Annex IV technical documentation, section by section

Providers of high-risk AI systems must draw up technical documentation before placing the system on the market and keep it up to date (Art. 11). Annex IV defines what the file must contain.

What Annex IV asks for

• A general description of the system — intended purpose, provider, version, how it interacts with hardware and software.
• A detailed description of its elements and the development process — architecture, algorithms, design choices, and the training, validation and testing data.
• Information on monitoring, functioning and control — human oversight measures and how outputs are interpreted.
• A description of the risk management system (Art. 9).
• Changes made through the lifecycle, including pre-determined changes and continuous-learning boundaries.
• The standards applied — harmonised standards or the alternative solutions used.
• A copy of the EU Declaration of Conformity (Art. 47).
• The post-market monitoring plan (Art. 72).

How Veritome structures it

Each system has a dedicated Annex IV editor — also reached from Evidence → Generate document, where picking the Art. 11 template routes you straight there. It splits the file into eight guided sections: General Description, System Elements & Development, Training, Validation & Testing Data, Testing & Validation Results, Human Oversight Measures, Risk Management Summary, Cybersecurity Measures, and Pre-determined Changes & Continuous Learning. Every section carries regulator-facing guidance, saves as you leave the field, and Export PDF renders an A4 technical file stamped with the system name and provider from the live record. The Declaration of Conformity and the post-market plan have their own editors — reference them from the file rather than duplicating.

Synced to the obligation

As each section is populated, Veritome auto-ticks the matching item on the Art. 11 obligation checklist, so the Documentation obligation — and the compliance score — always reflect the real state of the document.

Hash-sealed dossier records

The system's classification dossier is a tamper-evident chain: every submitted entry gets a SHA-256 fingerprint that folds in the previous entry's fingerprint, plus a verification ID. The Verify link on an entry opens a public verify page anyone can check without logging in, and approved generated documents carry their own SHA-256 fingerprint with a public verification page.