Updated post-market surveillance (PMS) requirements for medical devices in Great Britain came into force on 16 June 2025. The new Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024/1368), which was published in December 2024, aims to improve PMS requirements, foster better risk management and reduce safety concerns for patients.
Following the publication of the draft legislation in October 2024 and a period of public consultation, the regulations have been improved and a new Part 4A section has been added. This section includes details on:
- The manufacturer’s responsibility to report serious incidents of medical devices to the UK responsible person and the approved body for the device (if there has been one allocated) and in some cases, to the Secretary of State
- Implementing a PMS system and plan in place for each device that is put on the market
- The various components of the PMS report, safety update report and other relevant documentation that should be retained for submission
It is important that manufacturers who discover a risk related to the medical device or identify that it is not conforming with essential requirements, ‘must take the necessary preventive or corrective action as soon as possible to reduce that risk and bring the device into conformity.’
For updates and further resources, the MHRA recommends accessing the MORE portal.
