Draft Medical Devices (Fees Amendment) Regulations 2026

Caroline Johnson Excerpts

Wednesday 21st January 2026 General Committees

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

It is a pleasure to serve under your chairmanship, Ms Jardine. I agree that post-market surveillance is important for patient safety, but predictability for businesses and reducing the burden on them is also important.

On 12 May 2025, the Minister for Secondary Care, the hon. Member for Bristol South (Karin Smyth), said that the SI that we were discussing on that occasion—the Draft Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025—would increase the fees across the MHRA for devices from June. That included fees for various things, most of which were increased by between 9% and 16%, but some fees, such as for clinical investigation charges, were increased much more. She said at the time that this would

“ensure cost recovery until 2027”.—[Official Report, First Delegated Legislation Committee, 12 May 2025; c. 3.]

It is now January 2026 and the Government are back for more money. Why is that? They increased the fees for regulation 53 of the Medical Devices Regulations 2002—a regulation that the regulations that we are debating today also affect—from £240 to £261 back in June, and they plan to increase them again.

Let us consider why. In May, I raised some questions about the impact assessment produced for that legislation, for two reasons. First, it did not appear that the national insurance increase or the reduction in the national insurance threshold had been accounted for in the calculations. Secondly, the impact assessment assumed a 2.2% pay rise for civil servants for the years 2024-25 to 2026-27. Even then, that level was below inflation.

Regarding staff costs, the Minister in that debate said she thought they were NHS staff, but she later wrote to me to confirm that the national insurance contribution hikes were payable by the MHRA because the staff were civil servants. In response to my written questions, the Minister declined to say whether national insurance was included, but assured the House that the MHRA had “modelled…future costs”, that the uplift would be enough until April 2027 and that the MHRA would find “efficiency savings” if required to manage any future shortfall.

I asked the MHRA, by way of a freedom of information request, what increases it faced in national insurance costs as a result of reductions in the thresholds and increasing the rate. It said that it faced a yearly cost of £1.9 million. I also asked:

“What estimate has the MHRA made of the additional cost arising from the difference between”

the pay rise estimated in the impact assessment and the actual pay rise that was given. The answer was £1.2 million. That is a shortfall of £3.1 million, or 20% of the increase in fees from the last SI.

The MHRA said at that time that

“we believe that, while this extra cost”

—national insurance—

“was not included, our fees cost-recovery methodology and approved fees are still sufficient to cover projected costs over the next two years, without any negative impact on service delivery or financial sustainability.”

That letter was dated 1 August 2025, which is after that PMS legislation came into effect. There was a significant difference between the calculations that the MHRA produced and the £3.1 million figure, which raises questions about their accuracy and the grip that the Government have on the detail and our public finances.

The Government are now here again, wanting to increase the registration fee by an additional 15% to £300, but this time with no impact assessment. The regulations that we are discussing today not only increase the registration fee by 15% from April 2026, but add a maintenance fee of £300 for each device in a category listed, starting with

“the fee period immediately following that in which the person paid the fee for the device registration…due on the first day of each…period”.

That would seem to mean that if a device is registered between now and April, they pay £261 now and £300 on 1 April, which will presumably incentivise delaying any current registrations. I can see that the Minister has adjusted for this in future years, but he does not seem to have done so for those registering this year.

I am interested in how sure the Minister is that his estimate for the increase in the post-market surveillance of £17 million is robust, given that we are back six months after the Government were sure they had enough. This year, the de minimis assessment says that £6 million will come from grant in aid from DHSC, £4.9 million from DHSC financial support and £6.1 million from the fee income. The current registration fees are predicted to produce £1.6 million, leaving a difference of £4.5 million to be covered by fee increases.

The de minimis assessment’s best estimate says that the MHRA needs to make £4.3 million of that, which is £300 a year on each of the devices, in the way that the Minister described. However, it also says that

“we plan to seek approval for full cost recovery fee for subsequent years”,

which the Minister has confirmed is his plan today. Why is that not in today’s regulations? Is that because it would have required an impact assessment? How much will this cost businesses? This will be a further £10.9 million and, if £300 a year will get the Minister £6.1 million, then for £17 million he will need about £836. That is a massive increase on businesses coming down the track next year, which I do not think he has fully considered.

Burdens on businesses are important because they stifle activity and innovation. This Government have already added significant burdens to businesses: higher taxes and national insurance rates, the reduction of the national insurance threshold, the Employment Rights Act 2025 and, for family-owned businesses, the business property relief. They are now adding further costs, and I am concerned about the effects on innovation and early access to devices for patients.

