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CE IVD Directive

IVD Directive of EU

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.

How to define In-Vitro-Diagnostic Medical Devices (IVD)?

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


  • concerning a physiological or pathological state
  • concerning a congenital abnormality
  • to monitor therapeutic measures.

What is a Medical Device?

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:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap
  • investigation, replacement or modification of the anatomy or of a physiological process
  • control of conception.

Excluded are pharmacological or immunological means, which are regulated by appropriate drug laws.

CE Marking

The CE mark is the official marking required by the European Community. It shows the user, that this product fulfills all essential safety and environmental requirements as defined in the so-called European Directives. The manufacturer marks the instrument and produces a declaration of conformity describing the instruments' fulfillment with the guidelines and technical requirements.