A novel approach for increasing the traceability of 3D printed medical products

Abstract: According to the European Medical Device Directive (MDR (EU) 2017/745), medical products of all risk classes are obliged to be labelled with Unique Device Identification Codes (UDI). In order to meet the requirements of the MDR, a novel method of identification for additively manufactured metallic products was developed at the Fraunhofer Institute for Machine Tools and Forming Technology (IWU). The method provides a product traceability within its production process and during the whole product lifespan, and also functions as a counterfeit protection. This paper shows the integration of a unique identification during an additive manufacturing process for a titanium part. The readout of the integrated identification was executed using ultrasonic and eddy current methods, as well as micro computed tomography. Obtained results are discussed in the paper.

Object Details

• Location: Deutsche Nationalbibliothek Frankfurt am Main
• Extent: Online-Ressource
• Language: Englisch

References and Relationships

• Bibliographic citation: A novel approach for increasing the traceability of 3D printed medical products ; volume:6 ; number:3 ; year:2020 ; pages:315-318 ; extent:4 ; Current directions in biomedical engineering ; 6, Heft 3 (2020), 315-318 (gesamt 4)

Contributors, Places and Time

• Creator: Matvieieva, Nataliia ; Neupetsch, Constanze ; Oettel, Markus ; Makdani, Varun ; Drossel, Welf- Guntram

Further information

• DOI: 10.1515/cdbme-2020-3081
• URN: urn:nbn:de:101:1-2022101215230364320468
• Rights: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Last update: 15.08.2025, 7:30 AM CEST