Robustness

For IVDs, robustness studies show how much a test tolerates variation in factors such as temperature, incubation time or reagent volume before results shift. The findings feed the limits written into the instructions for use.

The robustness of an analytical procedure means the capacity of an analytical procedure to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal usage.

MDCG 2022-2, Section 4, Definitions (source: ICH Q2(R1))