Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

Considered in Grand Committee

14:56:00

Moved by

That the Grand Committee do consider the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. Relevant document: 6th Report from the Secondary Legislation Scrutiny Committee

My Lords, I am grateful to be here to debate these important regulations, which herald a much-needed shift in the way we manage medical devices in Britain. This draft statutory instrument represents the first step in a series of amendments that will be introduced in the near and medium term to reform the Medical Devices Regulations 2002 to enhance the safety of medical devices, ensure availability for patients and support innovation. To give one example—the most obvious one—the 2020 Independent Medicines and Medical Devices Safety Review, led by the noble Baroness, Lady Cumberlege, revealed the shocking experiences of patients with implanted pelvic mesh, which caused intense suffering to thousands of women. Their lives have been irrevocably changed and we must act on the lessons learned in the noble Baroness’s report. The review made it abundantly clear that, to keep patients safe, substantial reforms were needed to enable the Medicines and Healthcare products Regulatory Agency—the MHRA—to effectively regulate medical devices. Post-market surveillance, or PMS, is vital for patient safety. PMS refers to the activities that manufacturers conduct to collect and evaluate the experience gained from their devices in real-world use. The MHRA provides regulatory oversight of this process to ensure that safety issues are identified and addressed promptly. Historically, the Medical Devices Regulations have provided only limited provisions for PMS, with guidance covering the detail. Although many manufacturers perform PMS to not just an appropriate but a very high standard, this is not universal. Bringing these requirements into legislation will ensure clarity, level the playing field for manufacturers and, crucially, improve data quality reported to the MHRA, reducing the risk of safety failures. This statutory instrument is necessary to improve the ability of both manufacturers and the MHRA to identify issues with medical devices and take timely action. It delivers patient benefits in three key areas. First, it improves patient safety. This instrument will enable not only the MHRA but the whole health system to better protect patients by more closely monitoring the safety and performance of devices within the NHS and in local communities. This will result in more rapid identification, investigation and resolution of safety issues, allowing the NHS to focus resource effectively. The review led by the noble Baroness, Lady Cumberlege, reported that patients felt unheard and their concerns were often dismissed. These regulations will strengthen the patient voice by requiring manufacturers to undertake patient and public engagement during their PMS activities and monitoring. Secondly, this instrument will support more rapid access for the NHS and patients to transformative—I hope—technologies. These measures provide stronger assurance that products on the market are safe and effective, which will support the implementation of new routes to market. For example, this instrument will help support the introduction of an international reliance framework as part of future medical devices regulatory reform. Finally, this instrument will support innovation. The collection of real-world data can highlight opportunities for manufacturers to refine and improve devices. This process will result in more user-friendly and effective innovations, ultimately achieving better outcomes.

15:00:00

I will now take a moment to summarise the key provisions of this instrument. Once in force, it will ensure that any medical device placed on the market in Great Britain is subject to rigorous post-market scrutiny. This will enhance patient safety across the board, promoting a more consistent approach to PMS for the whole of the UK.

The instrument will set out in greater detail what must be included as part of a PMS system and a PMS plan. Manufacturers will need to ensure that this includes analysis of relevant data throughout the device’s lifetime, providing a more accurate assessment of device performance and leading to the faster identification and resolution of safety issues.

The instrument will provide greater detail for manufacturers on when and how to report serious incidents. The timelines for notifying the MHRA will be standardised throughout the UK, benefiting manufacturers that supply devices to both Northern Ireland and Great Britain and ensuring that safety issues are identified promptly, facilitating earlier interventions in order to safeguard patients. The introduction of new requirements to prepare regular reports summarising PMS data will ensure the continuous monitoring of device performance, with higher-risk devices subject to increased scrutiny.

In conclusion, this draft statutory instrument is timely. The growing use of innovative technologies and digital tools in the NHS has the potential to create a profound change in people’s health. This is critical to the Government’s ambition to rebuild the NHS; however, we must have effective measures in place to achieve this safely. These new regulations place patient care at the forefront. I beg to move.

