AI Documentation under the EU AI Act
For high-risk AI systems, the EU AI Act mandates comprehensive technical documentation. It is the basis for conformity assessments, market surveillance, and audits – and must be in place before deployment.
Who must document AI systems?
- Providers of high-risk AI systems (manufacturers, developers)
- Deployers using high-risk AI systems (Art. 26 EU AI Act)
- Importers and distributors of high-risk AI in the EU
- Companies developing GPAI models with systemic risk
What must be documented?
Annex IV of the EU AI Act defines the minimum content of technical documentation for high-risk AI systems. Deployers must also maintain their own usage documentation.
System description
Name, version, purpose, use case and geographic scope. Description of interaction with hardware, software, and other AI systems.
Risk assessment
Risk class under EU AI Act, justification of classification, conformity assessment results and identified residual risks.
Training data & methods
Origin and scope of training data, preprocessing steps, training architecture and metrics used for performance measurement.
Technical robustness
Accuracy, error rates, robustness against attacks and misuse. Results of testing under realistic conditions.
Human oversight
Description of interfaces for human monitoring, intervention options and shutdown mechanisms.
Declaration of conformity
EU declaration of conformity specifying the harmonised standards and technical specifications complied with.
Documentation in practice – 4 steps
Inventory AI systems
Record all AI systems in use and check which fall under the EU AI Act and what risk class they belong to.
Collect mandatory content
Gather all technical information per system: training data, architecture, test results, responsibilities.
Structure documentation
Record content in a structured, always-accessible format – organised according to Annex IV EU AI Act.
Keep current & audit
Update documentation on material changes and make it available to authorities on request.
Frequently asked questions about AI documentation
Does the documentation requirement apply to all AI systems?
No. Comprehensive technical documentation under Annex IV only applies to high-risk AI systems (Annex III EU AI Act). Lower requirements apply to minimal or limited risk AI.
How long must documentation be retained?
Providers must retain technical documentation for at least 10 years after the last system of that series is placed on the market.
What happens with missing documentation?
Authorities can deny market access, issue recall orders and impose fines of up to 3% of global annual turnover.
Can I use a template?
Yes, as long as it covers all mandatory content from Annex IV. SimpleAct provides structured documentation templates that meet all legal requirements.
Related topics
AI documentation with SimpleAct
Instead of Word documents and spreadsheets: SimpleAct guides you step by step through all documentation requirements – structured by EU AI Act, exportable for audits.
Get started for free