關于MDR程序重大變化的公告
請所有持有《醫療器械指令》范圍內證書的公司注意
自 2021 年 5 月 26 日起，根據 93/42/EEC 指令指定的認可機構將不能再進行首次認證，但NANDO已公布，根據MDR 2017/745/EU第120條，他們將負責監測根據 93/42/EEC 指令頒發的有效證書的活動。
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