Dr Zubir Ahmed
MP for Glasgow South West · Labour · United Kingdom
“I commend my right hon. Friend for how she has gone about reducing the use of asylum hotels in this country, after the shocking legacy left behind by 14 years of the last Government.”
“I am grateful to my hon. Friend for making such a powerful speech; she always holds up a moral compass to us all in this place. Does she agree that those who deny access to medical treatment to children as young as four—who, while waiting for medical treatment, get to the point of near-fatal dehydration—and those who deny cancer patients…”
“The Secretary of State will know very well that Glasgow South West is home to a storied, nationally significant collection of advanced manufacturing, from Type 26 frigate construction at BAE Systems, to small satellites at Craft Prospect, to the maritime supply chain at the Malin Group.”
“I start by commending my right hon. Friend on his thoughtful and considerate approach to this investigation and other matters during his time in office. He rightly spoke about culture, and others have spoken about ideology.”
“Friend share the findings of this report formally with the Scottish Government, because many of the findings on training, culture and clinical pathways will resonate there? Unfortunately, the Scottish Government have been less than forthcoming with their own investigations into this matter.”
“I did not know Jo, but I acutely remember the day when Jo was murdered. I was working as a doctor across the river in Guy’s hospital. I remember being unable to sleep that night, and seeing my right hon. Friend the Member for Ilford North (Wes Streeting) and my hon.”
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“I can reassure the hon. Member that my hon. Friend the Minister for Care is looking at funding and primary care provision in the round in coastal and poorer communities, and I would be delighted to take back his representations about Pharmacy First in rural settings.”
“I am always grateful for the hon. Gentleman’s wise counsel. He will know that I have regular meetings with my counterparts in the devolved nations. I am well aware of some of the remuneration schemes in Northern Ireland, and I am following them with interest.”
“When we came to the topic of the potential association between traumatic brain injury and brain tumours and my hon. Friend the Member for Bury St Edmunds and Stowmarket intervened on the hon. Member for Sleaford and North Hykeham, the medical man in me could not help himself. I looked at PubMed quickly to check whether there was indeed an association, and I picked out a paper that may be of interest to the medical people in this place. Following 24 years’ worth of data from Mass General Brigham hospital, with 75,000 patients on each arm looked at retrospectively, there would seem to be a mild association between severe traumatic brain injury and the diagnosis of malignant brain tumours.”
“I can assure her that that is in play and will be published shortly, in the spring or very early summer. She asked how that might interact with diagnostic capacity, and I can assure her that we are working at great speed to ramp up diagnostic capacity through the funding envelope that I mentioned. She will know that it is important, when we plan both for workforce and diagnostic capacity, to take account of AI moving at a rapid pace. We have already been able to eliminate one radiologist from breast cancer diagnoses, and it is entirely possible that we will be able to have a similar impact with technology on the rates of other cancers and, for example, lung cancer diagnostics. It is important that, as we work through the workforce plan, we take account of what the future will look like in that context.”
“She challenged me about publishing regular outcomes from the national cancer plan, and I can certainly commit to that. Those can be scrutinised in the normal way by the Health and Social Care Committee. The shadow Minister, the hon. Member for Sleaford and North Hykeham (Dr Johnson) talked about screening. She will know, as I do, that screening is important when it is evidence-based and where the benefits outweigh the harms. Screening is never harm-free, so it is important to ensure we are calculating these things based on expert evidence. Neither she nor I are experts in screening, so we always defer to the UK National Screening Committee and its deliberations and opinions on these matters. The shadow Minister asked me about the workforce plan.”
“On that note, it was my great pleasure to meet academics from Queen’s University Belfast in this place only a few months ago, where I reaffirmed my commitment as life sciences Minister to the life sciences sector plan being a true four-nation project. That of course includes Northern Ireland, and I know from my own academic interests that much expertise resides in Northern Ireland. The hon. Member for Epsom and Ewell (Helen Maguire) talked about benign tumours not being forgotten, and she is absolutely right. Those of us from a medical background know that it is a spectrum between benign and malignant tumours. Many benign tumours can evolve into malignant tumours, and they must be captured by plans such as the national cancer plan.”
“I am always grateful for the learned remarks of my hon. Friend the Member for Bury St Edmunds and Stowmarket (Peter Prinsley). I always feel like I learn so much from him. In fact, I learned so much tonight that I might add his contribution to my portfolio of continuing professional development when I submit myself back to the General Medical Council to extend my licence. The hon. Member for Strangford (Jim Shannon) always raises thought-provoking issues about four-nation working. I assure him that I continually and frequently discuss many matters pertaining to the health of our four nations with the Minister of Health in Northern Ireland. I can also reassure him of our UK-wide commitment to the life sciences sector plan and life sciences project.”
