The Directive: IVDD 98/79/EC

The Directive: IVDD 98/79/EC

IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October  7, 1998. It is separate from the Medical Device Directive with its own  dedicated set of requirements for manufacturers wishing to place medical  devices in the European Economic Area. The Directive sets out device  classification rules, requirements for both devices and manufactures  placing them on the market, ensuring safety and quality of these  products.


Under the IVDD 98/79/EC, an In-Vitro Diagnostic Medical Device is defined as:

“any  medical device which is a reagent, reagent device, 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”.

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