My Lords, as with the previous instrument, this side welcomes the instrument being laid. Once again, the lack of people queuing up to speak in this debate demonstrates that it is relatively uncontroversial; we now outnumber the audience, as it were. We obviously support this instrument. The Minister was absolutely right to refer to the report by the noble Baroness, Lady Cumberlege, and to the pain and misery that the valproate scandal—and other scandals—caused so many women. On that, I know that the Minister will not be able to answer me now but I wonder whether he can write to me on the recent report by the Patient Safety Commissioner. She suggested an initial sum to be paid to the victims of that scandal, as well as looking at future remedies. Are the Government any closer to considering the Patient Safety Commissioner’s recommendations? These women have suffered enough. They have been out of pocket and have suffered physically, financially and emotionally. I would welcome an answer on that at some stage, probably in writing. It is obviously right that we increase the scope for post-market surveillance. As a quick aside, noble Lords may know that I was a Member of the European Parliament for a few years. British companies used to lobby me on their concern that manufacturers could go to certain jurisdictions to get a CE mark then sell that product across the EU; they sometimes wondered whether the surveillance or testing of that product was sufficiently strong compared to in the UK. This gives us a huge opportunity now to be more aware of CE marks. The Health and Safety Executive for Northern Ireland says that “the CE mark is not a quality mark, nor a guarantee that the product meets all of the requirements of relevant EU product safety law”. It places an onus on suppliers to make sure that they comply, but not every product is tested. That is why it is important, particularly given the scandal to which the noble Baroness, Lady Cumberlege, referred in her report, that we now take the opportunity to ensure that these products are as safe as they claim to be—not only those manufactured in the UK and GB but, particularly, those coming from abroad. I want some sort of assurance that the Minister thinks this will be an effective way to make sure that we avoid that problem. Secondly, having left the EU a few years ago, we have to be aware that there was clearly some friction. Hopefully, we will move to a better relationship between the UK and the EU. We want to avoid unnecessary conflict, but has the Minister thought about what happens when, in the post-market surveillance, the UK regulator deems that a product from an EU country which might have a CE mark is not safe? How do we ensure that that does not cause conflict with the EU regulators for that product, and is it going be a constructive relationship? Are the EU standards organisations fully acquainted with what we will be doing here in the UK, and open to the fact that we might find that some products are not high quality and will therefore remove them from the UK market? Will that cause conflict with the EU, given that those products have a CE marking? It will be one way of trying to reduce some of that post-Brexit friction. We might be doing it for the best reasons, but they may feel it is undermining the CE mark. Lastly, can the Minister commit to ensuring that Northern Irish regulations remain closely aligned to Great Britain’s, so as to avoid confusion and delay? We know that the Windsor Framework produced a solution for Northern Ireland after the Brexit negotiations, but there are concerns for people in Northern Ireland about alignment with GB, understanding that there is also an alignment with the EU. Can the Minister make some commitment or give an assurance that Northern Ireland will remain as closely aligned to GB as it possibly can? With that, these regulations are not particularly controversial. We welcome the fact that there is post-market surveillance. We wish we could have done it as strongly before, given that there have been concerns about certain medical devices. It is really important that we learn the lessons from those scandals, particularly the pelvic mesh and other scandals that have caused so much misery and suffering. We must make sure that we do not see that sort of suffering again.

