MDCG 2021-7 : Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices – May 2021

This document is intended for manufacturers and authorised representatives of in vitro diagnostic medical devices (IVD) intended to detect and/or quantify markers of SARS-CoV-2 infection. This notice emphasises their responsibility for the ongoing evaluation of newly identified genetic variants of SARS-CoV-2. It is their responsibility to assess possible impacts on the ability of their device to meet its performance, risk and safety claims.