In addition to the consultation on the future regulation of medical devices in the UK, the government plans to introduce legislation in 2024 that will strengthen Post-Market Surveillance (PMS) requirements in Great Britain ahead of broader regulatory reforms. This initiative reflects the government’s commitment to enhancing patient safety as part of the upcoming medical device regulations.
The draft Post-Market Surveillance Statutory Instrument (PMS SI) was submitted to Parliament on 21 October 2024. It introduces new PMS requirements for medical devices that prioritize patient safety while ensuring continued access to safe medical technologies and maintaining the UK’s appeal as a market for medical technology innovators.
A draft version of the PMS SI was made available on the World Trade Organization (WTO) website on 26 July 2023, providing stakeholders with early notice of the proposed legislative changes. Following feedback from the WTO review, the MHRA has made several amendments to the draft PMS SI to enhance clarity and assist manufacturers in understanding their obligations. For further details on these changes, please refer to the official response to WTO members.
Key updates in the final draft of the PMS SI include:
- Specific requirements for what a PMS system must include, with a focus on methods for collecting PMS data to improve data capture and harmonization across manufacturers.
- Enhanced reporting obligations for serious incidents, aimed at facilitating quicker detection of safety issues.
- Clearer guidelines for manufacturers on when to consider a Field Safety Corrective Action (FSCA) to mitigate or prevent serious incidents, along with detailed requirements for Field Safety Notices (FSN) to better reach patients and users at risk.
- Stricter requirements for manufacturers to conduct periodic reviews of PMS data, particularly for implantable medical devices, to help detect safety trends or signals earlier.
The draft PMS SI will be debated in Parliament and is expected to come into force in the summer of 2025, following a six-month implementation period. A full impact assessment and equalities impact assessment have been prepared for the regulations.
Comprehensive guidance will be published before the PMS SI takes effect to help manufacturers understand their responsibilities and ensure smooth implementation.
More information can be found using the following link
The press release can be accessed using the following link
