European UnionAI Act, Article 11 (technical documentation)
Regulation (EU) 2024/1689, Article 11
An AI risk obligations rule binding public and private bodies.
- How the hook was established
- express
- What makes it apply
- Market targeting, Place of effect
- Obligation class
- Governance
- Audit expectation
- on_request
- Who audits it
- Regulator, Registered or designated auditor
As of .
What it requires
- This duty takes effect on for a high-risk AI system classified under Article 6(2) and Annex III, and on for one classified under Article 6(1) and Annex I (Article 113, third paragraph, point (c), as replaced by Regulation (EU) 2026/1744), other than a system related to a product covered by the Union harmonisation legislation listed in Section B of Annex I, to which, under Article 2(2), only Article 6(1), Article 60a and Articles 102 to 112 apply, and Articles 57, 58 and 59 apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation; a system already placed on the market or put into service before its date is reached only once its design changes significantly, or by if it is intended for use by public authorities.
- If you are the provider of a high-risk AI system, draw up its technical documentation before you place the system on the market or put it into service, and keep it up to date.
- Draw up the technical documentation so that it demonstrates the system complies with the Chapter III, Section 2 requirements and gives national competent authorities and notified bodies the information they need, in a clear and comprehensive form, to assess that compliance; include at least the elements set out in Annex IV.
- If you are an SME, including a start-up, or a small mid-cap enterprise, you may provide the Annex IV elements in a simplified manner; if you choose to, use the simplified technical documentation form the Commission establishes.
- If your high-risk AI system is related to a product covered by the Union harmonisation legislation listed in Section A of Annex I, draw up a single set of technical documentation that contains both the information this Article requires and the information those legal acts require.
These lines are LexLint's reading of the law's text, as of .
In the frameworks
- NIST AI RMF
- MAP 2.2Information about the AI system’s knowledge limits and how system output may be utilized and overseen by humans is documented. Documentation provides sufficient information to assist relevant AI actors when making decisions and taking subsequent actions.
Our reading of where this law's duties sit in each framework. It never says that running a control meets the law. How we read a framework against the law
If you get it wrong
Private right of actionNo
Penalty structure
Article 99(4)(a): non-compliance with the obligations of providers under Article 16 is fined up to EUR 15,000,000 or 3% of worldwide annual turnover, whichever is higher. Article 16, point (a), requires a provider to ensure its high-risk AI system complies with the Section 2 requirements, which include the Article 11 technical documentation this row states; Article 99(6) requires the lower of the two amounts for an SME, including a start-up; Article 99(6a), inserted by Regulation (EU) 2026/1744, gives the same lower-of treatment to a small mid-cap enterprise, since both apply to paragraph 4 fines.
- Rule
- Lower of for SME
- As of
- Currency
- EUR
- Fixed cap
- 15,000,000
- Turnover percentage cap
- 3
Who enforces it
Settledness
- As of
- Open questions
- What may an SME, including a start-up, or a small mid-cap enterprise omit or shorten when it provides the Annex IV elements 'in a simplified manner' under Article 11(1), as amended by Regulation (EU) 2026/1744?
What it makes you log
Who may demand the log
Regulator, Auditor or notified body
Logging duty
Article 11 requires the technical documentation to be drawn up before the system is placed on the market or put into service and kept up to date, so that it demonstrates compliance and lets national competent authorities and notified bodies assess it. It does not use the words logs, records or audit trail, so the duty is read as implicit. Its minimum contents are Annex IV's; how long the provider must keep it at the authorities' disposal is Article 18(1)'s duty, and the post-market monitoring plan of Article 72(3) forms part of it.
- Kind
- Implicit
- As of
- Provision
- Article 11(1)
- Trigger
- high_risk_systems
Why the legislator wanted it
Recital 71, second sentence.
- As of
- Quote
- This requires keeping records and the availability of technical documentation, containing information which is necessary to assess the compliance of the AI system with the relevant requirements and facilitate post market monitoring.
- Source link
- https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng
- Source kind
- Recital
- Purpose
- accountability_demonstration
- regulator_supervision
What this law does
The technical documentation of a high-risk AI system must be drawn up before the system is placed on the market or put into service, and kept up to date. Article 16, point (a), requires providers of high-risk AI systems to ensure that their systems are compliant with the requirements set out in Chapter III, Section 2, which include Article 11.
The technical documentation must be drawn up so as to demonstrate that the system complies with the requirements of Chapter III, Section 2, and to give national competent authorities and notified bodies the information they need, in a clear and comprehensive form, to assess that compliance, and it must contain at least the elements set out in Annex IV of the Regulation.
As amended by the Digital Omnibus on AI (Regulation (EU) 2026/1744), Article 11(1) lets an SME, including a start-up, or a small mid-cap enterprise (SMC) provide the Annex IV elements in a simplified manner, using the simplified technical documentation form the Commission is to establish for them, and notified bodies must accept that form for the purposes of the conformity assessment.
Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section A of Annex I is placed on the market or put into service, a single set of technical documentation must contain both the information Article 11(1) requires and the information those legal acts require.
The Commission may amend Annex IV by delegated act where necessary, in light of technical progress, so that the technical documentation provides all the information needed to assess compliance.
Article 11 sits in Chapter III, Section 2, so it takes effect on the schedule the Digital Omnibus on AI (Regulation (EU) 2026/1744, in force since ) wrote into Article 113: for a system classified as high-risk under Article 6(2) and Annex III, and for a system classified as high-risk under Article 6(1) and Annex I, rather than the Regulation's general application date.
Under Article 111(2), as the Digital Omnibus on AI rewrote it, the Regulation reaches the operators of a high-risk AI system placed on the market or put into service before the date Chapter III applies only if, from that date, the system's design changes significantly; in any case, the providers and deployers of a high-risk AI system intended to be used by public authorities must take the necessary steps to comply with the Regulation's requirements and obligations by .
Article 11 does not apply to a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section B of Annex I, to which, under Article 2(2), only Article 6(1), Article 60a and Articles 102 to 112 apply, and Articles 57, 58 and 59 apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation.
When LexLint raises it
When your app profile says your app makes high-risk automated decisions or processes biometric data.