Why Technical Documentation Matters
Under Article 11, every high-risk AI system must have technical documentation prepared before market release. This documentation serves two purposes: it demonstrates to regulators that your system meets all requirements, and it provides deployers with the information they need to use the system safely.
The documentation must be kept up to date throughout the system's lifecycle. Any material change to the system triggers an update obligation.
What Annex IV Requires
1. General Description of the AI System
A clear description of the intended purpose, the persons or groups of persons on which the system is intended to be used, and the system's interaction with hardware or software not part of the AI system itself. This must include the versions of relevant software or firmware and any requirements on connectivity.
2. Detailed Description of System Elements
The methods and steps performed for the development of the AI system, including the design specifications, the general logic of the AI system, the key design choices, and the assumptions made. This covers the algorithmic architecture, model training methodology, and computational resources used.
3. Monitoring, Functioning, and Control
Descriptions of the measures in place for human oversight, including the technical measures to facilitate interpretation of outputs. This section documents how humans can monitor, intervene in, and control the AI system's operation.
4. Risk Management System
A description of the risk management system implemented in accordance with Article 9, including the risks identified, the measures adopted to address them, and the residual risks after mitigation. This must be a living document, updated as new risks emerge.
5. Data Governance
Description of the data used for training, validation, and testing — including data collection methods, data preparation methods (annotation, labeling, cleaning), the origin of data, the scope and characteristics of the datasets, and measures to detect and address potential biases.
6. Performance Metrics
Detailed description of the metrics used to measure accuracy, robustness, and cybersecurity, and the expected levels of performance. This includes testing results under foreseeable conditions, including conditions that may lead to degraded performance.
7. Declaration of Conformity and CE Marking
A copy of the EU Declaration of Conformity, and a description of the conformity assessment procedure followed. For internally assessed systems (Annex VI), documentation of the quality management system.
The EU AI Act provides a simplified technical documentation option for SMEs and startups. The European Commission will establish standardized forms that reduce the administrative burden while maintaining essential compliance evidence. However, the simplified option does not reduce the substance of what must be demonstrated.
Lexara Advisory's Documentation Service
Annex IV documentation is where most companies need expert help. The requirements are specific, the format matters for regulatory review, and gaps in documentation can block market access.
Lexara Advisory — in partnership with Fruggr for technical tooling — provides complete Annex IV/V documentation packages that combine legal expertise with technical precision. We handle the legal documentation layer while Fruggr supports the technical measurement and monitoring infrastructure.
Contact Lexara Advisory for a documentation readiness assessment. We'll identify gaps in your current documentation and provide a structured plan to complete your Annex IV package before August 2026.