Directive 98/79/EC covers the placing on the market and putting into service of In Vitro Diagnostic Medical Devices.
It covers devices used in vitro for the examination of a specimen derived from the human body, including reagents, instruments and specimen receptacles.
A copy of the directive (external link) can be found on the Europa website.
MHRA has produced some general guidance covering this Directive in:
Bulletin 12 - Sale and Supply of In Vitro Diagnostic Medical Devices (IVDs)
(122Kb)
Guidance Note No 19 - Guidance Notes on In Vitro Diagnostic Medical Devices Directive 98/79/EC
