
Explanatory note on IVDR codes
出版:European Union

專家解讀視頻
基本信息
標準編號: EU MDCG 2021-14:2021
標準類別:Standard
出版單位:European Union
標準頁數(shù):0
標準簡介
The lists of codes and corresponding types of in vitro diagnostic medical devices (IVD) established by the above mentioned Regulation, namely, in its Annex II, takes into account various device types which can be characterised by design and intended purpose including companion diagnostics devices, devices for self-testing or for near patient testing, as well as by manufacturing processes and technologies used, such as sterilisation.