Theme COVID-19 Tests
Target Audience Manufacturers, Authorised representatives
Products concerned IVD
Documents mentioned IVDR (EU) 2017/746

MEDDEV 2.12-1


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.