E-viri
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Chen, Zhihui
Zhongguo yi liao qi xie za zhi, 2021-Sep-30, Letnik: 45, Številka: 5Journal Article
There are five-year transitional period for manufacturers after the issue of regulation(EU) 2017/746 on 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.
