DGM - Rules - IVDD - What are In Vitro Diagnostic Medical Devices?

Rules - IVDD

What are In Vitro Diagnostic Medical Devices?

In vitro diagnostic medical devices are defined as "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".

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