Medical Devices (Amendment) (Great Britain) Regulations 2023

Lord Hunt of Kings Heath Excerpts

Monday 5th June 2023 Grand Committee

[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.

[Lord Lansley (Con)]

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.