Transcatheter aortic valve implantation (TAVI or TAVR) is a newly introduced medical procedure enabled by a new device. Although its introduction does not represent that of all medical devices, it does illustrate a situation in which a device provides a new alternative to standard care in a specific group of patients. Unlike drugs, the medical device category is highly heterogeneous and includes both diagnostic and treatment (accessories, implantable, enablers) and capital equipment. The TAVI- case was discussed as one of the examples in the Policy Forum Meeting and the authors were acting as facilitators that summed up both the case as presented and the discussion between the members that followed. We wish to give a special thanks to the participants of the group work for their input to the discussion.