Current trends in the development and use of personalized implants: Engineering concepts and regulation perspectives for the contemporary oral and maxillofacial surgeon

The recently adopted Medical Device Regulation (MDR) has finally entered into force on 26 May 2021. As innovation and especially the advent of customized prostheses has deeply modified many surgical procedures in our discipline, it is imperative for the contemporary surgeon to become aware of the impact that the MDR will have on many aspects, including the choice of the manufacturer, the evaluation of the devices, point-of-care 3D printing labs, and medical software. In this paper, the authors tried to identify the cultural gaps in clinical practice that the MDR is supposed to fill. To achieve this purpose, a task force of experts was reunited, including CMF surgeons with direct expertise in medical software and 3D printing, mechanical and material engineers, facing the topic of the MDR from a multidimensional perspective. In this article, surgeons and engineers review many crucial aspects concerning the points of the regulation that mostly affect the field of implantable devices for the cranio-maxillo-facial skeleton. The result of interdisciplinary research is a paper aiming to provide surgeons with the knowledge on the fundamental processes of additive manufacturing, increasing the clinician’s awareness on the evaluation of a customized implant before surgery and on the underlying regulatory framework.