Why Technical Documentation?
Technical Documentation is the cornerstone of EU AI Act compliance for providers of high-risk AI systems. Art. 11 of Regulation (EU) 2024/1689 requires that the documentation be prepared before placing on the market and kept continuously up to date.
It serves as evidence for market surveillance authorities and forms the basis of the conformity assessment under Art. 43 EU AI Act.
Who must prepare the Technical Documentation?
The primary responsibility lies with the provider (Provider under Art. 16). In certain cases, deployers can also become providers – for example, when they substantially modify an AI system (Art. 25 EU AI Act).
The 13 Mandatory Sections Under Annex IV
1. General Description of the AI System
Intended purpose, name and version of the system, name and address of the provider, interaction with hardware and software.
2. Detailed Description of the Elements and the Development Process
Development methods and tools, design specifications, system architecture, computational and hardware requirements, description of data flows.
3. Detailed Information on Monitoring, Functioning, and Control
Capabilities and limitations of the system, levels of accuracy, foreseeable misuse, human oversight measures under Art. 14 EU AI Act.
4. Description of the Risk Management System
Documentation of the risk management system under Art. 9 EU AI Act: risk identification, assessment, mitigation, and monitoring throughout the entire lifecycle.
5. Description of Data Governance
Training, validation, and testing datasets: origin, scope, characteristics, suitability. Measures for detecting bias under Art. 10 EU AI Act.
6. Training, Testing, and Validation Methods
Training procedures, hyperparameter optimisation, testing and validation strategies, metrics and benchmarks.
7. Performance Metrics and Results
Accuracy, robustness, cybersecurity resilience. Performance across different groups of persons and usage scenarios.
8. Description of the Conformity Assessment Procedure
Internal procedure under Art. 43(2) or assessment by a notified body (Art. 43(1)) – depending on the Annex III category.
9. Description of Changes Made
Change log: versioning, date, type of change, and impact on conformity.
10. Human Oversight Measures
Detailed description of human oversight measures under Art. 14 EU AI Act: Who oversees? How is intervention carried out? What training is required?
11. Instructions for Users and Deployers
Instructions for use (Art. 13 EU AI Act): information for deployers on proper use, limitations, and expected performance.
12. EU Declaration of Conformity
Reference to the EU Declaration of Conformity under Art. 47 EU AI Act and, where applicable, the CE marking under Art. 48.
Checklist: Is Your Documentation Complete?
| Section | Present? | Common Mistake |
|---|---|---|
| General Description | — | Intended purpose too vague |
| Development Process | — | Decisions not traceable |
| Risk Management | — | Measures without risk mapping |
| Data Governance | — | Training data not described |
| Performance Metrics | — | Only overall accuracy, no subgroups |
| Human Oversight | — | No concrete override mechanism |
Create Technical Documentation with AIvunera
AIvunera generates a customised draft of the Technical Documentation – structured according to all 13 Annex IV sections, with article references and sector-specific content. Where details are missing, assumptions are transparently marked.