# Draw up technical documentation before placing a high-risk system on the market

- **Record type**: Obligation
- **Instrument**: Regulation (EU) 2024/1689 — Artificial Intelligence Act
- **Jurisdiction**: European Union
- **Category**: technical_documentation
- **Binding**: Yes
- **Applies from**: 2027-12-02
- **Provision**: Article 11 and Annex IV

## In brief

Draw up technical documentation before placing a high-risk system on the market is a legal requirement under the EU AI Act in the European Union (Article 11 and Annex IV). Technical documentation must be drawn up before a high-risk system is placed on the market or put into service and kept up to date. It applies from 2 December 2027.

## What the duty requires

Technical documentation must be drawn up before a high-risk system is placed on the market or put into service and kept up to date. It must demonstrate compliance with the Section 2 requirements and contain at least the elements in Annex IV, including a general description, development process, monitoring and control, risk-management description, and the applied standards. SMEs may use a simplified form provided by the Commission.

## What an organisation does about it

Maintain an Annex IV-structured technical file under version control.

## Controls that meet this duty

- Data governance and dataset documentation (supports): https://aipolicytracker.org/controls/data-governance-and-dataset-documentation
- Technical documentation, model cards and instructions for use (satisfies): https://aipolicytracker.org/controls/technical-documentation-and-model-cards

## Parent instrument

- Regulation (EU) 2024/1689 — Artificial Intelligence Act
  - Record: https://aipolicytracker.org/policies/eu-ai-act
  - Context file: https://aipolicytracker.org/policies/eu-ai-act.md

## Provenance

- **Permanent id**: AIPT-OBL-0008 (https://aipolicytracker.org/id/AIPT-OBL-0008; never changes or gets reused)
- **Record page**: https://aipolicytracker.org/obligations/eu-ai-act-technical-documentation
- **Official source**: https://eur-lex.europa.eu/eli/reg/2024/1689/oj
- **Provision**: Article 11 and Annex IV
- **Review status**: pending review
- **Confidence**: medium
- **Facts last confirmed**: never confirmed against the official source
- **Retrieved**: 2026-10-27
- **Licence**: https://creativecommons.org/licenses/by/4.0/
- **Cite as**: AIPolicyTracker (2026). "Draw up technical documentation before placing a high-risk system on the market (EU AI Act)" [AIPT-OBL-0008, not yet verified]. https://aipolicytracker.org/id/AIPT-OBL-0008 (accessed 27 October 2026).

> This record is a structured summary with a link to the official text. It is not legal advice. Open the official source before relying on any date or duty. How current each record type must be is published at https://aipolicytracker.org/verification; what a record must carry at all is published at https://aipolicytracker.org/coverage.
