医疗器械MDD指令与医疗器械MDR指令

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Directive 93/42/EEC 医疗器械MDD 指令，Applicable until 25.05.2021，适用期至2021年5月25日

Regulation (EU) 2017/745 医疗器械MDR指令，Applicable from 26.05.2021，适用于2021年5月26日开始。

Draft standardisation request as regards medical devices and in vitro diagnostic medical devices
关于医疗器械和体外诊断医疗器械的标准化请求草案 - 医疗器械协调标准
Draft standardisation request as regards medical devices and in vitro diagnostic.pdf (480.88 KB, 下载次数: 5)

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Draft standardisation request as regards medical devices and in vitro diagnostic medical devices

https://ec.europa.eu/docsroom/documents/43584/attachments/1/translations/en/renditions/pdf