What is the In Vitro Diagnostic (IVD) Medical Devices Directive?
An in vitro diagnostic medical device is defined by the IVD Directive 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 state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients”. Examples could include: • HIV test kits • blood gas analysers • home use pregnancy tests • blood collection tubes and specimen containers • multi-analyte control sera • immunoassay analysers and reagent kits • blood glucose monitors for diabetics Information on the directive and a copy of the directive text can be found on the European Commission website.
