TY  - CONF
A1  - Carl, Ann-Kathrin
A1  - Hochmann, David
T1  - Regulatory Framework for 3D Printed Custom-Made Devices in Europe
T2  - Beitrag zur 3. Additive Manufacturing Meets Medicine (AMMM) Konferenz
N2  - 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.
Y1  - 2021
UR  - https://www.hb.fh-muenster.de/opus4/frontdoor/index/index/docId/17390
SN  - 2699-1977
ER  -