Annex IV Technical Documentation
Annex IV of the EU AI Act defines the mandatory technical documentation that providers of high-risk AI systems must prepare and maintain. This documentation must be drawn up before the system is placed on the market and kept updated throughout its lifecycle.
Why technical documentation is critical
Annex IV documentation is the primary evidence artifact that regulators, notified bodies, and market surveillance authorities review to determine compliance. Without it, you cannot obtain CE marking, issue an EU Declaration of Conformity, or register your system in the EU database.
Non-compliance with documentation requirements falls under Tier 2 penalties: up to €15 million or 3% of global turnover. Documentation must be retained for at least 10 years after the system is placed on the market.
What the AI Act requires
Article 11 mandates that providers of high-risk AI systems draw up technical documentation in accordance with Annex IV before placing the system on the market. The documentation must demonstrate compliance with every requirement in Chapter III, Section 2 (Articles 8-15).
The documentation must be kept up to date and made available to national competent authorities upon request. For providers established outside the EU, the authorised representative must hold a copy.
Who must prepare Annex IV documentation?
Providers of high-risk AI systems bear primary responsibility. This includes any organisation that develops, commissions, or places a high-risk AI system on the EU market under its own name or trademark.
Deployers do not prepare Annex IV directly, but must verify that the provider has completed it. Deployers of certain high-risk systems must also prepare a Fundamental Rights Impact Assessment (FRIA). If a serious incident occurs, the documentation feeds directly into the Article 73 incident reporting process. All staff handling documentation should have completed AI literacy training.
What to include: Annex IV content structure
General description of the AI system
- Intended purpose and intended use scenarios
- Versions and relation to previous versions
- How the system interacts with hardware or software not part of the system itself
- Versions of relevant software or firmware and requirements for updates
Detailed description of system elements and development process
- Methods and steps for development, including use of pre-trained systems or third-party tools
- Design specifications: general logic, algorithms, key design choices and assumptions
- System architecture and computational resources used
- Data requirements (data sheets, training methodologies, data sets used, origin, scope, characteristics)
- Human oversight measures built into the system
Monitoring, functioning, and control
- Capabilities and limitations of the system, including expected accuracy levels
- Foreseeable unintended outcomes and sources of risk
- Human oversight measures, including technical measures to facilitate interpretation of system outputs
- Input data specifications
Risk management system
- Description of the risk management process applied (Article 9)
- Risk identification and analysis for each hazard
- Risk evaluation and residual risk assessment
- Risk control measures selected and applied
Changes throughout the lifecycle
- Pre-determined changes and the system's capability for self-learning
- Impact of changes on the system and its compliance status
- Version control and change logs
Standards and conformity with requirements
- List of harmonised standards applied (or common specifications / technical standards used)
- Article-by-article description of how each requirement in Chapter III Section 2 is addressed
- Testing procedures and validation results, including benchmarks and metrics used
EU Declaration of Conformity
- Copy of the EU Declaration of Conformity (Article 47)
- Contact details of the person responsible for the declaration
Common documentation mistakes
- Writing documentation after the system is deployed — it should be maintained throughout development.
- Documenting only the final model, not the training process, data choices, and iterative decisions.
- Failing to update documentation after significant system modifications.
- Missing residual risk analysis — documenting only identified risks without evaluating what remains.
- Not including data provenance and representativeness analysis for training datasets.
How ActLoom generates Annex IV documentation
- Auto-generated drafts — ActLoom pre-fills Annex IV sections from your system registration data, risk classification, and gap analysis results.
- Completeness checker — validates every required section is present and flags gaps before submission.
- Version control — tracks every change to documentation with timestamps and author attribution.
- Export-ready formats — generate PDF documentation packages ready for regulator submission or notified body review.
Related resources
Frequently asked questions
- What documents are needed for Annex IV?
- Annex IV requires 7 sections: general system description, detailed development process, monitoring and control, risk management system, lifecycle changes, standards conformity, and the EU Declaration of Conformity.
- Who must prepare Annex IV documentation?
- Providers of high-risk AI systems bear primary responsibility. Deployers must verify the provider has completed it.
- How technical does the documentation need to be?
- It must be detailed enough for competent authorities and notified bodies to assess compliance: specific algorithms, data specifications, accuracy metrics, testing results, and risk assessments — not just high-level descriptions.
- How long must the documentation be retained?
- At least 10 years after the system is placed on the market. It must be kept up to date and available to authorities upon request.
- What happens if documentation is incomplete?
- Without proper Annex IV documentation, you cannot obtain CE marking or register in the EU database. Non-compliance is a Tier 2 penalty: up to €15 million or 3% of global turnover.
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