
Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
出版:European Union

专家解读视频
基本信息
标准编号: EU MDCG 2022-1:2022
标准类别:Standard
出版单位:European Union
标准页数:0
标准简介
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.