Article 11 — Technical Documentation

Legal Provision

Technical Documentation: establishes the obligation to have specific technical documentation describing the AI system purpose and functioning, prepared and available.

Scope

Applies to providers of the high-risk AI system.

Requirement type

Duty: before placing a high-risk AI system on the market or putting it into service, and during its lifecycle.

Actions to demonstrate compliance

A. Binary (yes/no): if these elements are present, there is evidence towards demonstrating compliance.

• Technical documentation prepared in accordance with Annex IV of the AI Act.

B. Non-binary (require a contextual assessment): building on the binary actions, a contextual assessment of these points is required to further verify compliance with each specific legal basis.

• Comprehensive system description, including architecture and development environment.
• Inclusion of performance metrics, test protocols and outcomes.
• Mapping of system functionality to intended purpose and risk controls.
• Evidence of traceability across the system’s lifecycle, from design to deployment.
• Explanation of system behaviour, including known limitations and performance bounds.
• Transparent record of assumptions and design choices.
• Documented use of external libraries, pretrained models, and tools.
• Justification for any divergence from industry standards or best practices.
• Integration of risk management outcomes into the documentation.

Monitoring requirement

• Centralised and version-controlled repository of technical documentation.
• Logs of changes to the documentation following each system update or retraining.
• Internal documentation review audits, including records of reviewer comments and approvals.
• Access control and traceability of who accessed, edited, or updated the documentation.
• Procedures for making relevant documentation available to notified bodies and competent authorities upon request.
• System for ensuring that post-market monitoring outcomes are reflected in documentation updates.

Consequences of non-compliance

• Administrative fines up to €15 000 000 or 3% of total worldwide annual turnover.
• Penalties and enforcement measures adopted at the Member State level.