The MHRA's New Fee Charges You for Breadth, Not Size

On 1 April 2026 the MHRA replaced its one-off medical device registration fee of £261 with an annual fee, charged per GMDN category under which a manufacturer has products registered. The MHRA has indicated approximately £300 per category per year. It applies to any company with devices registered in Great Britain, whether UK-based or overseas.

Most coverage has reported the number. The number is not the interesting part. The interesting part is the denominator.

The unit of charge moved, and that changes who pays

The old fee was per registration event: you registered, you paid once, that was that. The new fee is per category, per year. So your annual UK cost is no longer a function of how many devices you have. It is a function of how many different kinds of thing you make.

Two manufacturers, same revenue, same device count, very different bills:

• Forty catheters, all within one GMDN category — one charge.
• Four products across four categories — four charges, for a tenth of the portfolio.

The MHRA expects roughly 60% of manufacturers to pay a single charge. The other 40% is where this gets expensive, and it is not the 40% you would guess — it is not the biggest companies, it is the most scattered ones. Diagnostics businesses and surgical-instrument makers, whose catalogues span many distinct device types by nature, are structurally exposed in a way a high-volume single-category manufacturer is not.

How scattered is a typical UK portfolio?

We looked at the manufacturers in our UK listing corpus and counted how many distinct device categories each one spans. Read these as an indication of shape, not as a quote — the limits are set out in full at the bottom, and they matter.

Categories spanned (estimated)	Manufacturers	Share	Indicative annual fee
1	4,850	38.9%	~£300
2	1,577	12.7%	~£600
3–5	2,078	16.7%	~£900–1,500
6–10	1,430	11.5%	~£1,800–3,000
11–25	1,551	12.4%	~£3,300–7,500
26+	979	7.9%	~£7,800+

So for nearly four in ten manufacturers this is a £300 line item and an administrative annoyance. For the 979 at the top of the table it is a four-figure annual cost that did not exist last year, arriving without a corresponding change in what they sell.

The shift also has a second-order effect worth planning for: adding a product in a new category now carries an immediate and permanent cost, pro-rated in the year you add it. A portfolio decision that used to be commercially neutral in the UK is now a recurring line item.

What to actually do

1. Count your categories, not your devices. Your finance team almost certainly budgeted the £261 one-off, or nothing at all. The number they need is a category count, and it is not on any invoice you have received.
2. Check how your products are actually coded. This is the step that catches people, and it is the reason our figures above are a range rather than a number — see below.
3. Look at your dormant registrations. A device you registered in Britain and never sold used to be a sunk £261. It is now an annual charge for as long as its category stays on your record. If a category exists on your registration only because of a product you no longer sell, that is now a recurring cost with no revenue behind it.
4. Do not confuse this with your other UK obligations. The fee is separate from the UKCA conformity assessment, from appointing a UK Responsible Person, and from the post-market surveillance requirements that came into force on 16 June 2025 — the last of which apply to CE-marked devices on the GB market too.

Why we are giving you a range and not a number

We could publish a single figure. It would be more quotable and it would be wrong, so here is the honest version.

The MHRA charges on GMDN Level 2 collective terms. GMDN is a hierarchy: individual preferred terms sit underneath broader collective terms. We hold preferred terms across our corpus; the official collective-term hierarchy is licensed data we do not currently have. So we can bracket the answer — a rollup of related terms gives a floor, the raw term count gives a ceiling — but we cannot compute your bill. Nobody can, from public data alone.

And one product can carry several GMDN codes. This is the part most likely to catch you out, and it pushes in the opposite direction. Where a device has components with genuinely different functions, those components can take their own codes rather than the finished article taking a single system-level code the way some regulators assign it. A kit, a system, or an instrument set with distinct functional parts can therefore touch more categories than the product count suggests — which means more charges, not fewer.

Both effects are real and they point opposite ways. That is why the table above is a shape rather than a quote, and why the only reliable answer is to confirm the coding against your own specific products rather than infer it from a device count.

Method, and what this is not

The fee change is as stated by the MHRA and given effect through the Medical Devices (Fees Amendment) Regulations 2026. £300 is the MHRA's own estimate, not a final published schedule — check the current fees page before budgeting.

The distribution table is derived from Meridian Trace's UK device listing corpus — 12,465 manufacturers carrying at least one GMDN code, as at 25 August 2026. Three limits:

• These are archived UK listings, not a live registration count. The distribution describes the shape of the UK register historically. Model your own position on your own portfolio, never on this table.
• We hold GMDN preferred terms, not the Level 2 collective terms the fee is charged on. Every figure is a bracket.
• Multi-code products are undercounted in a corpus that carries one code per record, for the reason above.

This is not regulatory or financial advice. Verify against the MHRA's current fees guidance, and confirm your device coding with your UK Responsible Person or notified body before acting.