Draft Medical Devices (Fees Amendment) Regulations 2026
(Limited Text - Ministerial Extracts only)
Read Full debateThe Committee divided: - Ayes: 11 / Noes: 4 - Question accordingly agreed to.
The Parliamentary Under-Secretary of State for Health and Social Care (Dr Zubir Ahmed)
I beg to move,
That the Committee has considered the draft Medical Devices (Fees Amendment) Regulations 2026.
It is a pleasure to serve under your chairship, Ms Jardine. I am grateful for the opportunity to open the debate on these regulations, which were laid before Parliament on 16 December 2025 and are due to come into force on 1 April 2026. The purpose of the regulations is to amend the Medical Devices Regulations 2002 and the Medical Devices (Northern Ireland Protocol) Regulations 2021 to update their fee structure. They do that by introducing a new medical devices registration fee, which provides additional funding for the Medicines and Healthcare products Regulatory Agency’s strengthened post-market surveillance of medical devices.
From 1 April 2026, the new annual fee will apportion the MHRA’s PMS costs more fairly across the sector and will replace the current per-application fee, which is insufficient to cover the costs of the post-market surveillance we wish to see in future. In 2026-27, the fee will be part-subsidised by the Department of Health and Social Care, with the intention that, subject to further ministerial and parliamentary approval, we will move to a fully cost-recovering annual fee model from 2027-28.
As to why the regulations are necessary in a modern MHRA regulatory framework, PMS refers to the work that the MHRA does to collect, review and act on safety and performance issues relating to medical devices on the market. The independent medicines and medical devices safety review highlighted the need for a higher-quality medical devices PMS framework. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, which came into force on 16 June 2025, were a key part of the wider reforms developed in response to the recommendations in that review. The 2024 regulations strengthen the medical devices safety and surveillance framework, improve patient safety and support the MHRA’s more risk-proportionate and innovation-friendly approach to regulation. However, they are also estimated to increase PMS workload by 60% to 70%, at an annual cost of around £17 million, so finding a sustainable funding model is vital.
Historically, the PMS of MHRA devices has been funded mainly by subsidy from the Department of Health and Social Care, and partly by the current per-application fee model. Subsidising ongoing regulatory activity through general taxation is not the MHRA’s usual approach to fees and services. The usual approach is based on His Majesty’s Treasury’s “Managing Public Money” guidance, which states that fees should be set on a full cost-recovery basis. Therefore, the regulations reduce subsidy by introducing a direct annual registration fee, so that those who benefit from access to the market fund the regulatory activity that underpins it.
On the intended operation of the regulations in practice, the new annual fee apportions the overall cost of the MHRA’s PMS activities by using the global medical device nomenclature system, which is a globally recognised system for naming and classifying medical devices. It is hierarchical, with broader groupings at higher levels and more granular entries at lower levels—for example, level 2 is a “category” and level 5 is an individual GMDN “term”.
Medical devices are registered with the MHRA using a GMDN code. Prior to placing devices on the market for use, the MHRA hosts a register of them called the device online registration system, or DORS—I am sorry, Ms Jardine, it is another acronym. The register is a valuable resource to monitor devices in circulation and to know when there are concerns about their uses. The proposed fee will be calculated using information from DORS; in practice, the MHRA will charge based on the number of chargeable GMDN level 2 categories that the manufacturer’s registrations fall into. It is important to note that if a manufacturer has multiple devices in the level 2 category, they will be charged only once a year for that category.
As the GMDN system is already in use for device registration, this approach also limits the administrative burden because fees can be calculated from existing data, rather than requiring additional information from the manufacturer, and is therefore less onerous. The MHRA consulted widely on the fee as part of its last statutory fees uplift and updated its approach based on stakeholder feedback. The consultation ran for two months, from August to October 2024, and was widely promoted and was supported by a small and medium-sized enterprise webinar.
The annual fee proposed in the consultation was £210 per GMDN level 5 term, using the most granular, fifth level of the GMDN structure. Most respondents did not support the proposal: 72% were opposed, 18% had no opinion and 10% supported it. Their concerns focused on the introduction of a new annual cost at short notice and the risk of a disproportionate impact on SMEs and areas that attract more GMDN registrations, such as in vitro diagnostics and—something that is close to my heart—surgical instruments.
In response to feedback, several changes were made. The MHRA set up a confidential, trusted advisory group of industry representatives to discuss the approach and seek further advice on implementation. That was welcomed by the members and provided useful feedback and assurance. The fee is being rolled out in a phased way to give the sector time to adapt and respond to its needs. The costs have been fully subsidised in 2025-26, and this instrument introduces a part-subsidised annual fee from 2026-27, with the intention to move to a fully cost-recovering annual fee model from 2027-28, subject, as I have said, to further ministerial review and parliamentary approval. The fee was remodelled to be charged at GMDN category level 2, rather than level 5, which is a higher, more general level, which will result in the costs being more equitably spread.
Overall, the MHRA estimates that, crucially, 56% of manufacturers will pay only £300 a year, and that 82% of manufacturers will pay no more than £900 a year. Crucially, SMEs are more likely to pay only £300 a year, as they are likely to have a more limited range of products compared with larger companies. To add further context, the medical technology sector generated £48 billion of turnover in 2023-24 and the total post-market surveillance cost was £17 million, representing 0.035% of total revenue. That is a good example of how consultation feedback and stakeholder engagement can be used to improve a proposal, in this case by modifying the fee structure to be more equitable and proportionate.
I recognise that manufacturers will always prefer to avoid additional costs, but I am satisfied that moving to a fair and, crucially, more predictable cost recovery approach to fund ongoing PMS is the right thing to do and that the changes made help to address the key concerns raised.
Finally, the MHRA has been working to help the wider medical technology sector to prepare for this change. The phased roll-out has given the sector time to adjust and get ready. The MHRA has published guidance explaining the new fee—how it will be calculated, what account holders need to do to ensure that their registration data is accurate, and how and when the payment needs to be made. The MHRA is improving the functionality of its DORS system so that account holders can see their chargeable GMDN categories, helping them to understand and check what they will be charged for in advance, to give them additional certainty. This new functionality will be ready for 1 April 2026. In the meantime, the MHRA has emailed all manufacturers directly with an estimated fee based on their registrations of November 2025.
In summary, these regulations introduce a necessary and fair annual registration fee from 1 April 2026 to help to fund the MHRA’s strengthened PMS ambitions, as well as its regulatory ambitions to make this country the world leader in life sciences and the medical technology sector. The approach has been improved in response to consultation feedback and is being introduced in a phased way to give maximum time to the sector to adapt, while ensuring that the MHRA has the resources it needs to protect patients and maintain confidence in our growing market. For those reasons, I commend the regulations to the Committee.
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.