Medical Devices (Amendment) (Great Britain) Regulations 2025

Baroness Finlay of Llandaff Excerpts

Tuesday 6th May 2025 Grand Committee

[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.

Dementia and Alzheimer’s Treatments

Baroness Finlay of Llandaff Excerpts

Thursday 1st May 2025 Lords Chamber

[Baroness Merron (Lab)]

My noble friend raises a very important point. In terms of trials, I will certainly be signing up—and I encourage noble Lords and their friends and families to do likewise—to Join Dementia Research, which is a collaboration between NIHR and a number of excellent charities, including the Alzheimer’s Society and Alzheimer’s Scotland, to take part in trials. There is no need to be a particular age or to have a diagnosis of dementia. I hope that noble Lords will join me in supporting this endeavour.

[Baroness Finlay of Llandaff (CB)]

My Lords, the commission on palliative care that I am currently involved in has found that by integrating services for patients with dementia, such as in the York Frailty Hub, the number of admissions to hospital can be decreased. People can stay at home with families supported and they can carry on living well within limited capabilities while we wait for new treatments and, hopefully, prevention to come along. Will the Minister meet me and Professor Mike Richards to go through some of the details of our findings? They have huge implications in saving finances for the NHS and improving care of patients.

[Baroness Merron (Lab)]

That is a very helpful offer which I will be pleased to accept. I compliment York on its initiatives, which set a very high standard. I will also discuss the points that the noble Baroness has raised with Minister Kinnock, who is the responsible Minister in this area.

Tobacco and Vapes Bill

Baroness Finlay of Llandaff Excerpts

2nd reading
Wednesday 23rd April 2025 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, I am grateful to be allowed to speak in the gap.

Laws send social messages. My maiden speech was on the Tobacco Advertising and Promotion Bill, introduced by the noble Lord, Lord Clement-Jones. Having looked after so many people dying young, leaving children bereaved, through lung cancer and mouth cancers, as well as amputees so addicted to cigarettes that they sat in wheelchairs in the snow at the hospital entrance to smoke, I know that addiction is not a choice; it dominates people’s lives.

At that time, we never imagined the tobacco industry’s creativity, developing nicotine vapes with high levels of highly addictive nicotine salts in one disposable vape that is equal to two packs of cigarettes. The companies have seen a transfer of two-thirds of their customers from cigarettes to vapes long-term. Their profits remain. The number of never-regular-smoking vapers—that is, vapers who had never regularly smoked—using the highest strength e-liquids of over 20 milligrams per millilitre has increased dramatically, to almost 45% in 2023-24. Over 81% of those had been vaping for more than six months and over 67% for more than a year. These high levels deliberately promote addiction and alter biological function, and young vapers are now showing damaged lung function.

In sessions of Learn with the Lords, for some time now I have asked every class to vote on vaping and whether vapes should be banned. They overwhelmingly want a ban. In 2023, one in five children used a vape, often at school. Their young brains are particularly susceptible to addiction, and their behaviour changes.

As for our high streets, we promote addiction with vape shops, betting shops and booze shops. The “polluter pays” principle, as so well outlined already, could mean that they pay much higher rates than food and other shops.

The Bill is important. It can ensure that levels of toxins, including addictive nicotine in vapes, are limited, but we need to be alert to the creativity of the tobacco industry.

Funerals: Death Certificate Delays

Baroness Finlay of Llandaff Excerpts

Thursday 3rd April 2025 Lords Chamber

[Baroness Merron (Lab)]

The noble Lord’s observations are correct. As I said, it is so important to be timely and sensitive at a time of bereavement. Governments and Ministers have been working to bring in the system over the last 50 years—in fact, it has been overdue for reform for that long, so I am very glad to have taken this action. Introducing this robust system means working with medical examiners as well as the bereaved, so that we hear from them about what has happened. We also work very closely across government, including with the MoJ and the Home Office. As the noble Lord will know, the medical examiner system is led by NHS England through the office of the National Medical Examiner. I reiterate that delays are not due solely to this introduction; it is very important to unpick this issue. We now have better data and get weekly reports, which is helping greatly.

