• European Commission Comments for Consideration on COVID-19 info on In Vitro Diagnostic Tests and Their Performance
  • Commission Working Document – Current Performance of COVID-19 Test Methods and Devices and Proposed Performance Criteria
  • An overview of the rapid test situation for COVID-19 diagnosis on the EU/EEA
  • Guidance on devices in the COVID-19 context

MDSS would like to make you aware that the European authorities are concerned about the performance of IVD devices associated with COVID-19.

The Commission has published a working document with performance criteria proposals for the different type of COVID- test methods and devices and as well guidance on descriptive information, quality control and safety measures.

MDSS strongly recommends reviewing the information and in particular the working document to:

  • Verify the performance of your company’s device is in line with what is proposed and expected by the by European Authority and
  • verify the instructions for use contain the recommended information on performance as well as on quality control and safety measures and implement further studies and changes as needed.