In vitro diagnostic medical devices are subject to the European Directive 98/79/EC (IVDD). Presenting a subgroup of medical products, their market access, use, and market surveillance is regulated. The Directive is implemented in the national laws of the member states.
According to the Directive, in vitro diagnostic medical devices include: reagents, reagent products, calibration materials, control materials, kits, instruments, apparatus, equipment, andsystems that are intended for use in the examination of specimens taken from the human body to diagnose diseases, to monitor a person’s physiological state, or to monitor therapeutic procedures.
Examples of in vitro diagnostic medical devices are :
hepatitis or HIV tests
clinical chemical tests
coagulation test systems
urine test strips
pregnancy tests
blood sugar monitoring systems for diabetics
receptacles manufactured specifcally for medical specimens
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