Contribution
My Lords, the noble Lord, Lord Kamall, asked further questions about the timing of the full impact assessment and why it is not being done this year. The reason is that the full impact assessment will refer to 2027-28, when the fees will be paid in full. Currently, because they are being subsidised for one year only, a de minimis assessment is required, but, when we have the full-fat version, that will be the right time for the impact assessment.
The noble Lord raised some questions that had been asked in the other place by Dr Caroline Johnson MP. I assure him that my ministerial colleague with responsibility for this area, Dr Zubir Ahmed MP, will reply to that Member of Parliament, and I will of course make sure that the noble Lord sees a copy of that response.
A question was raised about obsolescence and PMS. In response, I can say that if a manufacturer stops supplying a medical device, the company or its UK responsible person must update the MHRA registration by removing the product or stating that it has stopped being sold. Devices already on the market can stay in the supply chain or be used, as long as they are not recalled, and manufacturers are responsible for post-market surveillance duties. So, if the manufacturer no longer exists and has no legal successor, these duties do not transfer. For manufacturers outside the UK, the UK responsible person has to keep and provide plans and reports if requested. If there are any concerns, the MHRA will continue to monitor device safety and can act. The main summary is that manufacturers themselves or the UK responsible person are responsible for updating the MHRA.
The noble Lord, Lord Kamall, asked about the impact on small and medium-sized enterprises. I recognise, as I said in my opening, that new regulatory costs can be felt more sharply in this area, and that is why the MHRA listened carefully. It is also why the fee has been designed to spread costs more equitably across the sector, and why, once we had the consultation and the feedback, charging is to be based on a number of the GMDN categories that a manufacturer’s registered devices fall into, rather than the much more granular GMDN code. That matters for small and medium-sized enterprises because they are more likely to have closely related product variants that may attract multiple level 5 terms that sit within a single level 2 category. Under this approach, multiple products that are in one level 2 category are charged once a year, reducing repeat charges for minor product variations, which is important to SMEs. To re-emphasise, the MHRA estimates that about 56% of manufacturers will pay a single unit fee of £300 a year. It is SMEs that are most likely to fall into this lower charging group because they typically have a narrower product range than larger companies.
I can say to the noble Lord, Lord Kamall, that, as I said earlier, the charge is designed to be proportionate. I should say that if there were to be any waivers— I know that he did not specifically ask that but raised general concerns—that would simply shift costs elsewhere. We need to keep the charge predictable and proportionate, and to phase it in.
My final point is that SMEs stand to benefit from a stronger PMS framework. It will mean earlier identification of issues, fewer surprises and a more risk- proportionate, predictable regulatory approach. That is what supports responsible innovation, and I know that is of concern to the Grand Committee.
Taken together, these regulations put the funding of a strengthened PMS on a clearer, more sustainable and fairer footing, so that those who benefit from access to the UK market contribute fairly to the ongoing regulatory work that supports that access, because that regulatory work has to be paid for in some way. I cannot emphasise enough how the fee has been redesigned following the consultation. Often, noble Lords question the value of a consultation and whether it really makes change. I can say that, on this one, without a doubt, it has done, and I am grateful to all those who contributed.
Today, these regulations, if agreed by your Lordships’ Grand Committee, will mean that we can maintain confidence in the safety and performance of medical devices, support continued access, and ensure that the MHRA has the capacity to act quickly and proportionately should issues arise. For those reasons, I hope noble Lords will support these changes.