How medical devices are regulated in the UK

Abstract

Excluding medicines, most other healthcare products are medical devices.1 It is estimated that around 38 million people in the UK “have contact with” a medical device every day,2 and there are more than 80,000 different devices on the UK market.3 Examples include scanners, pacemakers, infusion equipment, condoms, pregnancy test kits, beds, wheelchairs and dressings.4 All but the very lowest risk devices must conform to specific European Directives. Here we look at the procedures now involved in the regulation of medical devices in the UK.