The MDCG has endorsed a 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices for the conformity assessment under IVDD and IVDR. The following devices are covered: IVDs for detection or quantification of SARS-CoV-2 nucleic acid, antigens and also detection or quantification of antibodies against SARS-CoV-2.
It is especially important to read through the Guidance, as it will present the basis for future Oh! It looks like you do not have access to this page.
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