Regulatory Framework for 3D Printed Custom-Made Devices in Europe
- Additive manufacturing (AM) has been growing continuously over the past 20 years, enabling unprecedented tailoring to the anatomy of each patient. In Europe, custom-made devices qualify for an exemption and pass a simplified approval process. New technologies, like AM, provoke questions about the adequacy of the current regulatory framework for custom-made devices. This article addresses the regulatory requirements for such devices in Europe and discusses the implications for AM. It concludes that the legal framework for custom-made devices entails uncertainties which need to be resolved to guide manufacturers through the regulatory requirements, highlighting the specific areas of focus for AM.
Author: | Ann-Kathrin CarlORCiD, David Hochmann |
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DOI: | https://doi.org/10.18416/AMMM.2021.2109542 |
ISSN: | 2699-1977 |
Parent Title (English): | Beitrag zur 3. Additive Manufacturing Meets Medicine (AMMM) Konferenz |
Document Type: | Conference Proceeding |
Language: | English |
Date of Publication (online): | 2023/11/13 |
Date of first Publication: | 2021/09/08 |
Provider of the Publication Server: | FH Münster - University of Applied Sciences |
Release Date: | 2023/11/14 |
Faculties: | Physikingenieurwesen (PHY) |
Publication list: | Hochmann, David |
Carl, Ann-Kathrin | |
Licence (German): | Bibliographische Daten |