Draft Medical Devices (Amendment) (Great Britain) Regulations 2023
(11 months, 1 week ago)
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The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)
I beg to move,
That the Committee has considered the draft Medical Devices (Amendment) (Great Britain) Regulations 2023.
It is a pleasure to serve under your chairmanship, Mr Stringer. Medical devices are currently regulated by the Medicines and Healthcare products Regulatory Agency in the United Kingdom, which helps to ensure that they are safe and perform as intended. The past few years have been a time of great change for medical devices. The covid pandemic saw huge advances in life sciences and diagnostic tests, and the UK’s decision to leave the EU has presented a great opportunity to strengthen our regulatory regime. We in this country are lucky to have a dynamic and pioneering medtech sector, and the MHRA is a renowned regulator with an established track record of innovation-friendly regulation.
The main objective of the instrument is to give the medtech sector additional time to transition to our post-EU exit regime for medical devices. To achieve that, it extends the time during which manufacturers and importers can place CE-marked medical devices on the GB market.
Since January 2021, to place medical devices on the GB market, manufacturers have had the choice of either following the UK route to market introduced after the UK’s exit from the EU and marking their devices with a new UKCA mark, or following EU legislation and affixing a CE mark. Without this statutory instrument, that flexibility would cease on 30 June 2023, and manufacturers would only be able to follow the UKCA route. That would impact an estimated 11,000 businesses that have registered devices with CE marking and not UKCA marking. To be clear, this instrument has no impact on medical devices already on the market with a UKCA mark.
The MHRA is working to implement an extensive reform to future regime medical devices, and the intention is that that core aspect will be applied from July 2025. Therefore, this SI will give the industry flexibility to continue to use CE or UKCA markings on medical devices until that date. This instrument will not only help to minimise any loss of medical devices from the market, but will ensure that patients can continue to access safe, high-quality medical devices and to smooth the transition to future regulatory requirements until 2025.
I will summarise some of the key changes. First, the instrument provides that medical devices compliant with the medical devices directive or active implantable medical devices directive with a valid declaration and CE marking can be placed on the GB market up until the expiry of the device certificate or 30 June 2028, whichever is sooner. Secondly, in vitro diagnostic medical devices compliant with the EU IVD directive can be placed on the GB market up until the sooner of the expiry of the device certificate or 30 June 2030.
Thirdly, medical devices, including custom-made devices, compliant with the EU medical devices regulation and IVDs compliant with the EU IVD regulation can be placed on the GB market up until 30 June 2030. That is in keeping with the Government’s response to the consultation on the future regulation of medical devices in the United Kingdom, which took place from September to November 2021.
By supporting these regulations, we can help to ensure that patients and the wider public benefit from continued access to quality, safe medical devices, that the UK therefore remains an attractive market for manufacturers of medical devices, and that the wider medtech industry has adequate time to prepare for transition to the future regulatory framework for medical devices planned for 2025. I commend the regulations to the Committee.
Karin Smyth (Bristol South) (Lab)
It is a pleasure to serve under your chairmanship, Mr Stringer. This is one of those fairly innocuous-looking SIs that hides a multitude of problems and incompetence. Many people in our constituencies rely on these medical devices—some 600,000 every day—so it is important that they remain available on the UK market.
The Minister did not outline the range of devices that we are talking about. This is not some technical issue; devices range from blood tests to wheelchairs, contact lenses and scalpels. I am sure that hon. Members have all taken a chance to look at the list of non-invasive, invasive, surgically invasive and active devices. I will not delay the Committee by detailing all of them, but it is a long list, so it really is shocking that we are here once again. Although we have plenty of time, the Committee is being rushed by the Government to approve the draft regulations as some sort of last-minute extension of the existing regulations to mitigate the Government’s failure over exiting the European Union, some seven years after the vote. We are talking about plasters today, so the draft regulations are opportune: yet another sticking plaster over the problems that the Government have encountered and their inability to negotiate a settlement that took account of these important devices.
We will support the draft regulations because, without them, people across our country would suffer greatly from not having access to things coming on to the market and so on, but we need to ensure continuity of supply. I have a number of questions on which I hope the Minister will be able to shed some light, because I am sure she does not want to have rushed, unquestioned legislation. Turning to paragraph 7.3 of the explanatory memorandum, it would be helpful if the Minister could provide some detail on the steps being taken to build the approved body capacity to meet the demand for UK conformity assessments. With regard to paragraph 6, can the Minister share any details on the “significant amendments” that we should expect to the UK medical devices regulations, which have been discussed in this place before? Any details would be very welcome, because it is not only patients who could be affected if we fail to extend the legislation.
