Medical Devices (Amendment) (Great Britain) Regulations 2023

Lord Markham Excerpts

Monday 5th June 2023 Grand Committee

Moved by

[Lord Markham]

That the Grand Committee do consider the Medical Devices (Amendment) (Great Britain) Regulations 2023.

Relevant document: 38th Report from the Secondary Legislation Scrutiny Committee (special attention drawn to the instrument)

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

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.

[Lord Hunt of Kings Heath (Lab)]

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.

--- Later in debate ---

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.

[Lord Markham (Con)]

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.

[Lord Lansley (Con)]

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.

[Lord Markham (Con)]

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.

[Baroness Wheeler (Lab)]

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.

[Lord Markham (Con)]

It is probably best if I write on those points. In terms of timing, the MHRA is planning a further consultation on its future regime from October, but I will come back on those other points.

[Lord Allan of Hallam (LD)]

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.

[Lord Markham (Con)]

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.

Motion agreed.