Chapter IIIHigh-Risk
Article 18
Documentation Keeping
Plain-Language Summary
Providers must keep technical documentation, quality management system documentation, and related records for a period of 10 years after the high-risk AI system has been placed on the market or put into service.
Keywords
documentationrecord retention10 yearstechnical documentationdeclaration of conformitynotified body
Legal Text
Article 18 — Documentation Keeping 1. The provider shall, for a period ending 10 years after the high-risk 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 47. 2. Each Member State shall determine the conditions under which the documentation referred to in paragraph 1 is to be kept available to national competent authorities.