MDCG 2021-21 Rev

Medical Devices Medical Device Coordination Group Document MDCG 2021-21 MDCG 2021-21 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 by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law. 1 / 15. Medical Devices Medical Device Coordination Group Document MDCG 2021-21 MDCG 2021-21 Revision 1 changes Tables 1 and 2 Footnote on vaccinated individuals revised Tables 4 and 5 Footnote on specimen types added Tables 6 and 7 1st column revised, title 3rd column revised All tables Minor editorial clarifications 2 / 15.

Medical 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

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  Performance, Diagnostics, Vitro, Vitro diagnostic

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