Draft Medical Devices (Fees Amendment) Regulations 2026
Debate between Zubir Ahmed and Caroline Johnson(2 weeks ago)
General CommitteesRead Full debate Read Hansard Text Read Debate Ministerial Extracts
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.
World Stroke Day
Debate between Zubir Ahmed and Caroline Johnson(3 months, 1 week ago)
Westminster HallRead Full debate Read Hansard Text Read Debate Ministerial Extracts
Westminster Hall is an alternative Chamber for MPs to hold debates, named after the adjoining Westminster Hall.
Each debate is chaired by an MP from the Panel of Chairs, rather than the Speaker or Deputy Speaker. A Government Minister will give the final speech, and no votes may be called on the debate topic.
This information is provided by Parallel Parliament and does not comprise part of the offical record
Dr Ahmed
My hon. Friend must have read my mind. As I was saying, our plan is only for England. Hon. Friends have already articulated the fact that in Scotland, despite the best efforts of clinicians in Glasgow, Edinburgh and Dundee, there has not been the ability—or the intent from the Scottish Government—to bring forward a proper 24/7 stroke thrombectomy service. That means that the time of day that Scottish patients have a stroke determines the outcome. They are literally being dealt a roulette wheel of care: 20th-century care out of hours and 21st-century care within office hours. It is simply unacceptable, and the UK Government stand ready to assist the Scottish Government in any way, shape or form they require to make sure that access to the highest quality of care is as available to patients in Scotland as it is to those in England.
Dr Caroline Johnson
I am grateful to the Minister for answering the question and talking about universal services being available from next year. Can he confirm whether they will be 24/7 and what he means by “universal”? If someone is living in a rural area, what is the greatest distance or time they should expect to travel to get to their local thrombectomy centre?
Dr Ahmed
What I mean by “universal” is indeed 24/7. As the hon. Member well knows, there are always challenges in delivering stroke care and heart attack care to rural communities. She, as a clinician, knows that we try our best, through the ambulance service and other forms of repatriation, to try to make sure there is equitable access wherever we can achieve it.
I thank my hon. Friend the Member for Stratford and Bow again for her kind words about the very small part that I played in her husband’s diagnosis. I am glad that he continues to do so well. I want to pay tribute to some of the charities involved in this space, because they have been instrumental in the innovation in stroke care over the past 20 to 30 years. I thank the Stroke Association, Different Strokes and Chest, Heart and Stroke Scotland for the incredible work that they do, including in my own constituency.
As the fourth largest cause of death for adults, stroke has a devastating impact on patients, families and the wider community. About one third of people who suffer a stroke will be left with some form of long-term disability. This is an important inequalities issue, as has already been discussed in this debate. Cardiovascular disease hits hardest in the most deprived parts of our country, including in parts of my own constituency, where people are more likely to smoke and less likely to have access to decent food and open green spaces. This Government were elected on a manifesto to tackle the biggest killers, including cardiovascular disease, and our health mission is committed to reducing deaths from heart disease and strokes by a quarter in the next 10 years.
I want to set out our reforms to the NHS, especially those which are part of our 10-year health plan, which will drive down rates of disease while helping people to live well for longer. Many Members in this Chamber are familiar with our three shifts: moving more care into the community, advancing the cause of digital health, and prioritising prevention over treatment.
On prevention, as much as I love my job as a surgeon I am still rooting for the public health Minister to put me out of business. She is taking forward strong preventive measures in her brief, through our Tobacco and Vapes Bill and by beefing up the NHS health check, which is England’s flagship cardiovascular prevention programme. That programme helps to target the abnormalities common to heart disease, to stroke, sometimes to diabetes and to kidney disease, and in many cases even to dementia through behavioural and clinical interventions. Each year, the programme engages 1.3 million people, preventing around 500 heart attacks or strokes. To improve access and engagement, we are developing the NHS health check online so that people can use it at home. That is being piloted by three local authorities until December.
