Medical Devices (Amendment) (Great Britain) Regulations 2025
(2 days, 11 hours ago)
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Baroness Merron
That the Grand Committee do consider the Medical Devices (Amendment) (Great Britain) Regulations 2025.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)
My Lords, this is a short—I hope—but technical SI, so it may be helpful to the Committee if I give some context. The Medicines and Healthcare Products Regulatory Agency regulates medical devices in the UK and helps to ensure that those products are safe and perform as intended. That includes ensuring that the legislation governing them is appropriate and keeps pace with advances in science and technology.
The 2002 regulations transposed relevant EU directives into domestic law and is now therefore considered to be assimilated EU law. The regulations contain references to several specific pieces of assimilated EU law that will form part of the regulatory framework for Great Britain. This is an important step towards delivering the Government’s 10-year health plan, in terms of the development of legislation apart from this SI. We need safe and effective medical technologies to achieve the shifts that will help build an NHS fit for the future, to take us from hospital to community-based care, from analogue to digital solutions and from treatment to prevention.
As we know, since the 2002 regulations were introduced, technology has advanced significantly. The MHRA has therefore set out plans to make a number of updates to the regulations—separate to the SI we are debating today, of course—to further improve patient safety and access to medical devices, as well as to keep the UK as an attractive market for medtech innovators. I assure noble Lords that, as part of this, there continues to be considerable engagement with the sector, not least because life sciences manufacturing is vital to the UK’s economic growth. In 2021-22, there were almost 119,000 people employed at life sciences manufacturing sites across the country. We will support the sector to flourish, in line with our growth agenda.
The MHRA is taking a phased approach to the implementation of the future medical devices regulatory framework in order to support system readiness and to minimise the risk of supply disruption for UK patients. A key piece of secondary legislation was made in 2024 to ensure that there is appropriate oversight of a device once it is in use. The further secondary legislation, to which I have referred, is expected to come into force in 2026. That legislation will update the regulatory requirements for devices before they are put on the market and will introduce key measures such as implant cards, unique device identifiers and an international reliance scheme for medical devices; in other words, it will take us forward to the place where we need to be.
In the meantime, the statutory instrument that we are here to debate will help provide continuity for the regulation of medical devices until the subsequent statutory instruments to which I have referred are put in place. I assure noble Lords that this instrument does not make changes to the current regulatory requirements. Instead, by maintaining the regulatory status quo, it will help ensure a smooth transition to a future regulatory framework that protects patient safety, improves access to transformative technologies and supports innovation.
This statutory instrument amends the Medical Devices Regulations 2002 to remove the revocation date of four pieces of assimilated EU law, so that they can continue to apply in Great Britain until such time as they are replaced with the updated law to which I have referred. The measure was consulted on from November last year to January this year. Of the 287 responses to the consultation, 83% were in favour, while a further 12% had no opinion. If this statutory instrument were not agreed to and the provisions expired in May—in other words, this month—there would be a significant gap in the regulatory framework, as well as risks to patient safety.
I will now give the Committee an overview of the four pieces of assimilated EU law for completeness; I know that noble Lords will be interested in this. First, the decision on common specifications for in vitro diagnostic medical devices sets out specifications that certain IVD devices must meet in order to demonstrate compliance with essential requirements.
Secondly, the regulation on electronic instructions for the use of medical devices establishes the conditions under which instructions for the use of medical devices may be provided in electronic form, instead of in paper form.
Thirdly, the regulation on devices manufactured utilising animal tissue, as well as their derivatives, sets out requirements to be met before those devices can be placed on the market.
Finally, the regulation on the designation and the supervision of approved bodies sets out further requirements relating to those bodies, which assess applicable medical devices for conformity with the regulations.
Although we are revoking the sunset dates instead of replacing them—not least because we do not wish to use up any more parliamentary time with debates on short, technical SIs such as this—the Government do not intend for this assimilated EU law to be kept in place indefinitely. I hope that will be a helpful and welcome reassurance. This SI serves as a temporary measure to maintain the status quo until more permanent measures are in place. In the meantime, this is important assimilated EU law that must continue to be complied with.
That will also ensure that unnecessary EU divergence is minimised, which is particularly important in this instance because, as noble Lords will be aware, Northern Ireland continues to operate under the EU framework for medical devices under the terms of the Windsor agreement. More broadly, I reassure the Committee that the regulations for Great Britain do, where appropriate, align with global best practice. As noble Lords will, I hope, be aware, the Government’s aim is to ensure patient safety while minimising unnecessary regulatory burden.
In conclusion, I am glad to say that the UK is a prime location to research, develop and manufacture pharmaceutical and medtech products. We want to continue to attract medtech manufacturing investments that deploy the latest innovations, are highly productive and are consistently high-quality. Key to achieving this objective is proportionate regulation, and implementing regulatory changes must be done in a sensible and measured manner.
