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

• Main Authors: Matvieieva Nataliia, Neupetsch Constanze, Oettel Markus, Makdani Varun, Drossel Welf- Guntram
• Format: Article
• Language: English
• Published: De Gruyter 2020-09-01
• Series: Current Directions in Biomedical Engineering
• Subjects: mdr; component identification; traceability; barcode; laser beam melting; powder bed fusion
• Online Access: http://www.degruyter.com/view/j/cdbme.2020.6.issue-3/cdbme-2020-3081/cdbme-2020-3081.xml?format=INT

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.