New paper covers top questions on UK custom dental devices

Anisha Hall Hoppe, Dental Tribune International

Wed. 14 February 2024

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LONDON, UK: A new article presents a comprehensive overview of the evolving regulatory landscape for custom-made medical devices in the UK, offering valuable insights and guidance for dental professionals and manufacturers. It underscores the importance of understanding and adapting to these changes to ensure the continued provision of high-quality, compliant custom-made devices within the dental industry.

Custom-made devices, tailored for individual patients based on specific prescriptions, play a pivotal role in dental healthcare. In the past, the production of such devices within the EU was governed by the Council Directive (EEC) 93/42 concerning medical devices (MDD), which was implemented in the UK through the Medical Devices Regulations 2002. However, everything changed with the introduction of Regulation (EU) 2017/745 (MDR), replacing the MDD and bringing in a new era of regulatory requirements.

The transition is marked by a divergence in regulatory frameworks within the UK itself, where Great Britain adheres to the UK-specific Medical Devices Regulations 2002, while Northern Ireland aligns with the MDR owing to the Northern Ireland Protocol. This divide raises critical questions for dental professionals and manufacturers, particularly concerning the classification, risk assessment and compliance of custom-made devices.

The overview outlines the obligations of the UK responsible person and the EU authorised representative, shedding light on the complexities faced by manufacturers in navigating these dual regulatory environments. For instance, manufacturers placing devices on the market in Great Britain are subject to the UK’s regulatory framework, whereas those targeting the Northern Ireland or EU markets must adhere to the MDR, highlighting the need for strategic compliance measures.

Furthermore, the document addresses the nuanced aspects of risk classification under both UK and EU legislation, emphasising the impact of device classification on regulatory requirements. For instance, Class I devices, generally considered low risk, have different compliance requirements compared with higher-risk categories, like Class IIb and Class III, which necessitate more stringent controls, such as the establishment of a quality management system and the preparation of periodic safety update reports.

The paper also explores the practical implications for Great Britain-based manufacturers who wish to place custom-made devices on the Northern Ireland or EU market, underlining the necessity of designating an authorised representative within Northern Ireland or the EU and adhering to the relevant MDR requirements. Similarly, non-UK manufacturers aiming to enter the Great Britain market must appoint a UK responsible person to ensure compliance with UK regulations.

This exploration is timely and critical, given the recent legislative changes propelled by the UK’s departure from the EU, the ongoing global COVID-19 pandemic and the nuanced implications of the Northern Ireland Protocol.

The paper, titled “Medical device regulations for custom-made devices: Answers to a further ten important questions”, was published online on 19 January 2024 in BDJ Team.