As I have set out, the continuation of this assimilated law is necessary to prevent significant disruption to the current regulatory framework and, consequently, negative impacts on patient safety. I beg to move.
Baroness Finlay of Llandaff (CB)
I thank the Minister very much for her introduction to this tide-over regulation, which is as it has been portrayed to us. I should declare that my son is involved in medical technology, in cardiology; you could say that our family has a bit of skin in the game, although I do not understand the technology that he is developing— it is so complicated.
I have just a couple of questions. As the new regulations are eventually developed, can the Minister confirm that there will be no more regulatory burden on those trying to innovate and that we might lessen the bureaucratic burden on them? Will there be compatibility reading across to the FDA regulations? The American market, which is subject to a lot of debate at the moment, is a potential market for devices developed in this country overall. In that process, can there be the assurance that we also do not jeopardise our European market, or the Far East on the global scale? We will need to export the technology that we develop.
Lord Rennard (LD)
My Lords, I share some of the concerns raised by the noble Baroness, Lady Finlay. As the Minister so carefully explained, it is essential that we preserve the existing regulations until they can be replaced. However, does she accept that, although an argument frequently used by supporters of Brexit was that they did not like so much regulation, what is happening now in our very successful life sciences industry—which wishes to do business abroad as well as in the UK—is that its products may become subject to both UK and EU regulations?
EU regulations have generally been recognised across the world as a basis for doing business, making it relatively easy for UK-based producers of medical devices to export them. Would it not be better in future to achieve regulatory alignment with the EU, so that businesses producing new products will not have two different sets of regulatory processes, and two sets of costs to contend with, when they innovate and improve their products? Will having separate UK regulations in future not run the risk that such businesses become more reluctant to innovate, and will this not be detrimental to patient care? If we want to improve patient safety and do all the other things the Minister outlined, would not this be done best in alignment with our major trading partners, using standards that are generally agreed internationally?
Lord Kamall (Con)
My Lords, I thank the Minister for introducing this statutory instrument. I want to be clear that we on these Benches recognise the need for this measure, since, without it, key regulatory provisions would expire at the end of this month, as the Minister explained. That would create uncertainty and risk disruption to the oversight of medical devices in Great Britain.
We understand that this instrument is, in essence, a stopgap, as the Minister said, and that the MHRA’s consultation, particularly with small and medium-sized enterprises and clinicians, demonstrated strong support for continuity. But while the measure preserves the status quo for now, it has provoked some questions about the Government’s long-term strategy. I am grateful to the Minister for reassuring us that this is definitely a temporary stopgap and that they are looking for a longer-term and more pro-innovation solution than when we were in the EU.
As the Minister said, this revokes the sunset clauses in four areas in particular: performance standards for diagnostic devices, electronic instructions for use, the regulation of devices containing animal tissue and the designation and oversight of approved bodies. These are not mere technical footnotes; they are essential to ensuring safety, clarity and public confidence in the medical device sector, so we understand that revoking their expiry is necessary to avoid disruption.
Can the Minister add any more detail at this stage to what she has already said? This first phase, focusing on pre-market regulation, is expected in 2026. What further reforms are expected to follow? I know that she explained some of that in brief—I suspect that she did not elaborate as much as she could have for reasons of time—but can she say a bit more about the future plans for this regulation? If she cannot now, perhaps she will write to me, because that was a very welcome move. I was going to ask lots of questions about whether the short-term fix will remain in place for the long term, but the Minister has reassured us. Nevertheless, perhaps she could set out some more details either today or in writing.
I do not believe in regulatory divergence for divergence’s sake, but let us be clear that neither should we agree with regulatory alignment for the sake of regulatory alignment. I understand the concerns of the noble Lord, Lord Rennard, but I recall that, when I was a Health Minister, many a supplier—regardless of whether they supported the UK leaving or remaining in the EU —asked me, “Now that we’ve left, can we take advantage of our independence and develop a more pro-innovation approach than the EU?” In technology—I spent 14 years in the European Parliament—the EU was known as an area for regulation; if you wanted innovation, that was in the US. We have to get a better balance between the two. Whereas the EU focuses more on the precautionary principle and less on innovation, perhaps we can get a better balance in this country, so that we do not align for alignment’s sake.
The Minister also mentioned Northern Ireland. As we know, as a result of what noble Lords, said there are some concerns in Northern Ireland but, given that the EU is seen as an area generating regulation, should the EU impose additional regulatory burdens on businesses in Northern Ireland? What steps will the Government take to support them to protect their competitiveness? That is one of the concerns I know from the most pro-innovation businesses in Northern Ireland.
