In Vitro Diagnostic (IVD) Device

In vitro diagnostic (IVD) devices are medical devices used to perform tests on samples, such as blood, urine, or tissue, taken from the human body. These tests are conducted outside of the body (in vitro) to diagnose diseases, monitor the progress of a disease, or determine the suitability of a treatment. They differ from in vivo tests, which are conducted in the body.

IVD devices encompass a wide range of tools. These tools can be individual components or entire systems, including reagents, reagent products, calibrators, kits, control materials, apparatuses, instruments, software, systems, or pieces of equipment—whether alone or in combination.

Some examples of IVD devices include:

• Allergy testing kits
• Blood glucose monitors
• Complete blood count (CBC) analyzers
• Coagulation analyzers
• HIV tests
• PCR tests
• Pregnancy tests

IVD devices can be found in laboratories, health care facilities, or in a patient’s home, and the devices may be small and handheld or complex. IVD devices do not treat patients—they provide information about the body’s functioning.

IVDs are regulated by government agencies such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. These agencies ensure that IVDs are safe and effective for their intended use. In the U.S., the FDA classifies IVD devices into three classes (Class I, II, or III) based on the level of risk associated with the device and the controls needed to ensure safety and effectiveness. The classification then determines the appropriate premarket approval process.