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
- 23/09/2026
- This two‑day conference is set to bring fresh ideas, forward‑thinking discussions, and valuable connections from across the industry.
We have lift‑off.
The BDIA National Conference 2026 is officially on the horizon, and we’re taking the event somewhere truly inspiring — the National Space Centre in Leicester. Make sure 23–24 September 2026 is firmly in your diary, as this two‑day conference is set to bring fresh ideas, forward‑thinking discussions, and valuable connections from across the industry.
Across the programme, delegates can expect thought‑provoking speakers, practical sessions, and opportunities to explore the innovations shaping our sector — all within a venue designed for curiosity, discovery, and big thinking.
Further details, including registration information and programme highlights, will be released soon. For now, we invite you to save the date and get ready for an event that promises insight, inspiration, and a setting that’s truly out of this world.
- 23–24 September 2026
- National Space Centre, Leicester
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.
