Brief Introduction about New Regulation of EU on IVDR

CHEN Zhihui

doi:10.3969/j.issn.1671-7104.2021.05.012

CHEN Zhihui. Brief Introduction about New Regulation of EU on IVDR[J]. Chinese Journal of Medical Instrumentation, 2021, 45(5): 530-535. DOI: 10.3969/j.issn.1671-7104.2021.05.012

Citation:

CHEN Zhihui. Brief Introduction about New Regulation of EU on IVDR[J]. Chinese Journal of Medical Instrumentation, 2021, 45(5): 530-535. DOI: 10.3969/j.issn.1671-7104.2021.05.012

Citation:

CHEN Zhihui. Brief Introduction about New Regulation of EU on IVDR[J]. Chinese Journal of Medical Instrumentation, 2021, 45(5): 530-535. DOI: 10.3969/j.issn.1671-7104.2021.05.012

Brief Introduction about New Regulation of EU on IVDR

CHEN Zhihui

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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.

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Brief Introduction about New Regulation of EU on IVDR

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