The regulation of medical devices in the UK: recent changes

Medical devices have been around for thousands of years. Neolithic dentists using drills made from flint heads were active in Pakistan 9000 years ago. Since those times, medical devices have greatly transformed the quality of our lives, facilitating the lengthening of our life span.

Regulation of medical devices is required to ensure that only devices that can be shown to be both safe and effective are allowed on to the market. According to the EU Medical Device Regulation (MDR), a medical device is:

‘Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used alone, or in combination, for human beings…’.

European Parliament and the Council of the European Union, 2017

Between 1993 and 2020 the regulation of medical devices in the UK required conformity assessment, resulting in a now very familiar ‘CE mark’ (Figure 1). This mark is recognised throughout the European Economic Area (consisting of the EU and three the four members (Iceland, Liechtenstein and Norway) of the European Free trade Association), as well as by Turkey. This marking allowed for the harmonisation of technical requirements, facilitating free movement of goods and removing national barriers to trade.