Medical Devices (Amendment) (Great Britain) Regulations 2023

Baroness Wheeler Excerpts

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?

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[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.