EU MDCG 2022-1:2022現行
Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
出版：European Union
專家解讀視頻
基本信息
標準編號： EU MDCG 2022-1:2022
標準類別：Standard
出版單位：European Union
標準頁數：0
標準簡介
This notice is addressed to manufacturers of in vitro diagnostic medical devices (IVDs) with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection1 who are based in countries outside the EU or the EEA and who place or intend to place the abovementioned devices on the EU market.