What is the Minister’s assessment of international comparators? In recent times we have seen a loss of pharma investment in the UK. Will the extra fees this year, and the prospect of hikes next year, deter investment? There is no impact assessment, so how can we be sure? I am particularly concerned about small businesses and microbusinesses. The de minimis assessment says that it is not possible to exempt microbusinesses. Why is it not possible? It is a political choice not to exempt them, but it is certainly possible to produce regulations that do.

As the Minister described, the consultation revealed widespread concern, with only 10% support. Changes have been made following discussion with a trusted advisory group. Who is in the trusted advisory group? Whose voices from micro and small businesses were heard in that group? There has been no further consultation and no impact assessment on the regulations the Minister has presented today.

I also have some specific questions about obsolescence. Do businesses need to pay a registration maintenance fee for putting a product on the market to sell or lease? That was previously a single charge that lasted for the product’s lifespan, however long that would be. There is now an annual fee. What provision is made for the clinical use and post-market surveillance of items that cease to be registered because a company goes bust or stops selling the item? Can the item still be used? How would a clinician know that the lapse of a previous licence had stopped, particularly if it was a personal piece of medical equipment such as a stethoscope? How does that affect post-market surveillance?

Could registration be discontinued for some items, where someone has several categories possible, in order to register another category and force obsolescence? For example, I have seen one case where the failure to produce spare parts lead to an entire trust having to replace every single defibrillator, at great expense. If a company went bankrupt and was no longer able to pay its post-market surveillance fee, the item would no longer be registered. How would that work?

I also want to ask about categories. Originally, as described in the consultation, the GMDN category was level 5, which is extremely specific. It is now level 2, which is better, but microbusinesses still pay the same charges as larger businesses, so a business selling one product would pay the same as a business selling dozens of products in the same category. Also, there is no accounting for the size of the product or the surveillance required. For example, the charge for an MRI scanner, worth £2 million, would be the same for as a single-use scalpel worth less than £1. Is that fair? I appreciate that people may sell more scalpels than scanners, but what about an umbilical artery dilator, of which not too many are used, at £24 each? Producers of inexpensive but highly specific and useful devices may be disadvantaged. What will the effects be on costs for patients? Again, there is no impact assessment, so we do not know. How much of the cost produced by these regulations does the Minister expect to be transferred back to the Government in paying for more expensive devices?

Overall, there are many more questions raised than answered by these regulations. Patient safety is paramount. There is, of course, a cost to ensure that devices are properly and proportionately regulated, but the Government also need to be responsible and careful with money. As they are, the regulations are a blunt tool adding costs to businesses and a promise of much more cost to come. There is no proper impact assessment, and there is a risk to small businesses and microbusinesses and to inexpensive, low-volume items. As such, I cannot support the regulations.

--- Later in debate ---

[Dr Ahmed]

I turn first to the Opposition spokesperson, the hon. Member for Sleaford and North Hykeham. Like me, she is a scholar of medicine, and she practiced in the NHS throughout all 14 years of the last Government. She will know, possibly at first hand, that the MHRA as a regulatory body has not been fit for purpose for a long time. It has lagged behind the inventions and innovations now available to patients, particularly in medical technology. She will also know it is this Government who are placing the MHRA at the service of patients by being bold in our reforming agenda and our leadership in regulating medical technology.

The proof point of that reform is our consultation with trusted groups, including trade associations such as the Association of British HealthTech Industries, the British In Vitro Diagnostics Association and the British Dental Association, all of which were consulted extensively over the course of these regulatory proposals, and with which I engage on a regular basis to garner their support, so that at every step of the way our life sciences sector plan is facilitated by our regulatory institutions and authorities. Indeed, the MHRA was present last week in front of a number of innovative biotechnology companies, whose message was loud and clear: they view the UK’s regulatory framework as first in class, innovative and forward-thinking, and they therefore see investing in our country as an attractive proposition.

On the impact assessment, I assure the Opposition spokesperson and the hon. Member for Winchester that we are not avoiding an impact assessment. In fact, we are supporting industry with a phased approach to fees, and we are open to an ongoing consultation and dialogue as this fee structure comes into place next year and the year after.

My hon. Friend the Member for Worcester is a learned Member of this House, and I entirely take on board his comments regarding insulin pumps. Wherever possible, in the discussions that I have had with my officials and the MHRA, we have said that this fee structure should include the totality of a device, rather than its component parts. I am very happy to take his comments back to my officials, so that we can make sure that he and his constituents are satisfied that there are no unintended consequences in that regard. I thank all Members for their contributions, and thank you, Ms Jardine.

