Medical Devices (Amendment) (Great Britain) Regulations 2023

Debate between Lord Allan of Hallam and Baroness Wheeler

Monday 5th June 2023 Grand Committee

[Lord Allan of Hallam (LD)]

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.

[Baroness Wheeler (Lab)]

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?

New Hospitals

Debate between Lord Allan of Hallam and Baroness Wheeler

Thursday 25th May 2023 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for reading out the Statement. It has been clear for the last year that we would have to come to this moment of the Government finally admitting that achieving their 2019 manifesto pledge for 40 new hospitals by 2030, under the new hospitals programme, was never on the cards, and that reality would have to take over. The Government must face the reality of the timescales and the scale of the money needed to address the NHS’s crumbling estate, and the reality of needing to prioritise and address the urgent rebuild and major maintenance problems of existing hospitals throughout the country, which are seriously endangering patient safety and the public.

This morning, it was reported that the announcement of the Government’s realisation of not being able to keep their promise was delayed

“because of fears about a backlash from Tory MPs”.

Was that vital information kept from the public because of such fears? Can the Minister tell the House when the target was abandoned internally?

We know that NHS maintenance costs have more than doubled, from £4.7 billion in 2011-12 to £10.2 billion in 2021-22, and about the dire condition that many hospital buildings are in. For example, Leeds Teaching Hospitals saw over 100 raw sewage leaks last year, including faeces leaking into wards and patient rooms; Hampshire Hospitals NHS Foundation Trust was forced to suspend some services because of a rat infestation; and the hospital in King’s Lynn, Norfolk, is one of the most prominent hospitals that has had to be propped up with steel and timber supports to stop its dilapidated roof caving in.

Do the Government have an estimate of how much they expect NHS maintenance costs to continue to rise until 2030? Is there a full overall strategic plan for this and the now-reprioritised 40 new hospitals programme? If so, when will it be published? After government announcements on the programme, only in February described by the Minister opposite as “world-class” and capable of being exported “around the world”, we have become familiar with the idea that the hospitals were not new, that many were not even hospitals and that “new” could include repairs and redecoration.

The Nuffield Trust put the number of new hospitals in the Government’s original programme—meaning those that we would all recognise as new—as three, not 40. The National Audit Office called the programme unachievable, and NHS Providers estimated the real costs of building new hospitals as £20 billion, not the £3.7 billion allocated by the Government. Can the Minister commit to publishing the latest estimate that his department has made of the cost of the now-revised programme? Can he now say specifically which of the new hospitals in today’s Statement are being kicked into the long grass beyond 2030?

The slow progress being made was clearly evident last February when it emerged that only 10 of the projects even had planning permission. Just last week the BBC reported that building work is yet to start for 33 of the 40 projects promised. Will the Minister commit to coming back to the House with detailed implementation, timescales, costs and scope of what is now proposed? The fact is that the programme has been hit with delays and uncertainty for years, and the longer this goes on, the higher the costs soar and the less likely it becomes that they will ever be built. Most of the hospitals in the programme are still waiting to hear what their final budget will be, and none of the six that were supposed to be ready for 2025 has full planning permission or funding yet.

On the seven hospitals built with reinforced autoclaved aerated concrete—RAAC—the Government acknowledged in December the enormous concerns and safety implications and committed to eradicating this from the NHS estate. The Government have now officially recognised what we all knew—that these hospitals are not safe to operate beyond 2030. We welcome the news that they will all be completely rebuilt and the promise that this will be fully funded. Can the Minister tell the House the specific funding that is to be committed to the seven hospitals? Can he also tell the House when we are to receive the full details of the new, reprioritised plan so that it can be properly scrutinised and assessed by this House?

[Lord Allan of Hallam (LD)]

My Lords, when I worked in business we had a maxim that we should always try to undercommit and overdeliver as a way of pleasing clients. It feels like the opposite is applying here, with the Government scrambling to show that they are not underdelivering on their overcommitment. Of course, 40 hospitals was a classic election promise, oversimplifying a much more complex need, with the reinforced autoclaved aerated concrete hospitals being one of those such complications that emerged once they had turned over the aerated concrete block.

I do not expect the Minister to comment on the election promise, but I hope he can comment further on three aspects of the Government’s programme that he has set out. The first is the modular hospital design approach, which certainly seems a very smart way to proceed if it can provide more and better-quality hospital capacity at lower cost. Of course, any negative impact of failures in design will be multiplied if you are using a similar, consistent design. We should remember that RAAC was the future once, and public buildings were built according to that specification because it was seen to be cheaper and better back in the 1950s and 1960s. What assurances can Ministers give us that they will get it right this time and that the modular approach being used everywhere is the right one? By the way, on branding, 2.0 is now very 1.0, and it might be more appropriate to call it “the metahospital” or “Hospital.AI” these days.

The second is the planning process, which the noble Baroness, Lady Wheeler, raised. It does not matter if the modular design allows much quicker construction if everything is held up in seeking the relevant permissions to build the hospital in the first place. I would be interested to hear how many of the schemes have been given planning permission already and the extent to which the Government see planning as potentially a disruptor to their plans.

Finally, on the risks, if there are delays or cost overruns, which we hope there will not be—but inevitably one sees those with schemes of this kind—I look for assurances from the Minister that the contracts are written in such a way that any additional bills will not fall back on the taxpayer and, crucially, that if some schemes overrun or get into difficulties and incur extra costs, it will not mean that other schemes in the programme have to be cancelled as the overall budget runs short.