Introduction
When you choose a dental lab, the restoration in your hand is only half the story. The other half is the paperwork behind it: who made it, to what standard, and whether the lab is properly registered to make it at all.
After more than 43 years at the bench, and now as Technician Director on the BACD board, I'm still surprised how often dentists aren't sure what to ask. Three names come up again and again: the MHRA, the GDC and DAMAS. They're often lumped together, but they do quite different jobs. Here's a plain-English guide.
MHRA, GDC and DAMAS: What Does Each One Cover?
Understanding who regulates what is crucial for clinical and legal compliance in UK dental practices. While often mentioned together, each body fulfills a distinctly different role across the restorative pathway:
Regulatory Overview
How each regulatory body operates across UK dental practice and laboratory workflows:
MHRA
Medicines & Healthcare products Regulatory Agency
The MHRA (Medicines and Healthcare products Regulatory Agency) regulates the medical devices market in the UK. Every crown, bridge, denture or appliance we make is a custom-made medical device under the UK Medical Devices Regulations 2002.
GDC
General Dental Council
Regulates dental professionals, not dental labs directly. Mandates complete clinical patient records, requiring lab prescriptions and manufacturer statements of conformity.
DAMAS
Dental Appliance Manufacturers Audit Scheme
A quality-management system built specifically for dental labs. Independently audited annually across traceability, material origin, technician training, and QC records.
Key Takeaway: They are not interchangeable. An MHRA registration isn't a DAMAS certificate, and neither is a “GDC registration” for an individual lab technician.
Is My Dental Lab MHRA Registered?
It should be. The MHRA's guidance is clear: dental labs are the manufacturers of custom-made dental devices, dentists are the prescribers, and manufacturers must register with the MHRA before placing devices on the market.
The MHRA states plainly that registering doesn't mean it has accredited or endorsed a lab. So if you see “MHRA approved” on a lab's website, treat it with care. Registration is a legal baseline, not a certificate of clinical excellence.
Verified UK Medical Device Manufacturer
Ambridge Ceramics is MHRA registered (Reg. 5775)
What Does the GDC Have to Do with My Lab?
The GDC regulates you, not us. But it matters to your lab choice, because the GDC expects you to keep complete patient records, including the lab prescription and the statement that comes back with the work. If your lab doesn`'`t send that statement, you have a gap in your records.
What is DAMAS Accreditation?
DAMAS is the quality system made for dental labs. A registered lab is audited against the DAMAS specification. The auditors look at real records, such as lab tickets, purchasing, cleaning logs, staff training and internal audits. It`'`s voluntary, which is exactly why it`'`s worth asking about: a lab that holds it has chosen to be checked.
Independently Audited Laboratory
Ambridge Ceramics is DAMAS registered (Reg. 040111)
What is a Custom-Made Device Statement?
It's the document that travels with the work. It identifies the device and the patient, names the prescribing dentist, lists the features you prescribed, confirms the device meets the essential requirements, and gives the manufacturer's name and address.
What Must Be Included in a Statement of Conformity:
The law requires one for custom-made devices in Class IIa and above, and the MHRA says it should be available to the named patient. Rather than leave anything to chance over which category a case falls into, we send a Patient Statement with every custom-made device that leaves our lab. That makes it simple for you to keep your records complete and to offer the statement to your patient.
Five Questions to Ask Your Lab
Whether you are evaluating a new lab or auditing your existing suppliers, these five questions will tell you immediately whether the laboratory operates with rigorous compliance:
Five Questions Every Dentist Should Ask Their Dental Lab
A compliant, professional dental laboratory will be able to answer all five without hesitation and readily provide documentary evidence:
Are you registered with the MHRA, and what's your registration number?
Dental labs manufacturing custom-made medical devices in Great Britain must be registered with the MHRA before placing items on the market.
Are you currently DAMAS registered, and can I see the evidence?
DAMAS provides third-party audited assurance of the lab's quality management system, materials traceability, equipment calibration, and staff competence.
Will every applicable case come with a custom-made device statement?
Required under the UK Medical Devices Regulations 2002 for Class IIa+ devices. This forms an essential part of your compliant GDC patient records.
How do you trace materials and work through the lab?
The lab should have robust tracking of lot numbers, batch records, alloy/ceramic origins, CAD/CAM milling logs, and certified CE/UKCA dental materials.
How do you check finished work against my prescription?
A rigorous multi-stage quality control protocol ensures the shade, occlusal scheme, contact tightness, and margin fit match your clinical Rx precisely.
A good lab will answer all five without hesitation.
MHRA vs GDC vs DAMAS: A Simple Comparison
Here is a side-by-side summary highlighting how each body impacts your practice and laboratory workflow:
MHRA vs GDC vs DAMAS: Quick Comparison
Understanding regulatory roles, jurisdiction, and what dental practices must verify.
| Comparison Area | MHRA | GDC | DAMAS |
|---|---|---|---|
| Who it covers | Medical device manufacturers, including labs | Dental professionals | Dental labs (voluntary) |
| What it does | Regulates the devices market | Sets professional standards and record-keeping | Audits lab quality systems |
| What your lab should show you | Registration number | (Applies to you, not the lab) | Current registration evidence |
Frequently Asked Questions
Quick answers to the most common questions UK dental clinicians have regarding regulatory bodies, quality audits, and laboratory documentation:
The Bottom Line
Good dentistry deserves good paperwork behind it. If you'd like to see our MHRA and DAMAS registration evidence, or a sample custom-made device statement, just ask.
Call us on 01765 607347 or send a message through the website, and we'll send them straight over.
R Mark Ambridge CDT RCSed
Managing Director, Ambridge Ceramics • Technician Director, BACD Board
With over 43 years at the bench in advanced restorative and implant dental technology, Mark leads Ambridge Ceramics with a dedication to clinical precision, high craftsmanship, and gold-standard regulatory compliance.
References & Regulatory Sources
Official UK Regulatory Documents & Standards:
- MHRA / GOV.UK: Custom-made devices in Great Britain (updated July 2026 )
- MHRA / GOV.UK: Register medical devices to place on the market
- General Dental Council: Standards for the Dental Team — Maintain and protect patients' information
- DAMAS: About DAMAS (Dental Appliance Manufacturers Audit Scheme)
- DAMAS: The DAMAS auditing and inspection process
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