Article 11: Technical Documentation and Annex IV
EU AI Act Article 11: providers of high-risk AI systems must prepare technical documentation before market placement. The nine Annex IV elements, retention and the simplified form for SMEs.
Providers of high-risk AI systems must prepare technical documentation before placing the system on the market or putting it into service (Article 11(1)). They must keep it up to date.
It must contain at least the Annex IV information that applies to the system. The rule applies from 2 December 2027 to Annex III systems (listed high-risk uses). For Annex I products, it applies from 2 August 2028 (Article 113(c)), except Section B (Article 2(2)). Provider fines reach EUR 15 million or 3% of worldwide annual turnover, whichever is higher (Article 99(4)). Next step: compare your system with Annex IV.
Annex IV lists nine points; cover those that apply to your system
General description
Intended purpose, provider name and version, interaction with other hardware and software, forms of market placement, hardware, user interface and instructions for use.
Elements and development process
Development methods, design specifications and key design choices, system architecture, computing resources, data requirements, human oversight assessment, validation and testing, and cybersecurity measures.
Monitoring, functioning and control
Capabilities and limits, accuracy for specific groups, foreseeable unintended outcomes and risk sources, human oversight measures and input data specifications.
Performance metrics
Why the chosen performance metrics suit this specific system.
Risk management system
A detailed description of the risk management system required by Article 9.
Changes over the lifecycle
Relevant changes the provider makes to the system.
Standards and other solutions
The harmonised standards applied in full or in part, or the solutions used to meet the requirements where none were applied.
EU declaration of conformity
A copy of the EU declaration of conformity required by Article 47.
Post-market evaluation
The system used to evaluate performance after market placement, including the post-market monitoring plan (Article 72(3)).
Four rules apply around the documentation
Before market placement
Prepare the documentation before the system is placed on the market or put into service, and keep it up to date (Article 11(1)).
Keep it for 10 years
Keep the documentation at the disposal of national authorities for 10 years after the system is placed on the market or put into service (Article 18(1)).
Simplified form for small firms
SMEs, including start-ups, and small mid-cap companies may provide the Annex IV elements in a simplified form. The Commission must set up the form, and notified bodies must accept it (Article 11(1)).
One set for product laws
If the system relates to a product under the Annex I Section A laws, draw up a single set of documentation that also covers those laws (Article 11(2)).
What Scanara does for Article 11
Annex IV documentation drafts
Scanara generates Annex IV documents from your inputs and assessment answers. You review and complete them. A draft is not automatically accurate or complete.
Document check
Scanara checks your compliance documents for required content. It does not check that the content is true.
Versioned evidence
Scanara keeps versions and timestamps of the documents and of the assessment answers behind them.
Common questions about Article 11
When must technical documentation be completed?
Before the high-risk AI system is placed on the market or put into service, and it must be kept up to date afterwards (Article 11(1)).
Can SMEs use simplified documentation?
Yes. SMEs, including start-ups, and small mid-cap companies may provide the Annex IV elements in a simplified form. The Commission must establish the form, and notified bodies must accept it for the conformity assessment (Article 11(1)).
How long must I keep technical documentation?
For 10 years after the AI system is placed on the market or put into service, at the disposal of the national competent authorities (Article 18(1)).
What happens if my documentation is incomplete?
Incomplete documentation breaks the provider duty to meet the requirements of Section 2 (Article 16(a)). Fines reach EUR 15 million or 3% of worldwide annual turnover, whichever is higher (Article 99(4)). For SMEs and small mid-cap companies, the lower of the two amounts is the limit (Article 99(6) and (6a)). On a reasoned request, providers must also demonstrate conformity to the national authority (Article 16(k)).
Read next: classification, risk management, quality and monitoring
Article 6: high-risk classification
Explains which AI systems are high-risk and so need Article 11 documentation.
Article 9: risk management system
Covers the system that Annex IV, point 5 requires you to describe.
Article 17: quality management system
Covers the written quality management system, whose documentation providers keep with the technical documentation (Article 18(1)).
Article 72: post-market monitoring
Covers the monitoring plan that Annex IV, point 9 requires.
Annex IV: technical documentation
Covers the nine Annex IV elements in more detail.
Scanara prepares evidence from your repositories
Scanara reads your connected GitHub repositories and runs rule-based scans for standard AI and machine-learning patterns. It can miss non-standard code. Separately, it generates draft documentation from templates and your assessment answers as evidence for your compliance work. You make the classification decisions.