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

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.

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.

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.

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.

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.