A position paper and questionnaire were recently published regarding the applicability of Artificial Intelligence (AI) in medical devices under MDR and IVDR regulations.
This questionnaire is jointly published by the German Notified Bodies Alliance for Medical Devices (Interessengemeinschaft der Benannten Stellen für Medizinprodukte in Deutschland - IG-NB) and Team NB.
This questionnaire was prepared in accordance with MDGG 2022-14 requests. It is to be understood in the context of MDR and IVDR Regulations as well as MDCG guidance (MDSW). Specific requirements of the AI Regulation 2024/1689 have not been considered and will be part of a comprehensive revision which is to follow. However, it should be acknowledged, that there is a considerable overlap of requirements stated in the AI Regulation and the existing regulatory and standards framework for software and AI.
This questionnaire follows the idea that the safety of AI-based medical devices can only be achieved through a process-oriented approach, whereby all relevant processes and phases of the life cycle must be considered.
Full information can be found here
