New European IVD regulation

Changes in technical documentation for IVD assays.

Since May 2017, the In-Vitro Diagnostic Directive (IVDD) is replaced by the new In-Vitro Diagnostic Regulation (IVDR). IVD device manufacturers have a five-year transition period to be fully compliant with all changes as set forth within this new regulation. A significant number of definitions will change, which may result in products currently not classified as an IVD device or accessory under the IVDD being included in the scope of the IVDR.

Important Changes

Your technical documentation needs to contain the results and critical analyses of all design verifications and design validation tests studies undertaken to demonstrate conformity of the device with the general safety and performance requirements of the IVDR.

Since the results will be used in regulatory submissions, it is essential that all data are obtained in line with the harmonized standards and applicable CS (Common Specifications) when available. In the new IVDR, typical analytical performance studies to be performed, according to harmonized standards, are:

  • Measuring Interval
  • Detection Capability
  • Analytical Specificity
  • Precision
  • Accuracy
  • Sample Type
  • Reference Interval
  • Stability