How this was checked

What the instructions for use must contain

Verified · last checked Settled, with the evidence a claim at this level needs.

Under the EU AI Act, a high-risk AI system must be accompanied by instructions for use, in an appropriate digital format or otherwise, that include concise, complete, correct and clear information that is relevant, accessible and comprehensible to deployers. The instructions must contain at least the identity and contact details of the provider; the characteristics, capabilities and limitations of performance of the system, including its intended purpose, the level of accuracy, robustness and cybersecurity against which it has been tested and validated and any known and foreseeable circumstances that may affect it, known or foreseeable circumstances that may lead to risks to health, safety or fundamental rights, where applicable its capabilities to provide information relevant to explain its output, when appropriate its performance regarding specific persons or groups of persons on which it is intended to be used, when appropriate specifications for the input data, and where applicable information enabling deployers to interpret its output and use it appropriately; pre-determined changes; the human oversight measures, including technical measures to help deployers interpret its outputs; the resources, expected lifetime and maintenance it needs; and, where relevant, a description of the mechanisms that allow deployers to collect, store and interpret the logs.

At a glance

The statement laid out, in its own words. The statement above and its sources are what count.

The form

  • Accompanies every high-risk system, in an appropriate digital format or otherwise
  • Concise, complete, correct and clear; relevant, accessible and comprehensible to deployers

The minimum content

  • Identity and contact details of the provider and, where applicable, its authorised representative
  • Intended purpose
  • Level of accuracy, robustness and cybersecurity tested and validated, and known and foreseeable circumstances that may affect it
  • Known or foreseeable circumstances that may lead to risks to health, safety or fundamental rights
  • Where applicable, capabilities to provide information relevant to explain its output
  • When appropriate, performance regarding specific persons or groups of persons
  • When appropriate, specifications for the input data
  • Where applicable, information to interpret the output and use it appropriately
  • Changes pre-determined at the initial conformity assessment
  • Human oversight measures, including technical measures to interpret outputs
  • Computational and hardware resources, expected lifetime, maintenance and care
  • Where relevant, the mechanisms to collect, store and interpret the logs

Where the book relies on it

Kind of evidence
documentarySettled by a first-hand source, quoted below with the day it was read.

The evidence

2. High-risk AI systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that include concise, complete, correct and clear information that is relevant, accessible and comprehensible to deployers. 3. The instructions for use shall contain at least the following information: (a) the identity and the contact details of the provider and, where applicable, of its authorised representative; (b) the characteristics, capabilities and limitations of performance of the high-risk AI system, including: (i) its intended purpose; (ii) the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity; (iii) any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights referred to in Article 9(2); (iv) where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information that is relevant to explain its output; (v) when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used; (vi) when appropriate, specifications for the input data, or any other relevant information in terms of the training, validation and testing data sets used, taking into account the intended purpose of the high-risk AI system; (vii) where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it appropriately; (c) the changes to the high-risk AI system and its performance which have been pre-determined by the provider at the moment of the initial conformity assessment, if any; (d) the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of the high-risk AI systems by the deployers; (e) the computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary maintenance and care measures, including their frequency, to ensure the proper functioning of that AI system, including as regards software updates; (f) where relevant, a description of the mechanisms included within the high-risk AI system that allows deployers to properly collect, store and interpret the logs in accordance with Article 12.

Regulation (EU) 2024/1689, Article 13(2) and (3), in the consolidated text CELEX 02024R1689 as consolidated on 27 July 2026 (English). Read from the file saved at sources/eu-ai-act/02024R1689-20260727-consolidated-EN.html, downloaded from EUR-Lex on 2026-10-08 and re-read on 2026-10-20. The whole of Article 13 carries the base marker in that text: Regulation (EU) 2026/1744 did not amend it., read

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