Technical documentation (Annex IV)

Article 11 requires the provider of a high-risk system to draw up technical documentation before placing it on the market and keep it up to date. Its minimum content is set out in Annex IV.

It includes, among other things: a general description of the system and its purpose; how it was developed (architecture, data used, how it was trained and validated); its capabilities and limitations, including expected accuracy; human oversight measures; the risk management system; changes made over its life; technical standards applied; the EU declaration of conformity; and the post-market monitoring plan.

Authorities can request it at any time, and it must be kept for 10 years. SMEs and, after the Digital Omnibus, small mid-caps can use a simplified form.