Institute of Clinical Physiology, CNR, Pisa, Italy.
Institute of Clinical Physiology, CNR, Pisa, Italy; University of Pisa, Pisa, Italy.
J Biomed Inform. 2019 May;93:103150. doi: 10.1016/j.jbi.2019.103150. Epub 2019 Mar 13.
Similarly 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.
The 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.
An approach for the management of each key point was suggested, resulting in different levels of implementation for UDI and traceability.
Among 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.
与美国已经实施的情况类似，医疗器械法规（EU）2017/745 和体外诊断医疗器械法规（EU）2017/746 中引入了独特器械标识（UDI）系统的概念，并且正在成为全球标准。本研究旨在根据生命周期和质量体系标准，为欧洲的独立软件医疗器械提供一种实现 UDI 和可追溯性的可能方法。
确定并分析 UDI 法规的要点，以确定与软件医疗器械制造相关的主要问题，特别是标签、隐私方面、UDI 分配标准和国际标准合规性。
提出了管理每个要点的方法，从而为 UDI 和可追溯性实现不同程度的实施。
在各种类型的医疗器械中，软件是一个越来越大的现实，具有非常特殊的特点，必须加以考虑。应考虑实施 UDI 的所有相关方面，以将安全性和可行性结合起来，从而有效地追踪这些医疗器械。
