Maxillofacial and Dental Laboratory Manager, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK; Maxillofacial and Dental Laboratory Manager, Broomfield Hospital, Mid and South Essex NHS Foundation Trust, Chelmsford, UK.
Br Dent J. 2023 Aug;235(3):205-210. doi: 10.1038/s41415-023-6104-2. Epub 2023 Aug 11.
A custom-made device is a medical device that is 'intended for the sole use of a particular patient' made 'in accordance with a written prescription'. In a dental setting, common examples of custom-made devices include crowns, dentures and orthodontic appliances. Until fairly recently, dental professionals who manufactured custom-made devices within the European Union (EU) were required to do so in accordance with Council Directive 93/42/EEC (Medical Devices Directive [MDD]), which was given effect in the UK by the Medical Devices Regulations 2002 (Statutory Instrument 2002/618 [UK MDR 2002]). The MDD has since been replaced by Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR]). However, the withdrawal of the UK from the EU, the COVID-19 pandemic and the implementation of the Ireland/Northern Ireland Protocol has led to different parts of the UK following different legislative frameworks. Dental professionals in Great Britain (England, Scotland and Wales) who manufacture custom-made devices must follow the relevant requirements of the UK MDR 2002 (although devices may be placed on the market in accordance with the EU MDR until 30 June 2024), while those in Northern Ireland are subject to the EU MDR. This paper provides answers to some key questions regarding the ways in which these legislative changes have impacted the provision of custom-made devices in the UK.
定制设备是指“根据书面处方”为特定患者“量身定制”的医疗器械。在牙科环境中，常见的定制设备包括牙冠、义齿和正畸器具。直到最近，在欧盟（EU）内制造定制设备的牙科专业人员都必须按照理事会指令 93/42/EEC（医疗器械指令[MDD]）进行制造，该指令在英国由 2002 年《医疗器械法规》（法定文书 2002/618 [英国 MDR 2002]）生效。此后，MDD 已被（EU）2017/745 号法规（医疗器械法规[EU MDR]）所取代。然而，英国退出欧盟、COVID-19 大流行以及《爱尔兰/北爱尔兰议定书》的实施，导致英国的不同地区遵循不同的立法框架。在英国制造定制设备的牙科专业人员必须遵循英国 MDR 2002 的相关要求（尽管设备可以按照欧盟 MDR 投放市场，直至 2024 年 6 月 30 日），而北爱尔兰的牙科专业人员则受欧盟 MDR 约束。本文针对这些立法变化对英国定制设备供应的影响，回答了一些关键问题。