[Dr Johnson]

The Minister is making a great speech, but he is not answering lots of the questions—I appreciate that he may not have all the answers. Can he commit to answering them by letter? Will he also talk about the possibility of obsolescence? If an item ceases to be registered—he is encouraging people to deregister things that they are no longer selling—can it still be used in the NHS? How would a doctor know whether something had ever been registered in the past and was safe?

[Dr Ahmed]

I am happy to write to the hon. Lady to give her a fuller answer. She knows that procurement in different parts of the NHS rightly reflects local clinical practices, although there are overarching national frameworks for buying such products. Innovation lends itself to the fact that, over time, patients will want to choose and move on to newer forms of devices that treat their conditions in line with the latest clinical evidence. I am very happy to write to her more extensively on obsolescence and her other questions.

I would like to address some points made on the following topics: the impact on SMEs; the impact on market attractiveness more extensively; GMDN suitability and transparency; clarity on costs; and the evaluation of value for money. I also want to make some points regarding Northern Ireland. On SMEs, as the Opposition spokesperson highlighted, I recognise that new regulatory costs can be felt more sharply by smaller firms, and the MHRA has listened carefully. That is why the fee has been designed to spread costs more equitably across the sector, and the majority will pay only £300 per year.

Following consultation feedback, charging is based on the number of GMDN level 2 categories that a manufacturer’s registered device falls into, rather than the much more granular level 5. That matters for SMEs because they are more likely to have closely related product variants that may attract multiple level 5 terms, but sit more generally within a single level 2 category. Under this approach, multiple products in one level 2 category are therefore charged once per year, reducing the need for repeat charges on minor product variations.

The MHRA estimates that around 56% of manufacturers will pay a single unit fee of £300 a year, and SMEs are most likely to fall into that group, because they typically have a narrower product range than the larger companies. The MHRA is not offering waivers or special SME rates. The charge is designed to be proportionate, and any waiver would simply shift costs elsewhere. The intention is to keep the charge predictable and proportionate, and to phase it in.

Finally, SMEs stand to benefit from a stronger PMS framework, leading to earlier identification of issues, fewer surprises and a more risk-proportionate and predictable regulatory approach that supports responsible innovation. I must make it clear that we are not asking for more money: we are simply changing the MHRA’s regulatory framework to put it on a more sustainable footing so that in the future it is less reliant on the taxpayer and, therefore, more pro-innovation, more pro-market and better able to have a healthier commercial relationship with new and established companies.

On innovation and UK attractiveness, a robust PMS framework is not a brake on innovation—far from it. It helps to make the market more predictable and investable, as per my conversations over the last couple of weeks with major and smaller biotech industry firms. In developing this instrument, we have ensured that the Secretary of State must have regard to three considerations set out in the Medicines and Medical Devices Act 2021: safety, availability, and the attractiveness of the whole of the United Kingdom as a place to research, develop, manufacture and, crucially, supply medical devices. This fee supports safety by ensuring the MHRA has sustainable funding for strengthened PMS, so that risks can be identified and acted on sooner. It supports availability by underpinning a stable and predictable system of oversight that helps to maintain continued safe access to effective devices.

[Dr Johnson]

Will this post-market surveillance continue if a device ceases to be registered?

[Dr Ahmed]

The anticipation would be that post-market surveillance will continue if devices are still used in a clinical setting.

PMS supports UK attractiveness by strengthening confidence in the market for patients, clinicians and investors, and by resourcing a more risk-proportionate, innovation-friendly approach to regulation, including making better use of real-world evidence and enabling more flexible and efficient regulatory burdens over time. A stronger PMS framework will also reduce uncertainty for innovators by enabling earlier proportionate action and helping to avoid sudden escalations that can disrupt plans or supply. By improving real-world evidence and post-market detail, it will also strengthen confidence in the UK as a place to generate evidence, invest and bring new devices to patients.

Hon. Members, including the hon. Member for Sleaford and North Hykeham, asked questions about global medical device nomenclature as the basis for apportioning costs. GMDN is internationally recognised for naming and grouping medical devices and is already used for UK device registration through the DORS, since 2018. Using GMDN categories means that the fee can be calculated from information that manufacturers already provide, making it less onerous, rather than creating a new system for reporting requirements purely for charging purposes. That helps to minimise the administrative burden across the sector, including for SMEs.

Category-based charging is also a practical and broadly proportionate proxy for the breadth of devices and types a manufacturer places on the market and, therefore, the likely level of PMS activity. It avoids a per-device approach and the complexity and burden of trying to calculate an actual PMS cost for each manufacturer.

