A 3D-bioprinting exemplar of the consequences of the regulatory requirements on customised processes

Computer-aided three-dimensional (3D) printing approaches to the industrial production of customised 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customised, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and US regulatory frameworks do not account for the differences between 3D-printing and conventional manufacturing methods or the ability to create individual customised products using mechanised rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products.