Annex IV of the EU AI Act specifies the technical documentation required for high-risk AI systems. This is not a one-time filing - it is living documentation that must be maintained throughout the system lifecycle. Here is how to approach it.
Overview of Annex IV Requirements
Annex IV documentation must demonstrate that your AI system was designed and operates in compliance with the regulation. It covers everything from system architecture to risk management to ongoing monitoring.
- General description of the AI system
- Detailed description of system elements and development process
- Information on monitoring, functioning, and control
- Description of appropriateness of performance metrics
- Risk management system documentation
- Changes made during system lifecycle
Section 1: General Description
Start with the basics: what does your AI system do, who is it for, and what decisions does it influence?
- Intended purpose and scope of use
- Categories of persons likely to be affected
- Versions of relevant software and hardware
- How the system interacts with other systems
- Forms in which the system is placed on market or put into service
Section 2: System Elements and Development
Document the building blocks of your AI system and how it was developed.
- Methods and steps used for development
- Design specifications and choices made
- System architecture showing main components
- Computational and hardware resources used
- Training methodologies and techniques
Section 3: Data Governance
Training data documentation is critical and often the hardest part to reconstruct after the fact.
- Training, validation, and testing data sets used
- Data collection processes and sources
- Relevance and representativeness assessment
- Data labeling procedures (if applicable)
- Data preparation operations (cleaning, enrichment)
- Bias examination and mitigation
Section 4: Human Oversight Measures
This section must demonstrate that humans can effectively oversee and intervene in AI decisions.
- Technical measures for human oversight
- Measures allowing human understanding of outputs
- Measures enabling human intervention or override
- Assignment of human oversight responsibilities
- Training and qualification requirements for oversight personnel
Section 5: Risk Management
Document your risk management process and how identified risks are mitigated.
- Risk management process description
- Identification of known and foreseeable risks
- Risk estimation and evaluation
- Mitigation measures implemented
- Residual risk assessment and acceptance criteria
Maintaining Documentation Over Time
Annex IV documentation isn't a one-time exercise. You must maintain and update it throughout the system lifecycle.
- Document all changes to the system
- Update risk assessments when scope changes
- Record ongoing monitoring results
- Track post-market feedback and incidents
- Version control all documentation updates
Frequently Asked Questions
How detailed does Annex IV documentation need to be?
Detailed enough that a competent third party could understand how the system works, what risks it poses, and how those risks are managed. When in doubt, include more detail.
Can I use existing documentation?
Yes, you can reference existing documentation (design docs, risk assessments, etc.) as long as they cover the required elements and remain current.
Who should own Annex IV documentation?
Typically a combination of product/engineering (technical details) and compliance/legal (risk management, oversight procedures). Assign clear ownership and review processes.
Key Takeaways
Annex IV documentation is your proof that your AI system was designed and operates responsibly. Building documentation practices into your development process from the start is far easier than reconstructing it later. Treat Annex IV as an ongoing obligation, not a one-time project.