Considered in Grand Committee
My Lords, I am grateful to be here to debate these important regulations. Plasters for a scraped knee, blood tests that detect cancer, pacemakers, pregnancy tests and software that calculates insulin doses for people with diabetes—medical devices are used by millions every day.
The MHRA regulates medical devices in the UK, helping to ensure that these products are safe and perform as intended. Today, almost 2 million different medical products are registered with the MHRA for use in the UK, of which an estimated 500,000 different product types are regularly used in the NHS. The past few years have been a time of great change for medical devices. The Covid-19 pandemic saw big advances in the life sciences and diagnostics sectors.
This instrument is intended to give the medtech sector additional time to transition to our post-EU exit regime for medical devices. It extends the time during which manufacturers and importers can place CE-marked medical devices on the Great British market.
Since January 2021, manufacturers wishing to place a medical device on the GB market have been able to follow either the post-Brexit UK route and use a UKCA mark or the EU legislation and use a CE mark. Without this SI, this flexibility would cease on 30 June this year, with only the UKCA route available. This will impact an estimated 11,000 businesses that have registered medical devices with the MHRA with a CE mark only. These regulations will allow industry the flexibility to use either mark on medical devices for longer.
Continuity of supply is key and we recognise that the industry needs more time to prepare to transition. Without it, manufacturers of medical devices without a UKCA mark would have to stop supplying their products in GB from this July. This could mean some patients losing access to the devices that they need. I make it clear that this instrument has no impact on medical devices already on the market with a UKCA mark.
I will now take a moment to summarise the key changes. First, the instrument provides that medical devices compliant with the EU medical devices directive or EU active implantable medical devices directive with a valid declaration of conformity and CE mark 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, or IVDs, that are compliant with the EU IVD directive can be placed on the GB market up until the expiry of the device certificate or 30 June 2030, whichever is sooner. Thirdly, medical devices and IVDs, including custom-made devices, that are compliant with the EU medical devices regulation or the EU IVD regulation can be placed on the GB market up until 30 June 2030. This is in keeping with the Government’s response to the consultation on the future regulation of medical devices, which ran from September to November 2021.
I thank the SLSC for its thorough review of this instrument. The committee raised with the MHRA the important practical concern of whether firms will be incentivised to seek UKCA certification at an additional cost if CE certification is still accepted. Since January 2021, it has been possible to use a UKCA mark on medical devices. In the year ending March 2023, an estimated 9% of new medical products—around 71,000—were registered with the MHRA with UKCA marking, despite CE marking being an option.
Manufacturers will be prompted to consider shifting to using the UKCA mark through the transition period, including as their CE certificates expire. To transition to the UKCA mark, many manufacturers will need to use a conformity assessment body approved by the MHRA. The capacity of these approved bodies is currently limited. The MHRA is working proactively to build approved body capacity to allow a smooth transition to the UKCA mark. The agency engages regularly with the medtech sector and will continue to do so as it develops a future regime.
By supporting these regulations, we can help ensure that patients and the wider public benefit from continued access to quality, safe medical devices; that the UK remains an attractive market for manufacturers of medical devices; and that the wider medtech industry has adequate time to prepare for the transition to the future regulatory framework for medical devices. I commend these regulations to the Committee.
My Lords, I thank the Minister for his explanation of the statutory instrument. I do not oppose it at all, although the fact that the Government are doing it seems to reflect the serious lack of preparation and planning for the post-Brexit world in which we now exist.
I have two points to put to the Minister. The first is in relation to the 30 June 2030 cut-off date for the sole use of UK conformity assessments for medical devices placed on the market in Great Britain. My understanding is that the transition timelines to 2030 are causing significant confusion for companies, especially SMEs in the health tech and medical devices sector. I refer noble Lords to paragraphs 7.6 and 7.7 of the Explanatory Memorandum in particular, which begin to explore some of the complexities. I say this to the Minister: a clear timeline would be very helpful in giving clarity and certainty to companies.
