Dentistry Portfolio

Sidebar CTA

News

30 Apr 2026

Custom-made medical devices: navigating regulation in a post-Brexit landscape

Custom-made medical devices: navigating regulation in a post-Brexit landscape

Bio: James Green is a maxillofacial and dental laboratory manager for Great Ormond Street Hospital (GOSH), London, and Broomfield Hospital, Chelmsford. He has lectured widely on the impact of Brexit and COVID-19 on custom-made medical device regulations and many of his articles on the subject – for publications such as the British Dental Journal and the Primary Dental Journal – form part of the World Health Organization COVID-19 Research Database. James is the first dental technician to have received two British Orthodontic Society (BOS) awards: the BOS Technicians Award in 2002 and the BOS Award to an Orthodontic Technician for Distinguished Service in 2024. 


To start, can you tell us about your career journey and your current role across Great Ormond Street Hospital and Broomfield Hospital? 

I trained as a dental technician at the Royal London Hospital in Whitechapel. This was followed by a couple of years at the Eastman Dental Hospital, part of the University College London Hospitals NHS Trust (UCLH). I’ve worked at Great Ormond Street Hospital (GOSH) since 2004 and Broomfield Hospital, in Chelmsford, since 2006. 

A lot of my work is for patients with facial clefts. The North Thames Cleft Centre, run jointly by GOSH, Broomfield and the Royal London Hospital, is the UK’s largest cleft lip and palate service and covers North London, Essex and South and West Hertfordshire. 

My work involves constructing a variety of different devices, such as dentures, obturators, orthodontic appliances, and cover plates for patients undergoing a resection due to a tumour or closure of an oronasal fistula. Many appliances are made on a same day basis, while the patient waits or undergoes surgery in theatre. I also carry out orthognathic model surgery planning and fabricate wafers that are used to reposition the jaws. 
 

You have spent many years working in maxillofacial and dental laboratories. How has the role of the dental technician evolved over that time? 

One of the biggest changes that come to mind is mandatory registration for dental technicians in 2008. When I qualified in 2001, the term 'dental technician' wasn’t a protected title and CPD wasn’t a legal requirement for technicians. 

Innovative techniques and materials, like intraoral scanning and 3D printing, have become commonplace. At GOSH, new devices have become part of my regular work. Ten years ago, I designed a splint to maintain the ear’s projection and dimensions following surgical reconstruction and I’ve now made these auricular splints for more than 300 children. 
 

Your session focuses on custom-made medical device legislation. For those less familiar, can you briefly explain why this area is so important to dental lab professionals? 

All custom-made medical devices provided by dental labs, such as orthodontic appliances, dentures, crowns and bridges, have to be produced in accordance with the relevant medical device legislation. This also applies to appliances fabricated by other dental professionals within dental practices, so it’s important for all dental professionals to be aware of any new medical device regulations. 
 

Following Brexit and COVID-19, there have been significant regulatory changes. Where do we currently stand with custom-made medical device legislation in the UK? 

In the EU, the Medical Device Regulation (MDR) has replaced the Medical Device Directive (MDD) . When the UK left the EU on 31 January 2020 and entered an 11-month transition period, any new EU legislation that came into force during this time was transposed into UK law. The EU MDR was due to come into force in May 2020, and the UK was set to adopt these new regulations, but once the pandemic took hold, the EU postponed the EU MDR for a year. This meant that the EU MDR would not be fully implemented until the transition period ended, so the EU MDR never became UK law.  

As a consequence, medical device manufacturers in Great Britain continue to follow the UK MDR 2002, which is essentially the MDD with amendments, while Northern Ireland follows the EU legislation, due to the Northern Ireland Protocol and Windsor Framework. 
 

From a practical perspective, what should dental technicians and laboratories be doing now to ensure they remain compliant with current regulations? 

Medical device legislation in the UK has become more complex following Brexit and the pandemic. Medical device regulations have undergone significant change over the last few years and further amendments are expected. It’s good practice for all dental professionals who provide custom-made devices to stay up to date with the current regulations. A good way to do this is by undertaking CPD on the subject. 
 

What can delegates expect to take away from your session at the Dental Technology Showcase? 

All dental professionals can have a role in providing custom-made devices. Delegates attending my session will learn which activities are subject to medical device regulations. They should gain a better understanding of custom-made medical device regulations and the legal requirements that dental professionals have when providing custom-made devices, both in the UK and the EU. 
 

Why would you encourage dental technicians and the wider dental team to attend your session? 

Custom-made devices must be made in accordance with current medical device regulations, so my talk will be relevant to any dental professional who provides custom-made devices. Delegates who attend my session will have the opportunity to ask questions about the topic and I’ll do my best to answer them. 
 

Finally, what are you most looking forward to at the Dental Technology Showcase this year? 

I’ve been speaking at CloserStill Media events for a decade. The British Dental Conference & Dentistry Show and the Dental Technology Showcase give dental professionals the perfect opportunity to see new technology first-hand and learn about the latest developments. 

As an Orthodontic Technicians Association (OTA) and Dental Technologists Association] (DTA) council member, I’m looking forward to catching up with members of both organisations and meeting those who may be interested in joining. 


Don't miss Jame's session " Custom-made medical device legislation: where are we following Brexit and COVID-19?" on Saturday 16 May 2026, 12:45-13:30 at the Dental Tehcnicians' Hub.

View all News
Loading

Sponsors


 

Partners


 

Our Events