[Baroness Finlay of Llandaff (CB)]

My Lords, at the Commission on Palliative and End-of-Life Care, chaired by Professor Sir Mike Richards, we have heard from medical examiners and the bereaved. It is clear that the ability for the bereaved to speak to a medical examiner and go through things in detail is very supportive. However, the delays in notifying the cause of death and transferring the case notes seem to be from the doctor who had seen the patient. The medical examiner cannot start until both those events have happened, and at that point their work begins. So the increasing digitalisation of the health service and of notifications could speed up these processes. Does the Minister agree that the digitalisation proposals from the noble Lord, Lord Darzi, will bring about those changes and simplify the process?

[Baroness Merron (Lab)]

I agree that those changes—the move from analogue to digital, which will be outlined in the 10-year plan—will indeed help in this area, as well as many others.

Prostate Cancer: National Screening Programme

Baroness Finlay of Llandaff Excerpts

Thursday 27th February 2025 Lords Chamber

[Baroness Merron (Lab)]

Again, I am sure that the noble Baroness would agree that the important thing is that people ensure that they do not ignore the situation. I agree that the situation that we inherited was hugely difficult, particularly in some areas, around GPs. In the 10-year plan, which will be published in the coming months, there will be a big focus on the move from sickness to prevention, from analogue to digital, and from hospital to community. In all three pillars, greater access to GP appointments will be included.

[Baroness Finlay of Llandaff (CB)]

My Lords, as the Minister rightly highlighted, there are detection gaps, and one in 50 people have aggressive disease at the time of diagnosis. When this proves to be hormone-therapy or chemotherapy resistant, how many centres can offer strontium, which can be very effective for metastatic bone pain, as that is how some people present?

[Baroness Merron (Lab)]

I was glad to have the opportunity to discuss this with the noble Baroness. Having looked into it, we do not currently hold this data. However, where strontium therapy is appropriate and preferred to improve patient outcomes, it will be offered. This is, of course, a clinical decision.

NHS: Electronic Patient Record Systems

Baroness Finlay of Llandaff Excerpts

Wednesday 12th February 2025 Lords Chamber

[Baroness Merron (Lab)]

The noble Lord is an exemplar when he describes the quality of care and the joined-up approach of the data and information relating to him. I am delighted to hear that Bedford Hospital was so good to him. I am sure it will appreciate him sharing that with your Lordships’ House, and I add my thanks too.

[Baroness Finlay of Llandaff (CB)]

My Lords, as part of the tailored support that the Minister spoke about earlier, can she explain about the cybersecurity provisions? The ransomware attack on Synnovis last June meant patients’ blood groups were unable to be matched, so there was a call-out for O-negative blood. Patients transfer between the devolved nations of the UK, between Wales and England, and across the border, to a lesser extent, between Scotland and England. Is she having discussions about United Kingdom-tailored cybersecurity support for these rollout systems?

[Baroness Merron (Lab)]

We regularly liaise and work closely with the devolved Governments. More than £338 million has been invested in cyber resilience to date. In March 2023, the department published the cybersecurity strategy for health and social care, which runs until 2030. This is an area of huge importance, as the noble Baroness identifies, and one we continue to press.

Community Pharmacy Closures

Baroness Finlay of Llandaff Excerpts

Tuesday 28th January 2025 Lords Chamber

[Baroness Merron (Lab)]

That point is understood, which is why I thought it important to bring to your Lordships’ House the announcement in the media release from my ministerial colleague Stephen Kinnock. As I mentioned in answer to an earlier question, integrated care boards have a role to play. They should—in fact, they are required to—have regard to the pharmaceutical needs assessment conducted every three years by local authorities. That ought to identify where there are gaps and allow consideration of how to fill any such gaps.

[Baroness Finlay of Llandaff (CB)]

My Lords, given the estimate that community pharmacies save some 38 million consultations that would otherwise have been in general practice each year, and the fact that 97% of pharmacy staff report shortages in accessing different medicines as prescribed, how are the Government planning to allow community pharmacies to adjust medicines—as has been recommended by Community Pharmacy England—so that they can modify prescriptions, rather than spend time recontacting the GP when they are themselves familiar with the items?

[Baroness Merron (Lab)]

The noble Baroness raises a good point and work is continuing to resolve that. It might also be helpful to say that NHS England has commissioned an economic analysis of the cost of providing pharmaceutical services and that will inform future funding arrangements. I say that in answer to the point the noble Baroness made about the potential savings that can accrue if we maximise the role of pharmacies.

