Rising MHRA registration fees: a mounting burden for dental labs

Steve Campbell explains why the proposed rise in MHRA registration fees could disproportionately affect dental laboratories – and what is being done to challenge it.

From April 2026, the Medicines and Healthcare Products Regulatory Agency (MHRA) introduced a new annual charging structure for medical device registration.

Manufacturers are now charged £300 each year for every chargeable GMDN Level 2 category, or Level 1 where no Level 2 exists.

During the introduction of the system, there was considerable uncertainty over how dental devices should be categorised and very little dental-specific guidance available to laboratories. The DLA, worked with the MHRA, obtained clarification and helped members understand which categories applied to their products, reducing the potential financial exposure for many.

Another substantial increase

You might reasonably have expected everyone to be given time to see how that new system operated. Instead, only months after its introduction, the MHRA launched another consultation proposing to increase the annual charge from £300 to £511 from 1 April 2027. That is an increase of more than 70% in 12 months.

I make no apology for saying that the DLA considers an increase of that magnitude extraordinary. Government talks about supporting small businesses, reducing regulatory burdens and providing businesses with greater certainty. Those commitments have to mean something in practice.

Reducing the cost of government cannot simply mean transferring more of that cost onto small businesses through higher compulsory fees.

Is the system proportionate?

Medical devices encompass an enormous range of risk. Some devices understandably require significant post-market surveillance, investigation, safety action and regulatory resources.

But dental laboratories predominantly manufacture individually prescribed custom-made medical devices. Yet a micro dental laboratory can face the same unit charge for a GMDN category as a vastly larger medical device manufacturer.

We believe risk, scale and actual regulatory workload should matter.

Questions that need answers

How many dental laboratories have been inspected? What non-compliance has been identified? What does regulating our sector actually cost?

If dental laboratories are being asked to pay considerably more, those are entirely reasonable questions. In response, we prepared a formal challenge calling for the proposed increase to be paused and the underlying charging structure reviewed. We sent it to the MHRA, relevant government ministers and parliamentary select committees.

We also mobilised our membership, we provided members with guidance for responding to the consultation and a separate template letter that could be sent to their constituency MPs. The objective was to ensure that government heard both the collective voice of the DLA and the voices of the individual businesses that will actually have to pay these fees.

On 10 September, we received a formal letter from Lawrence Tallon, chief executive of the MHRA. The MHRA has acknowledged the DLA’s concerns and confirmed that our representations will be considered alongside the other consultation responses. Most importantly, the chief executive has confirmed that the MHRA will contact the DLA directly to arrange a meeting to discuss our concerns in greater detail.

We welcome that meeting, but our position has not changed.

What happens next?

We will be asking the MHRA to justify the proposed 70% increase. We will ask for evidence about the actual cost and level of post-market surveillance associated with dental technology. We will challenge whether a charging system that does not adequately recognise differences in manufacturer size, device risk and regulatory workload is genuinely proportionate and we will continue to make the point that cost recovery cannot become a blank cheque handed to a regulator and ultimately paid for by compliant small businesses.

The DLA supports strong regulation. We support effective post-market surveillance. We support patient safety without reservation, but good regulation must also be proportionate, transparent, accountable and evidence-based.

The job is not finished.

Our objective now is to use that engagement to secure a fairer outcome for DLA members and to ensure that the voice of UK dental laboratories is heard clearly when decisions affecting their businesses are made.

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