Artificial intelligence (AI) systems offer new possibilities for the diagnosis and treatment of diseases for the benefit of patients. In recent years, a growing number of AI systems have gained access to regulated markets such as Europe and the USA as medical devices. However, these are usually static AI systems in which the learning process is completed before commissioning and the underlying AI model no longer changes. This is intended to ensure that the verification and validation relate to a specific development status of the AI system. This approach excludes continuously learning AI systems from market access and thus prevents the use of a continuous learning process as a significant technical advantage of AI systems.
Against the background of the future European Artificial Intelligence Act (AIA) and the current legislation on medical devices, the aim of this VDE DGBMT recommendation is to identify a solution to the current innovation-inhibiting approach for continuous-learning AI systems in the European market. At the heart of this is a so-called "anticipatory CE conformity assessment", which provides for the planning and approval of intended changes even before commissioning.
The VDE DGBMT recommendation is primarily aimed at the national competent authorities and notified bodies as well as the European legislator.
The German version is available on this page.
