The In Vitro Diagnostic Medical Devices Directive (98/79/EC, as amended), came into force on the 7th June 2000. The Directive covers both devices and accessories and which are defined as;
any medical device (as defined under the Medical Devices Directive) 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
The Directive (98/79/EC, as amended) has been replaced by a new EU Regulation No. 2017/746. This new Regulation shall apply from 26th May 2022, however specific articles within the Regulation will apply before this date.