Technical documentation is the backbone of conformity assessment. Without it a provider cannot show that its high-risk AI system meets the requirements, and authorities cannot check it.
What belongs in it
Annex IV lists the content: a general description with intended purpose and versions; a detailed description of system elements and development process including architecture, design choices and computing resources; information on training, validation and test data; performance metrics and their limits; a description of the risk management system, the human oversight measures, the standards applied, the EU declaration of conformity and the post-market monitoring system.
Documentation as an ongoing process
The documentation must be kept up to date. For AI systems under continuous development, every significant change to model, data or purpose must be reflected. This is practical only if documentation emerges from the development process, from versioned model cards, data sheets and test reports, rather than being written up in one document at the end.
Simplifications and deadlines
The AI Act provides a simplified form of technical documentation for SMEs and start-ups. Under the Digital Omnibus, obligations apply from 2 December 2027 for Annex III high-risk systems and from 2 August 2028 for systems in products under Annex I. The documentation must be kept for ten years after placing on the market.
Links to other obligations
The technical documentation refers to post-market monitoring and to reporting serious incidents. Anyone already documenting under product law, for example for medical devices, can integrate the content into existing documentation.