欧盟医疗器械法规体系中对于独立软件的鉴定及分类

Identification and classification of standalone software in regulation system of EU

随着医疗器械的种类越来越多,用于医疗的软件产品(这样的产品被称为"独立软件")在医疗器械领域中的作用也越来越大,独立软件的概念已被广为接受。在2014年实施的《医疗器械监管条例(650号令)》中,明确规定了与健康医疗相关的独立软件也是医疗器械。文章重点介绍了欧盟委员会出版的指南中确定独立软件是否为医疗器械的程序以及独立软件是否为体外诊断医疗器械的步骤,并从有源治疗用医疗器械、与体外诊断医疗器械匹配使用的软件2个方面对独立软件进行分类,为国内制订相关细则提供参考。

Medical software named as standalone software plays a more and more important role in the field of medical device with the development of medical devices. It＇s pointed out in Regulations on the Supervision and Administration of Medical Devices（State Council Decree No. 650） that medicine-associated standalone software is seen as a kind of medical device. The procedures were introduced to determine if standalone software was a kind of medical device or a kind of in vitro diagnosis device in the regulation system of EU. Standalone software was classified as the ones for active medical device and in vitro diagnosis device respectively, and references were provided for the establishing detail regulations in China.