“That issue is close to my heart, and I reassure him that through the continued opening of community diagnostic centres up and down the country and £2 billion of funding, I am determined to ensure that diagnostics is improved and available closer to home wherever possible. The hon. Member for North East Hampshire (Alex Brewer) talked about her friend being diagnosed with a brain tumour in A&E. As someone who was a young casualty officer many years ago, that resonated strongly with me. The A&E department is the last place where any tumour should be diagnosed, but I remember it happening far too frequently as a young casualty officer. One litmus test of the success of our cancer plan will be that much fewer of those diagnoses will be undertaken in an unplanned fashion in A&Es up and down our country.”
“Friend is having, and I am happy to put the council in touch with him to further those discussions regarding how we attract the brightest and the best to our country to advance the cause of life sciences generally, as well as the cause of researching rare cancers. The hon. Member for Wokingham (Clive Jones) talked more specifically about referral targets. I can reassure him that we are totally committed as a Government to hitting those national standards on 62-day waits. He challenged us to go to 100%. I caution him that although 85% is possible, 100% is not, usually for clinical reasons. There may be genuine clinical reasons why patients cannot access treatment within 62 days in terms of planning and specialist access. My right hon. Friend the Member for Hayes and Harlington (John McDonnell) talked about diagnostics.”
“Member for Mid Dunbartonshire (Susan Murray) for their thought-provoking contributions to this debate, as well as my hon. Friend the Member for Edinburgh South West (Dr Arthur), who talked so passionately about these issues. I thank him once again for bringing forward his private Member’s Bill, which will do so much to move the dial on research, not only on brain tumours but on rare cancers more generally. He had a specific ask about visa costs for talent coming from elsewhere in the world, and I assure him that we are looking seriously into these issues. Only today, I was chairing a session of the Life Sciences Council, where we talked about the global talent fund. That is pertinent to the discussions that my hon.”
“I am very happy to go away and consult with the Human Tissue Authority regarding the facility we have at the moment, which is quite sizeable, for securing consent to research on tissue from living persons and deceased persons. As a transplant surgeon, I am relatively au fait with some of the consent issues that can arise in using tissue from deceased persons, and I am always very happy to encourage consideration of those issues wherever possible. The hon. Member rightly challenged us to improve our architecture for digital consent. We continue to do so through our “analogue to digital” platform, on which the 10-year health plan is based, not only for care but for research. I thank my hon. Friend the Member for Colne Valley (Paul Davies) and the hon.”
“I start by thanking my hon. Friend the Member for Mitcham and Morden (Dame Siobhain McDonagh), and the hon. Members for Witney (Charlie Maynard) and for Kingswinford and South Staffordshire (Mike Wood) for supporting this important debate. I would like to take a few moments to acknowledge the contributions of all hon. Members across this House—from personal experience, I know how hard it is to talk about these issues when people close to your family are lost to brain tumours. They include my aunt, who was instrumental in my pursuing a career in medicine. She passed away in 1997, only four months after a diagnosis of glioblastoma. The hon. Member for Witney asked about consent in relation to tumour tissue research, which is a really important and pertinent topic.”
“I am grateful to the right hon. Member for his remarks. At the risk of turning this into some sort of medical journal club—I will move on quite swiftly, Madam Deputy Speaker—let me point out that the association is based on retrospective data, and we all know that we have to be a little bit cautious with retrospective data. As for the question of research, I can assure the right hon. Member that we are committed to spending more of the £2 billion NIHR budget on rare cancer research, some of which is ringfenced. The hon. Member for Sleaford and North Hykeham asked about rural areas. In the workforce plan, we are committed to ensuring—”
“I thank my hon. Friend for all her advocacy on behalf of all her constituents, but particularly Amani’s family. This is a story with which I am very familiar, and I can reassure my hon. Friend that I am committed to ensuring that medical research is properly funded so that, indeed, it is not the duty of bereaved parents or parents to raise the money.”
“We know that one of the most effective ways to improve survival from cancer, including brain cancer, is to catch it and treat it early, so we have committed to reducing the number of rare cancers diagnosed in emergency settings, including brain tumours, which cannot be staged like other cancers and have therefore not been previously captured by early diagnosis measures.”
“First, we aim to save 330,000 more lives by 2035 by ensuring that three in every four people diagnosed in 2035 will be cancer-free or living well with cancer five years after diagnosis. Secondly, we will achieve the three cancer performance targets, which I mentioned earlier, by the end of March 2029. Finally, we will improve the quality of life for people living with cancer. Rare and less common cancers are a priority for the Government, and this is the first ever cancer plan with a whole chapter dedicated to rare cancers. We aim to be in the top quartile of European countries for 14 rare cancers, including brain tumours, where we currently rank 22nd out of 24. We will pull every lever available to drive improvements for these cancer types.”
