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Vitro Diagnostic Tests And Their Performance
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ec.europa.euGuidelines on COVID-19 in vitro diagnostic tests and their performance 1. Objective and Scope Testing for the presence of or past exposure to the SARS-CoV-2 virus is an essential aspect of combatting the COVID-19 outbreak and the associated public health crisis. Wider testing is urgently needed for successful pandemic control.
MDCG 2021-21 Rev
ec.europa.euMedical Devices Medical Device Coordination Group Document MDCG 2021-21 Rev.1 1 / 15 MDCG 2021-21 Rev.1 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices Revision 1 – February 2022 This document has been endorsed by the Medical Device Coordination Group (MDCG) established