Contribution
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.