“Since this Government took office, over 213,000 more people are getting a cancer diagnosis on time, over 36,000 more people are starting treatment on time, and rates of early diagnosis are hitting record highs. Despite these vital signs of recovery, we know that our NHS is still failing far too many cancer patients and their families, as Members from across the House have highlighted this evening. We know that brain tumours remain one of the hardest cancers to treat, and it remains a challenging and underserved area of research. Last week, the Government published our national cancer plan. We now have a blueprint to shift the dial on rare and challenging cancers, underpinned by three key targets.”
“I am hearing my hon. Friend’s call to action loud and clear. I can report to her that—this is in addition to the other ongoing clinical trials in the area of brain tumour and glioma research—in October 2025, RECURRENT-GB opened for recruitment. This is a new UK multi-centre randomised controlled trial, supported by nearly £2 million of NIHR funding, which will explore, for instance, whether surgery can improve the quality of life for patients with glioblastoma when the glioblastoma comes back after treatment. I know that my hon. Friend will hold our feet to the fire when it comes to recruitment and the money being used appropriately, and I am delighted to continue working with her in that regard.”
“We wish to be held accountable on these commitments and to drive forward progress for rare cancer patients, and we will therefore appoint a national clinical lead for rare cancers, who will provide independent arbitration. The actions I have listed make up just a small part of our plan. It will turn cancer, which is one of the country’s biggest killers, into a treatable chronic condition. We have developed our plans with patients, charities, families and clinicians, and have heard from many Members today. We are grateful for the continued campaigning on rare cancers and brain tumours.”
“I could not agree more with my hon. Friend, and that is why NIHR funding has been specifically allocated. One of the tests for a grant is the diversity of the population it will serve. We recognise the challenges presented by brain tumours. By publishing regular performance data at a more granular level and adding diagnosis in emergency settings to our basket of early diagnosis metrics, we are committed to moving the dial on these issues. For all patients diagnosed with rare cancers, we will prioritise access to specialist treatment and multidisciplinary teams to ensure that they benefit from the best of evidence-based care. We will work with charities to support rare cancer patients, and to ensure that they have access to the right information to manage their cancer care.”
“I hope I have reassured them that we are determined to improve survival rates for patients, and ensuring that everyone has access to the highest-quality care and the highest-quality research. The national cancer plan embodies these ambitions and sets out how we will achieve them. Through our significant research investments and our support of the private Member’s Bill on rare cancers, in 2026 we will begin to shift the dial on outcomes for brain tumour patients.”
“This important legislation will make it easier for researchers to connect with patients living with rare cancers, including brain tumours; streamline recruitment into clinical trials; and ensure that our regulatory system delivers for patients. As set out in our 10-year health plan, we will ensure that the UK is a global leader in clinical research. This Bill will accelerate the clinical trials needed to deliver the most effective cutting-edge treatments and the highest-quality care for patients facing a rare cancer diagnosis. I look forward to seeing it progress towards Royal Assent. I once again thank hon. Members for giving me the chance to set out our plans on rare cancers.”
“Furthermore, we are partnering with Cancer Research UK to provide £3 million to co-fund the CRUK brain tumour centres of excellence. This will ensure that we accelerate the move from foundational research to delivering innovative treatments for patients. These investments have the potential to shift the dial and the UK’s position as a leading location for brain tumour treatment research. As reaffirmed in the national cancer plan, this Government are proud to support the Rare Cancers Bill, introduced by my hon. Friend the Member for Edinburgh South West, which passed its Second Reading in the other place last month. I thank my hon. Friend the Member for Mitcham and Morden and other hon. Members for their support and their moving contributions to the debates on the Bill.”
“Sacking people is above my pay grade, so I will revert to the Secretary of State’s opinion on that, but my hon. Friend can certainly be reassured that we will hold them accountable, just as she will hold me accountable. She might give me the sack at this rate, so I had better be careful. We are grateful for the continued campaigning on rare cancers. We look forward to working further with partners to deliver improvements in outcomes for brain cancer patients, and we know that the improvements promised through this plan rely on good research. That research has already begun, with over £25 million invested in the NIHR brain tumour research consortium, which aims to transform outcomes for adults and children —and their families—who are living with brain tumours, ultimately reducing the number of lives lost to cancer.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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 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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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 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.”
“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.”
“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.”
“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.”
“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.”