Providers of high-risk AI systems must draw up technical documentation under Annex IV before placing them on the market (Art. 11, Art. 16(b) AI Act). SimpleAct keeps it as a dossier per system: seven sections with required fields, a status workflow and hints on which module the information usually comes from.

At a glance

Included from: Professional
Where in the app: Prove compliance → Documentation → Annex IV
Output: Dossier with seven sections, status DRAFT → REVIEW → APPROVED → FINAL
Legal basis: Art. 11, 16, 17 and Annex IV AI Act
API: /api/v1/documentation/ai-system/{id}/annex-iv

Who sees the dossier

The steps "Annex IV: master data" and "Annex IV: workflow & approval" only appear in the documentation assistant when the system is classified as high risk and your role in "Classification & roles" is provider. For deployers the app hides them, because the provider draws up the technical documentation (Art. 11, Art. 16(b)). For limited or minimal risk they are dropped, because Annex IV only applies to high-risk systems. If a system already holds dossier entries, it stays reachable anyway.

The seven sections

All fields are required. A section counts as ready when all required fields are filled; otherwise the app shows "Gap" or "Missing".

Section	Fields
Intended use and limits	Intended purpose, target users, known limitations, misuse scenarios
Data governance pack	Data sources, quality controls, handling of bias-relevant data, data minimisation and legal basis
Testing and validation pack	Test plan, quality metrics, robustness and stress results, known failure modes
Human oversight pack	Oversight model (human in the loop, human on the loop, manual override), intervention and stop criteria, responsible roles, training plan
Logging and traceability pack	Log coverage, retention, access model, monitoring cadence
Post-market monitoring plan	Monitoring cadence, incident and complaint flow, reassessment triggers, owner
User instructions pack	Intended use, prohibited use cases, operator instructions, limitations disclosure, human review criteria, feedback channel, owner, version and approval date of the instructions

Not a literal copy of Annex IV

The seven sections group the information by work package, not by the numbering of Annex IV. Before finalising, check that every Annex point relevant to your system is covered, for example system architecture, cybersecurity (Art. 15) or the list of applied standards. You can upload supplementary documents as files (up to 20 MB each).

Workflow

Status	Meaning
DRAFT	Being worked on.
REVIEW	Under review. When an approval is requested, the dossier moves here automatically.
APPROVED	Approved. With an approval workflow, the last approval stage sets this status; a rejection returns the dossier to DRAFT.
FINAL	Finalised. Remains a manual step with a completeness check.

How it connects to other modules

Each field names its typical source: AI inventory, legal logic, risk assessment, technical evidence, incident management.
You set up the multi-stage approval for Annex IV in the approvals module (object type ANNEX_IV).
For high-risk systems, the share of filled required fields counts 10% towards the compliance score.

Annex IV dossier