Study 2016-01 (HTA) A framework for the managed introduction of 3D Printed medical devices in Belgium
3D printing of medical devices is a rapidly growing technology for which reimbursement claims at INAMI/RIZIV are becoming more frequent. Today, however, evidence on the benefits for the patient and the cost-effectiveness of these 3D printed implants seems to be scarce. Furthermore, this technique faces important legal challenges: how are 3D printed devices classified within the EU medical devices regulation and what requirements should they comply with before being placed on the market? How can intellectual property of the production process and of the product be protected? What about (product) liability in a situation where different parties can intervene as ‘manufacturer’ of a number of possible products, etc. In this scope, this study will draft a framework for the guided introduction of 3D printed medical devices in Belgium.