Theme COVID-19 – Performance evaluation
Target Audience

All stakeholders

Products concerned


Documents mentioned

IVDR (EU) 2017/746

Directive 98/79/EC


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.