Changes in materials for IVD medical devices


Category (Significant, non-significant)

Changes which need testing of additional samples, such as:

  • Change of sources or types of materials (conjugate, antibodies, antigens, primers or substrate)
  • Change to the sample preparation, such as the inclusion of a stabilizer for an IVD that is intended to simplify preparation requirements or increase sample stability.

Change in material, which results in design specifications change, such as:

  • Formulation change of reagents of test kits (buffer concentration, addition of preservatives).
  • Change from a liquid to solid reagent and vice versa.


A change in supplier or vendor of the material, but the material meets the manufacturer’s previously reviewed specification.

Non - Significant
Change of sources of non-critical materials, such as magnesium stearate from an animal to vegetable source in a reagent of an IVD kit with no change in performance specification.

Non - Significant