My second point picks up the point that the Minister made right at the end of his opening speech about the MHRA’s capacity and its plans to reform the current regulatory system. I pay tribute to the MHRA’s work and am sure that it will rise to the challenge but the plan includes proposals
“to reclassify products, to increase information gathered at the point of devices’ registration, to strengthen post-market surveillance requirements to ensure better incident monitoring reporting and vigilance, and to introduce alternative routes to market”.
I can see the reasons for this, of course, but additional regulatory burdens for industry to supply the UK may mean that manufacturers will not bother and will focus on the EU and other larger, certainly more valuable, markets. The number of products made just for the NHS is very small indeed.
The Minister will be aware that the Chancellor talked in the Budget about the rapid, almost automatic approval of devices approved in markets such as the US. Is the MHRA signed up to this? It seems essential to build on current product recognition routes from the EU and rapidly explore building a UK product regulation equivalence route for the approval of medical devices to include other trusted jurisdictions, such as the US, for a greater proportion of products. I would be grateful if the Minister could comment on this.
I now come to the very serious capacity and capability constraints. Clearly, the MHRA has suffered from the reduction in its funding, especially on the devices front. I hope that the Minister will be able to say what is being done to improve it. Also, what philosophy will the MHRA adopt in future? Will it continue to oversee the regulatory process in relation to devices or will it take a more expansive, more centralised and certainly more expensive FDA-style approach, with the attendant recruitment challenges that that brings? It has been announced that one of the MHRA’s senior executives, Dr Laura Squire, will focus on devices and that there is a recognition of skill shortages but I cannot begin to overestimate the problem for UK companies if, in meeting the target that the SI now sets, they find that one of the major problems is a lack of capacity in the MHRA to provide the necessary speedy regulatory assurance that is required.
This comment can generally be made about the post-Brexit arrangements as a whole. If, by “taking back control”, the Government mean that they are serious about developing a new regulatory regime that serves the public interest and is effective in attracting industry to this country, they really must ensure that the regulatory system is both fast and effective. This is the major issue that must lie behind this SI.
My Lords, I will speak about the medical devices issues in these regulations. I thank my noble friend the Minister for introducing them. To some extent, I share some of the concerns expressed by the noble Lord, Lord Hunt of Kings Heath. He and I will recall our debates on what is now the Medicines and Medical Devices Act 2021, which provides the power under which these regulations are being made. When the new medical device regulations are laid, we will look very carefully at the extent to which they reflect the considerations put into Section 15 of the 2021 Act, which are about not just the quality, safety and availability of medicines but the ability to support both clinical research and the supply and manufacture of medical devices in this country.
That latter point bears directly on this statutory instrument, which is helpful in that respect because it extends the transitional period. This will create an opportunity for manufacturers based in or exporting to the United Kingdom to supply medical devices here. They will be able to adapt to the changes in the regulations that are yet to come—we do not know when. My noble friend might like to tell us a bit more about that timing since, in a sense, extending the transitional period is all very well but you have to kick the transition off. We need our regulations to be in place in order to see how significant the differences between the existing regulations and the future ones are and how different our regulations are from those that apply in the European Union.
I will make a general point, on which I know my noble friend can say little at this stage. When we debated medical devices regulation and initially agreed that we would accept the UK CE marking for a period of time, there was always a question as to whether it made much sense to disapply the UK CE marking and when to do so.
We have to think about this very carefully. We are now extending the transition to 2028 or 2030. Between now and then, I hope we can get our regulations in place and enter into a review of the trade and co-operation agreement. One of the objectives of the TCA really ought to be for the United Kingdom and the EU to agree more by way of mutual recognition of conformity assessments. Back in December, at the Trade and Technology Council with the United States, the European Union initiated work to look at further mutual recognition in areas such as pharmaceuticals and medical devices. We are increasingly moving to a point where the greatest benefit to patients and public health would be progressive harmonisation of regulation and mutual recognition of conformity assessments, whereby approved bodies from around the globe are able to do them to similar high standards.
