What Documents Are Required Under the EU AI Act?

EU AI Act Documentation Requirements

For providers of high-risk AI systems, the EU AI Act (Regulation 2024/1689) mandates comprehensive technical documentation under Annex IV. This documentation must be prepared before the AI system is placed on the market.

Annex IV Requirements

The technical documentation must contain:

1. General Description — A description of the intended purpose, the persons or groups on whom the system is intended to be used, and the versions of relevant software.

1. Detailed Description of Elements — Information about the methods and steps used for development, including training methodologies, data sets used, and design choices.

1. Monitoring, Functioning, and Control — Descriptions of the system's capabilities and limitations, the degree of accuracy, and foreseeable unintended outcomes.

1. Risk Management System — Documentation of the risk management process applied throughout the lifecycle, including identification of known and foreseeable risks.

1. Data Governance — Description of training, validation, and testing data sets, including data collection processes, data preparation, and potential biases.

1. Logging Capabilities — Technical description of automatic logging capabilities, including the logging period and level of detail.

1. Human Oversight Measures — Information about how the system supports human oversight, including technical tools for output interpretation.

1. Accuracy, Robustness, and Cybersecurity — Metrics used to measure accuracy, expected levels of accuracy, and cybersecurity measures.

Conformity Assessment

High-risk AI systems listed in Annex III must undergo a conformity assessment before being placed on the EU market. This includes:

• Self-assessment for most high-risk systems
• Third-party assessment for biometric identification systems
• EU Declaration of Conformity
• CE marking

Cost Comparison

Traditional compliance documentation with consultants costs €50,000+ per assessment (source: market analysis). Automated platforms can reduce this to €49-199/month for continuous monitoring and documentation generation.

Sources

• EU AI Act — Regulation (EU) 2024/1689, Annex IV
• European Commission Harmonised Standards for AI
• ENISA NIS360 2024 Report