Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023

Tuesday 6th February 2024 Grand Committee

Considered in Grand Committee

15:45

Moved by

[Lord Markham]

That the Grand Committee do consider the Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

My Lords, I am grateful to be here today to debate these important regulations. Before I begin, I draw the attention of noble Lords to my entry in the register of interests regarding my shareholding in a company which conducts private sector health screening.

To discuss this SI effectively, I must first set out some context. The provisions in the instrument concern in vitro diagnostic—IVD—devices. These are medical devices that test samples taken from the human body to monitor a person’s overall health or to treat and prevent diseases. Examples of IVD devices include blood tests to detect HIV or hepatitis, tests for cancer biomarkers and more commonly known tests such as pregnancy tests. The Medicines and Healthcare products Regulatory Agency—MHRA—is the UK regulator for medical devices, including IVD devices.

This SI is necessary first and foremost because it enables the MHRA effectively to enforce regulations in Northern Ireland, protecting patient safety. Without this SI, the MHRA will lack important powers equivalent to those in place across the rest of the UK.

Secondly, the SI is particularly beneficial given that life sciences and medical technology are major growth sectors in Northern Ireland, and this Government are committed to making Northern Ireland thrive. The SI will unblock UK-wide clinical studies of medical devices and IVD devices that include Northern Ireland locations. Northern Ireland has a unique regulatory position under the Windsor Framework, including access to the EU single market. By providing for a stable regulatory environment in Northern Ireland, this SI will further enable the whole of the UK to remain an attractive market for research and development of medical technologies.

In May 2022, the EU replaced its regulatory framework for IVD devices with a new regulation, the EU in vitro diagnostic regulation, which I will refer to as the EU IVDR. The EU IVDR has automatically applied in Northern Ireland since 2022 under the terms of the Windsor Framework. The Command Paper published last week reaffirms our commitment to unfettered access. This SI facilitates consistency in the operation of device regulations in Northern Ireland and GB, where beneficial to Northern Ireland, and reflects the unfettered access of Northern Ireland IVD devices to the GB market.

I will now take a moment to summarise the key provisions this instrument introduces. The SI lays down proportionate penalties and gives the MHRA powers to serve compliance notices for breaches of the EU IVDR in Northern Ireland. Although the MHRA previously had the necessary tools to respond to safety concerns, the statutory instrument further strengthens this toolkit. It gives the MHRA powers to designate and monitor notified bodies in relation to the EU IVDR and charge fees related to these activities. Notified bodies in the UK can carry out the technical conformity assessment of IVD devices for EU regulatory compliance, allowing the manufacturer to affix the “CE” and “UK(NI)” marks for placing their devices on the market across the UK.

Sponsors of performance studies for new IVD devices in Northern Ireland will need to apply to an ethics committee in the UK for an ethical review and hold sufficient insurance to meet any potential financial liability in the event of injury or death from participation in the study. The instrument also creates an arbitration procedure for refused performance study applications. It allows studies of IVD devices and clinical investigations of medical devices taking place in both Northern Ireland and Great Britain to require only a contact person to be established in Northern Ireland, rather than a legal representative, supported by a sponsor or legal representative established in Great Britain. This reduces the burden on businesses and makes it straightforward for studies and investigations to include sites across the whole of the UK. It will enable more studies and investigations to go ahead in Northern Ireland.

The SI allows a coronavirus test that complies with the EU IVDR and the new EU common specifications to be placed on the Northern Ireland market without needing to obtain separate approval from the MHRA, as is the current UK requirement. This will reduce burdens and avoid duplication of costs for Northern Ireland businesses wanting to place Covid tests on the market across the whole UK.

The SI includes specific provisions to ensure unfettered access of qualifying Northern Ireland IVD devices to the Great Britain market with no additional barriers or burdens to Northern Ireland traders. This product-specific legislation sits alongside general protections for Northern Ireland’s unfettered access to the rest of the UK under the United Kingdom Internal Market Act 2020.

These provisions allow us to honour our current commitments under the Windsor Framework and will strengthen the regulation of IVD devices in Northern Ireland, to the benefit of patients and businesses. For these reasons, I am content to bring forward this legislation today. I commend these regulations to the Committee.

[Baroness Finlay of Llandaff (CB)]

My Lords, I should declare that my son is a cardiologist and founder of Rhythm AI and Echopoint Medical—I think those medical devices do not completely fall within the scope of this, but I declare it anyway just in case.

It is notable that the medical devices road map from the MHRA, which set a future regulatory framework for devices and was published on 9 January, talks about four statutory instruments. Does this form part of those four? Are others due to come, and if so, when?