The Minister alluded to the number of businesses involved in this work, but manufacturers of these devices—both in the EU and here in the UK—need to have some sort of certainty. The lead-in time for some of this work is massive, as is the research and development capability needed to produce the devices. This last-minute rush is no good for businesses, and although the Minister tried to say that the draft regulations provide certainty, we contend that extending them for another few years, without a clear indication of the route to the full UKCA marking, does not provide certainty. Beyond the consultation, what conversations are the Government having with manufacturers to ensure that we have some realistic timescales about the future? As I said, this is a real worry for our constituents as well as medical professionals, people involved in prescribing the devices and those accessing them.
In paragraph 13.3 of the explanatory memorandum, the Government indicate that they do not
“expect a significant cost impact on small and/or micro businesses”,
because the draft regulations are a continuation of the “status quo”. Again, that is not good enough, because it contradicts the statement that the extended period is a “transition”. I am sure we all know that small businesses operate on tight margins. It is difficult to run a small business, so small businesses would welcome further details about what action will be taken to assist them in transitioning from CE marking to UKCA marking. I understand that there may be working groups looking at this issue, which is to be welcomed, but it would be very welcome if the Minister could inform us about that point.
It is vital that we get this right as we look to the future, so I ask the Minister: what is the Government’s long-term plan to ensure the success of the UKCA regime for medical devices? If this is the route we are going down, we want to make it a success. If the Minister could indicate—[Interruption.]
Karin Smyth
To complete the point that I was making, we are interested in what the Government’s long-term plan is to ensure the success of the UKCA regime for devices.
It would also be helpful if the Minister indicated the Government’s view on alignment. What is their intention for future alignment with the EU? Is it their intention for us to be aligned with anyone but ourselves? What impact will that have on our future businesses?
The extension of acceptance of CE-marked medical devices will act as a transition, and we would all welcome clarification from the Minister of what that transition will look like. What steps will the Government take, in the time that we are allowing them, to support the manufacturers and supply chains that are indispensable to all those who rely on medical devices, to support jobs, and to preserve our global reputation for research, innovation and high standards?
Patrick Grady (Glasgow North) (SNP)
I will echo a lot of what we have heard from the hon. Member for Bristol South on the Labour Front Bench; there were some very fair points, well made. These innocuous-looking regulations actually cover a very wide range of devices, many of which our constituents find essential for going about their daily business and daily lives.
Here we are, in a Commons Committee Room, not taking back control, not doing things differently, but extending regulations that have already been in place and operating very successfully across the European Union for many years—but now with the added Brexit bonus of all the bureaucracy and resources necessary to approve a statutory instrument that has the effect of maintaining the pre-Brexit status quo. I am sure that that is what all the Conservative Back Benchers who campaigned so hard for Brexit were looking forward to when they were out knocking doors and then found themselves elected to this place. The necessity of these regulations demonstrates exactly the kind of policy and legislative cliff edge that the Government were repeatedly warned about, particularly as they brought forward the Retained EU Law (Revocation and Reform) Bill, which of course they are now having to retreat from in the face of amendments made by the House of Lords.
The Minister says that the Government want to bring forward their own framework for regulating medical devices, so perhaps she can give us a preview of her vision for that and how it will diverge from the European Union’s. Will the United Kingdom have higher standards than the European Union for the production and manufacture of medical devices? I am sure that she will also want to reassure us that the Government have absolutely no intention of allowing poorly made, poorly tested or otherwise substandard devices to enter the UK market, and certainly not as part of any trade deals that they might be looking to make with non-European countries.
In the meantime, we will have to continue to consume time and energy and much passion—as is visible on the Conservative Back Benches here today—dealing with these kinds of extensions, carry-overs and all the rest, because Brexit has not been the great liberation that was promised. It has made many aspects of life more difficult, more complex, more bureaucratic and more precarious for many people—particularly, in this case, people who rely on access to medical devices and want confidence in and assurance of the quality of what they are going out to access through the NHS or on the UK market. The statutory instrument is yet another example of how Brexit has not lived up to any of the promises that were made.
Emma Hardy (Kingston upon Hull West and Hessle) (Lab)
These are hugely significant regulations. As co-chair of the all-party parliamentary group on surgical mesh, I want to focus my contribution on vaginal mesh.
The Minister will be aware of how medical devices have harmed and disabled tens of thousands of women, leaving them in excruciating pain and unable to live the lives that they lived previously. It has been a national scandal. I recognise a previous Prime Minister’s interest in this area: the right hon. Member for Maidenhead (Mrs May) commissioned the work by Baroness Cumberlege that culminated in the report entitled “First Do No Harm”, which looked at the scandal of the use of vaginal mesh. It feels like the regulations could have been an opportunity to address some of the difficulties that her report found.
As I said, the use of vaginal mesh, due to the plastic that it is made from, has harmed tens of thousands of women. I know that the Minister is aware of the issue, because I have corresponded with her at length on it. The use of mesh was suspended in 2018, but the problems inherent then are still inherent now. The yellow card system for reporting difficulties with medical devices still is not working in the way it should, and not enough women or people are aware of it. There is concern that some medical devices are being approved based on previous approvals and therefore they are going through on the nod, without the detailed scrutiny they require.
