MHRA registration and dental device manufacture

Many members of the Dental Technologists' Association (DTA) are concerned about what appears to be in-clinic manufacturing of custom-made dental devices which does not abide by current regulatory requirements. In trying to maintain a level playing field with regard to regulatory compliance, the DTA - as a professional body - continues to provide guidance to its members and raise awareness of regulations to all professional bodies responsible for the UK manufacturer of these custom-made dental devices.

According to current regulations, in order for manufacturers of custom-made dental devices to legally comply - from the in-clinic manufacture of anything from a bruxism splint to a crown - by law, requires registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and also requires the manufacturer to provide each patient with a statement of manufacture for each device. This relates not only to the manufacture of dental devices in the UK but also to the importation of dental appliances from overseas, more of which later.

This statement of manufacture provides details about the device, including the manufacturer's address, their MHRA reg number, that it's intended use is for a specific patient, and a confirmation that it conforms to relevant standards and a registrant clinician's prescription. It also details the materials used. The clinician who prescribed the appliance is responsible for making the patient aware of this statement and must provide it upon request.

But who should comply with the MHRA registration requirements, and are there any exceptions? Some have suggested that clinicians are exempt from registration with MHRA, as they hold the view that their own in-clinic milling is not manufacturing but rather, as per the previous MDD regulation, '...adapt(ing) devices already on the market to their intended purpose for an individual patient'.

Put simply, by law, this cannot be the case. The manufacturer is not exempt just because the manufacturing occurs in the dental clinic. The DTA has consistently lobbied the GDC, governments and other professional bodies with regard to this issue saying that, as it is for dental laboratories, such in-clinic fabrication should always be regulated by the MHRA. If MHRA registration is necessary for registered dental technicians, then surely it must be the same for dentists manufacturing in their clinics.

The GDC has also presented papers to indicate that compliance with the MHRA is an essential requirement for custom-made dental devices in the UK. These requirements are made very clear in the Standards for the Dental Team 2013. GDC publication. Standard 1.9.1

It states that: If you make a dental appliance, whether you are a dental technician, dentist, or any other registrant, you must understand and comply with your legal responsibilities as "manufacturer" under the Medical Device Regulations (MDR). (ref GDC published 'Guidance on Commissioning and manufacturing dental appliances'.) This includes the legal requirement to register with the Medicines and Healthcare products Regulatory Agency (MHRA).

Registrants who arrange for dental appliances to be made

If you prescribe a dental appliance to be made by a person in the UK who is not a registered dental technician, you may put your registration at risk. Equally, you may put your registration at risk if you receive a dental appliance made in the UK by a person who is not a registered dental technician. The signing off of an appliance as fit for the market by a registered dental technician assumes that they can trace by audit the manufacturing processes and that the materials used within that process are appropriate for oral cavity use.

Registrants who sub-contract or prescribe dental appliances to be made outside the UK

If you decide to either sub-contract the manufacture of a dental appliance or use a dental laboratory or agent which sources dental appliances from outside the UK you take on additional responsibilities. These include a responsibility to ensure that the manufacturer or their authorised representative has complied with all relevant obligations in the UK Medical Device Regulations (MDR).

So, every GDC registrant that manufactures custom-made dental devices is required to register with the MHRA and provide the patient with the statement of manufacture, and the DTA will continue to indicate that this should continue to be seen as an oral healthcare team opportunity to work within the law and showcase the dental laboratories' essential role in oral healthcare.

For those who are still sceptical, then maybe the extracts from the NHS Business Authority2 will make interesting reading. See Figure 1 below.

Figure 1

A further interesting requirement of the NHS appears later in this page,3 providing direct clinician advice on their in-house milling of custom-made dental devices (see Figure 2 below). There cannot be one requirement for NHS appliances from dental laboratories and a legal case for non-compliance for private/independent dentistry in-clinic manufacturing. It's all manufacturing of custom-made dental devices and requires the manufacturer to register with the MHRA.

