Draft Medical Devices (Amendment) (Great Britain) Regulations 2023
(Limited Text - Ministerial Extracts only)
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The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)
I beg to move,
That the Committee has considered the draft Medical Devices (Amendment) (Great Britain) Regulations 2023.
It is a pleasure to serve under your chairmanship, Mr Stringer. Medical devices are currently regulated by the Medicines and Healthcare products Regulatory Agency in the United Kingdom, which helps to ensure that they are safe and perform as intended. The past few years have been a time of great change for medical devices. The covid pandemic saw huge advances in life sciences and diagnostic tests, and the UK’s decision to leave the EU has presented a great opportunity to strengthen our regulatory regime. We in this country are lucky to have a dynamic and pioneering medtech sector, and the MHRA is a renowned regulator with an established track record of innovation-friendly regulation.
The main objective of the instrument is to give the medtech sector additional time to transition to our post-EU exit regime for medical devices. To achieve that, it extends the time during which manufacturers and importers can place CE-marked medical devices on the GB market.
Since January 2021, to place medical devices on the GB market, manufacturers have had the choice of either following the UK route to market introduced after the UK’s exit from the EU and marking their devices with a new UKCA mark, or following EU legislation and affixing a CE mark. Without this statutory instrument, that flexibility would cease on 30 June 2023, and manufacturers would only be able to follow the UKCA route. That would impact an estimated 11,000 businesses that have registered devices with CE marking and not UKCA marking. To be clear, this instrument has no impact on medical devices already on the market with a UKCA mark.
The MHRA is working to implement an extensive reform to future regime medical devices, and the intention is that that core aspect will be applied from July 2025. Therefore, this SI will give the industry flexibility to continue to use CE or UKCA markings on medical devices until that date. This instrument will not only help to minimise any loss of medical devices from the market, but will ensure that patients can continue to access safe, high-quality medical devices and to smooth the transition to future regulatory requirements until 2025.
I will summarise some of the key changes. First, the instrument provides that medical devices compliant with the medical devices directive or active implantable medical devices directive with a valid declaration and CE marking 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 compliant with the EU IVD directive can be placed on the GB market up until the sooner of the expiry of the device certificate or 30 June 2030.
Thirdly, medical devices, including custom-made devices, compliant with the EU medical devices regulation and IVDs compliant with the EU IVD regulation can be placed on the GB market up until 30 June 2030. That is in keeping with the Government’s response to the consultation on the future regulation of medical devices in the United Kingdom, which took place from September to November 2021.
By supporting these regulations, we can help to ensure that patients and the wider public benefit from continued access to quality, safe medical devices, that the UK therefore remains an attractive market for manufacturers of medical devices, and that the wider medtech industry has adequate time to prepare for transition to the future regulatory framework for medical devices planned for 2025. I commend the regulations to the Committee.
Maria Caulfield
I will do my best to respond to the points made by hon. Members. The hon. Member for Bristol South asked a number of questions. She is right: there is a long list of devices, which fall into various classes of device that the MHRA regulates, and there are different rules for the different types of devices. The MHRA has taken a wide-ranging approach in consulting with the industry and the medtech sector. The consultation that was developed between September and November 2021 is still being looked through. That is why we have this SI: because the MHRA has taken on board some of the concerns and suggestions of the industry.
The final regulations will be operational from 2025. We have set that date so that we have a lead-in period, and then a transition time up to 2030. The MHRA regularly engages with trade associations, for the very reasons that the hon. Lady set out. The recent consultation received more than 900 responses. The explanatory memorandum includes a contact at the MHRA; any industry people listening who have concerns or suggestions and did not manage to take part in the consultation can still make contact with the MHRA, which will be able to give guidance and support on the plans. When we are further down the road to 2025, the MHRA will issue guidance to the industry as well.
Further regulations will be introduced later this year in relation to the long-term changes, and we will keep Members updated on that. This is a big change and the MHRA is doing a significant amount of work in this space. It is taking steps to ensure that, in implementing the further changes to medical devices regulations, it has the capacity and capability to continue to perform, as it always has, to the highest level, putting patient safety first but supporting the industry as well.
The hon. Lady talked about future realignment. As part of our wider work to reform medical devices regulation and take advantage of Brexit opportunities, we will make provision for alternative routes for medical devices to reach the GB market. That will involve possible recognition of devices with approval from other trusted regulators. We will keep Members updated on that as we work towards it.
Emma Hardy
I am concerned about the point about other trusted regulators. Different countries have completely different rules for medical devices. I will not mention vaginal mesh again, but the rules in the USA are quite different from those across the European Union. The community would be incredibly concerned if we were to accept other countries’ criteria for what is considered safe or not. I hope that the Minister will explain that we will have a stricter and more thorough system for regulating what goes inside our bodies.
Maria Caulfield
I take the hon. Lady’s point, and that is exactly the point that I wanted to make: we want to have the safest regulations possible. However, that does not close the door to recognising the work of other regulators. As I say, we will keep Members fully informed of those decisions as we go forward.
I know that this is slightly out of scope, Mr Stringer, but on the use of mesh, that was done while we had the existing EU regulations for CE-marked devices. There is now the possibility to track devices—they have barcodes on them—such as breast implants or replacement hips, and we have certainly accepted almost all the recommendations of the Cumberlege review, which looked specifically at mesh. I do not wish to test the Chair’s patience by going outside the scope of the draft SI, but that is why it is important that when we set the new UK mark, we learn lessons from the past. The CE mark has served us well, but there were instances of safety being compromised.
Emma Hardy
I thank the Minister for giving way again, and I thank you, Mr Stringer, for your generosity. Will the Minister indulge me by commenting quickly on the yellow card system and on how people can report more effectively?
Maria Caulfield
Absolutely, Mr Stringer. I am happy to follow up on the yellow card outside the Committee, because it is outside the scope of the regulations.
The aim of the draft regulations, as we move away from the CE mark to the UK mark, is to give businesses time to transition to the new regulatory regime, which we are planning to introduce in 2025, with some transitional arrangements after that date. The MHRA is working hard with industry and is in regular contract with trade associations. We want to make the transition as smooth as possible, and the draft SI will allow the sector leeway so that we can introduce the changes at pace.
Question put and agreed to.