The PQ IVD Assessment Team hosted a webinar on the 23rd of August for IVD manufacturers to provide an update on the transition from Emergency Use Listing (EUL) to Prequalification (PQ) for SARS-CoV-2 IVDs. The objectives of this workshop were to describe the transition process and introduce two new TSS documents: TSS20 – In vitro diagnostic medical devices used for the qualitative detection of SARS-CoV-2 nucleic acid and TSS21 – SARS-CoV-2 antigen rapid diagnostic tests for professional use and self-testing.
Presentations were delivered by the PQ IVD Assessment and Inspections Teams followed by a comprehensive Q&A session. The workshop was attended by more than 40 participants and the questions covered timeframes for the transition period and PQ assessment, requirements for clinical data and analytical studies, site inspection and product changes.
The IVD Assessment Team would like to thank the IVD manufacturers for their active participation and feedback. We look forward to continued engagement for a smooth transition from EUL to PQ for SARS-CoV-2 diagnostics.
A recording of the workshop can be accessed at the following link: