What changed
MHRA has consolidated and continues maintaining a GOV.UK collection hub for GB medical device PMS and vigilance. The collection links manufacturer-facing guidance on PMS requirements (including summary tables and a table of key changes), supplementary vigilance system guidance (including examples of reportable incidents and field safety notice guidance), MORE reporting guidance, and device PSUR resources (including a standardised PSUR format and PSUR guidance tied to the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024). MHRA guidance pages state these Regulations came into force on 16 June 2025.
Why it matters
This MHRA hub concentrates the operational materials that support compliance with Great Britain’s device PMS and vigilance framework, including incident and FSCA notification expectations and the reporting route via MORE. For PV/medical device vigilance functions, treating the collection as the authoritative index supports inspection readiness (evidence that procedures reference current MHRA materials), reduces risk of using outdated reporting pathways or templates, and helps ensure aggregate device safety documentation (PSUR format/guidance) is aligned to the Regulations 2024 framework that MHRA guidance states has been in force since 16 June 2025.
Practical implication
Safety/Device Vigilance owner to: (1) confirm SOPs and training link to MHRA’s “Medical devices: post-market surveillance” collection as the live index; (2) validate operational readiness to submit adverse incident and FSCA-related reports via MHRA’s referenced MORE route; (3) confirm device PSUR process uses MHRA-linked standardised PSUR format and PSUR guidance tied to the Regulations 2024 framework; (4) update internal regulatory intelligence trackers with the 16 June 2025 in-force date cited across MHRA guidance, and monitor related MHRA future regime pages for further updates.