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.