State of the art of COVID-19 rapid antibody tests and state of the art & IVDR

The IVDD requires from the manufacturers to design and manufacture devices in such a way that they are suitable for the intended purpose, taking into account generally acknowledged state of the art. The manufacturer should therefore justify why the device is suitable for the intended purpose claimed, in light of the state of the art (MDCG, 2021). 

The newly published MDCG Guidance aims at helping manufacturer to fulfill this requirement.  Firstly, it defines . . .

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