Medical Device Regulation: Implications for dental nurses

The Medical Device Directive is being repealed and replaced by the Medical Device Regulation. This article provides an overview of what this change means for UK dental nurses, in particular those who have a role in manufacturing custom-made devices.

Introduction

Dental appliances intended for the sole use of a particular patient, such as orthodontic appliances (Green, 2013, 2015), bruxism splints (Green, 2016) and mouthguards (Green, 2017), are called custom-made devices (CMDs). Under the General Dental Council (GDC) Scope of Practice (General Dental Council, 2013), dental nurses are permitted to partake in various aspects of the CMD manufacturing process. Provided they are trained, competent and indemnified, additional skills that dental nurses can carry out on prescription from, or under the direction of, another registrant include: