Additively manufactured custom-made Titanium implants and related challenges under the regulation (EU) 2017/745

Abstract

This diploma thesis addresses additively manufactured custom-made titanium implants with respect to the state of the art of this technology and the related challenges according to the regulation (EU) 2017/745.It starts with an introduction to the legal framework for medical devices and discusses the Medical Device Regulation (EU) 2017/745 and the Austrian Medical Device Act (MPG 2021). In this regard, custom-made devices, which are a particular type of medical devices, are discussed and their regulatory requirements are presented. The analysis of regulatory requirements for custom-made devices shows that fewer requirements are needed if the medical device is intended to be used for one specific patient. The regulatory demand becomes even more reduced when the custom-made device is manufactured and used only within a health institution. To provide regulatory knowledge using a hands-on application about manufacturing custom-made devices within a health institution (Center for Medical Physics and Biomedical Engineering, General Hospital of Vienna), an example of an additively manufactured custom-made subperiosteal implant, designed and printed with the Selective Laser Melting is provided. Throughout the process of manufacturing, relevant regulatory documents and standards are indicated and a standard operating procedure is established for future projects of this kind.