Draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024
(1 month ago)
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The Parliamentary Under-Secretary of State for Health and Social Care (Andrew Gwynne)
I beg to move,
That the Committee has considered the draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
It is a pleasure to serve under your chairmanship, Mr Efford. I will begin by setting out the policy context for the regulations.
The 2020 independent medicines and medical devices safety review, led by Baroness Cumberlege, highlighted the consequences of inadequate post-market regulations for patients, especially women, who received pelvic mesh implants. The review found that the system often failed to listen to patients’ concerns and acted too slowly when issues were identified. Those women have suffered horrendously as a result. The review called for substantial changes to the Medicines and Healthcare products Regulatory Agency, the MHRA, to ensure patient safety, including improved regulation of medical devices to enhance the collection of adverse incident data to reduce patient safety risks and prevent a recurrence of harm.
This statutory instrument will deliver improved safety for patients. It will introduce clearer and more robust requirements on medical device post-market surveillance—PMS—so that manufacturers are required to collect and evaluate the safety and performance of medical devices in a thorough and consistent manner, once they are in real-world use.
What will this mean for patients in the UK? This instrument represents the first step in a series of amendments to reform the Medical Devices Regulations 2002. These changes are designed to enhance the safety of medical devices, to ensure availability and to support innovation.
This instrument will create a strong foundation for this medtech regulatory reform and deliver patient benefits in three key areas—first, by improving patient safety. This instrument will not only enable the MHRA, but the whole health system to better protect patients by more closely monitoring the safety and performance of medical devices. This includes medical devices within the NHS and in our local communities, thereby supporting the Government’s mission to shift focus from hospital to community. This will result in more rapid identification, investigation and resolution of safety issues, allowing the NHS to focus its resources more effectively. While doing so, these regulations will also strengthen the patient voice by requiring manufacturers to undertake patient and public engagement where appropriate during their post-market surveillance.
Secondly, this statutory instrument will provide stronger assurance that devices supplied to the market are safe and effective, supporting both the continuation of supply, and improved access for the NHS and patients to potentially transformative technologies. With stronger assurance of safety and efficacy, we are able to implement new routes to market. For example, this instrument will help support the introduction of an international reliance framework, taking into account, where it is safe to do so, decisions made by comparable regulators. We intend to lay that draft legislation in 2025 as part of future medical devices regulatory reform.
Finally, this instrument will support innovation and economic growth by providing regulatory certainty for manufacturers considering placing their medical devices on our market. The collection of real-world data can result in more user-friendly and more effective innovations by highlighting opportunities for improvement, ultimately achieving better outcomes for patients.
I will now take a moment to summarise the key provisions of this instrument. Once in force, this statutory instrument will ensure that any medical device placed on the Great Britain market is subject to rigorous post-market scrutiny. This will enhance patient safety across the board, thereby promoting a consistent approach to PMS throughout the UK, where of course Northern Ireland has its own arrangements. This statutory instrument will set out in greater detail what must be included as part of a PMS system and a PMS plan. Manufacturers will need to ensure that their PMS system includes analysis of relevant data throughout the medical device's lifetime.
This comprehensive approach allows for a more accurate assessment of device performance, ultimately leading to faster identification and resolution of safety issues. This statutory instrument will provide greater detail on when and how to report serious incidents. The timelines for notifying the MHRA will be standardised throughout the UK, benefiting manufacturers that supply medical devices to both Northern Ireland and Great Britain and ensuring that safety issues are identified and investigated promptly.
The introduction of new requirements to share summary reports at regular intervals means that medical devices will be continually monitored to ensure their performance, with higher-risk devices facing even more scrutiny. These measures encourage manufacturers to monitor both serious and non-serious incidents over time, which will aid recognition of adverse safety trends and signals, supporting the containment of potential safety issues before they escalate.
I commend these measures to the Committee.
Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
It is a pleasure to serve under your chairmanship, Mr Efford. I think we all understand the context of the IMMDS review. Having spoken on Sunday afternoon to a lady who is suffering having had a mesh put in—the skin has never healed over the top and she is facing difficulties—I fully understand the reasons for the regulations. We all want safety; we all want the equipment that doctors like me use to be safe. We also all want support for the science and technology sector, and we all want people in the UK to have early access to the very best new medical devices. As such, the importance of the regulations is not just that they are there and they are strong, but that they are proportionate and effective in their aims. I have a few questions in regard to that.
First, the MHRA will be sent lots of data—reports on 3 million medical devices at one, two and three-year intervals, depending on the type of device. Is the MHRA required to look at that data, or to check whether manufacturers are required to produce these reports, or even to check that manufacturers have produced these reports? If it does have such a requirement, does the MHRA have the resources to look at all this extra data and to review it? If it does not have such a requirement, what is the point?
The cost estimate in the impact assessment talked about £310 million over 10 years, but for 3 million devices that does not seem particularly high. Six months is being given for these regulations to become legally enforced. Is that long enough for businesses to prepare and for the MHRA to get ready to look at this?
How much of this cost will be passed to the NHS, and how much has the NHS budgeted for such costs? How will the NHS comply with the legal requirement to get patient experience data? The Minister talked about the importance of getting patient experience data where appropriate, so what will the exemptions be? If someone was having a Guedel Airway put in, they would probably be unconscious and might not be aware of how effective the device was—if they woke up it would probably be more effective than if they did not, I suppose, but it is quite difficult.