I am very grateful to the noble Lord for his comments. The Committee will not know, but he mentioned to me beforehand that he might raise products from other jurisdictions and that I might have to write to him. I should just like to say that his prediction was right: I will have to write, but I shall say a couple of things briefly. As far as product safety from other jurisdictions is concerned—I will come to the European Union and other jurisdictions later in my closing remarks—there is a scheme for implant cards. I mentioned at the beginning that this SI will, in all probability, be the first of a number which will, at some point, cover putting implant cards into products so that their exact provenance can then be traced. If something comes from another jurisdiction that does not use that method, obviously I hope that that is in itself a way of ensuring some level of safety. We have both mentioned pelvic mesh, for instance, which has been absolutely deadly. I will say something about that in a minute, but a few years ago there was another scandal involving really nasty breast implants which leaked. When this is fully rolled out, if a woman has a breast implant, we will have the implant card attached to the product and its provenance can be immediately seen: you can see exactly where it came from. That will hopefully ensure an increased level of safety. As far as the victims—I think that “victims” is the right description—of pelvic mesh are concerned, I know that this has been going on for a while, but the Government are now looking at various options and, at some point in the near future, there will be an announcement on what exactly will be done. This instrument marks an important change in how we manage medical devices in Great Britain. It will enable not only the MHRA but the whole of the health system to better protect patients. That is what this entire SI is about. The Government acknowledge that patient safety remains paramount, and these regulations must be carefully balanced to support innovation and ensure patients have access to the most effective medical devices. Where appropriate, the new draft PMS regulations align with international requirements—which the noble Lord mentioned—helping to support the availability and favourability of the Great Britain market and reduce the additional burden on manufacturers supplying medical devices across multiple jurisdictions. The new PMS requirements will also provide a level of regulatory certainty for manufacturers, hopefully making the UK a more attractive location to launch their products. As I mentioned in my opening comments, this draft statutory instrument represents the first legislative step towards broader medical devices regulatory reform. It will create a strong foundation for further regulatory amendments that enhance the safety of medical devices, ensuring their availability and supporting innovation. It will do this by introducing measures for medical devices after they are placed on the market. The MHRA is also developing measures for medical devices before they are placed on the market, with the intention to lay additional draft legislation before Parliament in 2025. As I mentioned at the beginning, this will include measures for unique device identifiers—implant cards—and new rules to ensure that claims are consistent with the intended purpose of a device, although there is already existing legislation that covers that to a degree. It will also deliver changes to the classification of some medical devices. As part of this subsequent legislation, we intend to introduce a framework for international reliance that takes into account, where it is safe to do so, decisions made by comparable regulators in Australia, Canada, the EU and the USA when determining whether a product can be sold in the UK. Delivering these regulations first, ahead of wider regulatory reform, enables this framework by providing the MHRA with stronger assurance that devices are safe and perform as intended. It demonstrates the Government’s commitment to patient safety and responds directly to the Independent Medicines and Medical Devices Safety Review, which I and the noble Lord mentioned earlier, led by my noble friend Lady Cumberlege. The review highlighted the terrible consequences for patients when medical devices do not do what they are supposed to. The MHRA has taken a pragmatic approach to the development of this instrument and prioritised patient safety while supporting global harmonisation across the UK medical device industry. These regulations will be subject to a six-month implementation period. The majority of devices registered with the MHRA have EU regulatory approval and already comply, or are moving towards compliance with, EU PMS requirements. Therefore, given the similarity of these requirements with those in the EU, we do not expect manufacturers to have difficulty meeting these new GB requirements within this timeframe; however, the MHRA will continue to monitor the situation, and talk to and support industry to get it to readiness. The MHRA is prepared for these regulations. The strengthened PMS requirements are expected to increase the volume of data and vigilance reports submitted to the MHRA. However, we anticipate that accompanying improvements to data quality will off-set this burden and support automation within the existing MHRA systems. Before I move to my conclusion, there was one more point, about Northern Ireland. As the noble Lord mentioned, this SI, unlike the previous one, is covered by the Windsor Framework, so a separate process applies to Northern Ireland. Having said that, I trust that we have demonstrated the need for these regulations to ensure that patients and the public continue to benefit from safe access to medical devices. As the first legislative step of the wider medical devices regulatory reform, this instrument will create a strong foundation and allow for future changes to enhance the safety of medical devices, ensuring their availability and supporting innovation. In turn, we intend to support our life sciences sector to create an environment that fosters safe innovation—I emphasise that.

I would like to have some more details, in writing, about the conversations that we will have with the EU if our post-market surveillance finds something wrong with a product that has a CE mark to make sure that that will be done co-operatively and will not be seen as causing unnecessary friction. I know that the Minister discussed international co-operation in an earlier answer. There is no need to answer now, but if he could include that in a letter to me that would be welcome.

A process of consultation has been ongoing for quite a while. It has been done in a very constructive way on all sides, I hope, and certainly on the UK side. I will write to the noble Lord about that, as he asked.

Motion agreed.

Committee adjourned at 3.16 pm.