This document is intended for manufacturers that are developing AI-enabled medical devices to identify considerations as they make critical technical and governance choices.
It is intended to provide considerations specific to where AI-enabled medical devices may necessitate new or different approaches than those more broadly applicable to medical devices and medical device software, building upon existing work and harmonization efforts IMDRF has published. Rather than exhaustively cover all steps of the AI-enabled medical device life cycle, the document highlights key considerations as well as internationally-recognized standards and resources for manufacturers to additionally
consider.
Given the rapid pace of advancement in the field of AI, this document attempts to reflect the most current considerations for manufacturers of AI-enabled medical devices.