On December 7th, 1998, the EU directive for "In-vitro-Diagnostic Medical Devices" (IVD Directive) was published in the Official Journal of the European Communities and became effective since June 7th, 2000.
An "In-Vitro-Diagnostic Medical Device" is any medical device used In-vitro for the examination of specimens, including blood- and tissue donations, derived from the human body.IVD can be a reagent, calibrator, control material, kit, instrument, apparatus, equipment, system, or specimen receptacles, intended by the manufacturer to be specifically used for in-vitro diagnostic examination. IVD are mainly used to of provide information
The definition of a "Medical Device" includes any instrument, apparatus, appliance, material or other article, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
Excluded are pharmacological or immunological means, which are regulated by appropriate drug laws.