James I. J. Green DipSci (Den Tech), HNCSci (Den Tech), LBIDST, FOTA, MDTA Maxillofacial and Dental Laboratory Manager, Great Ormond Street Hospital for Children NHS Foundation Trust, London; Broomfield Hospital, Mid and South Essex NHS Foundation Trust, Chelmsford, UK.
Prim Dent J. 2023 Mar;12(1):43-50. doi: 10.1177/20501684231153906.
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.
20 世纪 90 年代，欧盟颁布了三项指令，旨在协调欧盟范围内医疗器械的监管。定制医疗器械（CMD）受 1993 年 6 月 14 日第 93/42/EEC 号理事会指令（医疗器械指令 [MDD]）管辖，英国通过 2002 年医疗器械法规（UK MDR 2002）实施该指令。条例（EU）2017/745（医疗器械条例 [EU MDR]）取代了 MDD，并在英国的《医疗器械（修订等）（欧盟退出）条例 2019》中得到转化。英国于 2020 年 1 月 31 日退出欧盟，并进入 11 个月的过渡期（IP），在此期间，任何新的欧盟立法也在英国生效。欧盟 MDR 原定于 2020 年 5 月 26 日（在 IP 期间）全面实施，但由于 2019 年冠状病毒病（COVID-19）大流行，该日期被推迟一年，至 2021 年 5 月 26 日（IP 结束后）。因此，英国对 2002 年《医疗器械法规》的进一步修订，即《医疗器械（修订等）（欧盟退出）条例 2020》，将欧盟 MDR 从英国法规中删除。自 2021 年 1 月 1 日起，在大不列颠制造的 CMD 可符合 2002 年《英国医疗器械法规》（经修订）或欧盟 MDR（至 2023 年 6 月 30 日），而在北爱尔兰制造的器械则单独受欧盟 MDR 管辖。CMD 必须附有一份声明、标签和使用说明书（视风险类别而定）；本文针对这些立法变更后，就这一文件提出了十个问题。
