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.
Protecting the UK Dental Industry
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.
Guidance for the Industry
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.
Non-compliant devices
What are the risks and 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.
Importing medical devices
Can medical devices be imported into the UK?
The importation of medical devices is regulated to ensure that the MHRA has oversight of the products being placed on the market.
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
Online purchasing
What should I look for when purchasing online?
The online supply of counterfeit and non-compliant dental products is a growing problem, and ensuring that the products you are purchasing are legal helps to protect you and your patients
Non-Compliance Equipment Reporting
How to report non-compliance products
The BDIA gathers reports of counterfeit or non-compliant products from its members to inform engagement with the MHRA.
Why medical device regulation matters
Contributes to patient safety
Helps to ensure that products perform as intended
Aligns with GDC standards
Safeguards against enforcement action
Provides product traceability and transparency
Contact the BDIA team for more information on device regulation