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Medical devices that incorporate medicines
There are now thousands of medical devices in use for the diagnosis, prevention, treatment or monitoring of disease or disability, and for contraception. Some of the devices used within the body also incorporate a medicine. What are the implications for the regulation of, and dissemination of information about, such products?
The criterion by which a product is classified as a medical device, rather than a medicine, is that its intended primary action is not achieved by pharmacological, immunological or metabolic means. To be sold or supplied in the UK, a medical device must be accompanied by the 'CE' mark which indicates that it complies with 'Essential Requirements' set out in a series of EU Medical Devices Directives. Overseeing whether the product meets …