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…’.
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.
Register now to continue reading
Thank you for visiting British Journal of Nursing and reading some of our peer-reviewed resources for nurses. To read more, please register today. You’ll enjoy the following great benefits:
Limited access to clinical or professional articles
Unlimited access to the latest news, blogs and video content