Karin Smyth

I know that many hon. Members want to talk about the provisions in the Bill covering many important issues. I will therefore speak briefly about two Government amendments relating to medical device licensing and information sharing. I will first address new clause 94 regarding medical devices licensing, and consequential amendments new clauses 99 to 101 regarding medical devices disclosure. These amendments are about ensuring that Great Britain’s medical devices regulatory framework remains fit for the future. As we know, medical technology is evolving rapidly, particularly in areas such as software and artificial intelligence, while our current framework was designed for a very different technological landscape. This set of amendments establishes the statutory foundation for a future medical device licensing regime, applying to Great Britain only. EU medical devices legislation will continue to apply in Northern Ireland. Such a regime would require medical devices to be licensed and certain persons operating within the supply chain to hold a licence. By placing the detail in the regulations, the amendment allows us to work with patients, healthcare professionals and the medical device sector to create a regulatory framework that protects patients, supports innovation and strengthens the UK’s life sciences sector.