Medical Device Regulations and custom-made device documentation: A further ten frequently asked questions and their answers.

Abstract

During the 1990s, three Directives were enacted that aimed to harmonise the regulation of medical devices within the European Union (EU). Custom-made devices (CMDs) were subject to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive [MDD]), which was given effect in the UK by the Medical Devices Regulations 2002 (UK MDR 2002). Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR]) replaced the MDD and was transposed into the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 in the UK. The UK left the EU on 31 January 2020 and entered an 11-month implementation period (IP), during which any new EU legislation that was enacted also took effect in the UK. The EU MDR was scheduled to be fully implemented on 26 May 2020 (during the IP) but this was deferred for one year, until 26 May 2021 (after the IP had concluded), as a result of the coronavirus disease 2019 (COVID-19) pandemic. Consequently, the EU MDR was removed from the UK statute book by a further amendment to the UK MDR 2002, the Medical Devices (Amendment etc.) (EU Exit) Regulations 2020. Since 1 January 2021, CMDs manufactured in Great Britain can conform to either the UK MDR 2002 (as amended) or the EU MDR (until 30 June 2023) while devices manufactured in Northern Ireland are subject to the EU MDR alone. CMDs must be supplied with a statement, a label and, depending on the risk class, instructions for use; this paper answers ten questions regarding this documentation following these legislative changes.