Article 18: Documentation keeping
Chapter 3 High-Risk AI Systems - Section 3: Obligations of providers and deployers of high-risk AI systems and other parties
(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.
(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 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.
(3)
Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the technical documentation as part of the documentation kept under the relevant Union financial services law.
Related Recitals
- Recital 66: Scope of the requirements
- Recital 71: Development documentation
- Recital 72: Transparency
- Recital 81: Quality management system
- Recital 131: Obligation to register high-risk models
- Recital 156: Validity of the system for market surveillance and conformity of products
- Recital 157: Position of national authorities or other bodies
- Recital 158: Supervision and market surveillance of AI systems in the financial sector
- Recital 159: Powers of competent authorities for biometric data
- Recital 161: Responsibilities and competencies
- Recital 162: Synergies at Union level
- Recital 163: Scientific panel as supporter of the Office for AI
- Recital 164: Competencies of the AI Office
- Recital 173: Powers of the Commission after delegation
Do you have questions?
We are happy to support you with your AI project!