In partnership with the European Regional Office and WHO Country Office in Ukraine the PQ IVD Assessment Team held a virtual Workshop on the 10th of February with regulators from the National Regulatory Authority and IVD manufacturers based in Ukraine. The aim of this workshop was to provide both manufacturers and regulators involved with assessment of IVDs for national registration and/or emergency use authorization a comprehensive understanding of the Prequalification and Emergency Use Listing (EUL) IVD assessment processes.
Presentations were delivered by PQ Team members on the assessment components of IVD Prequalification, the Collaborative Registration Procedure (CRP) and EUL assessment with a focus on SARS-CoV-2 diagnostics. Questions from the participants covering manufacturer requirements for PQ, common non-compliances observed during site inspections and implementation of the CRP were answered during the workshop. The IVD Assessment Team would like to thank colleagues in EURO and WCO Ukraine as well as the participants for the fruitful session and look forward to further engagement with Ukraine stakeholders.