Article 18: Documentation Keeping

Official Statutory Text

Article 18 Documentation keep ing 1. The provider shall, for a period ending 10 years after the high-r isk AI system has been placed on the marke tor put into service, keep at the disposal of the national competent authorities: (a) the technical documentation refer red 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 47. 2. 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 bankr up tor ceases its activity prior to the end of that period. 3. Providers that are financial institutions subject to requirements regard ing their internal gover nance, arrangements or processes under Union financial services law shall maintain the technical documentation as par tof the documentation keptunder the relevant Uni on financial services law .