Updated on April 10^th 2024 based on the version and article numbering approved by the EU Parliament on March 13^th 2024.

1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of transparency shall be ensured with a view to achieving compliance with the relevant obligations of the provider and deployer set out in Section 3.

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:

1. the identity and the contact details of the provider and, where applicable, of its authorised representative;
2. 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;‍
3. 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;
4. 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;‍
5. 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;
6. 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.
   

‍

[Previous version]

‍Updated on Feb 6^th 2024 based on the version endorsed by the Coreper I on Feb 2^nd

1. High-risk AI systems shall be designed and developed in such a way to ensure that their

operation is sufficiently transparent to enable deployers to interpret the system’s output and use it appropriately. An appropriate type and degree of transparency shall be ensured with a view to achieving compliance with the relevant obligations of the provider and deployer set out in Chapter 3 of this Title.

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 users.

3. The instructions for use shall contain at least the following information:

1. the identity and the contact details of the provider and, where applicable, of its authorised representative;
2. 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);
   (iiia) where applicable, the technical capabilities and characteristics of the AI system to provide information that is relevant to explain its output;
   (iv) when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used;
   (v) 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 AI system;
   (va) where applicable, information to enable deployers to interpret the system’s output and use it appropriately.
3. 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;
4. the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of AI systems by the deployers;
5. 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;

    ea. where relevant, a description of the mechanisms included within the AI system that allows users to properly collect, store and interpret the logs in accordance with Article 12.