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The In Vitro Diagnostic Medical Devices Directive introduced for the first time common regulatory requirements dealing specifically with the safety, quality and performance of in vitro diagnostic medical devices (IVDs), thereby bringing them into line with other medical devices.
The Directive was initially implemented into UK law by the In Vitro Diagnostic Medical Devices Regulations 2000, which have now been consolidated in the Medical Devices Regulations 2002 (S.I. 2002 No. 618), as amended by the Medical Devices (Amendment) Regulations 2003 (S.I. 2003 No. 1697).
This guidance note represents the Department of Health’s current view of the law. It is intended as general guidance only and should neither be regarded as an authoritative statement of the law, nor as having any legal consequence.
Guidance Note 19 - Guidance Notes on In Vitro Diagnostic Medical Devices Directive 
