UK introduces new PMS regulation for Great Britain

As part of its post-Brexit demarcation from the rest of Europe, the UK has introduced stand-alone Post-Market Surveillance (PMS) regulations that have been integrated into The Medical Devices Regulations 2002. The new requirements apply to Great Britain (GB), comprising England, Scotland and Wales. Northern Ireland will continue to recognise the EU regulations for medical devices, including the PMS aspects.

The new regulation takes effect from 16 June 2025 and, although based on the PMS requirements in (EU) 2017/745 (MDR), they includes several significant differences. The regulation is titled ‘The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024’, copies of which can be accessed from here. A summary of the main changes can be found here.

Multiple guidance documents have been made available by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to assist manufacturers marketing their devices in GB to understand the new definitions and requirements, which are detailed on this web page. In addition, manufacturers will need to sign up the the MHRA’s vigilance reporting database, MORE, details of which can be found here. Detailed guidance on managing the Field Safety Notice (FSN) and Field Safety Corrective Action (FSCA) process for the UK has also been made available, together with a template for fulfilling the GB requirements for Periodic Safety Update Reports (PSURs), accessible from here.

Finally, in December 2024, MHRA updated its Road Map for Medical Device Regulatory Reform, which can be accessed from here.