• Elisabetta Bianchini, Martina Francesconi, Marisa Testa, Maya Tanase, and Vincenzo Gemignani.
• Institute of Clinical Physiology, CNR, Pisa, Italy. Electronic address: elisabetta.bianchini@ifc.cnr.it.
• J Biomed Inform. 2019 May 1; 93: 103150.

Background And ObjectivesSimilarly to what already established and implemented in the United States, the concept of the Unique Device Identification (UDI) system has been introduced with the European Regulations for medical devices MDR (EU) 2017/745 and in-vitro diagnostic medical devices IVDR (EU) 2017/746 and it is on the way to become a worldwide standard. The aim of this work was to provide a possible approach for the implementation of UDI and traceability in Europe for standalone software medical devices according to lifecycle and quality system standards.MethodsThe key points of the UDI regulation were determined and analyzed in order to identify the main issues related to the manufacturing of software medical devices and, in particular, labeling, privacy aspects, UDI assignment criteria, and international standards compliance.ResultsAn approach for the management of each key point was suggested, resulting in different levels of implementation for UDI and traceability.ConclusionsAmong the various types of medical devices, software is an increasingly large reality with very specific characteristics that must be taken into consideration. All the relevant aspects for the implementation of the UDI should be taken into consideration to combine safety and feasibility in order to effectively pursue the traceability of these medical devices.Copyright © 2019 Elsevier Inc. All rights reserved.

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