Despite the Government’s warm words about us being an attractive market, the problem is that the UK is becoming an increasingly less attractive market because our application-to-approval time has extended beyond that of other countries such as the US and Australia and, I think, Japan. Clinical trials in general are not being brought to the UK. During the pandemic, we showed that MHRA approval could allow us to be the fastest in the world with vaccine development and, more recently, with treatment of sickle cell disease. However, low numbers of patients are now enrolled in studies. For the life sciences to develop, trial and test new technologies, they need to be able to do so rapidly. How will the MHRA have adequate workforce to deal with an increased workload from Northern Ireland? Has that been factored in?

How will the risk assessment be set? It is important to recognise that some developments will fail and fall by the wayside. A realistic risk assessment recognises that a whole population needs to be studied. That is best done with post-market surveillance, which is key to evaluating the implementation of any new technology in the real world.

There is a view that our regulations have become tighter, making it too hard and burdensome for device development to be brought to the NHS; as the UK market is small, we need to make it particularly attractive for innovation. The eventual market, being small, would allow us to keep our innovations and market them abroad once they had gone through full approval processes. What steps are in place for mutual recognition agreements to be taken forward?

A paper from Birmingham Health Partners, Alternative Routes to Market for Medical Devices, suggests there are three routes. I gather that Switzerland has now undertaken to adopt the Food and Drug Administration approval systems from the US, registering the file—for us, it could be registered with the MHRA—with a post-market surveillance plan in place. Of course, the initial safety standards must be met, but it is in the real world that benefits and risks are revealed.

For our deficits and gaps in the NHS, there are problems that we need to solve by pulling new technology and diagnostics in. But the golden age of innovation will happen only if there is fast approval to evaluate, with good surveillance so that those innovations with problems are rapidly dropped and those with promise and better patient outcomes continue to be developed. This innovation has to happen across primary and community care as well as hospital specialty services. It requires the recognition of intrinsic risk by adjusting the risk threshold, including that not to innovate is also a risk.

The public understands the need to innovate. In the related areas of clinical trials, which I think is an important but salutary comparator, we have dropped from being fourth in the world to being 10th in the world, which is much to the loss of our NHS and our patients, as well as, obviously, innovation business. Our time for the regulatory review is greater, so we are slower than many other countries. How will these regulations strip out unnecessary processes and bureaucracy and speed up processes to make us attractive to innovators? Northern Ireland being in the unique position that it is now in could be a very important market for innovation, with its fast and easy access and attractions for those developing in vitro devices.

[Lord Allan of Hallam (LD)]

My Lords, I was grateful to the Minister for his description of in vitro devices, which is not necessarily obvious from the regulations. I hope that he can confirm that the “in vitro” bit is misleading; we are talking about lots of tests that are done in plastic and no longer glass, so it is a Latin hangover. I think that I am right in thinking that this applies to everything, whether it is a stick test or whatever device it is; it applies to any kind of diagnostic test.

On the regulations, I shall offer a one-sentence Brexit whinge, which is just to say: “Oven-ready, ha ha ha!” Looking at these regulations, we are now in legislative spaghetti territory, where to do something quite small and simple requires pages and pages of legislation to enact it. We are in a very messy regulatory situation, and it is only going to multiply over time. That was the first point that I wanted to raise.

It would be helpful if the Minister could say, for the health area for which he is responsible, the extent to which the Government have assessed how far there will now be divergence between Northern Ireland and Great Britain in the relevant health areas. There are two different scenarios. In one, the UK stands still, but the EU moves on, which is effectively what has happened here: the EU has updated its law, and we are now having to respond, because it will apply in Northern Ireland. So even if we do nothing, there will be change, and we should be reasonably capable of extrapolating that by looking at past behaviour and the EU’s legislative programme. Of course, the other scenario is where we actively diverge from the EU.

I hope that, in both scenarios, the Minister will be able to confirm that there is somebody—or a team somewhere in DHSC—who has all this mapped out. It may not have been possible before Brexit, when we were still living in la-la land—but, since we have had the experience of the retained EU law Bill, where the number of laws that we found tripled from the first exercise to the current iteration, it is important for businesses out there that we understand how much retained EU law there is in the health area, how much of it will be relevant and how much will require this kind of statutory instrument to ensure that we can respect both the Northern Ireland and the Great Britain settlement.

