BDIA Regulatory FAQs
Device Regulation FAQs
Dental and medical devices are strictly regulated to ensure that the products on the market are safe and effective. Manufacturers, distributors and others involved in the supply chain all have obligations under the regulations.
Dental professionals also have an important role to play, and we have prepared a series of short regulatory explainers to help members of the dental team understand the importance of regulation and how to make sure that you and your practice remain compliant.
Medical device regulation
What is device regulation and why does it matter?
If you’re new to device regulation and what it means for the products you use in your practice, this is the place to start. This FAQ will cover:
- What is a medical device?
- How devices are classified
- Who is responsible for regulation of medical devices
- What are my responsibilities as a dental professional?
Counterfeit and non-compliant devices
What are the risks, and what steps do I need to take?
Counterfeit and non-compliant devices can put you and your patients at risk, so it’s important to understand the dangers of these products and what you can do to avoid them. This FAQ will cover:
- The different types of counterfeit and non-compliant devices
- How to tell whether a device is genuine
- What to do if you suspect a device is counterfeit or non-compliant
- The risks of using counterfeit or non-compliant devices.
Importing medical devices
Can medical devices be imported into Great Britain?
The importation of medical devices is regulated to ensure that the MHRA has oversight of the products being placed on the market. This FAQ will cover:
- The requirements for importing a medical devices into Great Britain
- Personal importation of medical devices
- Using imported devices or supplying them to others
- How these requirements are enforced.
Chairside manufacturing
What are the requirements for producing custom made devices?
Technologies such as CAD/CAM and 3D printing mean that it’s possible to produce custom-made medical devices, such as crowns and bridges, within the dental practice. Doing so comes with additional regulatory requirements, and this FAQ will cover:
- The types of device covered by these requirements
- The registration, labelling and post-market obligations you will have
- How to produce a custom-made device statement
- Product marking of custom-made devices.
DENTAL SHOWCASE
Our Events
- 10/02/2026
- BDIA Symposium exploring how innovation and manufacturing can drive the future of the UK dental industry. Join us at the Nexus Building at the University of Leeds.
BDIA SYMPOSIUM 2026
The BDIA is partnering with the University of Leeds and Mimetrik to deliver an exciting new event on 10 February 2026 at Nexus, Leeds, exploring how innovation and manufacturing can drive the future of the UK dental industry.
The day will bring together voices from academia, industry, professional bodies, and policy to share best practice, explore opportunities for collaboration, and discuss how to translate research into real-world solutions. Highlights will include keynote presentations, breakout discussions, and workshops focused on regulation, funding, and industry–academic partnerships, with the day closing on a panel Q&A and networking reception.
This will be a must-attend event for anyone passionate about shaping the next chapter of dental innovation in the UK. More details and booking information will follow soon – for now, please save the date.
Venue
Nexus
Discovery Way
University of Leeds
Leeds
LS2 3AA
- 02/12/2025
- The Midwinter Meeting offers a great chance to network, connect new colleagues, build relationships, and shape the future of dentistry.
BDIA Midwinter Meeting 2025
We’re delighted to announce that the BDIA Midwinter Meeting will take place on Tuesday 2nd December 2025 at the historic RAF Club in London.
This exclusive gathering will bring together senior leaders, decision-makers, and stakeholders from across the dental industry for an afternoon of discussion, reflection, and networking in one of London’s most iconic venues.
Venue
Royal Air Force Club
128 Piccadilly
London
W1J 7PY
Confirmed Speakers
- Ian Wilson, Co-Founder, Bridge2Aid
- Dave Gudgeon, Head of External Affairs, Reconomy
- Robert Reid, Deputy Director, Innovative Devices, MHRA
- Mark Hyde, Commercial Director, BDIA
Midwinter Meeting programme
- 11.00 – 11.30 – Arrival/coffee
- 11.30 – 11.45 – The BDIA President’s & Chief Executive’s Welcome
- 11.45 – 13.00 – Our speaker sessions
- 13.00 – 13.45 – Pre-dinner drinks – The Churchill Bar
- 13.45 – 16.00 – Midwinter Lunch
- 16.00 –17:00 – Churchill Bar available to members (cash bar)
Ticket Booking
To book your tickets for Midwinter 2025 please email [email protected]
Dress code
Business casual
Gallery of Dental Showcase Events
Join us in championing the dental industry
Join the BDIA today and take your dental business to the next level. Whether you are a manufacturer, supplier, or service provider, the BDIA offers a range of resources and benefits to support your success.
