Regulatory framework of 3D-printed custom-made medical devices at the point-of-care: a case study at the Rizzoli Orthopedic Institute

An important aspect of modern medical treatments and patient care is personalization. Additive manufacturing offers advanced solutions for designing and printing complex geometries and its application in orthopedic surgery is becoming increasingly widespread, enabling the on-demand production of tailored medical devices. This thesis analyses the European regulatory framework applicable to custom-made medical devices manufactured by healthcare institutions for internal use, with reference to Regulation (EU) 2017/745 of the European Parliament and of the Council, commonly referred to as Medical Device Regulation (MDR), and related guidance documents. The study focuses on the experience of the 3D printing laboratory, ‘3Dlab’, of the IRCCS Rizzoli Orthopedic Institute (IOR) (Bologna, Italy), which is involved in the production of custom-made anatomical models and patient specific surgical instrumentation. Although Annex XIII of the MDR defines a specific regulatory pathway for such devices, confusion still remains for the necessary detailed provisions. The inherent variability associated with device customization and additive manufacturing at the point-of-care makes it difficult to establish universal standards, thereby complicating the process of demonstrating conformity for healthcare institutions. The primary objective of the present dissertation is to address regulatory compliance to guarantee quality, safety and effectiveness of custom-made anatomical models produced within the 3Dlab, through an in-depth analysis of the regulatory obligations and exemptions for custom-made medical devices manufacturers. The determination of regulatory and documentation requirements is based on the clinical workflow established recently in IOR. Behind its specific application, the present work offers an interpretative and operational model to support other healthcare institutions in the implementation and integration of an internal 3D printing service.