I am also curious: the Minister referred to the fact that the EU’s updated law was implemented as a regulation, which of course applies directly, rather than a directive, which needs transposition. He said that it applied from May 2022, but we are regulating only now. I am genuinely curious as to what happened in the intervening period. Is it the case that if somebody had been selling non-conforming devices, they would get away with it for that period because the law did not catch up? I am curious to hear what the Government’s intention is. Presumably, this scenario is going to be repeated: there will be new bits of EU law and we have to follow on and make sure that they are implemented for Northern Ireland. I am genuinely interested in the Minister’s comments on the Government’s strategy: are they concerned at all that there may be these gaps, or is it something we just have to live with now?

16:00

The third area I want the Minister to comment on is how this will work for manufacturers of the testing devices we are talking about. I was struck that the Explanatory Memorandum said that there are “roughly 19” in Northern Ireland, which is great; it should be “roughly 20” or “exactly 19”, so “roughly 19” is a really curious framing. So, there is a small number in Northern Ireland, but we have really got four different constituencies or three different constituencies and then a twist: we have manufacturers in Northern Ireland who wants to sell only in Northern Ireland; we have manufacturers in Northern Ireland who also want to sell to GB, and the Minister indicated that the Government have certainly made it a priority to not get in the way of that; we have manufacturers in GB who want to sell to Northern Ireland; and then we have any of the above who might want to sell to the EU as well as to the domestic markets. My understanding from ploughing through some of the documentation is that, if you have a certificate of conformance in the EU—a “CE” mark—that will be valid until the sooner of either the expiry of the current certificate or 30 June 2030. So, my understanding is that, for a manufacturer at the moment who wants to sell to any of those markets—Northern Ireland, UK or EU—the simplest thing is to go with the “CE” mark. That would allow you access to all those markets at least until 2030, and maybe you want to start worrying about the UK mark as you get nearer to that date. It would be really helpful to hear that confirmed.

I am also really curious about this notion of “notified bodies”, which the statutory instrument says the Secretary of State will be responsible for now. The Minister talked about the MHRA and “CE” marks. Again, I read some of the literature on this, which seems to suggest that the MHRA is no longer a notified body for the granting of “CE” marks and, if you follow the trail, it takes you to something called an “approved body”, which the MHRA is. I am, again, genuinely curious: if I produce a new diagnostic test within the scope of the statutory instrument, can the MHRA give me a “CE” mark, or is it the case that the Secretary of State will be notifying other regulators to give “CE” marks to GB or Northern Ireland manufacturers who want one? As I say, I am a little confused. Reading everything, my understanding is that the MHRA can no longer give “CE” marks, but I stand to be corrected if that is the case. Again, from a manufacturers point of view, it is really important and it might be helpful if there were some kind of grid that says, “You are making this kind of device, you want to sell it in these places—GB, Northern Ireland, EU—here are the three marks that you need”. There is an NI mark as well, and I am, again, curious about that one. You might need a “UKCA” mark, a “UK(NI)” mark and a “CE” mark, and my very simple question is: who can give me which, and which covers which markets?

As I say, I did my best, ploughing through lots of literature—certainly, the SI does not tell us anything; we would be completely lost if we read this. I do not know whether the Government have in train something like that which helps people understand, very simply, which notified/approved body can hand out which and which you need, depending on your situation within those scenarios. I hope those are helpful comments for the Minister in trying to unpick what is a very complex piece of legislation for something actually quite small.

Just to return to my opening remarks, I am somewhat concerned, and I think we should all be concerned, about, over the years, the size of the body of law we are going to build up for really quite small regulatory matters. Particularly if we end up, frankly, with our device and the EU standards being identical, we will end up with a large body of law to do very little. I know it is not something the Minister can control, but I feel it is worth putting on the record each time we come across a statutory instrument in this area.

[Baroness Merron (Lab)]

My Lords, I also thank the Minister for setting out the provisions in the regulations and for trying to unravel the many pages before us. This seems to be one of those innocuous measures that are needed just because that is where we are, but I very much take on board the comments of the noble Lord, Lord Allan, which are worth wider government consideration.

Clearly, these regulations are needed to support the implementation of new EU regulations that came into operation in Northern Ireland in May last year. They are important in that we have to secure continuity of supply and trade in medical devices within the UK and the EU, and the draft regulations affect a diverse range of equipment and systems to examine specimens in vitro, including items such as blood grouping reagents, pregnancy test kits and hepatitis B test kits, to give just a few examples.

As the noble Baroness, Lady Finlay, said, it is important that we support innovation. The medtech sector provides a huge contribution to our health service and our vibrant life sciences sector, from catching killer diseases early all the way through to preventing infections. The products we are talking about are found in doctors’ surgeries, hospitals and our own homes. They are part of our daily lives. We certainly know from the pandemic how difficult it can be to replace them if supply is disrupted, so we are here to ensure that supply disruption does not happen.