This brings me to the point that the noble Lord, Lord Hunt, made very well. There is an important capacity in the Medicines and Healthcare products Regulatory Agency. I remember that, at the end of the pre-Brexit period, the MHRA was undertaking 40% of assessments for high-risk medical devices for the European Union as a whole. Notwithstanding the quotation from the Chancellor of the Exchequer, we do not want to arrive at a point where we are receiving or are the beneficiaries of other people’s assessments; we want to maintain the capacity to do them here. As things stand, that will not happen in a market that is relatively small, with a UKCA marking system that is correspondingly modest in scope.
If, through mutual recognition, we can arrive at a position in which UK-approved bodies can be notified bodies for EU purposes, it will make an enormous difference. At the moment, we have a one-way street: until 2028 or 2030, we will be giving UK CE marking recognition here but the EU will not do the same for us. An important objective of our renegotiation must be that we secure recognition of our marking.
That will solve everybody’s problems. The EU has had repeated delays in the implementation of its medical devices regulations, the principal reason for which is the lack of capacity in its notified bodies. We do not have the capacity that we require either. I am not entirely sure how many we have at the moment; I am told that there are four approved bodies in this country. However, until our draft regulations are published, we do not know to what extent those approved bodies feel themselves ready to provide UKCA markings for these new regulations.
Either way, both we and the European Union would benefit from the ability of providers in both the United Kingdom and elsewhere in Europe to operate both UK CE and UKCA, and for things like technical assessments to be interchangeable between the two. We are using EU technical assessments to some extent, and we want to maintain the capacity of this country to do the high-quality technical assessments we have done for many years, and for them to be incorporated into UK CE marking as well UKCA marking.
I hope that my noble friend will at least say that we have not abandoned the objective to arrive at mutual recognition of conformity assessments and that the transition will literally buy us time, and that we register the great advantage it would be if we used that time to arrive at mutual recognition in the future.
My Lords, these Benches also welcome the Minister’s introduction to this statutory instrument. I am starting to get used to being presented with a statutory instrument and told, “You can either support this or the sky could fall in on the heads of some part of British industry tomorrow”. It is a fairly straightforward choice: of course we support the statutory instrument going ahead to allow the medtech sector a little more breathing space.
A number of questions have already been touched on about where we are going. The first is a specific one. The MHRA has said that the start date for the new UK regime is 1 July 2025, after which, as I understand it, no new devices with CE marks will be recognised. The existing ones will roll over, as we are discussing today, but post 1 July 2025, any new devices coming onto the market will need the UKCA mark. I have had representations from people in the industry who think that that is what the collective information they have received means, but it would be helpful if the Minister could clarify that: that after 1 July 2025, the new UK regime is in place and new CE marks will not be recognised after that date.
The second question is one correctly raised by the noble Lord, Lord Hunt: where the capacity to carry out the assessment will come from. Of course, the will is there, but what if the staff are not? The Minister is used to discussing in this House staffing across all different aspects of the health sector. This is another aspect where specialist staff will be needed. I am particularly mindful of the Minister’s introduction, when he talked about the important role of software now in medical devices, many of which are software controlled. That is a specialist and high-value area, and it is important that we get some assurances that there will be the capacity, or the Government have a path to developing the capacity, to have people who can do the approvals, particularly of sophisticated software-controlled devices and—dare I say it—flavour of the month, artificial intelligence-controlled devices, which will be embedded in future. Again, that is a very high value, specialist function. MHRA will need to have the capacity to certify devices that use artificial intelligence and other sophisticated forms of software.
The third question is a very specific one about class 1 low-risk devices, which, as I understand it, are things such as wheelchairs and stethoscopes. Again, it would be helpful if the Minister clarified what is intended here and how they fit into the transitional scheme that is being extended today.
The fourth question is about labelling. It would be really helpful for people in our medtech industry who are seeking to export to understand how labelling will work, and specifically in the context of the Great Britain/Northern Ireland question. The Minister referred to medical devices for the Great British market. There is an issue of intonation here: is it the “great British” market or the “Great British” market? I think in this case it is the latter: the market of Great Britain, not Northern Ireland, because of the arrangements we have there. It is really important that people who are making devices understand how labelling will work, particularly if they are selling devices across the island of Ireland, where they are in the Northern Irish and Republic of Ireland markets, but also exporters more generally.