We have already begun trialling more than 130,000 lifesaving heart health checks in the workspace—in offices, shop floors and commercial areas—all across the country. That will also help to reduce the risk of stroke. The hon. Member for Sleaford and North Hykeham asked about community pharmacy. Community pharmacy can and will continue to provide free blood pressure check services for anyone over the age of 40.
On rehabilitation, the stroke quality improvement for rehabilitation programme has increased the percentage of patients discharged from hospital to community stroke services from just under 66% when this Government took office to almost 70%. There is much more to be done, of course, but I believe that we are moving in the right direction.
As hon. Members are aware, the NHS fell behind in the last 14 years—certainly behind the private sector—in using digital technology. That was an appalling inequity, so let me come to our shift from analogue to digital. Half of all people who experience a stroke in England are now recovering thanks to revolutionary scanners that mean patients can avoid the risk of serious disability. The world-first technology that is coming online will analyse CT scans of stroke patients arriving in hospital, identifying them within 60 seconds. That means that the average time between a patient arriving at a hospital and starting life-saving and life-changing treatment is shortened from 140 minutes to only 79, resulting in less disability and a greater quality of life. I am pleased to update the House that since the roll-out last summer, the tool has been used to interpret the brain scans of more than 60,000 patients.
This Government believe that working people have the right to expect the same level of rehabilitative services as the wealthy. That is why we are so gladdened by the new state-of-the-art rehab gym hub at Montagu hospital in Doncaster, which is a perfect example of the best of the NHS that we wish to bring to the rest of the NHS. The suite relies on robotic therapies, which are otherwise provided only in private healthcare. The machines combine robotics with gamified, interactive activities to enhance both physical and cognitive recovery following a stroke—an example of what the seamless integration of physiotherapy and investment in digital health can achieve for stroke patients.
We are also forging partnerships with medtech companies to deliver the next generation of healthcare for patients. Reneural, which has partnered with Hillingdon Hospitals NHS foundation trust, is bringing virtual reality stroke rehabilitation to patients, and enabling therapists to remotely deliver and monitor stroke rehabilitation. Our shift from analogue to digital is supporting both in-hospital and community-based therapy, and, in many ways, allowing equality between rural and urban communities.
I am not saying that everything is perfect—far from it—or that there will not be bumps along the way. However, in a few short months, we have improved the outcomes of more than 60,000 patients, which is a testament to the actions of this Government. Through focus, and by delivering on the promises of digital and bringing the best of the NHS to the rest of the NHS, we can, and we will, do better for stroke patients and their loved ones.
Procurement, Slavery and Human Trafficking Regulations: NHS
Debate between Zubir Ahmed and Caroline Johnson(3 months, 1 week ago)
Commons ChamberRead Full debate Read Hansard Text Read Debate Ministerial Extracts
Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
It is a pleasure to speak in this debate on the draft National Health Service (Procurement, Slavery and Human Trafficking) Regulations 2025. I thank the Under-Secretary of State for Health and Social Care, the hon. Member for Glasgow South West (Dr Ahmed), for bringing forward the regulations and welcome him to his place at the Dispatch Box.
This important issue goes to the very heart of the values that underpin our national health service. It is a vast organisation—one of the largest in the world—with supply chains that reach across many sectors and many countries. With that scale comes a responsibility to ensure that the products and services we rely on to care for patients are sourced ethically, and that the health service does not, even inadvertently, contribute to exploitation or modern slavery.
As an NHS consultant, I know that the idea that any item used in the care of patients, from surgical gloves to hospital linen, could have been produced through exploitation or forced labour is abhorrent to all of us. These regulations seek to strengthen the NHS’s ability to identify, prevent and address such risks—an ambition that I am sure commands support right across the House. Indeed, this work began under the last Conservative Government. The Health and Care Act 2022 passed new regulations to address the risk of modern slavery in NHS supply chains, and in December 2023 we delivered a review into those risks, supported by NHS England, which examined where the greatest risks lay and how they could be mitigated. Although we welcome the direction of travel, there are, however, some important questions about how the regulations will work in practice and how we will ensure that the regulations deliver what is intended in a fair way.
