WHAT ARE IVD MEDICAL DEVICES?
According to the IVDD, in vitro diagnostic medical devices include: reagents, reagent products, calibration materials, control materials, kits, instruments, apparatus, equipment, and systems that are intended for use in the examination of specimens taken from the human body (tissue, blood, urine, etc.) to diagnose diseases, to monitor a person’s state of health, or to monitor therapeutic procedures.
Examples of in vitro diagnostic medical devices are:
• Hepatitis or HIV tests • Clinical chemistry • Coagulation test systems • Urine test strips • Pregnancy tests • Blood sugar monitoring systems for diabetics • Receptacles manufactured specifically for medical specimens