This Directive relates to medical appliances for in vitro diagnostics and their accessories. The Directive refers to the accessories as fully-fledged medical appliances for in vitro diagnostics.

The Directive describes a medical appliance for in vitro diagnostics as follows: 'each medical appliance that is a reagent, a reactive product, a calibration material, a control material, a kit, an instrument, a device, an appliance or a system that is used separately or in combination and which the manufacturer intends to be used for the in vitro investigation of specimens originating from the human body, including donor blood and tissue, exclusively or principally with the objective of providing information on the physiological condition, the health, the illness or a congenital defect or for determining the safety thereof and the level of compatibility with potential receptors'.

The In Vitro Diagnostics Medical Devices Directive 98/79/EC came into force on 7th December 1998 and has a transition period until 7th June 2000.