INS and diabetes mellitus: The potential risk of patient injury of an insulin delivery AI-based medical device system should be taken into account in the risk management process. In the case of an evolutive DL–based medical device without continuous ongoing safety assessment, a wrong dosage administration due to an AI error could provoke a serious adverse event (ie acid ketosis coma for a patient with diabetes). A risk management plan should be available and regularly updated with AI changes impact on safety plan.