ANNEX IV
Technical documentation referred to in Article 11(1)
The technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to the AI system in question:
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1.
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A general description of the AI system, including:
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a)
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the intended purpose, the name of the provider and the version of the system, making clear the connection to previous versions;
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b)
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How the AI system interacts or can be used to interact with hardware or software, including with other AI systems that are not part of the AI system itself, if applicable;
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c)
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the versions of the relevant software or firmware and any requirements regarding version updates;
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d)
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the description of all forms in which the AI system is marketed or put into use, such as software packages embedded in hardware, downloads or APIs;
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e)
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The description of the hardware on which the AI system is to be run;
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f)
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If the AI system is a component of products, photographs or illustrations: the external features, markings and internal layout of those products;
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g)
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A basic description of the user interface provided to the user manager;
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h)
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usage instructions for the use manager and a basic description of the user interface provided to the use manager, if applicable.
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2.
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A detailed description of the elements of the AI system and the process for its development, including:
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a)
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The methods and steps performed to develop the AI system, including, where relevant, the use of pre-trained systems or tools provided by third parties and how they were used, integrated or adapted by the provider;
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b)
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the design specifications of the system, in particular the general logic of the AI system and of the algorithms; the main design choices, including the rationale and assumptions made, including with respect to persons or groups of persons with respect to whom the system is intended to be used; the main classification choices; for which optimization the system is designed and the relevance of the different parameters; the description of the expected output and output quality of the system; the decisions with respect to any trade-offs with respect to technical solutions adopted to meet the requirements of Chapter III, Section 2;
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c)
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the description of the system architecture with an explanation of how software components build on or provide information to each other and how integration into the overall processing takes place; the computational tools used to develop, train, test and validate the AI system;
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d)
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if relevant, the data requirements for the data sheets describing the training methods and techniques and the sets of training data used, including a general description of these data sets and information on their origin, scope and main characteristics; how the data were obtained and selected; labeling procedures (e.g., for supervised learning), data cleaning methods (e.g., outlier detection);
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e)
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an assessment of the human supervision measures needed in accordance with Article 14, including an assessment of the technical measures needed to facilitate the interpretation of the output of AI systems by persons responsible for use, in accordance with Article 13(3)(d);
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f)
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if applicable, a detailed description of predetermined changes to the AI system and its performance, together with any relevant information related to the technical solutions introduced to ensure the AI system's continued compliance with the relevant requirements of Chapter III, Section 2;
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g)
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the validation and testing procedures used, including information on the validation and testing data used and their main characteristics; the statistics used to measure accuracy, robustness, and compliance with other relevant requirements of Chapter III, Section 2, as well as potentially discriminatory effects; logs on and all reports of testing dated and signed by those responsible, including with respect to pre-established changes referred to in point (f);
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h)
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cyber security measures employed.
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3.
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Detailed information on the monitoring, operation and control of the AI system, specifically with respect to: the performance capabilities and limitations of the system, including the different measures of accuracy for specific individuals or groups of individuals for which the system is intended to be used and the overall expected level of accuracy relative to the intended purpose; the foreseeable unintended results and sources of risk to health and safety, fundamental rights, and discrimination given the intended purpose of the AI system; the human supervision measures required in accordance with Article 14, including the technical measures taken to facilitate interpretation of AI system outputs by persons responsible for use; specifications on input data, if applicable.
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4.
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A description of the appropriateness of the performance statistics for the specific AI system.
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5.
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A detailed description of the risk management system in accordance with Article 9.
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6.
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A description of the relevant changes made to it by the provider during its lifetime.
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7.
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A list of the harmonized standards applied in full or in part, the references of which have been published in the Official Journal of the European Union. Where such harmonized standards have not been applied, a detailed description of the solutions adopted to meet the requirements of Chapter III, Section 2, including a list of other relevant standards and technical specifications applied.
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8.
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A copy of the EU declaration of conformity referred to in Article 47.
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9.
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A detailed description of the system in place for evaluating the post-market performance of the AI system in accordance with Article 72, including the post-market monitoring plan referred to in Article 72(3).
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