Article 11: Technical Documentation | EU AI Act

Article 11 of the AI Act provides crucial information about technical documentation organizations are expected to prepare and readily make available to regulatory authorities when needed.

Organizations must ensure that they have the necessary technical documentation of high-risk AI systems ready before such a system is made available on the market. Such documentation should be kept updated at all times and drawn up in a way that provides the national competent authorities with the necessary information in a clear and comprehensible manner to assess the system’s compliance with the requirements of the AI Act. It shall contain, at a minimum, the elements set out in Annex IV.

However, small and medium enterprises (SMEs) and startups may provide it in a manner consistent with the Annex IV guidelines. The Commission will provide a template of such documentation that is acceptable to notified bodies for the purposes of the conformity assessment.

Furthermore, the Commission is empowered to adopt delegated acts under Article 97 to update Annex IV as needed to ensure that technical documentation remains comprehensive and aligns with technical advancements, thereby facilitating the assessment of system compliance with the outlined requirements.