On 16 June 2025, the UK Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 came into force, marking the first step in the reform of the UK legislation for medical devices. The regulations apply to Great Britain (England, Wales and Scotland), and medical devices placed on the market in Northern Ireland must follow the post-market surveillance rules set out in EU legislation.

The details of the regulations are set out in our previous blog post. In summary, the new regulations will ensure all manufacturers have an effective system in place to monitor devices once they are in use, collect comprehensive safety data, report serious incidents, and take swifter action when issues arise.  The MHRA has also published substantial guidance on the new requirements, which sets out how the new requirements apply across different types of devices. There is also a helpful video explainer.