Medical Devices (Amendment) (Great Britain) Regulations 2025

Lord Rennard Excerpts

Tuesday 6th May 2025 Grand Committee

[Lord Rennard (LD)]

My Lords, I share some of the concerns raised by the noble Baroness, Lady Finlay. As the Minister so carefully explained, it is essential that we preserve the existing regulations until they can be replaced. However, does she accept that, although an argument frequently used by supporters of Brexit was that they did not like so much regulation, what is happening now in our very successful life sciences industry—which wishes to do business abroad as well as in the UK—is that its products may become subject to both UK and EU regulations?

EU regulations have generally been recognised across the world as a basis for doing business, making it relatively easy for UK-based producers of medical devices to export them. Would it not be better in future to achieve regulatory alignment with the EU, so that businesses producing new products will not have two different sets of regulatory processes, and two sets of costs to contend with, when they innovate and improve their products? Will having separate UK regulations in future not run the risk that such businesses become more reluctant to innovate, and will this not be detrimental to patient care? If we want to improve patient safety and do all the other things the Minister outlined, would not this be done best in alignment with our major trading partners, using standards that are generally agreed internationally?