Medical 3D printing, intellectual property and regulation

This chapter provides an overview of applicable legal frameworks to the main uses of 3D printing in medicine. In particular, medical device regulation and intellectual property (IP) are explored. 3D printing is not an unregulated field, but there can be ambiguities about how particular legal frameworks, developed in a pre-3D printing era, can be applied. Questions also arise about whether these frameworks need to be changed to better facilitate the desirable uses of 3D printing and protect against undesirable uses. This chapter presents a snapshot of these issues and gives a summary of legal issues associated with the use of 3D printing in the medical field need to consider, focusing on IP and medical device regulation.