This Directive shall apply to in vitro diagnostic medical devices and their accessories.
‘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:
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concerning a physiological or pathological state
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concerning a congenital abnormality
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to determine the safety and compatibility with potential recipients
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to monitor therapeutic measures
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