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. 2021 Mar;10(1):64-88. doi: 10.1177/2050168420980980.
A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the (COVID-19) pandemic.In the UK, in preparation for the country's planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.
定制设备（CMD）是一种专为特定患者设计的医疗器械。在牙科环境中，CMD 包括义齿修复设备、正畸矫治器、磨牙症夹板、言语假体和治疗阻塞性睡眠呼吸暂停、创伤预防和正颌手术辅助（弓丝和牙合间夹板）的设备。自 1993 年以来，CMD 的生产和供应一直受欧盟指令 93/42/EEC（医疗器械指令，MDD）的约束，在英国通过 2002 年《医疗器械法规》（法定文书 2002/618）生效，及其后续修正案。条例（EU）2017/745（医疗器械条例，EU MDR）取代了 MDD 和其他关于医疗器械的欧盟指令，即理事会指令 90/385/EEC（有源可植入医疗器械指令，AIMDD）。欧盟 MDR 于 2017 年 4 月 5 日公布，2017 年 5 月 25 日生效，经过三年过渡期，将于 2020 年 5 月 26 日全面实施，并废除 MDD，但由于 COVID-19 大流行，该日期推迟至 2021 年 5 月 26 日。在英国，为了应对该国计划退出欧盟，在必要时对欧盟 MDR 进行了修改，并将其纳入英国法律（《医疗器械（修订等）（欧盟退出）法规 2019，英国 MDR》）。英国于 2020 年 1 月 31 日退出欧盟，进入过渡期，于 2020 年 12 月 31 日结束，这意味着从 2021 年 1 月 1 日起，在英国从事 CMD 处方和制造的牙科专业人员必须按照新立法进行操作，而北爱尔兰仍遵循欧盟立法和实施日期。本文阐述了英国牙科环境中与 CMD 生产和供应相关的要求。
