.] 

2. Providers that are credit financial institutions regulated by Directive 2013/36/EU subject to requirements regarding their internal governance, arrangements or processes under Union financial services legislation shall maintain the technical documentation as part of the documentation concerning internal governance, arrangements, processes and mechanisms pursuant to Article 74 of that Directive kept under the relevant Union financial services legislation[The Council amended this clause, and it has been provisionally agreed on subject to final checks by the EP.]