Open AccessRegulatory Concerns about Medical Device Manufacturing Using 3D Printing: Current State of the Issue
Author(s) -
Н. Н. Карякин,
И. И. Шубняков,
А. О. Денисов,
А. В. Качко,
Р. В. Алыев,
Р. О. Горбатов
Publication year - 2018
Publication title -
travmatologiâ i ortopediâ rossii
Language(s) - English
Resource type - Journals
eISSN - 2542-0933
pISSN - 2311-2905
DOI - 10.21823/2311-2905-2018-24-4-129-136
Subject(s) - 3d printing , standardization , legislature , state (computer science) , quality (philosophy) , business , engineering ethics , engineering , computer science , political science , law , mechanical engineering , philosophy , epistemology , algorithm
Custom-made implants, orthotics, orthoses, models for surgical planning and education, and much more are now created using 3D printers. In this article, the authors suiiunarized information on laws and regulations in the domain of legal support for 3D printing of medical devices in Russia and abroad. 3D printing is one of the promising avenues in developing new methods of treatment, so iiiunediate establishing of clear criteria for its legal regulation is necessary. As is, there are still many gaps in the legislative framework. The issues of the quality of 3D models, material standardization and manufacturing processes using 3D printing technologies remain unresolved. When using custom-made medical devices, respecting the rights of patients and preventing the use of prohibited or restricted materials are essential. Yet, legal barriers to this irmovative direction of medicine must be avoided.