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.