Laboratory recently carried out a survey to find out how the profession feels about the way it is regulated and the uncertainty around illegal manufacture – find out the results here.
Laboratory’s recent survey on the regulation of dental devices and manufacturing has now closed, and the response has been strong. Thank you to all 81 people who took the time to share their views – the volume and consistency of responses reflect just how important these issues are to dental technicians, clinical dental technicians (CDTs), and laboratory owners.
The survey gathered input from technicians, lab managers, CDTs and others working across the sector.
Who can sign the statement of manufacture?
One of the key areas of confusion is around who is permitted to sign the statement of manufacture for a custom-made dental device:
- 80% of respondents said the GDC and MHRA do not make this clear
- Over 23% believe any GDC registrant can sign the statement of manufacture
- Nearly 8% believe anyone can.
So, who can legally sign? The Dental Technologists Association (DTA) has stated to its members that only a registered dental technician can do so – but is this supported by published General Dental Council (GDC) or MHRA policy? If this rule exists, what is it based on, and where can it be found? These are not minor technicalities, this is core regulatory information that professionals need in order to comply with the law.
Information sharing and illegal manufacture
Another key concern is the handling of illegally manufactured custom-made dental devices.
Some 94% of respondents believe the GDC and MHRA should have a formal policy in place to share information and take appropriate action. Yet only 6% believe such a policy exists, and 42% aren’t sure.
The result is a lack of clarity around how – or even whether – issues of illegal manufacturing are dealt with. For a profession that is expected to meet strict regulatory standards, this lack of transparency is a significant concern.
Fitness to practise and accountability
The question of liability in fitness to practise (FtP) cases was also addressed. Technicians appear to be clear on where responsibility lies:
- Nearly 96% believe the dentist should be held to account if a device fails and it was made by a non-registrant
- More than 77% said that if a registered technician warns a dentist about an issue with a device and is told to proceed anyway, the dentist should be held liable.
These responses suggest strong consensus among technicians about where accountability should sit – but is that what happens in practice?
Data collection and enforcement
Around 96% of respondents believe the GDC should collect data on illegal manufacture and the use of non-registrants in patient complaints.
Data collection is a fundamental part of modern regulation, but technicians are unsure whether this is actually happening. If it is, where is that data going, and is it informing enforcement?
Which devices fall under regulation?
Respondents also highlighted confusion about which dental devices are subject to MHRA regulation:
- Over 79% believe dentists using CAD/CAM must register with the MHRA
- Nearly 84% believe the same applies to nurses making splints or retainers
- Some 58% believe this includes bleaching trays
- More than 43% included sports mouthguards.
At the same time, 94% of respondents said there should be a clear list of regulated devices. The absence of such a list leaves room for inconsistency and misunderstanding, and it makes compliance more difficult than it needs to be.
Education and compliance
Over 98% of respondents believe dentists should be taught how to comply with the Medical Devices Regulations (MDR). In addition, 89% believe nurses should be taught this too, while 95% said that dental hospitals should also be required to comply.
If these groups aren’t being trained – or if the regulations aren’t being consistently followed – it raises the question of how well the wider profession understands the regulatory responsibilities involved in dental device manufacture.
Seeking answers
Laboratory has put these questions – and others – to the GDC, DTA and Dental Laboratories Association. The GDC initially said it would respond, then asked for more time, and now over a year later, has stopped replying. The DTA and DLA were also asked for their understanding of these issues and whether they have policies in place – both declined to comment.
The GDC is required by its own regulator, the Professional Standards Authority (PSA), to ensure its policies are transparent. Yet at present, there is no technician on the GDC Council, meaning no direct representation or route to clarity on these issues.
Meanwhile, GDC-registered technicians have faced FtP cases for errors relating to statements of manufacture – but what would happen if a statement of manufacture was signed by a non-registrant? That question remains unanswered.
Next steps
This survey shows a clear need for greater transparency and consistency in how regulation is communicated and enforced. Technicians are not asking for special treatment – they are asking for clarity, fairness and representation. They want to understand the rules they are being asked to follow.
Trade associations such as the DTA and DLA exist to represent their members. That includes helping to interpret regulation, seeking clarification when needed, and making sure their members are supported in meeting their legal obligations. If the current system leaves their members exposed, these bodies are well placed to raise the issue – and help drive change.
Will they now act? Will the PSA require the GDC to bring clarity to these unresolved questions?
The profession is waiting.
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