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 |
|---|---|
| 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 |