Finally, on international trade, not strictly within the remit of these regulations, so I hope the Minister and her officials will forgive me—this does not have to be answered straight away—has the Minister or the department assessed the impact of recent US tariffs on medical device imports? Does the UK import a substantial number of medical devices from the US? I know that we talked about the importance of the US as an export market. Will these tariffs have an impact on medical devices from the US, particularly those that have been made with components imported from outside the US into the US before being re-exported? Does that have a price implication? Have the Government made any assessment of the implications for availability, cost and affordability, particularly for NHS procurement? Clearly, as the noble Lord, Lord Rennard, and others said, there is the impact on medical device suppliers exporting to the USA. Has any assessment been made of that market? Across the House, we all want a thriving life sciences sector in this country, but we should be assessing the impact of the proposed tariffs. I know some of them have been in abeyance.
I recognise that I have asked many questions, and I do not expect the Minister to have all the answers straight away, despite the advances of iPad technology and wireless communication. Maybe one day that will extend to telepathy. Perhaps the Minister can write to me on the questions that she is unable to answer today. In drawing my remarks to a close, I will be clear that noble Lords on these Benches support this measure as a necessary step to prevent regulatory disruption, but the real test follows. I hope the Minister, in answering the questions, is able to share a clear timeline for the programme for reform as we hopefully move towards a more pro-innovation approach.
Baroness Merron (Lab)
I am grateful to noble Lords for their valuable contributions and the way in which they have raised issues relating not just to the statutory instrument before us but this whole area of important work. I am also grateful for the support more broadly on the need to get the legislation right in order to protect patients, get the best medical technology within our grasp and support innovation. I am sure we will return to this subject. I will respond to a number of the points, and I will come back to noble Lords on anything significant that I have not responded to.
I reiterate that this SI is essential if we are going to prevent what I would call significant disruption. The words used were “a stopgap”. I think that is a fair legal term in this setting. It will preserve the status quo as we progress to more comprehensive regulation, which I know is what noble Lords are interested in.
The noble Baroness, Lady Finlay, asked for an assurance that we would not jeopardise not just the European market but other markets because we need to export technology. That is a fair point. I can say in response that over recent years we have learned important lessons from the implementation of new medical devices regulations in the EU as well as the global approach to regulation. How has this informed our approach to regulatory reform? It is why the Government are taking a phased approach to the delivery of these regulations to support the sector and adapt to the changes. It is also the reason why we are in continued discussion and are working closely with the sector.
We recognise the benefit of international harmonisation of medical device regulations in order to reduce, as we would all like, unnecessary regulatory burden or duplication of assessment for manufacturers, which is something that has been raised many times with me and I am sympathetic to. This means that, where sensible, we will align with the regulations of other jurisdictions, including those in the EU. Any reform to assimilated law will be to support domestic priorities and the Government’s national health and economic growth missions.
The noble Lord, Lord Rennard, raised a number of points. He raised the issue of products being subject to EU and UK regulations and whether this would make tech companies less likely to innovate. I believe the noble Lord also argued that we should be in line with the EU, and he raised the important issue of Northern Ireland. On these points, we will seek to align with international best practice and EU regulations where they are sensible, support manufacturers and support where we want to get to on patient safety and the contribution of medical technology.
On Northern Ireland, the MHRA is the competent authority for devices placed on the Northern Ireland market. It continues to have oversight of medical devices across the whole of the UK. We will continue to monitor any risks to the supply of devices to the whole of the UK market. I can give the assurance that, at present, the supply is stable and processes are in place to identify alternatives if needed. My final reassurance is that the SI before us today will not have any impact on the supply of devices to Great Britain or Northern Ireland.
The noble Lord, Lord Kamall, also raised a number of key points and requested more detail on what further reforms are expected to follow. He also raised regulatory alignment, making the point that, in his opinion, the EU can be more cautious and asking how we as a country can be more innovative. The noble Lord also asked about Northern Ireland and about the impacts that US tariffs have in respect of medical devices.
On plans for regulatory reform, the MHRA has published plans to introduce several SIs to amend the framework for medical devices. The post-market surveillance SI, which will come into force in June as noble Lords may recall, represented the first significant step in this reform. That legislation will put in place strengthened legal requirements for how manufacturers monitor and report on their devices once they are being used.
In November last year, the MHRA launched a consultation on further aspects of regulatory reform which will inform a subsequent pre-market SI that introduces, among other things, a new international reliance scheme, measures to improve traceability of implantable medical devices, more risk-proportionate changes to the classification of certain devices and the prohibition of misleading claims. We expect that legislation to come into force in 2026. I think that all those will put us in a much better place than we are currently, because they will allow us to keep pace with changes in the market.
The MHRA also continually monitors the UK’s medtech landscape for developments that could affect patient safety and the implementation of regulations. Details of further regulatory proposals will be communicated when available, and I look forward to bringing those before your Lordships’ House.
On US tariffs, there are ongoing discussions, and I will not seek to pre-empt them. The MHRA will monitor any impacts once they become clearer. That is very much under a watching brief.
I hope I have demonstrated the need for these regulations, not just for the public currently but as being key to the forthcoming 10-year plan. I hope that the Committee will agree that we are continuing with this assimilated law to prevent significant disruption to the current framework and to ensure that patients, device users and the economy are all protected.