AI in Medical Devices - Regulations and Clinical evidence, a conversation

This document offers a review of the landscape surrounding the use of artificial intelligence (AI) in medical devices, highlighting the definitions, recommendations, and regulations shaping its implementation. It examines the complexities of defining AI in the medical context and surveys existing regulatory initiatives, consensus recommendations, and standards proposed by various international organizations. The piece emphasizes the need for common standards in the clinical evaluation of high-risk AI applications to promote transparency and evidence-based medicine. The authors explore existing gaps in current guidelines and the need for clarity as a result of the fast pace of AI advancement in medical tools, to ensure the safe and effective deployment of AI within healthcare. It looks into EU laws that may impact how AI medical systems can be used, or how much information can or must be disclosed. The article concludes by calling for practical, evidence-based standards that consider clinical risks and promote international regulatory convergence.