1st August 2023 UK Government announces indefinite extension to CE marking > Read More...
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Summary

This directive, along with two associated directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive, cover all medical equipment for use in Great Britain. The directives came fully into force in June 2000 and are enforced in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA). Different regulations apply for devices to be placed on the market or put into use in Europe and Northern Ireland.
 
The IVD directive includes equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. It covers equipment used in laboratories, not in the patient environment and also excludes any products which come under the scope of one of the other two medical directives. 

 

See our In-Vitro Diagnostic Medical Devices Directive page for the EU

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