Does the IVDR have implications for individual clinical laboratories?
Yes, in vitro diagnostic assays designed and manufactured in health institutions are within the scope of the IVDR. This is a major change for laboratories relying on user-defined tests and home-brew assays, as these were not regulated under the previous directive (IVDD). Additional requirements will need to be met by laboratories continuing user-defined tests after May 2022, once IVDR fully applies. Beckman Coulter Life Sciences is creating support and educational materials to help you to navigate through IVDR requirements. Please visit IVDR website section for more information.