Technical documentation
The full paper trail a provider must keep, design records, testing results, risk assessments, that proves their high-risk AI system meets EU law.
The Simple Version
The full paper trail a provider must keep, design records, testing results, risk assessments, that proves their high-risk AI system meets EU law.
Detailed Explanation
Technical documentation is required under Articles 11 and 12 and detailed in Annex IV of the EU AI Act. It must be drawn up before placing the system on the market and continuously updated. It includes a general description of the system, design specifications, information on training and validation data, risk management documentation, accuracy and robustness metrics, human oversight measures, and cybersecurity capabilities. Providers must retain documentation for ten years after the last system is placed on the market. Market-surveillance authorities may request access at any time.
Key Characteristics
- Specified in Annex IV and required before CE marking
- Must be updated throughout the system's operational life
- Retained for ten years post-market and accessible to authorities on request
- Includes data governance records, risk management documentation, and testing results
Why It Matters
Engineering and compliance teams must establish living documentation practices from the start of AI development, retrofitting documentation for a complex production system is costly and risk-prone.
Real-World Analogy
Like the design history file maintained for a medical device, a comprehensive, structured record proving the product was designed, tested, and manufactured to meet regulatory requirements.
Common Misconceptions
- Technical documentation is a one-time submission, it must be kept updated throughout the system's operational life and retained for ten years.
- Internal development documentation satisfies the requirement automatically, documentation must meet the specific content requirements of Annex IV.