This questionnaire was prepared in accordance with the request of MDCG, published in the Medical Device Coordination Group (MDCG) position paper in August 2022, for notified bodies to develop common guidance for manufacturers to assist them in the application phase (MDGG 2022-14 Position Paper, Transition to the MDR and IVDR, Notified body capacity and availability of medical devices and IVDs, Section 16).
Questionnaire:
Artificial Intelligence (AI) in medical devices
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.