The final issue I think is interesting is information-sharing and government distributing information to the sector. Paragraph 12.4 of the Explanatory Memorandum says that there will be
“some costs for the industry associated with familiarisation with the regulations”.
I think it is much bigger than that, and the noble Lord, Lord Lansley, was quite right: the industry needs to understand the direction of travel, particularly around convergence/divergence. The sector, which, as the Minister rightly said, is an important one in the United Kingdom as a whole—not just in Great Britain, in this case—is in a very different place and needs the information now that will enable it to plan. For example, if a UK-based entity will in future be trying to conform to two very divergent regimes in the EU and Great Britain, it may well want to structure accordingly. It might want to have separate legal entities in the EU and the United Kingdom. The situation would be quite different if the message the Government are giving is that there will be the kind of convergence the noble Lord, Lord Lansley, talked about, whereby approvals might be transferable.
The sector needs to make those kinds of decisions quite quickly. We are talking about an extension of the CE mark to 2030 but, as I said in my opening question, we are talking about the new British regime kicking in in 2025. That is not far away in business terms, so it is extremely important that we get some clarity from the Government—to the extent that they can give it—about the future direction of travel and whether they hope for or aspire to a regime of mutual recognition or instead anticipate that it would be quite divergent.
We need information not just about the technical details of what these regulations mean today but about the direction of travel and how approval processes may be changing over time, which is important. As I said, we will not oppose a statutory instrument that needs to be in force by 1 July to stop the sky falling on people’s heads, but I hope the Minister will take this opportunity to answer some of the questions that people building businesses in the United Kingdom and elsewhere need answers to in order to get essential devices. That kind of information would help them to plan and be most effective in supporting patients.
My Lords, I thank the Minister for introducing the SI and other noble Lords who have spoken today. Those of us involved in the somewhat tortuous passage of the Medicines and Medical Devices Act 2021, and subsequent SIs designed to bring about the transition from the previous, easily understood CE assessment under EU legislation to the UK conformity assessment marking system for medical devices, knew and predicted that the new and complex system needed much more time to develop the new arrangements and work out how they would work, and that the deadline set by the Government for transition would inevitably have to be extended. This last-minute SI fully recognises this, although many questions and issues remain unclear, as we have heard.
Given the complexity of the assessment marking system and what is proposed in this SI, I thank our Secondary Legislation Scrutiny Committee for setting out concise reasons, which were clearer than the SI’s Explanatory Memorandum, about the key points of what the SI seeks to do and why the seven-year extension for some medical devices is needed. On the reasons, the committee says:
“The extension is partly in response to a Europe-wide shortage of assessment capacity for these and other goods and also due to the Medicines and Healthcare products Regulatory Agency’s intention to strengthen the future regulatory framework for medical devices … in a way that both improves safety while also enabling innovation”.
I would be grateful if the Minister could comment on the Europe-wide shortage and the impact that it is currently having.
We have seen today that nobody is at all clear about what is going to happen, when the work and the timelines for MHRA’s new framework will be ready and when the extensive reform that will apply from 2025 will be published. I look forward to the Minister’s explanation of what paragraph 7.3 of the SI Explanatory Memorandum anticipates are the steps the MHRA will take
“to build approved body capacity to meet the demand for UKCA … marking”—
to which a number of noble Lords referred—in order to achieve the capacity when the transition periods after 2025 expire for the relevant medical devices. The capacity covers in particular the ability to assess higher-risk medical devices which we are not yet in a position to assess.
Paragraph 6.9 of the memorandum refers to the MHRA’s intention to lay “further instruments” under the MMD Act and “significant amendments” to regulations. Can the Minister update the Committee on the proposed timetable for this? Is the consultation exercise undertaken last year still under consideration by the MHRA as part of its developing policy? Will a further consultation on the MHRA’s new framework proposals be undertaken and, if so, what is the timescale for this?
The SLSC points out that the MHRA’s plans for reform are extensive. My noble friend Lord Hunt referred to them: reclassifying products, gathering information at the point of registration, strengthening surveillance, better incident reporting and so on. The committee stressed that these are excellent aims, but how and when the MHRA will achieve them—or try to—remains unclear.
