11.02 - Additional Technical Documentation

The technical documentation of the high-risk AI application has to demonstrate that the high-risk AI system complies with the requirements of EC regulation and has the necessary information to assess the compliance of the AI system.

In addition, compliance with EC AIA requires that the high-risk AI system related to a product with other regulatory requirements shall draw up a single technical documentation. So for all of the regulatory compliance requirements imposed on a high-risk application, there should only be one technical documentation.

The check is manual, and you need to provide a statement confirming that you have mechanisms to verify the compliance of the AI application with EC AIA. If you are using the Seclea Regulation Compliance feature, then the assessment and tracking of AI compliance with EC AIA are carried out by Seclea. Also, you must upload a statement confirming that there is only one technical documentation for the respective high-risk AI application.