Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • General
  • Published:

Medical device legislation for custom-made devices after the UK has left the EU: answers to a further ten important questions

British Dental Journal volume 235, pages 205–210 (2023)Cite this article

Abstract

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 The MDD has since been replaced by Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR]).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.

Key points

  • The withdrawal of the UK from the EU, the COVID-19 pandemic and the implementation of the Ireland/Northern Ireland Protocol have led to different parts of the UK following diverging medical device legislation.

  • Custom-made devices in Great Britain must be manufactured in accordance with the Medical Devices Regulations 2002 (Statutory Instrument 2002/618), while those in Northern Ireland are subject to Regulation (EU) 2017/745 (EU Medical Device Regulation).

  • Further changes to medical device legislation are expected following the Government response to the consultation on the future regulation of medical devices.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

Fig. 1

Similar content being viewed by others

References

  1. Official Journal of the European Communities. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. 1993. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042&from=EN (accessed December 2022).

  2. UK Government. The Medical Devices Regulations 2002. 2002. Available at https://www.legislation.gov.uk/uksi/2002/618/pdfs/uksi_20020618_en.pdf (accessed December 2022).

  3. Green J I J. The impact of medical device regulation on hospital doctors who prescribe and manufacture custom-made devices. Br J Hosp Med (Lond) 2020; 81: 1-6.

  4. Official Journal of the European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 2017. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745 (accessed December 2022).

  5. Official Journal of the European Union. Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions. 2020. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0561&from=EN (accessed December 2022).

  6. Green J I J. Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices. Prim Dent J 2021; 10: 64-88.

  7. UK Government. The Medical Devices (Amendment etc) (EU Exit) Regulations 2019. 2019. Available at https://www.legislation.gov.uk/uksi/2019/791/pdfs/uksi_20190791_en.pdf (accessed December 2022).

  8. Official Journal of the European Union. Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (2019/C 384 I/01). 2019. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12019W/TXT(02)&from=EN (accessed December 2022).

  9. UK Government. The Medical Devices (Amendment etc) (EU Exit) Regulations 2020. 2020. Available at https://www.legislation.gov.uk/uksi/2020/1478/pdfs/uksi_20201478_en.pdf (accessed December 2022).

  10. UK Government. European Union (Withdrawal Agreement) Act 2020. 2020. Available at https://www.legislation.gov.uk/ukpga/2020/1/pdfs/ukpga_20200001_en.pdf (accessed December 2022).

  11. UK Government. Protocol on Ireland/Northern Ireland. Available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/840230/Revised_Protocol_to_the_Withdrawal_Agreement.pdf (accessed December 2022).

  12. UK Government. The Medical Devices (Northern Ireland Protocol) Regulations 2021. 2021. Available at https://www.legislation.gov.uk/uksi/2021/905/pdfs/uksi_20210905_en.pdf (accessed December 2022).

  13. UK Government. Regulating medical devices in the UK. 2023. Available at https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk (accessed July 2023).

  14. UK Government. Implementation of the Future Regulations. 2023. Available at https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations (accessed July 2023).

  15. Green J I J. Medical device legislation for custom-made devices after the UK has left the EU: answers to ten important questions. Br Dent J 2021; 231: 513-521.

  16. Green J I J. Medical Device Regulations for custom-made devices: answers to ten important questions. BDJ Team 2022; 9: 39-48.

  17. UK Government. Custom-made devices in Great Britain. 2020. Available at https://www.gov.uk/government/publications/custom-made-medical-devices/custom-made-devices-in-great-britain (accessed December 2022).

  18. UK Government. Government response to consultation on the future regulation of medical devices in the United Kingdom. 2022. Available at https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom (accessed December 2022).

  19. General Dental Council. Scope of practice. 2013. Available at https://www.gdc-uk.org/docs/default-source/scope-of-practice/scope-of-practice.pdf (accessed December 2022).

  20. Green J I J. The Role of Mouthguards in Preventing and Reducing Sports-related Trauma. Prim Dent J 2017; 6: 27-34.

  21. UK Government. Borderlines with medical devices and other products in Great Britain. 2023. Available at https://www.gov.uk/government/publications/borderlines-with-medical-devices (accessed July 2023).

  22. UK Government. Medicines and Medical Devices Act 2021. 2021. Available at https://www.legislation.gov.uk/ukpga/2021/3/pdfs/ukpga_20210003_en.pdf (accessed December 2022).

Download references

Author information

Authors and Affiliations

  1. 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

    James I. J. Green

Authors
  1. James I. J. Green
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to James I. J. Green.

Ethics declarations

The author declares no conflicts of interest.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Green, J. Medical device legislation for custom-made devices after the UK has left the EU: answers to a further ten important questions. Br Dent J 235, 205–210 (2023). https://doi.org/10.1038/s41415-023-6104-2

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41415-023-6104-2

Search

Advanced search

Quick links