Prisons: Health Services

Baroness Finlay of Llandaff Excerpts

Tuesday 14th January 2025 Lords Chamber

[Baroness Merron (Lab)]

I certainly agree with my noble friend that there are huge opportunities to improve healthcare for prisoners. On new prison design, I reassure her that all prison design will be fit for purpose because medical architects will be commissioned. That new design includes, for example, medical cells so that as many healthcare needs as possible can be met in prison. On my noble friend’s point about ICBs, it is a retained service, so it is not currently delegated to ICBs. It is the responsibility of health and justice commissioners to collaborate closely with ICBs to ensure continuity of care. The electronic referral service means that patients in prison can have access to the developments to which others in the community have access.

[Baroness Finlay of Llandaff (CB)]

My Lords, a quarter of a century ago, I worked with the then Minister for Prisons following the difficulty we had releasing a shackled remand prisoner. The recommendation was that every prison should have a link with a hospice service in their area to ensure appropriate care, particularly for prisoners who cannot be transferred out of prison and who may wish to die in their cell, with their cellmate providing some of the support for them as they are dying. Can the Minister tell us how many prisons actually have such links?

[Baroness Merron (Lab)]

I thank the noble Baroness for raising such an important point and for having worked on this in the past. I will need to write her with the exact figures, but we do know that more needs to be done to address health issues. However, we are keen to ensure, and are working towards making sure, that healthcare for prisoners, whether at the end of their lives or earlier, is appropriate and meets their needs, whichever is the right way to do it. Great strides have been made in that regard.

Hospice Funding

Baroness Finlay of Llandaff Excerpts

Monday 6th January 2025 Lords Chamber

[Baroness Merron (Lab)]

The noble Lord makes a very interesting point. Of course, the introduction of gift aid supported charitable funding, including to hospices, and I know was very warmly welcomed. These are all important ways of looking at funding and we will consider the best way forward, but I note from discussions with the hospice movement that hospices very much value their autonomy in terms of funding; the more linked it is to government funding, the less autonomy they have. We want dignified and appropriate care for patients and families, and to find the best way to deliver that.

[Baroness Finlay of Llandaff (CB)]

My Lords, I pay tribute to Lady Randerson, who was a great supporter of hospice and palliative care services in Wales, as well as a dear friend. I declare that I am vice-president of Hospice UK and have been involved in setting up the palliative care commission, which will be chaired by Professor Sir Mike Richards and will start to take evidence this week. Can the Minister inform us of the department’s work to look at different funding formulae, such as the one we developed in Wales, which respects the individual autonomy of the voluntary sector while ensuring that some of the black holes of provision can be filled? Will the Government collaborate with the commission by providing as much evidence as possible so that Professor Sir Mike can come up with some really firm recommendations for the future?

[Baroness Merron (Lab)]

I associate myself with the tributes paid to the great contribution that the late Lady Randerson made to this House. She will be sorely missed. In addition to Minister Kinnock meeting major stakeholders, including Macmillan, Together for Short Lives and a number of other organisations and charities to discuss sustainability of funding, Ministers will continue to have discussions with NHS England, because the other area is about getting the money promptly, which has not happened to date. Again, that has caused huge difficulties. We very much look forward to seeing the commission’s findings and recommendations and will look at how we can work to support it.

Health: Quad-demic

Baroness Finlay of Llandaff Excerpts

Tuesday 10th December 2024 Lords Chamber

[Baroness Merron (Lab)]

The noble Lord will be aware that being prepared for winter is crucial. It has felt for too long as though winter crises have almost become normalised. Certainly, our move towards a 10-year plan will ensure that we have an NHS that can provide all year round. To give one statistic on Covid, in the week beginning 1 December there were 1,390 hospital beds occupied by confirmed Covid-19 patients per day, which was 41% lower than in the same week last winter. However, we are absolutely aware of this issue and we are not expecting a difficulty in respect of beds.

[Baroness Finlay of Llandaff (CB)]

My Lords, in her original Answer the Minister spoke about hygiene measures. I wonder whether she could expand on the advice that will be given to the public about considering washable face masks that can be recycled; about improving handwashing because of norovirus; and, particularly as we go into the Christmas season, about not washing poultry, which causes the droplet spread of campylobacter in kitchens and can lead to severe gastrointestinal infections. These will all increase the workload on the NHS if combined with the other infections that we have spoken about.

[Baroness Merron (Lab)]

Prevention is key, rather than just focusing on cure. Communications thus far are focusing on handwashing; I will discuss the other points the noble Baroness raises with the department.