Chapter 3 - 3D and 4D printing of medical devices

Abstract

This chapter provides an overview of the additive manufacturing of medical devices. Based on definitions adopted by international regulatory bodies, it is argued that, unlike certain materials of clincal use, 3D printing materials do not qualify as medical devices. Instead, regulators evaluate the entire medical device production system, which includes materials, software, digital models, manufacturing equipments, and the device itself. Medical device classification schemes are presented, along with specific examples, and regulatory efforts are described in detail. Special attention is given to point-of-care 3D printing facilities. They produce personalized anatomical models and patient-matched surgical tools whose positive impact is beyond doubt. Nevertheless, they are challenging from the regulatory point of view, as discussed in the final part of this chapter.