Description: Within the Belgian scientific institution Sciensano, i.e. the merger of the Scientific Institute of Public Health (WIV-ISP) and the Veterinary and Agrochemical Research Centre (CERVA-CODA), an internal project started to prepare Sciensano to candidate as European Union reference laboratory, within the remit of Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Sciensano's organisation consists of scientific directorates, structured in scientific services in function of their core activities, performing under a quality and environmental management system. With its expertise in the evaluation of in vitro diagnostic medical devices, their day-to-day use, safety and performance issues, and its ISO/EN 15189 accredited National Reference Centre (NRC) for Hepatitis Viruses, and NRC for Influenza Virus, we believe Sciensano is able to provide tools, resources and expertise to the European Union reference laboratory network under the IVDR.
Learning Objectives:
understand how the Belgian scientific institution Sciensano is preparing to candidate as European Union reference laboratory, within the remit of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
reflect on the needs and goals of the European Union reference laboratories.
