1. High-risk AI systems shall be designed and developed in such a way to ensure that their operation is sufficiently transparent with a view to achieving compliance with the relevant obligations of the user and of the provider set out in Chapter 3 of this Title and enabling users to understand and use the system appropriately.
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 information referred to in paragraph 2 shall specify:
- the identity and the contact details of the provider and, where applicable, of its authorised representative;
- the characteristics, capabilities and limitations of performance of the high-risk AI system, including:
(i) its intended purpose, inclusive of the specific geographical, behavioural or functional setting within which the high-risk AI system is intended to be used;
(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, which may lead to risks to the health and safety, or fundamental rights referred to in Article 9(2);
(iv) when appropriate, its behaviour 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;
(vi) when appropriate, description of the expected output of the system.
- the changes to the high-risk AI system and its performance which have been predetermined by the provider at the moment of the initial conformity assessment, if any;
- 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 users;
- 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;
- a description of the mechanism included within the AI system that allows users to properly collect, store and interpret the logs, where relevant.