BSI-ISO IVDR 780538-R000

Issued by BSI under EU Regulation 2017/746 (IVDR), this EU Quality Management System Certificate confirms Microbix’s compliance with the most current European framework governing in vitro diagnostic medical devices. It authorizes Microbix to place Class B unassayed IVD controls intended to monitor the performance of assays for the detection of infectious agents on the EU market, with validity running through September 2029.