Draft Medical Devices (Amendment) (Great Britain) Regulations 2023

Karin Smyth Excerpts

Monday 22nd May 2023 General Committees

[Karin Smyth (Bristol South) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Stringer. This is one of those fairly innocuous-looking SIs that hides a multitude of problems and incompetence. Many people in our constituencies rely on these medical devices—some 600,000 every day—so it is important that they remain available on the UK market.

The Minister did not outline the range of devices that we are talking about. This is not some technical issue; devices range from blood tests to wheelchairs, contact lenses and scalpels. I am sure that hon. Members have all taken a chance to look at the list of non-invasive, invasive, surgically invasive and active devices. I will not delay the Committee by detailing all of them, but it is a long list, so it really is shocking that we are here once again. Although we have plenty of time, the Committee is being rushed by the Government to approve the draft regulations as some sort of last-minute extension of the existing regulations to mitigate the Government’s failure over exiting the European Union, some seven years after the vote. We are talking about plasters today, so the draft regulations are opportune: yet another sticking plaster over the problems that the Government have encountered and their inability to negotiate a settlement that took account of these important devices.

We will support the draft regulations because, without them, people across our country would suffer greatly from not having access to things coming on to the market and so on, but we need to ensure continuity of supply. I have a number of questions on which I hope the Minister will be able to shed some light, because I am sure she does not want to have rushed, unquestioned legislation. Turning to paragraph 7.3 of the explanatory memorandum, it would be helpful if the Minister could provide some detail on the steps being taken to build the approved body capacity to meet the demand for UK conformity assessments. With regard to paragraph 6, can the Minister share any details on the “significant amendments” that we should expect to the UK medical devices regulations, which have been discussed in this place before? Any details would be very welcome, because it is not only patients who could be affected if we fail to extend the legislation.

The Minister alluded to the number of businesses involved in this work, but manufacturers of these devices—both in the EU and here in the UK—need to have some sort of certainty. The lead-in time for some of this work is massive, as is the research and development capability needed to produce the devices. This last-minute rush is no good for businesses, and although the Minister tried to say that the draft regulations provide certainty, we contend that extending them for another few years, without a clear indication of the route to the full UKCA marking, does not provide certainty. Beyond the consultation, what conversations are the Government having with manufacturers to ensure that we have some realistic timescales about the future? As I said, this is a real worry for our constituents as well as medical professionals, people involved in prescribing the devices and those accessing them.

In paragraph 13.3 of the explanatory memorandum, the Government indicate that they do not

“expect a significant cost impact on small and/or micro businesses”,

because the draft regulations are a continuation of the “status quo”. Again, that is not good enough, because it contradicts the statement that the extended period is a “transition”. I am sure we all know that small businesses operate on tight margins. It is difficult to run a small business, so small businesses would welcome further details about what action will be taken to assist them in transitioning from CE marking to UKCA marking. I understand that there may be working groups looking at this issue, which is to be welcomed, but it would be very welcome if the Minister could inform us about that point.

It is vital that we get this right as we look to the future, so I ask the Minister: what is the Government’s long-term plan to ensure the success of the UKCA regime for medical devices? If this is the route we are going down, we want to make it a success. If the Minister could indicate—[Interruption.]

[The Chair]

Order.

--- Later in debate ---

On resuming—

[Karin Smyth]

To complete the point that I was making, we are interested in what the Government’s long-term plan is to ensure the success of the UKCA regime for devices.

It would also be helpful if the Minister indicated the Government’s view on alignment. What is their intention for future alignment with the EU? Is it their intention for us to be aligned with anyone but ourselves? What impact will that have on our future businesses?

The extension of acceptance of CE-marked medical devices will act as a transition, and we would all welcome clarification from the Minister of what that transition will look like. What steps will the Government take, in the time that we are allowing them, to support the manufacturers and supply chains that are indispensable to all those who rely on medical devices, to support jobs, and to preserve our global reputation for research, innovation and high standards?