The SLSC also refers to the MHRA’s current slow progress: it still does not have estimates of the total number of registered medical devices that are UKCA rather than CE marked. Of the 789,581 new medical products that were registered with the MHRA between April 2021 and March 2022 only just over 9% were UKCA marked. Is the Minister confident that this rate of progress will enable the MHRA to have a proposed new scheme in place in 2025 for transition to 2030?
Since the MMD Act, noble Lords have expressed serious concerns that, despite being a deeply respected body, the agency is just not properly resourced for the hugely expanded role and remit placed on it; the noble Lord, Lord Lansley, queried this, as did my noble friend Lord Hunt. What is the planned MHRA annual budget for 2023-30? What additional resources will it be provided with in order to enable it to meet the timescales and deadlines set out in the SI? Is the Minister satisfied that there will be sufficient capacity and capability within both MHRA and the UK conformity assessment bodies? That is crucial if we are to avoid medical products being withdrawn from the market because of delays or unregulated devices in the market.
I fully agree with noble Lords that the importance of having a clear indication of the long-term plan and route to be taken for the full operation of the UKCA mark cannot be emphasised enough if patients’ safety and their continued access to the extensive range of medical devices covered by the MMD Act and related SIs are to be achieved. The excellent briefing from the industry body, the British Healthcare Trades Association, summed it up when it said:
“Without the regulations or a clear timeline, businesses face a tangled landscape of inter-related laws and regulations against which corporate decisions must be made with unclear costs, deadlines and risks”.
Paragraph 13.3 of the Explanatory Memorandum indicates that the Government do not expect
“a significant cost impact on small and/or micro businesses”
because the draft regulations are a continuation of the “status quo”. Can the Minister explain how this can be when it earlier describes the extended period as a “transition”? Small businesses operate on tight margins and need certainty and clarity. What further information is to be given to them to assist them in transitioning from CE marking to UKCA marking? How will the MHRA share information about the new rules with businesses, the public and patients?
Finally, I just want to underline the huge range of devices that noble Lords have been talking about, which includes invasive, non-invasive, surgically invasive and active devices. Can the Minister confirm, as the noble Lord, Lord Allan, asked, that class 1 medical devices—these are low-risk devices, such as wheelchairs and stethoscopes—are exempt from the new transitional arrangements of the SI, as the MHRA guidance seems to indicate?
I was going to ask about the labelling requirements but the noble Lord, Lord Allan, covered them. There is particular importance here in terms of their impact in Northern Ireland. My noble friend Lady Ritchie is here but did not speak; she will be concerned about that issue.
I look forward to the Minister’s response to the key questions asked by noble Lords, especially on the expected timing of the new MMD regulations. I also look forward to his response on mutual recognition, which the noble Lord, Lord Lansley, spoke about.
I thank noble Lords for their valuable interventions; I will try to answer a lot of their points as far as is possible.
First, I completely agree that clarity is vital in this market. As ever, as well as trying as best as I can to reply now, I will follow up in writing so that there is absolute clarity there. A lot of this depends on the timing. I say this up front in answer to the question from the noble Lord, Lord Allan, on whether things will change for new products from 2025: no. In effect, we are saying that the deadline is the deadline and, as long as a product is approved during that period, it will run to 2028 or 2030. In fact, new products will now be largely under the new EU regulations so will generally run to 2030. Effectively, that 2025 deadline will apply to any new products even if they are approved and get their CE registration after 2025—say, in 2026. Generally, they will run up to the 2030 deadline.
I hope that what I have said clears up that point but, again, I will set all this out in writing; I am sure that I will be thumped by the team behind me if I misspoke. I think I proved the point very well in my explanation just now: this is non-trivial. As a businessperson by background, I know that, if you want people to invest in this market, they absolutely need to understand the rules.
Two major themes came through in all the points and questions. First, we want to maximise the supply of products. That has to be a good thing for us in making sure that we benefit as much as possible, and it goes to us recognising other quality—for want of a better word—regulators. You could say that approving the ceiling now up to 2028 and 2030 is a step along that way.
