In Vitro Diagnostic Medical Devices

The "in vitro diagnostic medical device" means 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, solely or principally for the purpose of providing information:
- concerning a physiological or pathological state, or
- concerning a congenital abnormality, or
- to determine the safety and compatibility with potential recipients, or
- to monitor therapeutic measures.

• 1. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations, in practice by many of the so-called Product Directives.
• 2. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
• 3. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 30 countries).
• 4. CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/ vigilance authorities.