|Theme||COVID-19 – Performance evaluation|
IVDR (EU) 2017/746
This document details the performance evaluation conditions for IVD’s intended for the detection or quantification of:
- SARS-CoV-2 nucleic acid,
- SARS-CoV-2 antigens,
- antibodies to SARS-CoV-2.
This MDCG comes in the absence of common specifications in this area but may serve as a basis for future common specifications that will be developed in the near future under Article 9 of Regulation (EU) 2017/746.