Figure 2

Further guidance is also provided by the government to clinicians needing to register with the MHRA because they are manufacturers of custom-made dental devices by milling in-clinic or other such manufacturing methods.4 The link provided is to GOV.UK advice on how to Register medical devices to place on the market.

It states: You must register if you or your company sells, leases, lends or gifts:

• Class I, IIa, IIb or III devices you have manufactured

• Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name

• Any system or procedure pack containing at least one medical device

• Custom-made devices

• IVDs you have manufactured

• IVDs undergoing performance evaluation

It is quite plain manufacturing of Custom- made dental devices requires MHRA registration. It is the law, and registrants need to know that this "affect(s) your work and they need to follow the requirements..." (Standard 1.9).

Within the GDC document on custom- made dental devices that require registration, the Council clearly defines a range of dental appliances that they describe as manufactured, 'mainly outside of the mouth'. The GDC then provides a range of examples, including fixed bridges, bleaching trays, crowns, splints, retainers, etc., that they regard as custom-made dental device manufacturing, thus requiring by law for the manufacturer to register with the MHRA.

Likewise, the GDC indicates that a clinician who accepts dental appliances made in the UK by an unregistered dental technician or a dental laboratory not registered with MHRA may also put their registration at risk. The Standards for the Dental Team, standard 1.9 clearly states that as a registrant 'You must find out about laws and regulations affecting your work and follow them'.

And finally, with regard to registrants signing off on overseas manufactured custom-made dental devices it can be impossible to verify the materials used in manufacture and the UK registrant - dental technician or dentist - is legally liable for any problems that might result from say, an allergic reaction to alloys used in the device once placed in the patient's mouth.

It is best to source from trusted suppliers with reputable and traceable manufactures sources. Cheap probably means suspect materials from which you could be manufacturing and then signing off custom made dental devices and for which you will be taking responsibility. This is also something that GDC registrants should be indemnified or insured to carry out.

Keeping up-to-date with such MHRA regulations is something we all as registered professionals need to do, while those wider attributes of professionalism includes displaying honesty and ethical behaviour. Within the education sector of Oral Healthcare team of professionals an updated requirement has been introduced from 2025 by the GDC called 'Safe Practitioner - Framework'6 This outlines for students a range of attributes that professionals should show such as P1.12 'Describe the responsibility that dental practices and individual practitioners have in compliance with legal and regulatory framework' therefore all team members are expected to know about the legal requirements and in particular for dental technicians the manufacturing of custom- made dental devices under MHRA (UK MDR).

Note

Regarding Medical Devices Regulations (MDR) which came into force 26 May 2020. Since 26 May 2021, the EU Medical Devices Regulation (Regulation 2017/745) (EU MDR) has applied in EU Member States and Northern Ireland. As these EU regulations did not take effect during the transition period, they were not EU law automatically retained by the EU (Withdrawal) Act 2018 and therefore do not apply in Great Britain. Therefore, refer to the UK MHRA MDR regulations for custom-made dental devices.

Please get in touch if you have any queries relating to this article, email info@dta-uk.org

References

1 Standards for the Dental Team 2013. GDC publication. Standard 1.9

https://www.gdc-uk.org/docs/default- source/information-standards-and-guidance/guidance- documents/guidance-on-commissioning-and- manufacturing-dental-appliances79b4ee91c3a64f 12b5772a26dec28601.pdf?sfvrsn=9463dd00_10#:~:t ext=From%2026%20May%202020%20the,comply%2 0is%20a%20criminal%20offence

Accessed June 2025.

2,3 NHS Business Authority.

https://faq.nhsbsa.nhs.uk/ knowledgebase/article/KA-01757/en-us

Accessed June 2025

4 https://www.gov.uk/guidance/register-medical-devices- to-place-on-the-market

5 https://www.gov.uk/guidance/register-medical-devices- to-place-on-the-market#who-must-register

6 The Safe Practitioner: A framework of behaviours and outcomes for dental professional education - Dental Technician https://www.gdc-uk.org/docs/default- source/education-and-cpd/safe-practitoner/spf-dental- technician.pdf?sfvrsn=75edb41e_3