EU AI Act Annex IV : Technical Documentation Referred To In Article 11(1)

Introduction

The European Union Artificial Intelligence Act (EU AI Act) is a pioneering regulatory framework that addresses the ethical and legal challenges posed by artificial intelligence technologies. With the EU AI Act looming into effect, organizations developing or deploying so-called “high-risk AI systems” must pay close attention to a critical component: Annex IV – Technical Documentation Referred to in Article 11(1). This annex sets out the minimum required content of technical documentation that must accompany a high-risk AI system before placement on the market or putting into service. Understanding Annex IV is essential for compliance, smooth conformity assessment, and avoiding regulatory pitfalls.

What Is Article 11(1)?

Annex IV of the EU AI Act outlines the requirements for the technical documentation that providers of high-risk AI systems must prepare and maintain under Article 11(1). This documentation serves as proof that an AI system complies with the Act’s obligations and can be assessed for conformity by regulators or notified bodies. It must include detailed information about the AI system’s design, development, and intended purpose—covering elements such as system architecture, algorithms used, data sources, data governance practices, and the measures taken to manage risks and ensure accuracy, robustness, and cybersecurity.

The technical documentation also needs to describe the testing, validation, and performance evaluation processes, as well as any post-market monitoring and human oversight measures in place. Its purpose is to ensure traceability and accountability throughout the AI system’s lifecycle. By requiring this documentation, Annex IV aims to create transparency about how high-risk AI systems are built and operated, making it easier for authorities to verify compliance and for providers to demonstrate that their systems are safe, reliable, and respect fundamental rights.

What Does Annex IV Require?

Annex IV lays out a detailed checklist of information that must be included in the technical documentation of a high-risk AI system. The following are the main elements (as applicable) drawn from the text.

1. General Description of the AI System

• Its intended purpose, the provider name, version of the system (reflecting relation to previous versions).
  
  

• How the AI system interacts with, or can be used to interact with, hardware or software not part of it (including other AI systems).
  
  

• Versions of relevant software/firmware and version-update requirements.
  
  

• Description of all forms in which the AI system is placed on the market or put into service (software packages, embedded in hardware, downloads, APIs).
  
  

• Description of the hardware on which the AI system is intended to run.
  
  

• If the AI system is a component of other products: photographs or illustrations showing external features, internal layout, marking.
  
  

• Basic description of the user-interface provided to the deployer; instructions for use.
  

2. Detailed Description of Elements and Development Process

• Methods and steps for development including use or modification of pre-trained systems or third-party tools.
  
  

• Design specifications: logic of algorithms, key design choices, rationale, assumptions regarding persons/groups, classification choices, what the system is optimized for, trade-offs.
  
  

• System architecture: how software components feed into each other, computational resources used in development/training/testing/validation.
  
  

• Data requirements: data sets used in training, their provenance, scope, characteristics, labelling procedures, cleaning/outlier detection.
  
  

• Human oversight measures (Article 14) and how system outputs are interpretable (Article 13(3)(d)).
  
  

• Pre-determined changes to system & performance, and technical solutions for continuous compliance.
  
  

• Validation and testing procedures: description of testing/validation data, metrics used for accuracy, robustness, discriminatory impacts; test logs, signed reports; cybersecurity measures.
  

3. Monitoring, Functioning and Control

• The system’s capabilities and limitations in performance, including accuracy levels for specific persons/groups; expected overall accuracy for intended purpose.
  
  

• Foreseeable unintended outcomes and sources of risk to health/safety, fundamental rights, discrimination.
  
  

• Human oversight measures (Article 14) and technical measures to facilitate interpretation of outputs.
  
  

• Specifications on input data (where appropriate).

4. Performance Metrics

Description of the appropriateness of performance metrics for the specific AI system. 

5. Risk-Management System

Detailed description of the risk-management system, in accordance with Article 9 of the AI Act. 

6. Changes to the System through its Lifecycle

Description of relevant changes made by the provider throughout the lifecycle of the AI system. 

7. Harmonized Standards and Compliance Solutions

• A list of harmonized standards applied (published in Official Journal of EU).
  
  

• If no harmonized standards applied, then a detailed description of the solutions adopted to meet the requirements in Chapter III, Section 2 (including other technical specifications). 

8. EU Declaration of Conformity

A copy of the EU declaration of conformity referred to in Article 47 of the AI Act. 

9. Post-Market Monitoring Plan

Detailed description of the system for evaluating performance in the post-market phase, in accordance with Article 72 (including post-market monitoring plan)

Why Annex IV Matters For AI Providers & Deployers?

• Compliance anchor: For any high-risk AI system (as defined under the AI Act), you cannot place it on the market or into service unless you have this documentation ready in the form required by Article 11/Annex IV.
  
  

• Conformity assessment readiness: National authorities or notified bodies will use this documentation to assess whether your system meets the legal requirements.
  
  

• Transparency and audit trail: Annex IV ensures your AI system’s development lifecycle, data, architecture and oversight are properly documented—key in case of audits or investigations.
  
  

• Risk mitigation: By documenting limitations, performance, risk management, lifecycle changes and monitoring, you reduce liability and better manage governance of your AI system.
  
  

• Harmonization interplay: If your high-risk AI is part of a product covered by existing harmonized legislation (see Annex I), the documentation needs to integrate both AI Act and that product-legislation aspects (via Article 11(2)).
  
  

• SME & start-up relief: Annex IV provides for simplified documentation forms for SMEs, offering some flexibility while still meeting legal minimums.
  

Practical Steps To Prepare Your Technical Documentation

1. Map whether your AI system is classified as high-risk under the AI Act (see Annex III).
   
   

2. Review Annex IV’s checklist and build a documentation template aligning with each major element (general description, development process, monitoring/control, performance metrics, risk management, lifecycle changes, standards applied, declaration of conformity, post-market plan).
   
   

3. For SMEs: check whether you qualify for simplified forms and if so, use the Commission’s simplified template when available.
   
   

4. Align your documentation with other compliance obligations (e.g., product safety/CE marking) if your AI system is part of a product under harmonized legislation.
   
   

5. Keep documentation live—update it whenever you make changes to the system, version releases, architecture updates, or performance/monitoring changes.
   
   

6. Store documentation in a fashion ready for audit or inspection by notified bodies or national competent authorities.
   
   

7. Include the post-market monitoring plan and ensure post-deployment performance and risk tracking are in place.
   
   

8. Maintain clear traceability between your documentation and actual development/testing records, logs, and version control for transparency.
   

Conclusion

Annex IV of the EU AI Act sets a robust, detailed framework for what technical documentation high-risk AI systems must carry. It’s not merely a formality — it is central to the legal compliance of AI systems in the EU, enabling authorities to verify that the system meets key regulatory requirements. If you are a provider or deployer of a high-risk AI system, you should treat Annex IV not as optional but as an essential component of your risk-governance, development lifecycle and market-access strategy.