This questionnaire is jointly published by the German Notified Bodies Alliance for Medical Devices (Interessengemeinschaft der Benannten Stellen für Medizinprodukte in Deutschland – IGNB) and Team NB – The European Association of Medical devices Notified Bodies. Previous versions have been drafted by IG-NB alone.
This document is to be understood in the context of Medical Device Regulation (MDR; Regulation (EU) 2017/745) and In Vitro Diagnostics Regulation (IVDR; Regulation (EU) 2017/746) as well as MDCG guidance on Medical Device Software (MDSW). Specific requirements of the Artificial Intelligence Regulation (AI Regulation (EU) 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…
