Source: OJ L, 2024/1689, 12.7.2024Current language: EN
- Artificial intelligence act
Basic legislative acts
- AI act regulation
Article 11 Technical documentation
Summary What does Article 11 of the AI act regulation say?
This article sets out the technical documentation requirements for providers of high-risk AI systems.
It establishes that this documentation must be prepared before a system is placed on the market or put into service, must demonstrate compliance with the requirements set out in Chapter III, Section 2, and must be kept up to date.
The article also includes a notable accommodation for SMEs and start-ups, allowing them to fulfil the documentation requirements using a simplified form that the Commission will establish.
The article connects directly to Annex IV, which specifies the minimum elements the documentation must contain, and the Commission is empowered to amend that Annex to keep pace with technical progress.
Important points:
- Providers of high-risk AI systems must draw up technical documentation before placing the system on the market or putting it into service, and keep it up to date.
- SMEs, including start-ups, may use a simplified documentation form established by the Commission, which notified bodies are required to accept for conformity assessment purposes.
- Where a high-risk AI system relates to a product covered by Union harmonisation legislation listed in Section A of Annex I, a single set of technical documentation covering both sets of requirements must be drawn up.
Springlex's summary of the article, a reading aid, not a substitute for the legal text.
The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date.
The 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, 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 small and microenterprises. Where an SME, including a start-up, 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.
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 shall be drawn up containing all the information set out in paragraph 1, as well as the information required under those legal acts.
The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this Section.
Relevant recitals
Recital 66 Coverage of mandatory requirements
Requirements should apply to high-risk AI systems as regards risk management, the quality and relevance of data sets used, technical documentation and record-keeping, transparency and the provision of information to deployers, human oversight, and robustness, accuracy and cybersecurity. Those requirements are necessary to effectively mitigate the risks for health, safety and fundamental rights. As no other less trade restrictive measures are reasonably available those requirements are not unjustified restrictions to trade.
Recital 71 Record-keeping and technical documentation
Having comprehensible information on how high-risk AI systems have been developed and how they perform throughout their lifetime is essential to enable traceability of those systems, verify compliance with the requirements under this Regulation, as well as monitoring of their operations and post market monitoring. 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. Such information should include the general characteristics, capabilities and limitations of the system, algorithms, data, training, testing and validation processes used as well as documentation on the relevant risk-management system and drawn in a clear and comprehensive form. The technical documentation should be kept up to date, appropriately throughout the lifetime of the AI system. Furthermore, high-risk AI systems should technically allow for the automatic recording of events, by means of logs, over the duration of the lifetime of the system.
Springlex and this text is meant purely as a documentation tool and has no legal effect. No liability is assumed for its content. The authentic version of this act is the one published in the Official Journal of the European Union.
Definition
conformity assessment
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national competent authority
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notifying authority
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market surveillance authority
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conformity assessment body
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deployer
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AI system
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risk
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notified body