Confidentiality is also an issue. If a medical device like a new hip is being put into somebody, will the Government provide information to manufacturers on who has got their hips, or is the manufacturer expected to guess? Or is the NHS expected to act as a go-between, and if so, how will that work in practice?
The regulations are also a bit of a burden on small businesses. I notice the Government have made the decision, as evidenced in the impact assessment, to include all small businesses—even micro-businesses—under these regulations. Has the Minister considered whether that will incentivise businesses to set up elsewhere, in Europe or overseas, reducing UK innovation and reducing the likelihood that manufacturers will apply for a UK Conformity Assessed mark because there is more regulation in the UK than elsewhere? Will that delay access to new devices for our patients in this country? In particular, the “similar devices outside of GB” requirement requires even the smallest businesses to find out similar devices’ safety, around the globe. That is possibly something that a large multinational corporation could do, but a micro-business in, perhaps, Oxford or elsewhere would find it difficult to find all that information. The cost proportional to the business will be extremely high, which will reduce the number of new people entering the market.
Overall, the Government have the right intention to provide for patient safety. However, the longer period that safety has to be viewed over and the additional regulation compared to the European Union mean that, once again, the Government have chosen to take an EU regulation and gold-plate it, to the detriment of Britain, and ultimately potentially that of patients.
Andrew Gwynne
I thank the hon. Lady for her valuable contribution. These regulations introduce clearer, more robust requirements for post-market surveillance of medical devices, to improve patient safety and to signal a crucial shift in the way in which we manage medical devices in Great Britain.
The hon. Lady raised some important points. First, on the MHRA and whether it is appropriately resourced to cope with the likely increase in incident reporting as a result of this regulatory change, let me reassure her that the measures introduced in this instrument should not have a significant impact on MHRA capacity. Its systems and processes to provide regulatory oversight for vigilance reporting are already in place. The measures within this statutory instrument are expected to increase the volume of safety data reported to the MHRA. However, the accompanying improvements to data quality will support automation and reduce burdens associated with data analysis. To ensure that the MHRA’s systems for vigilance reporting are fully equipped to handle the new reporting requirements for manufacturers, we will verify system-readiness through comprehensive testing and validation ahead of the date of application of these regulations.
As the regulator for the whole United Kingdom, the MHRA is committed to protecting patient safety while enabling a regulatory environment in which the life sciences sector is able to innovate and to launch new medical products in the interests of public health across the UK. Contrary to the hon. Lady’s assertion that the regulatory burden will be increased and will therefore squash innovation, the opposite is the intention of this Government. The intention is to ensure that there is a clear regulatory framework throughout the United Kingdom—without having the disparities that we have at the moment—and to ensure that better, smarter use of the data will be available. The closer scrutiny of the efficacy of these medical devices will encourage innovation in medtech and in life sciences.
Dr Caroline Johnson
The Minister is saying that more regulation will encourage innovation. I am not sure I agree with that premise, but does he accept that these new regulations will lead to a higher regulatory burden on people wanting to set up medtech companies in the UK than in the EU or elsewhere?
Andrew Gwynne
We could get into a theological debate about the benefits or otherwise of regulations, but this statutory instrument will provide certainty and clarity across all four nations of the United Kingdom. It will provide a known framework for medtech and life science companies operating, or wishing to operate, in the UK. I see this as a good piece of secondary legislation to bring about the certainty that we want to give companies wishing to operate, or which are operating, in the United Kingdom, and to set up a common framework across our four nations. I see that as good. Regulatory divergence with another part of the United Kingdom is not, in my mind, good for business—particularly where a company wants to operate on both sides of the Irish sea.
On patient confidentiality and the cost estimates for the NHS, I hope the hon. Lady will forgive my having to write to the Committee on that point because the tablets of stone have not yet reached me from Mount Sinai.
On the hon. Lady’s question on innovation being reversed and whether people have long enough to prepare, we believe that the measures in the statutory instrument do give people long enough to prepare—not least because many of those companies are already operating in the parts of the United Kingdom that the instrument will bring our regulation in line with. Therefore the extra capacity that is needed in the system will not be to the detriment of the measures in this statutory instrument.
Dr Johnson
Parts of the UK are working to EU regulations, but does the Minister recognise that the statutory instrument he is bringing forward will introduce into the whole of the UK market, regulations that are not currently present in either the UK or EU markets?
Andrew Gwynne
I recognise that we are not only bringing Great Britain in line with Northern Ireland but adding other patient safety measures. If the hon. Lady is saying—I hope she is not—that the result of the Cumberlege review is that we do nothing in this area to improve the issues highlighted by it, she is within her powers to oppose these measures. However, we think not only that ensuring regulatory consistency throughout the United Kingdom is the right thing to do, but that this statutory instrument gives us the opportunity to start to put right some of the shocking, appalling things that we know have happened, as highlighted by the Cumberlege review. That is what these measures seek to do.
This Government are committed to the delivery of a framework for medical device regulation that prioritises patient safety—that is the crucial thing that we are seeking to do—and that gives patients access to the medical devices they need, and ensures that the United Kingdom remains an attractive market for medical technology innovators. We have an obligation to patients and the public to maintain the highest standards of safety and efficacy for the medical devices they rely on. These regulations are an important first step to deliver this framework, and they place patient safety at the forefront. They will enable not only the MHRA but the whole health system to better protect patients.
I am grateful to the hon. Lady for her contribution, and to Members across the Committee for considering these regulations today. I hope they will join me in supporting these regulations, so that we have consistency across the UK and put patient safety at the heart of medtech and life sciences.
Question put and agreed to.