Lack of Clinical Data for Medical Devices is Putting Patients' Lives at Risk, Says Medicines and Healthcare Products Regulatory Agency

When Suzanne Ludgate of the Medicines and Healthcare products Regulatory Agency (MHRA), the government regulaor of medical devices in the UK, says she was "appalled at how many devices are brought to market with a lack of appropriate clinical data," you know there must be a problem. Medical devices cover everything from a plaster to a pacemaker and the number available for use is staggering: about 80,000 in the UK and 200,000 in Europe - nobody truly knows how many devices there are, as there is no publicly-available list or database. Worldwide, the market for medical devices is thought to be worth £200bn per year.

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