In vitro diagnostics, or IVDs, are products or tests that are used for the detection of diseases, conditions, or infections.
These devices can aid in the determination of the state of health of an individual by examining and evaluating specimens derived from the human body (such as blood or tissue samples).
IVD manufacturers that wish to take their product to multiple markets must abide by the relevant regulations, such as the requirements outlined in Title 21 of the Code of Federal Regulations (CFR) for the United States (US) and the In Vitro Diagnostic Regulation (IVDR) in the European Union (EU).