As has been said, the Explanatory Memorandum sets out that these regulations should affect only some 19 businesses in Northern Ireland and cost less than £5 million to implement, but it is important to acknowledge and put on record that they are a valuable part of the UK medtech ecosystem. On these Benches, we certainly support the regulations, which we believe will secure unfettered access to the British market for Northern Ireland businesses and ensure continuity of supply.

I also have a few questions that I hope will be helpful for the Minister. It is welcome that the previous fee structure is being retained to reduce disruption for Northern Ireland operators, but could he say what assessment has been made of any impact on the MHRA’s responsibilities as a regulator? Could he also confirm that it will be resourced to fulfil those responsibilities?

Previously, Ministers have talked about future realignment of regulations on medical devices following our departure from the EU, including consideration of alternate routes to the British market. Can the Minister say a bit more about what opportunities there might be in this area? What is the timeline for the future regulatory regime that the Government want to bring into force? As the Government have not yet set out their proposals, is there a timeline for doing so?

I note that medical devices did not receive attention in the Windsor deal, which was understandably disappointing to some suppliers, which cited the complexity of navigating the current system. Is the Minister considering adding other product classes, such as other devices, to its scope? Will he also clarify the status of devices on which a conformity assessment has been performed by a UK notified body? Following on from the questions from the noble Lord, Lord Allan, in this regard, will it be possible to place devices bearing a “CE” conformity mark, as well as the EU Northern Ireland mark, on to the EU market? Is it the case that no UK notified body has been appointed? If that is the case, when will this be dealt with and what is the delay down to?

In summary, we are pleased to support these amendments to the regulations to secure continuity of supply for the critical medtech sector. I look forward to hearing the Minister’s response.

[Lord Markham (Con)]

I thank noble Lords for their contributions and the spirit in which they were made in terms of helpfulness and trying to make the market as open and productive as possible.

I shall try to answer the questions in turn. To the noble Baroness, Lady Finlay, I say, yes, this is part of the four SIs.

On the noble Baroness’s whole question about making the UK market attractive to innovation, that is exactly what this is all about. On her point about clinical trials, my understanding is that there was a period when we slipped down the league on timings. I am told that a lot of that was because we were trying to prioritise Covid issues but, as I understand it today, we are now back within the timeframes. While we slipped down to 10th place in the league, the understanding from recent business coming in is that we think that we are making our way back up into the champions league spots, for want of a better phrase. I am assured that we have seen quite an improvement in the time taken in clinical trials.

On the noble Baroness’s question about what this means for the MHRA—the noble Baroness, Lady Merron, asked a similar question—we do not believe that this should have a significant impact. At the same time, I am totally with the sentiment that we do not want the MHRA to be a bottleneck, not just in this area but generally because speed to market is important here. In the last Budget, we agreed quite an increase in the MHRA’s budget, exactly so that it is able to pass such things through more quickly.

On the points about mutual recognition, it is absolutely our direction of travel. We are looking to do that with other authorities. Again—this also goes to the question of the noble Lord, Lord Allan—we are recognising the “CE” marks until 2030. That is probably a good example of mutual recognition.

[Lord Allan of Hallam (LD)]

The “CE” mark recognition is an example of one-way recognition, not mutual recognition, because it does not go the other way.

[Lord Markham (Con)]

Absolutely. Clearly, we would like it both ways, for obvious reasons. There are a number of areas where we are still being open about our rules—not just to the EU but to other countries as well, with the hope that there is some reciprocation down the line. That is definitely the intention. Talking to the regulators, I know that the situation is crazy. We know that the Australian, Canadian or Singapore regulators are top-notch, so we should be satisfied with their work in many cases. The feeling often is that stage one towards that recognition is that, while we might have slightly different standards, recognising that where they have conducted tests, rather than reconducting those tests, we should at least recognise that each other has done the tests correctly. We should take that data and that should speed things up.

In answer to the question of the noble Lord, Lord Allan, we are talking about any type of diagnostic test—

[Baroness Finlay of Llandaff (CB)]

May I intervene before the Minister moves off the subject of mutual recognition? Perhaps I may clarify whether he envisages this being similar to the Orbis project for drug approval recognition, particularly regarding oncology and cancer drugs, where FDA approval is recognised. There are different levels, so that things can come through to clinical application quickly. What is the position as regards us recognising FDA approval for development? Do the Government intend for that to be adopted by the MHRA, rather than devices having to go through all of our processes as well? Will we recognise the FDA system, with increased focus on post-marketing surveillance?

