Article 11: Technical Documentation (Annex IV)
EU AI Act Article 11 technical documentation requirements — what belongs in your Annex IV dossier, how to structure it, and how Scanara automates it.
Article 11 Annex IV defines 9 mandatory documentation categories covering system description, development process, monitoring capabilities, risk management, change logs, conformity standards, EU declaration, post-market monitoring, and notified body information. Annex IV SMEs and start-ups may use a simplified template that the Commission will provide. August 2, 2026.
Article 11 of the EU AI Act requires providers of high-risk AI systems to create and maintain comprehensive technical documentation before placing their system on the market.
Technical documentation must exist before the system is placed on the market , and must be kept up to date throughout its lifecycle.
The 9 Mandatory Documentation Sections
1. General System Description
Intended purpose, provider information, versions, hardware/software interactions, and deployment forms.
2. Development Process & Elements
Design specifications, system architecture, data requirements, computational resources, and training methodologies.
3. Monitoring & Control
Detailed information on monitoring, functioning, control capabilities, and performance metrics.
4. Risk Management System
Description of the risk management system established under Article 9.
5. Change Log & Lifecycle Updates
Comprehensive record of all relevant changes made throughout the system lifecycle.
6. Conformity Standards & Solutions
List of harmonised standards applied or other solutions used to demonstrate conformity.
7. EU Declaration of Conformity
Copy of the EU declaration of conformity as required by Article 47.
8. Post-Market Monitoring Plan
Description of the system in place to evaluate AI system performance after market placement (Article 72).
9. Notified Body Information
Where applicable, detailed technical information to be provided to the notified body.
Documentation Requirements at a Glance
How Scanara Automates Technical Documentation
Auto-Generate Architecture Descriptions
Scanara analyzes your codebase to automatically draft system architecture descriptions, data flows, and component interactions required in Section 2.
Track Changes from Git History
Automatically generate change logs for Section 5 by analyzing git commits, pull requests, and version tags throughout your AI system's lifecycle.
Link Risk Register to Documentation
Connect your Article 9 risk management findings directly into Section 4 documentation, ensuring consistency and traceability.
Common Questions About Article 11
Related EU AI Act Requirements
Article 6: High-Risk AI Classification
Understand which AI systems are classified as high-risk and therefore require Article 11 technical documentation.
Article 9: Risk Management System
Section 4 of your technical documentation must describe the risk management system required by Article 9.
Article 17: Quality Management System
Technical documentation must integrate with your quality management system established under Article 17.
Article 72: Post-Market Monitoring
Section 8 requires documentation of your post-market monitoring plan as mandated by Article 72.
How Scanara Helps
Scanara automates EU AI Act compliance from code to dossier. Connect your GitHub repos and get compliance reports in minutes.