TAE21 - Instructions for Use

AI application 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.

• Detail or upload a document detailing the Instructions for Use that will be provided to the users and how they will be accessed.

• Detail or upload a document detailing the identity and contact details of the provider and, where applicable, of its authorised representative

• Detail or upload a document detailing the expected lifetime of the AI system.

• Detail or upload a document detailing the necessary maintenance and care measures to ensure the proper functioning of that AI system, including as regards software updates

• Describe or upload a document describing in detail the purpose of the application

• Detail or upload a document detailing your assessment of the accuracy of the AI system and if it reaches an appropriate level given its intended purpose. List any known or foreseeable circumstances that may have an impact on that.

• Detail or upload a document detailing your assessment of the extent to which the AI system is resilient as regards errors, faults or inconsistencies that may occur within the system or the environment in which the system operates, in particular, due to their interaction with natural persons or other systems. List any known or foreseeable circumstances that may have an impact on that.

• Detail or upload a document detailing your assessment of the measures in place to ensure that the AI system is resilient as regards attempts by unauthorised third parties to alter its use or performance by exploiting the system vulnerabilities and whether they are appropriate to the relevant circumstances and the risks. List any known or foreseeable circumstances that may have an impact on that.

• Detail or upload a document detailing your assessment of the measures in place to address AI-specific vulnerabilities. This will include, where appropriate, measures to prevent and control for attacks trying to manipulate the training dataset (‘data poisoning’), inputs designed to cause the model to make a mistake (‘adversarial examples’), or model flaws. List any known or foreseeable circumstances that may have an impact on that.

• Detail or upload a document detailing the sources of risks to health and safety in view of the intended purpose of the AI system. This should include any known or foreseeable circumstances, including under conditions of reasonably foreseeable misuse.

• Detail or upload a document detailing the sources of risks to fundamental rights in view of the intended purpose of the AI system. This should include any known or foreseeable circumstances, including under conditions of reasonably foreseeable misuse.

• Detail or upload a document detailing the capabilities and limitations in performance, including the degrees of accuracy for specific persons or groups of persons on which the system is intended to be used and the overall expected level of accuracy in relation to its intended purpose.

• Detail or upload a document detailing the specifications of the input data for the AI system

• Detail or upload a document detailing any 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, including how they affect its performance.