In Vitro Diagnostic Regulation: What it means for clinical flow cytometry labs

The EU has replaced its In Vitro Diagnostic Medical Devices Directive (IVDD, 1993) with the In Vitro Diagnostic Regulation (IVDR) due to huge advances in technology, such as next-generation sequencing moving from research to routine testing. The revised IVDR deadline that pertains to laboratory-developed tests is 26 May 2024.

To find out more, download this free eBook on IVDR which:

  • introduces readers to the IVDR
  • outlines the differences between the IVDR and the IVDD
  • explains the regulatory impact of the new regulation
  • introduces the changes in in vitro diagnostics labs, particularly those using laboratory-developed tests
  • illustrates the problems and solutions using a case study

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E-book cover In Vitro Diagnostic Regulation: what it means for clinical flow cytometry labs