In Vitro Diagnostic Medical Devices Directive

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 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) (185Kb) 

Guidance Note No 19 - Guidance Notes on In Vitro Diagnostic Medical Devices Directive 98/79/EC (289Kb)




Page last modified: 02 April 2008