ABSTRACT
The In Vitro Diagnostic Device Directive (IVDD) covers the placing on the market and putting into service of in vitro diagnostic (IVD) devices and their accessories. For the purposes of the IVDD, accessories are treated as IVD devices in their own right (Directive 98/79/EC §1(1)). An IVD device is “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body” (Directive 98/79/EC §1(2(b))).
