The Directive: IVDD 98/79/EC
IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October 7, 1998. It is separate from the Medical Device Directive with its own separate set of requirements for manufacturers wishing to place medical devices in the European Economic Area. This directive does not specifically list out the devices that fall under it. Rather, the responsibility is placed on the manufacturer to determine what directives apply to their device. The directive sets out device requirements, requirements for manufactures placing the device on the market, and also demands on safety and quality of the devices.
Under the IVDD 98/79/EC, an In-Vitro Diagnostic Medical Device is defined as “any medical device which is a reagent, reagent device, 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, solely or principally for the purpose of providing information concerning a physiological state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients”.