Similarly, we want to maximise capacity for our regulators. If you start to approve other quality regulators’ approvals, you are in effect pooling capacity and using their regulatory capacity as well. We know that that is an issue. In the last Budget, the MHRA was given a £10 million funding increase to make sure that it can recruit, but we recognise that it having that capacity is vital to all this.
On the point about mutual recognition, we can of course do it in only one way but, as in most free trade arguments, there is an understanding that it is generally to our benefit to recognise other quality regimes. That is to our benefit in terms of having a high supply of quality items here. Clearly, you want them to do the same in reverse. As ever in these things, there is a bit of trade-off in the negotiation: “Do I want to hold back so that I can maximise my leverage and get them to agree with it all?” Generally, as mentioned by the Chancellor, we are at the moment on the page of it being in our interests to recognise quality regulations from other countries because that can maximise our supply. We hope that they will recognise ours in a similar way, obviously, but that is in their power rather than ours.
I will try to answer some specific questions. There was a question from the noble Lord, Lord Allan, about class 1, low-risk products. Generally, the answer is yes, but this again goes to some of the confusion so I will definitely set this out in writing as well. It is not a blanket “yes”, which I appreciate does not help. Class 1, low-risk devices will benefit from the transitional periods in this instrument only where they are within the EU’s own transitional arrangements. I hope that that make sense.
My noble friend was talking about capacity. One aspect of it is the capacity of the regulators here and in the EU but, in some ways, I am equally concerned about the capacity in the approved bodies, or notified bodies as the EU has them. That is what has been delaying the EU’s regulations and its ability to implement them. It could equally be a problem here. We would both have less of a problem if the approved bodies in the European Union and the United Kingdom were all able to work on both sets of certificates.
Yes; that is what I mean by pooling capacity, for want of a better phrase. My noble friend is saying that we can effectively use the EU’s capacity if we are willing to accept that it is doing proper scrutiny and measurement of products. By and large, we would all agree that that is a sensible approach, just as, similarly, there are situations in a lot of clinical research where, even if the regulators want a final sign-off, accepting each other’s data has to be sensible in terms of pooling capacity.
As ever with these things, it takes two to tango. We need to prove willingness on our side. I hope that the recent Windsor Framework agreement is a way to put things on a co-operative basis. Building trust on both sides takes a series of steps but we are trying to put our best foot forward and we hope that that is met in response.
This goes to the point about the EU-wide shortage of approved body capacity, which impacts us all. If, as we all agree, we want the best supply of products here, it must clearly be a concern if they cannot get through that way. If a company is finding that, through a lack of capacity, they cannot get through the EU route because there is no capacity there, it now has the opportunity to take the UKCA route if our capacity is in place, with the increases to the MHRA to which I referred.
When the Minister writes—I understand that this is very complex; I would certainly appreciate having it in writing—could he refer to three things? The first is small businesses; the SI says that it will not have an impact on them but it is clear that it will. When? The second is the timetable for the new MHRA framework being in place, whether there will be consultation around it and whether that process is separate or uses the consultation that took place last year. The final issue is that of the timetable for the new MMD regulations—that is, the timescale by which we will see them coming along. It will help us make sense of the totality of this if we know when all this work is coming forward.
On the labelling question, I wonder if I could helpfully suggest to the Minister something like an infographic, which shows what labels are needed in Great Britain and Northern Ireland and which labels would be helpful on which dates. Somebody who is making devices could just look at that and go, “I’ll need that kind of labelling at this stage of the transition process”. That would help.
I absolutely agree. To clarify—I may have used the terms interchangeably—I am talking here about the Great Britain market. It is a great British market as well but we are talking particularly about Great Britain because we know that, under the Windsor Framework, Northern Ireland has separate CE arrangements.
I think I have answered as much as I can at this point. I will clarify further in writing. I thank noble Lords because this debate has been incredibly valuable in making sure that we are getting this right; it is non-trivial, to say the least. With that, I commend this instrument to the Committee.