浅谈欧盟体外诊断医疗器械新法规  

Brief Introduction about New Regulation of EU on IVDR

作　　者：陈智慧 CHEN Zhihui(Agilent Biosciences(Hangzhou)Co.Ltd.,Hangzhou,310000)

机构地区：[1]安捷伦生物(杭州)有限公司,杭州市310000

出　　处：《中国医疗器械杂志》2021年第5期530-535,共6页Chinese Journal of Medical Instrumentation

摘　　要：新的欧盟体外诊断医疗器械法规2017/746于2017年5月颁布后留给生产企业五年的过渡期.从新法规颁布的背景.主要变化.新法规的影响.企业应对策略.应采取的主要准备工作等方面进行介绍.以期为国内体外诊断医疗器械企业在按照新法规进行产品CE认证时提供帮助。There are five-year transitional period for manufacturers after the issue of regulation(EU)2017/746 on in vitro diagnostic medical devices(IVDR)in May,2017.The article introduces the background,major change,the impact of new regulation and the coping strategies of enterprises,the main preparation work should be taken etc,to provide reference or help for the domestic manufacturers when they prepare the CE marking according to IVDR.

关 键 词：欧盟 体外诊断 警戒系统 上市后监督 过渡期 

分 类 号：F203[经济管理—国民经济]