Annex IV Technical documentation referred to in Article 11(1)

its intended purpose means the use for which a product with digital elements is intended by the manufacturer, including the specific context and conditions of use, as specified in the information supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;, the name of the provider and the version of the system reflecting its relation to previous versions;

how the AI system interacts with, or can be used to interact with, hardware means a physical electronic information system, or parts thereof capable of processing, storing or transmitting digital data; or software means the part of an electronic information system which consists of computer code;, including with other AI systems, that are not part of the AI system itself, where applicable;

the versions of relevant software means the part of an electronic information system which consists of computer code; or firmware, and any requirements related to version updates;

the description of all the forms in which the AI system is placed on the market or put into service, such as software means the part of an electronic information system which consists of computer code; packages embedded into hardware means a physical electronic information system, or parts thereof capable of processing, storing or transmitting digital data;, downloads, or APIs;

the description of the hardware means a physical electronic information system, or parts thereof capable of processing, storing or transmitting digital data; on which the AI system is intended to run;

where the AI system is a component means software or hardware intended for integration into an electronic information system; of products, photographs or illustrations showing external features, the marking and internal layout of those products;

a basic description of the user-interface provided to the deployer;

instructions for use for the deployer, and a basic description of the user-interface provided to the deployer, where applicable;

the methods and steps performed for the development of the AI system, including, where relevant, recourse to pre-trained systems or tools provided by third parties and how those were used, integrated or modified by the provider;

the design specifications of the system, namely the general logic of the AI system and of the algorithms; the key design choices including the rationale and assumptions made, including with regard to persons or groups means a group as defined in Article 2, point (11), of Directive 2013/34/EU; of persons in respect of who, the system is intended to be used; the main classification choices; what the system is designed to optimise for, and the relevance of the different parameters; the description of the expected output and output quality of the system; the decisions about any possible trade-off made regarding the technical solutions adopted to comply with the requirements set out in Chapter III, Section 2;

the description of the system architecture explaining how software means the part of an electronic information system which consists of computer code; components means software or hardware intended for integration into an electronic information system; build on or feed into each other and integrate into the overall processing; the computational resources used to develop, train, test and validate the AI system;

where relevant, the data requirements in terms of datasheets describing the training methodologies and techniques and the training data sets used, including a general description of these data sets, information about their provenance, scope and main characteristics; how the data was obtained and selected; labelling procedures (e.g. for supervised learning), data cleaning methodologies (e.g. outliers detection);

assessment of the human oversight measures needed in accordance with Article 14, including an assessment of the technical measures needed to facilitate the interpretation of the outputs of AI systems by the deployers, in accordance with Article 13(3), point (d);

where applicable, a detailed description of pre-determined changes to the AI system and its performance, together with all the relevant information related to the technical solutions adopted to ensure continuous compliance of the AI system with the relevant requirements set out in Chapter III, Section 2;

the validation and testing procedures used, including information about the validation and testing data used and their main characteristics; metrics used to measure accuracy, robustness and compliance with other relevant requirements set out in Chapter III, Section 2, as well as potentially discriminatory impacts; test logs and all test reports dated and signed by the responsible persons, including with regard to pre-determined changes as referred to under point (f);

cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; measures put in place;