Technical Documentation
Article 11 and Annex IV set out what the file must contain: system description, design choices, data, training and testing, performance metrics, risk management, and post-market plan. It must exist before the system goes to market and be maintained afterwards. It is the compliance artefact — no file, no conformity. In practice: The document an authority asks for first, which teams start writing far too late. Plain-English summary of Article 11 / Annex IV. The binding text is Regulation (EU) 2024/1689. ...