That technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups, and SMCs, may provide the elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall establish a simplified technical documentation form targeted at the needs of SMEs, including start-ups, and SMCs. Where an SME, including a start-up, or an SMC, opts to provide the information required in Annex IV in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.
How this was checked
Simplified technical documentation
Verified · last checked Settled, with the evidence a claim at this level needs.
Under the EU AI Act as amended in 2026, SMEs, including start-ups, and small mid-cap companies may provide the elements of the technical documentation specified in Annex IV in a simplified manner. The Commission must establish a simplified technical documentation form targeted at the needs of those companies, a company choosing to provide the information in a simplified manner must use that form, and notified bodies must accept the form for the purposes of the conformity assessment.
At a glance
The statement laid out, in its own words. The statement above and its sources are what count.
The rule, as amended in 2026
| Question | Answer |
|---|---|
| Who may | SMEs, including start-ups, and small mid-cap companies |
| What | Provide the elements of the Annex IV technical documentation in a simplified manner |
| The form | The Commission must establish a simplified form for those companies; a company that chooses the simplified manner must use it |
| Notified bodies | Must accept the form for the purposes of the conformity assessment |
Where the book relies on it
- The AI Act File, What the file has to contain. About The AI Act File
- Kind of evidence
- documentarySettled by a first-hand source, quoted below with the day it was read.
The evidence
in Article 11(1), the second subparagraph is replaced by the following: [...] Regulation (EU) 2024/1689 provides for several measures for small-scale operators, which should be extended to SMCs where appropriate while safeguarding the overarching objectives and level of protection afforded under Regulation (EU) 2024/1689.
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