The Government could look at creating a database of everyone with permanently implanted medical devices, including details of the device type, so that they could be tracked. We have a system at the moment whereby many different medical devices are used in our bodies. The women I have been referring to were treated like guinea pigs. These products were tested inside them and then, when they reported problems, they were ignored and belittled. There was no way of identifying the exact type of medical device that was inside each woman. No information was available about the composition of the plastic that was used.
Paragraph 6.9 of the explanatory memorandum is about the MHRA’s public consultation on the future regulation of medical devices. Are we going to start looking at barcodes or tracking numbers on devices that are put inside people, so that when someone reports a problem they can be told, “Okay, we know exactly what you have inside you and exactly what it is made of,” and we can therefore identify groups of women, in this case—or of anybody—that have been impacted by the specific device?
Another issue is how to report a problem with a medical device. At the moment, it is a lottery what ends up inside you, because different things are approved, and it is a lottery whether you are told about the yellow card system and how to report. In the future regulation of medical devices, are we looking at an automatic reporting system where people are given the information? Personally, I want to get rid of the yellow card system altogether. Those are the kinds of questions that I would like the Minister to respond to.
Maria Caulfield
I will do my best to respond to the points made by hon. Members. The hon. Member for Bristol South asked a number of questions. She is right: there is a long list of devices, which fall into various classes of device that the MHRA regulates, and there are different rules for the different types of devices. The MHRA has taken a wide-ranging approach in consulting with the industry and the medtech sector. The consultation that was developed between September and November 2021 is still being looked through. That is why we have this SI: because the MHRA has taken on board some of the concerns and suggestions of the industry.
The final regulations will be operational from 2025. We have set that date so that we have a lead-in period, and then a transition time up to 2030. The MHRA regularly engages with trade associations, for the very reasons that the hon. Lady set out. The recent consultation received more than 900 responses. The explanatory memorandum includes a contact at the MHRA; any industry people listening who have concerns or suggestions and did not manage to take part in the consultation can still make contact with the MHRA, which will be able to give guidance and support on the plans. When we are further down the road to 2025, the MHRA will issue guidance to the industry as well.
Further regulations will be introduced later this year in relation to the long-term changes, and we will keep Members updated on that. This is a big change and the MHRA is doing a significant amount of work in this space. It is taking steps to ensure that, in implementing the further changes to medical devices regulations, it has the capacity and capability to continue to perform, as it always has, to the highest level, putting patient safety first but supporting the industry as well.
The hon. Lady talked about future realignment. As part of our wider work to reform medical devices regulation and take advantage of Brexit opportunities, we will make provision for alternative routes for medical devices to reach the GB market. That will involve possible recognition of devices with approval from other trusted regulators. We will keep Members updated on that as we work towards it.
Emma Hardy
I am concerned about the point about other trusted regulators. Different countries have completely different rules for medical devices. I will not mention vaginal mesh again, but the rules in the USA are quite different from those across the European Union. The community would be incredibly concerned if we were to accept other countries’ criteria for what is considered safe or not. I hope that the Minister will explain that we will have a stricter and more thorough system for regulating what goes inside our bodies.
Maria Caulfield
I take the hon. Lady’s point, and that is exactly the point that I wanted to make: we want to have the safest regulations possible. However, that does not close the door to recognising the work of other regulators. As I say, we will keep Members fully informed of those decisions as we go forward.
I know that this is slightly out of scope, Mr Stringer, but on the use of mesh, that was done while we had the existing EU regulations for CE-marked devices. There is now the possibility to track devices—they have barcodes on them—such as breast implants or replacement hips, and we have certainly accepted almost all the recommendations of the Cumberlege review, which looked specifically at mesh. I do not wish to test the Chair’s patience by going outside the scope of the draft SI, but that is why it is important that when we set the new UK mark, we learn lessons from the past. The CE mark has served us well, but there were instances of safety being compromised.
Emma Hardy
I thank the Minister for giving way again, and I thank you, Mr Stringer, for your generosity. Will the Minister indulge me by commenting quickly on the yellow card system and on how people can report more effectively?
The Chair
Order. I have allowed the debate go beyond the scheduling and timing of the draft regulations, because I did not want to restrict it, but if hon. Members now focus on what the statutory instrument says, that will be helpful.
Maria Caulfield
Absolutely, Mr Stringer. I am happy to follow up on the yellow card outside the Committee, because it is outside the scope of the regulations.
The aim of the draft regulations, as we move away from the CE mark to the UK mark, is to give businesses time to transition to the new regulatory regime, which we are planning to introduce in 2025, with some transitional arrangements after that date. The MHRA is working hard with industry and is in regular contract with trade associations. We want to make the transition as smooth as possible, and the draft SI will allow the sector leeway so that we can introduce the changes at pace.
Question put and agreed to.