Medical Device Regulations and custom-made device documentation: Ten frequently asked questions and their answers

Abstract

Dental professionals who practice in the UK must follow the General Dental Council (GDC) Standards, one of which is to “find out about laws and regulations that affect your work and follow them”. Dental professionals manufacture custom-made devices (CMDs) and the legislation that governs these devices has changed. Medical devices manufactured within the European Union (EU) were previously subject to Council Directive 93/42/EEC (Medical Devices Directive [MDD]), which was given effect in UK law by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618 [UK MDR 2002]). Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR]) was scheduled to replace the MDD on 26 May 2020, but this was postponed for one year due to the coronavirus (COVID-19) pandemic. In preparation for the UK’s departure from the EU, the EU MDR was largely transposed into The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (Statutory Instrument 2019/791 [UK MDR 2019]), which amended the UK MDR 2002, and was expected to come into effect on 1 January 2021 but a further amendment, The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (Statutory Instrument 2020/1478 [UK MDR 2020]), removed these provisions. As of 1 January 2021, medical devices in Great Britain are subject to either the UK MDR 2002 (as amended) or the EU MDR (until 30 June 2023) while those in Northern Ireland must be manufactured in accordance with the EU MDR. This paper provides the answers to some key questions regarding the documentation that must be supplied with CMDs following these changes.