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，他們將負(fù)責(zé)監(jiān)測根據(jù) 93/42/EEC 指令頒發(fā)的有效證書的活動。
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