In vitro diagnostic medical device

A medical device that can be used for analyzing human physiological fluids (such as blood, urine, etc.) to determine:

• Disease or pathological conditions;
• Fetal developmental anomalies during pregnancy;
• Blood group or tissue/organ compatibility for transplantation;
• Monitoring and evaluating the patient’s condition or the effectiveness of treatment.

Depending on the class of the in vitro device, it may either be listed in the Register of entities responsible for placing medical devices, active implantable medical devices, and in vitro diagnostic medical devices into circulation, or require the involvement of a conformity assessment body (for devices in List A, List B, and in cases where the in vitro device is intended for self-testing).