Draw up technical documentation before placing a high-risk system on the market
Download: JSON · MarkdownUnder EU AI Act, Article 11 and Annex IV
What this label means
- Verified
- — a named reviewer opened the official source and confirmed the record; the date and the reviewer are shown.
- Pending review
- — linked to the official source and in the queue for a reviewer to confirm.
- Source-linked
- — linked to the official source, not yet confirmed by a reviewer.
On this page 9 sections
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.
- Instrument
- EU AI Act
- Jurisdiction
- European Union
- Nature
- Legal requirement
- Source reference
- Article 11 and Annex IV
- Applies from
- 2 December 2027
- Who it binds
- Provider / developer
- Evidence examples
- 1
- Framework mappings
- ISO/IEC 42001:2023, NIST AI Risk Management Framework 1.0
- Controls that meet it
- 2
- Official source
- Open official text
- Verification
- Pending review · source-linked
What does it require?
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.
Practical action
Maintain an Annex IV-structured technical file under version control.
Who does it apply to?
Providers of high-risk AI systems.
- Actors
- Provider / developer
- Sectors
- Cross-sector / all sectors
Applies from:
Which controls meet this duty?
Satisfies: the control, operated properly, does the work the duty asks for. Supports: it contributes but the duty needs more. Each control page lists every other duty it serves, so work done once can be counted once.
-
satisfiesProcessProduct or model owner · at launch and on material changeTechnical documentation, model cards and instructions for use
Serves 14 recorded duties · evidence: Technical documentation file, Model card or deployer information pack, Instructions for use
Versioned technical file structured to the required elements.
-
supportsProcessData governance lead · once per ai systemData governance and dataset documentation
Serves 8 recorded duties · evidence: Dataset documentation sheet, Data quality and bias check report, Dataset approval for use
Dataset sheets supply the data sections.
Templates that cover this duty
Generated from the records. Free · no account · links emailed to your work address. This duty is cited in each file with its source reference and a link back here.
- AI System Inventory
Register · XLSX and DOCX · v6
- EU AI Act Role and Risk Classifier
Checklist · XLSX · v4
- EU AI Act Article 50 Transparency Kit
Kit · DOCX and XLSX · v32
- ISO/IEC 42001 Gap Assessment and Statement of Applicability
Assessment · XLSX · v3
What evidence would a reviewer expect?
| Evidence | Type | Notes |
|---|---|---|
| Annex IV technical file | document |
Framework mappings
Original editorial crosswalks. They cite clause numbers only and reproduce no standard text; confidence reflects how direct the mapping is.
See every European Union duty mapped this way →
| Framework | Reference | Note | Confidence |
|---|---|---|---|
| ISO/IEC 42001:2023 | Clause 7.5 Documented information; Annex A control on system documentation | Original editorial mapping. | high |
| NIST AI RMF 1.0 | GOVERN 1.4, MAP 3.x | Documentation practices. | medium |
Frequently asked questions
Is this a legal requirement?
Yes. It is a legal requirement under EU AI Act (Article 11 and Annex IV).
Who must comply with this obligation?
Providers of high-risk AI systems.
When does this obligation apply?
It applies from 2 December 2027.
What evidence shows compliance?
A reviewer would expect: Annex IV technical file.
Which frameworks map to this obligation?
It is mapped to ISO/IEC 42001:2023 Clause 7.5 Documented information; Annex A control on system documentation, NIST AI Risk Management Framework 1.0 GOVERN 1.4, MAP 3.x. These are editorial crosswalks with a stated confidence, not official mappings.
Which controls satisfy this obligation?
Data governance and dataset documentation; Technical documentation, model cards and instructions for use.
What should an organisation do in practice?
Maintain an Annex IV-structured technical file under version control.
Cite this record
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). Data licensed CC BY 4.0.
Permanent id AIPT-OBL-0008: it never changes or gets reused, and its address keeps working if this page moves.
Cite the official text alongside it: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence, Official Journal of the European Union, https://eur-lex.europa.eu/eli/reg/2024/1689/oj.
BibTeX
@misc{aipolicytracker2026_drawuptechnicaldocumenta,
author = {{AIPolicyTracker}},
title = {{Draw up technical documentation before placing a high-risk system on the market (EU AI Act)}},
year = {2026},
howpublished = {\url{https://aipolicytracker.org/obligations/eu-ai-act-technical-documentation}},
url = {https://aipolicytracker.org/obligations/eu-ai-act-technical-documentation},
urldate = {2026-10-27},
note = {Data licensed CC BY 4.0. Accessed 27 October 2026}
}
Change history
No change to this record's tracked fields has been recorded since 15 October 2026, when field-level history began.
Similar obligations in other instruments
- Providers must document and register a conclusion that an Annex III system is not high-risk — EU AI Act, European Union
- Providers of GPAI models must maintain technical documentation and inform downstream providers — EU AI Act, European Union
- Developers must document high-risk systems and disclose known risks — Colorado AI Act, Colorado (United States)
- Developers must supply deployers with documentation of the technology — Colorado ADMT law (SB 26-189), Colorado (United States)
Disclaimer: informational only, not legal advice. Verify every claim against the linked official sources and consult a qualified lawyer before acting.