EU MDCG 2021-14:2021现行

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.