Background and Aims: Additive manufacturing or three-dimensional printing is a novel production methodology for producing patient-specific models, medical aids, tools, and implants. However, the clinical impact of this technology is unknown. In this study, we sought to characterize the clinical adoption of medical additive manufacturing in Finland in 2016–2017. We focused on non-dental usage at university hospitals. Materials and Methods: A questionnaire containing five questions was sent by email to all operative, radiologic, and oncologic departments of all university hospitals in Finland. Respondents who reported extensive use of medical additive manufacturing were contacted with additional, personalized questions. Results: Of the 115 questionnaires sent, 58 received answers. Of the responders, 41% identified as non-users, including all general/gastrointestinal (GI) and vascular surgeons, urologists, and gynecologists; 23% identified as experimenters or previous users; and 36% identified as heavy users. Usage was concentrated around the head area by various specialties (neurosurgical, craniomaxillofacial, ear, nose and throat diseases (ENT), plastic surgery). Applications included repair of cranial vault defects and malformations, surgical oncology, trauma, and cleft palate reconstruction. Some routine usage was also reported in orthopedics. In addition to these patient-specific uses, we identified several off-the-shelf medical components that were produced by additive manufacturing, while some important patient-specific components were produced by traditional methodologies such as milling. Conclusion: During 2016–2017, medical additive manufacturing in Finland was routinely used at university hospitals for several applications in the head area. Outside of this area, usage was much less common. Future research should include all patient-specific products created by a computer-aided design/manufacture workflow from imaging data, instead of concentrating on the production methodology.

Introduction: 3D printing has quickly found many applications in medicine. However, as with any new technology the regulatory landscape is struggling to stay abreast. Unclear legislation or lack of legislation has been suggested as being one hindrance for wide-scale adoption.Methods: A scoping review was performed in PubMed, Web of Science, SCOPUS and Westlaw International to identify articles dealing with legal issues in medical 3D printing.Results: Thirty-four articles fulfilling inclusion criteria were identified in medical/technical databases and fifteen in the legal database. The majority of articles dealt with the USA, while the EU was also prominently represented. Some common unresolved legal issues were identified, among them terminological confusion between custom-made and patient-matched devices, lack of specific legislation for patient-matched products, and the undefined legal role of CAD files both from a liability and from an intellectual property standpoint. Data protection was mentioned only in two papers and seems an underexplored topic.Conclusion: In this scoping review, several relevant articles and several common unresolved legal issues were identified including a need for terminological uniformity in medical 3D printing. The results of this work are planned to inform our own deeper legal analysis of these issues in the future.