Draft Medical Devices (Amendment) (Great Britain) Regulations 2025

Caroline Johnson Excerpts

Wednesday 23rd April 2025 General Committees

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

It is a pleasure to serve under your chairmanship, Sir Edward. We can all agree that we want safety. We want the equipment that doctors such as me use to be safe, reliable and regulated to the highest standards. We also want strong support for the science and technology sector, and patients in the UK to have early access to the best and most innovative medical devices. The instrument removes the revocation dates currently attached to four pieces of assimilated EU law, currently enshrined in the Medical Devices Regulations 2002. By doing so, it keeps those EU regulations in force until new, bespoke UK regulations are introduced.

There was significant concern that allowing that assimilated EU law to expire under the sunset clause would disrupt the UK medical devices regulatory framework and could negatively impact patient safety. In response, the MHRA conducted a public consultation involving device manufacturers, healthcare professionals, patient groups and businesses. Based on the results of that consultation, the MHRA proposed removing the revocation date for those four pieces of EU law. That proposal was welcomed, with 83% of respondents favouring maintaining the status quo.

Opposition Members support these pragmatic measures, and we welcome any legislation that protects patient safety. However, it is essential that the new UK regulatory framework is delivered in a timely manner to provide clarity for industry stakeholders. In that spirit, I would be grateful if the Minister could provide clarity on a few points.

First, the retention of these laws is intended as a temporary transitional measure, with the first phase of the new UK regime—the pre-market regulations—expected in 2026. Is that information up to date, and when can we expect further details on the timeline, publications and upcoming consultations?

Looking ahead to the new UK regulations, particularly those on post-market surveillance of medical devices, are the new UK replacements for assimilated EU regulations expected to diverge significantly from the current EU frameworks when they take effect, or will they remain broadly aligned with them?

Although the amendment regulations extend across the UK, in practice they apply only to England, Wales and Scotland. Northern Ireland remains subject to the 2017 EU medical device regulation and the 2017 in vitro diagnostic medical device regulation. If these frameworks impose additional regulatory or administrative burdens on manufacturers and distributors in Northern Ireland, what steps will the Government take to support those businesses and help protect their competitiveness?

Finally, will the Minister comment on how she expects US tariffs to affect medical devices, including their manufacturers and their availability, in the UK?

[Ashley Dalton]

I thank the shadow Minister for her input, and I will try to respond to the points she raised. The MHRA has published the road map for this process, and I can let her have a copy of it after the debate; it sets out the timeframe for the various steps that need to be taken. Specifically on further SIs, there will be a further SI dealing with two of these issues by the end of the year, and two further SIs in 2026 and 2027.

On Northern Ireland, we are obviously aware that there are concerns and issues that have to be dealt with differently. Once the provisions have been updated, the GB framework will still refer to EU law, but certain domestic requirements may differ from those in other jurisdictions. However, we recognise the benefit of international harmonisation of medical device regulations. Of course, we will ensure that any future legislation meets our obligations under the Windsor framework.

On US tariffs, the Committee will appreciate that there is an ongoing discussion, and decisions have not yet been made by the US. I would not want to pre-empt or second-guess any decisions made by colleagues. Obviously, those tariffs will be taken into account once we have a final view of what they might look like.

[Dr Johnson]

My understanding is that the US Government are reviewing whether the tariffs will affect medical pharmaceutical products. However, some manufactures of medical devices, as per this SI, are concerned that the tariffs that have already been announced affect medical devices. Can the Minister please give more clarity on that?

[Ashley Dalton]

I am not able to give further clarity on that today, but I am more than happy to write to the shadow Minister when we have some more clarity.

I hope I have set out why these regulations, while only a small part of the wider reform programme, are nevertheless important to ensuring a smoothly functioning regulatory environment. They will give manufacturers certainty and ensure that patients can continue to access safe and effective devices. They are just a small part of the reforms that are under way, and I am grateful to members of the Committee for playing their part in bringing them into force.

Question put and agreed to.