It is important that IVD products are accurate and reliable. Let’s look at the reasons why.
First, performance evaluation is important for patient safety. It ensures that the results of IVD products are valid and reliable. Faulty or inaccurate test results can have serious consequences for patient safety by leading to wrong diagnoses or incorrect treatment.
IVD products are performed in various medical facilities and laboratories around the world. Performance evaluation ensures a consistent quality standard of tests regardless of their location. This is critical for comparability of results and ensuring overall quality in healthcare.
Thorough performance evaluation of in vitro diagnostics also enables manufacturers to improve existing tests and develop new ones. This promotes innovation in healthcare and helps discover new diagnostic and treatment options.
Also of importance is that there are strict regulatory requirements for IVD products in many countries. The risk class and performance evaluation are often a key criterion for the approval and sale of such tests on the market.