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關(guān)于MDR程序重大變化的公告

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自 2021 年 5 月 26 日起,根據(jù) 93/42/EEC 指令指定的認(rèn)可機(jī)構(gòu)將不能再進(jìn)行首次認(rèn)證,但NANDO已公布,根據(jù)MDR 2017/745/EU第120條

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MDR程序的法律通知

您可以查看我們新發(fā)布的《醫(yī)療器械安排程序公告通知》的詳細(xì)信息。

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MDR 過渡流程

根據(jù)(EU)2023/607法規(guī),只要滿足某些條件,MDD證書的有效期將被延長。點(diǎn)擊這里獲取詳細(xì)信息。

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UDEM Certificate

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