Article 11 Technical Documentation

For a high-risk AI system, Article 11 makes technical documentation a pre-market or pre-service requirement. The file must be drawn up before the system is placed on the market or put into service, kept up to date, and written to demonstrate compliance with the high-risk requirements in Chapter III, Section 2.

The documentation should let a national competent authority or notified body understand the system without reverse-engineering the product. A usable file therefore starts with system identity and intended purpose, then shows how design, data, testing, risk controls, human oversight, cybersecurity, conformity, and post-market monitoring support that intended purpose.

Treat Annex IV as a technical-file table of contents. The first section identifies what the system is and how it is supplied. The second section explains how it was built. Later sections show how it is monitored, controlled, tested, changed, and assessed against the AI Act requirements.

The strongest documentation is traceable: every claim about system purpose, data, model behavior, oversight, cybersecurity, performance, and residual risk points to a controlled artifact such as a requirements record, architecture diagram, dataset sheet, test report, risk-control register, release note, user instruction, or conformity file.

Annex IV does not stop at design-time evidence. It asks for the harmonised standards applied in full or in part when their references have been published in the Official Journal of the European Union. If no such harmonised standards have been applied, the file must describe the solutions adopted to meet the high-risk requirements and list other relevant standards and technical specifications applied.

The same file should include a copy of the EU declaration of conformity and a detailed description of the post-market system used to evaluate performance. Article 72 makes the post-market monitoring plan part of the Annex IV technical documentation.