First, what demands do we expect that the regulations will place on the NHS? They apply to all public bodies procuring goods and services for the NHS in England, including NHS England, hospital trusts and integrated care boards. Will each organisation have to make its own separate risk assessment? Has an estimation been made of the time that that is expected to take? How many people are expected to be required for organisations to fulfil the requirement, and what will be the associated cost? Will any mechanisms be put in place to prevent duplication, for example, where suppliers are already reporting under the Modern Slavery Act 2015?
Secondly, I turn to implementation and support. Regulations are not enough on their own; they must be embedded in practice. What steps will NHS England take to support procurement teams in applying these rules consistently and effectively and in maintaining the same standards across all the public sector bodies that are covered by these regulations? The regulations require NHS England to issue guidance, which is welcome, but how comprehensive will that guidance be? With NHS England being abolished, who will produce it? Will there be accompanying training and practical support for procurement teams to ensure consistency across the system? What will happen to a supplier if they are found to be non-compliant? Will the consequences be decided by NHS England centrally, or by individual trusts or ICBs? Will there be independent oversight to assess progress? With all the churn in NHS England and ICBs and the cuts to their budgets, how will they have the time and space to do that?
Next, I turn to the impact on business. The NHS relies on a wide range of suppliers, many of which are small and medium-sized businesses that bring innovation, flexibility and local expertise. Can the Minister confirm that the new requirements will not place undue burdens on suppliers or deter small businesses from bidding for NHS contracts? We must uphold the highest ethical standards, but we must also avoid creating unnecessary bureaucracy that excludes capable businesses from contributing to patient care.
Finally, I turn to the issue of co-ordination across Government. Many NHS goods are sourced internationally from complex and often opaque global supply chains. It is crucial, therefore, that our framework aligns with the broader cross-Government effort to tackle modern slavery, including at the Home Office and the Foreign Office. I would be grateful if the Minister outlined how those links are maintained in practice.
The question of co-ordination is not new. During the passage of the Great British Energy Act 2025, an amendment was introduced in the Lords to stop GB Energy from sourcing panels linked to forced labour. The Government’s initial position was that existing laws already addressed that risk, but later down the road, the Government heeded those calls by introducing their own amendment to block GB Energy from using slavery-linked solar. That episode shows how important it is to have clear and joined-up action across Government when addressing the risks of modern slavery.
The NHS should be a beacon of integrity as well as excellence. Patients and the public rightly expect that the care provided in our hospitals is not, however indirectly, tainted by the exploitation of others. The regulations are a step forward in ensuring that our health service lives up to that ideal. We welcome the intent and the ambition behind the regulations, but we will continue to push to ensure that they work in practice and without unintended consequences.
Dr Ahmed
I am grateful for the comments of the Opposition health spokesperson. Proportionality is the theme of the day when it comes to anything that we implement in the NHS at a global scale. The appropriate training will be provided. As the hon. Lady well knows from her time in government, conversations across Departments, particularly on these issues, are always ongoing. We are always willing and able to flex as we learn and as we feel our way through these regulations. The hon. Lady will recognise their importance and primacy when engaging in supplier contract negotiations, and therefore businesses both small and large can feel confident that, if they follow ethical procurement practices, their business is most welcome in the national health service.
I want to end by reminding colleagues that these regulations are not just about what we can do on these isles but what we can do to eliminate modern slavery across the globe. NHS England is one of the biggest buying organisations in the UK. We have a golden opportunity at the moment to leverage its purchasing power to influence supply chains not only in the UK and Europe but right across the world. Today, Parliament can send a clear signal to the world that we will not tolerate human rights abuses and that, if a company wants to do business with the NHS, they must get their house in order. Under this Government, there will be no compromise with the evil of slavery. I ask colleagues from all sides to help us to keep that promise, to back our NHS and its staff and to help us to keep this country’s conscience clean. I commend the regulations to the House.
Question put and agreed to.
Resolved,
That the draft National Health Service (Procurement, Slavery and Human Trafficking) Regulations 2025, which were laid before this House on 9 September, be approved.