Regulatory Concerns about Medical Device Manufacturing Using 3D Printing: Current State of the Issue

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Abstract

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.

About the authors

N. N. Karyakin

Privolzhsky Research Medical University

Author for correspondence.
Email: fake@neicon.ru

Nikolay N. Karyakin — Dr. Sci. (Med.), rector

Nizhny Novgorod

Россия

I. I. Shubnyakov

Vreden Russian Research Institute of Traumatology and Orthopedics

Email: fake@neicon.ru

Igor I. Shubnyakov — Dr. Sci. (Med.), chief researcher

St. Petersburg

Россия

A. O. Denisov

Vreden Russian Research Institute of Traumatology and Orthopedics

Email: fake@neicon.ru

Alexey O. Denisov — Cand. Sci. (Med.), executive secretary

St. Petersburg

Россия

A. V. Kachko

Privolzhsky Research Medical University

Email: fake@neicon.ru

Anna V. Kachko — head of the Legal Department

Nizhny Novgorod

Россия

R V. Alyev

Privolzhsky Research Medical University

Email: fake@neicon.ru

Ramil V. Alyev — orthopaedic surgeon

Nizhny Novgorod

Россия

R. O. Gorbatov

Privolzhsky Research Medical University

Email: fake@neicon.ru

Roman O. Gorbatov — orthopaedic surgeon, head of the Laboratory of Additive Technologies

Nizhny Novgorod

Россия

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