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.

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NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES. PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS The listed regulatory status for products correspond to one of the below: IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use." ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagent. Analytical and performance characteristics are not established." CE-IVD, CE: Products intended for in vitro diagnostic use and conforming to the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. (Note: Devices may be CE marked to other directives.) RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures." LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only." No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.