Every dental laboratory in the UK that makes crowns, dentures, aligners or other appliances to a dentist's prescription has to register with the Medicines and Healthcare products Regulatory Agency. Since April 2026 that registration has carried an annual fee. The MHRA now proposes to raise it by 70 per cent.

The proposal is in the agency's consultation on statutory fees, published on 17 August 2026. From 1 April 2027 the medical devices post-market surveillance registration fee would go "from £300 to £511 per chargeable Global Medical Device Nomenclature (GMDN) level 2 category". The consultation closed on 25 September. The MHRA has not yet published its response.

The Dental Laboratories Association, which says it represents more than 1,100 members and nearly half the dental laboratory profession, has written to Layla Moran MP, chair of the Commons Health and Social Care Committee, asking for the rise to be paused. "What [dental laboratories] should not be expected to accept is an unexplained 70% increase in a fee introduced only 12 months earlier," its director of policy, Steve Campbell, said, as reported by GDPUK. The association also argued that higher manufacturing costs could eventually be borne by practices, the NHS or patients.

What the fee is, and why it exists

The fee funds the MHRA's post-market surveillance work: collecting and acting on adverse incident reports, field safety notices and other safety data once devices are in use. That system was strengthened by regulations that came into force on 16 June 2025.

It replaced the old one-off registration fee on 1 April 2026. It is charged once a year for each GMDN level 2 category a manufacturer is registered under, however many products sit in that category. A lab making several types of appliance that fall in one category pays once.

That structure was itself a concession to dental labs. When the MHRA first consulted in 2024, it proposed charging per GMDN code at the most detailed level. Its September 2025 government response records that respondents said manufacturers of "dental apparatus" among others "would be disproportionally impacted" because they hold more codes at that level than most. The agency moved to the broader level 2 category instead, and estimated that around 60 per cent of manufacturers would pay a single charge.

The rise is the slower option

The DLA calls the increase unexplained. The consultation does explain it, although not in terms that will reassure labs.

When the fee was introduced, the MHRA said the 2026/27 rate would be part-subsidised by government and that it would move to full cost recovery in 2027/28. The new consultation says it is now "proposing not to move to full cost recovery next financial year but to continue with the phased approach for 2027/28 and 2028/29". The £511 figure includes an 8.93 per cent inflation uplift applied to most MHRA fees, and still reflects a continued partial government subsidy of £8.45 million for 2027/28 and 2028/29.

In other words, £511 is the regulator's cushioned number. The full cost of the service is higher, and the consultation says the MHRA will "explore longer-term options for PMS funding" rather than committing to a figure. A lab owner reading this should plan for £511 as a floor rather than a ceiling once the phasing ends.

There is no relief for small firms. The MHRA's fee guidance states that it "will not offer waivers, SME rates, instalments, or payment plans" on this fee. The consultation proposes a new support scheme for small businesses, but it covers only new medicines, scientific advice and clinical trials, not device registration.

THE SLOWER OPTION
The 70% rise is the cushioned step: the full-cost fee behind it has no figure and no date.
The MHRA device registration fee would rise from £300 to £511 in 2027/28, and the full-cost fee that follows has no figure or dateA chart of the MHRA’s annual post-market surveillance registration fee per GMDN level 2 category, by financial year, from a zero baseline. Before April 2026 there was no annual fee, only a one-off registration charge. In 2026/27 the fee is £300. From 1 April 2027 the MHRA proposes £511, an increase of £211 or 70%, highlighted. For 2028/29 the fee has not been set and remains part subsidised. The full-cost fee after that has not been published; the full-cost fee is drawn as an open hatched area above £511, because the proposed fee still reflects a government subsidy. A track above the chart shows that the September 2025 plan put full cost recovery in 2027/28, and that the August 2026 consultation has moved it later with no date. Source: MHRA consultation on statutory fees (August 2026) and its September 2025 government response.ANNUAL FEE PER GMDN LEVEL 2 CATEGORYFull cost recoveryPlanned, Sept 2025Now: no date set£0£200£400£600Fee not yet setstill subsidisedFull costnot publishedNo annual feeone-off charge£300£511Proposed1 Apr 2027+£211+70%Before Apr 20262026/272027/282028/29After that
Bars show the annual fee per GMDN level 2 category from a zero baseline. The full-cost fee is unpublished, so it is drawn only as open above £511, the still-subsidised figure; the track above shows full cost recovery slipping from 2027/28 to no stated date.Source: MHRA, Consultation on statutory fees (August 2026), Proposal 6; MHRA, Government response on medical device fees (September 2025). The Reliance.

What it means in money

For a lab registered under one category, the rise is £211 a year. That is small next to a lab's other costs, and the DLA's objection is as much about direction and predictability as the sum itself. Its members are mostly small and micro businesses, and they have now had two fee changes in two years with a third implied.

A lab working across several categories pays the increase on each. The MHRA said in 2025 that it believed its register held "some obsolete products", and its fee guidance tells manufacturers to check their registered categories in its online registration system (DORS) so they are charged only for devices they still place on the market. For a lab, tidying that list is the one lever it has over the bill.

What this means for your practice

Expect it in lab prices from April 2027, if it goes ahead. On its own, £211 a year per category will not move a lab's fees much. Combined with materials, wage and energy costs, it is one more reason for a lab to put up prices at the start of the financial year. If you are negotiating a fee schedule with your lab this winter, ask whether it includes the MHRA fee change and for how long prices are fixed.

Don't be surprised if smaller labs consolidate. Fixed regulatory costs that rise faster than inflation weigh most on one- and two-person labs. If you depend on a small local lab, a conversation about its plans now is cheaper than finding a new lab in a hurry.

If your practice makes its own appliances, check your position. Chairside milled crowns, printed occlusal splints, bleaching trays and in-house aligners are all made to a patient-specific prescription. MHRA guidance names dental practices as health institutions, and says that where a device meets the definition of a custom-made device, the custom-made rules "should take precedence" over the health institution exemption. Manufacturers of custom-made devices must register with the MHRA before placing them on the market. The guidance does not spell out how that applies to a practice making appliances for its own patients. If you make devices in-house and are not registered, get a written answer from the MHRA rather than assuming you are exempt.

Check your lab's registration. Registration is public on the MHRA's device register. Confirming that the lab you use is registered, and that the statement MHRA guidance requires comes with each custom-made device, takes a few minutes and is worth doing before the fee change prompts some labs to rethink their registrations.

The decision now rests with the MHRA and the Department of Health and Social Care. The consultation was UK-wide, run jointly with Northern Ireland's Department of Health. A government response, and the regulations to set the new fee, would need to follow before April. We will report the outcome when it is published.


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