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. 2022 Jun;11(2):22-31. doi: 10.1177/20501684221101472.
Dental professionals who practice in the UK must follow the General Dental Council (GDC) Standards, one of which is to . 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.
在英国行医的牙科专业人员必须遵循英国牙科协会（GDC）的标准，其中之一是……牙科专业人员制造定制设备（CMD），管理这些设备的法规已经发生变化。以前，在欧盟（EU）内制造的医疗器械受理事会指令 93/42/EEC（医疗器械指令[MDD]）管辖，该指令通过 2002 年《医疗器械条例》（法定文书 2002/618[英国 MDR 2002]）在英国法律中生效。《医疗器械条例》（EU）2017/745（EU MDR）原定于 2020 年 5 月 26 日取代 MDD，但由于冠状病毒（COVID-19）大流行，该日期被推迟了一年。为了为英国退出欧盟做准备，EU MDR 在很大程度上被纳入 2019 年《医疗器械（修订等）（欧盟退出）条例》（法定文书 2019/791[英国 MDR 2019]），修订了英国 MDR 2002，并预计于 2021 年 1 月 1 日生效，但进一步的修订，2020 年《医疗器械（修订等）（欧盟退出）条例》（法定文书 2020/1478[英国 MDR 2020]）删除了这些规定。自 2021 年 1 月 1 日起，英国大不列颠的医疗器械受英国 MDR 2002（经修订）或 EU MDR（至 2023 年 6 月 30 日）管辖，而北爱尔兰的医疗器械必须符合 EU MDR 的规定。本文提供了一些关于这些变化后必须随 CMD 提供的文件的关键问题的答案。