On transparency, the MHRA is improving DORS, so as of 1 April account holders can see the chargeable GMDN level 2 categories linked to their registrations. Ahead of the go-live, MHRA has written directly to all manufacturers with their estimated fees so that they can check in advance their registration data and plan their budgets accordingly.

On clarity of costs, the consultation proposed an annual fee of £210 per GMDN term at level 5. The feedback was clear that that would be disproportionate, because level 5 is more granular in some areas than in others, exposing SMEs and manufacturers of devices such as in vitro diagnostics and surgical instruments to higher costs. In response, the MHRA redesigned the fee, so its charging is based now on the GMDN level 2 category, which is much broader, and consistent across product ranges. The unit price is higher because there are fewer level 2 categories than level 5, so the amount to recover is spread across fewer units, and the cost base has been updated to reflect inflation since the consultation.

The fee is also being introduced with a phased approach to give manufacturers time to adapt. The PMS has been fully subsidised by the DHSC in the year 2025-26, and this instrument introduces a part-subsidised annual fee model by 2026-27. The intention is to move to a fully cost recovery annual fee from 2027-28, once the new arrangements are embedded and a full impact assessment can be prepared.

On value for money and evaluation, the main objective of strengthening post-market surveillance is to improve health outcomes by increasing the quality and quantity of safety and performance data, and reducing the time from identifying a risk to making a corrective action. That supports patient safety and continued access to safe, effective devices and enables a more risk-proportionate, pro-innovation approach to regulation by strengthening the evidence base and supporting earlier proportionate action where needed.

[Dr Johnson]

If a device ceases to be registered, can a doctor still use it in the NHS—legally?

[Dr Ahmed]

As the hon. Lady knows, doctors are able, in certain circumstances, to prescribe unlicensed treatments to their patients if they feel it is a proportionate act to take. It is not something that is in guidelines or routinely recommended, but is at times at the discretion of individual clinicians. Clearly, that would be a peripheral activity, and something that could be looked at by local governance processes; but I am confident that these regulations strengthen the current post-market surveillance, so we are moving to a place of greater safety for the totality of the system.

The fee funds around 102 staff working across key areas, including medical device safety and surveillance yellow cards, software and diagnostics, and compliance and safety data. Roughly three quarters of these posts are existing roles, previously funded through the DHSC subsidy, with around one quarter being new posts that the MHRA expects to fill by the end of March 2026. Performance will be monitored through indicators such as the volume and quality of vigilance reporting, field safety corrective action and trend reporting, signal detection, and timeliness from the initial signal through to alerts and the corrective action being applied. The MHRA is committed to strengthening its internal metrics and producing new KPIs to track performance. These will be reviewed through the biennial fees uplift process to ensure that costs remain efficient and proportionate, and to avoid over or under-recovery.

I turn briefly to Northern Ireland. As hon. Members know, the regulatory position is different from that of Great Britain: under the Windsor framework, the EU devices regulations apply in Northern Ireland. This means that devices placed on the NI market must meet relevant EU requirements. The European Commission has recently announced that EUDAMED registration will become mandatory by May 2026. EUDAMED is the European Commission’s database that collects and stores data about devices on the EU and NI market. It is free for users, as it is funded centrally by the European Commission. In practice, that means that manufacturers, or their representatives, of devices—other than those that are custom-made—that are placing them on the EU or NI markets must register their devices on EUDAMED from 28 May 2026.

Out of a desire to avoid duplicative obligations, we are taking forward a separate piece of regulation that will mean that on 28 May 2026, devices other than custom-made ones, placed on the NI market will need to be registered with EUDAMED and will no longer need to be registered with MHRA, so the fee will not apply. Under EU regulations, custom-made devices are excluded from EUDAMED. They will still need to be registered with the MHRA, and will incur the fee.

Taken together, these regulations put the funding of the strengthened PMS on a clearer, more sustainable footing, so that those who benefit from access to the UK market contribute fairly to the ongoing regulatory work that supports their access. The fee has been redesigned in response to consultation feedback, is being phased in to give the sector time to adapt, and uses existing registration data to keep the administrative burden on business low.

Ultimately, this is about maintaining confidence in the safety and performance of medical devices, supporting continued access, and ensuring that the MHRA has the capacity to act quickly and proportionately if issues arise. I am happy to write to hon. Members if there any detailed points that I have not addressed; I have taken on board the comments of the hon. Member for Sleaford and North Hykeham and I am happy to write to her and the Committee. For those reasons, I invite the Committee to support these regulations for the sake of patient safety and our commercial environment, and I commend them to the Committee.

Question put.