D 1.2 - Standardization, certification and ethical implication of new business models for personalized medical products

Medical devices and products are considered critical products taking into account their impact on people's lives. Prosthesis, are even more critical products since they can be seen as external medical devices which are implanted in the patient's body and remain there for a long period and sometimes till the end of his life. In this regard this deliverable aims at investigating the certification issues related to manufacturing of personalized prosthesis and eventually analysis of the developed business models (in task 1.1) in terms of their conformity with relevant regulations and legislations. To this end chapter 2 is dedicated to definition of problem and goals to be reached within task 1.2. Then, in chapter 3, a broad state-of-the-art analysis is done to understand the existing European legislation, regulations and directives in terms of certification of medical devices. Chapter 4 is dedicated to analyse the issue of certification in the scope of Fab@Hospital considering the case of personalized coronary stents. Eventually chapter 5 will analyse the certification issue of the selected business model in task 1.1.