16:15

[Lord Markham (Con)]

I am probably not qualified to speak specifically about the Orbis project read-across but, at the general level, that is definitely the direction of travel, if you speak to the MHRA. As I said, there are almost two levels to it. The complete level is where you just take it lock, stock and barrel. That is the slightly harder one, but at least the preliminary step towards that is recognising when they have done a batch of tests. I know from a previous life—during Covid, for instance, when a lot of tests were about—that you have to do a number of samples, test them against a control group and see where they come out against that. Those were internationally recognised tests, so if the US, Canada or Australia have done tests on those devices, rather than doing our own tests, let us at least accept them. Those are the two stages of that.

On the point about divergence, this SI tries to make sure that the GB and Northern Ireland markets are as similar as possible. My understanding of how we used to regulate EU “CE” devices was that we would take the “CE” marks and then often tweak them slightly to make them relevant for the domestic market. Apparently, France, Germany and all the countries do that. With this SI, as I mentioned, we are recognising “CE” marks generally until 2030 on a voluntary basis—so, obviously, we can tweak them as much as we like. Northern Ireland generally has to accept those devices because of the Windsor agreement, but it still has that tweaking ability, for want of a better word, that we always used to have when we were in the EU. The idea behind this SI is to allow us to tweak it from both ends—the GB end and the Northern Ireland end—so that it is common, and we have read-across so that the product will work under the “CE” mark in both Northern Ireland and across in GB.

This was explained to me this morning, so my officials can tell me later whether I have been a decent student. For general clarity, as ever, I will happily write this all down, but I hope that makes sense.

[Lord Allan of Hallam (LD)]

It does; that was a helpful and clear explanation. However, if somebody has tweaked their test for Northern Ireland and they also want to sell to the EU, are they able to do so? For example, can they send it south of the border into the EU? Or would that require an untweaked “CE” mark, and, if so, who gives them that? That is really the heart of it.

[Lord Markham (Con)]

My understanding of all this—again, I will tell the noble Lord to the best of my knowledge and correct it if I am wrong—is that we always used to tweak it when we were part of the EU. It was generally accepted that we would tweak a bit, and so would France and Germany. That did not stop products being sold across, so I do not believe that they will need to untweak it, for want of a better word. Again, if I am wrong about any of that, I will clarify it.

On the question of what happens between March 2022 and now, I will let the noble Lord know in writing about what happens during that period.

My understanding is that the MHRA is neither a notified body nor an approved body. It does not set “CE” marks or “UKCA” marks itself; it tests them and looks at the conformity, but it does not establish any, for want of a better word.

On the questions raised by the noble Baroness, Lady Merron, that I did not pick up on before, we do not think the fee structure will have much impact on the MHRA.

The noble Baroness also asked what the opportunities are and what kinds of visions will come from this. I freely admit that this is a complicated space. However, one area where I have seen an opportunity is around the precision medicine space. For example, for the next set of cancer treatments, it will be possible to take a sample of the malignant tissue or cells and adjust the messenger RNA to, effectively, get your own body to attack those cells. The problem is that each one of those medicines you produce is individual to you, so it becomes difficult to regulate each individual medicine under the regulatory framework, as it would take ages and destroy the point of the exercise. The MHRA, however, has developed an umbrella mechanism, allowing it to treat all the individual medicines as regulated and approved. That is a major opportunity. My understanding is that the EU has not managed to be quite as fleet of foot, so it is not there yet. That is just one example I have seen; it is very important, as it allows us to charge ahead in terms of the precision medicine space. Moving forward, that will help us establish ourselves in the clinical trials and life sciences fields. I understand the points the noble Lord makes about all the complications due to some of these post-Brexit situations, but, actually, this is one area that is very positive. It will be a huge benefit for us going forward.

On the question asked by the noble Baroness, Lady Merron, about the future vision, I think it is sensible to agree a baseline based upon what we see in reputable countries with standards—such as Canada and Australia —making it as easy as possible to regulate. It would not be ideal if that meant we had to do it just one way, as we would prefer to do it both ways. However, it would still make us attractive as it would be possible to do clinical trials for our products here and know that it will work. However, where we can forge ahead in areas such as precision medicine, where you need tailored and expert help, let us really try and do that. So I think there are some really exciting possibilities.

I hope that gives a flavour of our vision and how we are trying to progress matters in this space. I realise I have not answered every question, but it has been quite a useful debate. I have definitely found it useful to tease out the details. If I may, I will go back to my notes.

I trust that I have provided sufficient answers to the questions and, as I said, I will write to follow up. I hope and trust that I have demonstrated the necessity of these regulations to honour our current commitments under the Windsor Framework agreement. With that, I commend this instrument to the Committee.

Motion agreed.