RT Journal Article
SR Electronic
T1 How medical devices are regulated in the UK
JF Drug and Therapeutics Bulletin
JO Drug Ther Bull
FD BMJ Publishing Group Ltd
SP 82
OP 84
DO 10.1136/dtb.2020.03.0023
VO 48
IS 7
YR 2010
UL http://dtb.bmj.com/content/48/7/82.abstract
AB 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.