Medical device legislation for custom-made devices after the UK has left the EU: answers to ten important questions.

Abstract

The 1990s saw the introduction of three European directives that aimed to harmonise medical device legislation within the European Union (EU), which were given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618). Dental professionals who prescribe and manufacture custom-made devices were required to do so in accordance with the relevant requirements of one of these directives, Council Directive 93/42/EEC (Medical Device Directive [MDD]). The MDD has been replaced by Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR]) and this paper answers some important questions regarding the ways in which this affects the provision of custom-made devices in a dental setting.