Discussion paper on proposed new regulatory changes on 3D technology: a surgical perspective

Three‐dimensional (3D) printing or additive manufacturing involves manufacturing a 3D model by laying down successive layers of materials controlled by specifications set in a digital file. Rapid evolution of this technology has allowed increased access to printers and print materials enabling customization of care to patient‐specific anatomy and pathology. In addition, 3D digital files created prior to the printing process can play important roles in clinical decision‐making and education. These digital files may simply be used in the surgical planning process or be used through the means of augmented reality (AR) or virtual reality (VR) (Fig. 1). Currently, custom‐made implants are excluded from regulatory oversight necessitating revision of these regulatory rules. With the widening application of 3D technologies, the role of a surgeon may also be blurred with that of a researcher, manufacturer and supplier necessitating new definitions of these roles and what constitutes a medical device. This discussion paper is to review the new proposed regulatory changes and its implications on the surgical workforce and practice.