Custom-Made Dental Devices: Reminder on UK Compliance Requirements

The Dental Technologists Association (DTA), as the professional body representing dental technologists across the UK, is committed to supporting and protecting the high standards of UK manufacturing for custom-made dental devices.

We would like to remind all stakeholders that any custom-made dental devices or related products imported into the UK must fully comply with UK regulations. Guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) makes clear that responsibility for compliance lies with the manufacturer, supplier, or exhibitor.

If you intend to sell, lease, lend, or gift devices in the UK, you must register with the MHRA and meet all UK market requirements. This includes ensuring products carry the correct UKCA or CE marking, appointing a UK Responsible Person (where required), and fulfilling all other obligations set out by the MHRA.

Non-compliance risks not only undermining patient safety but also disadvantaging those manufacturers who already meet stringent UK standards. The DTA strongly advocates for a level playing field, ensuring that UK dental technologists, who work to exacting regulatory requirements, are not placed at a competitive disadvantage by products that do not meet the same criteria.

We encourage all members of the dental community to review the official MHRA guidance:

Summary of key MHRA compliance points 

Medical device requirements overview 

For clarification on specific regulatory matters, we advise contacting the MHRA directly.

The DTA will continue to stand firm in supporting compliance, patient safety, and the protection of UK-based dental technology manufacturing.