New guidance on the PMS requirements has now been published by the MHRA

MHRA

New MORE Guidance on implementing the changing data requirements for medical device reporting.

The MHRA has released a new guidance to support medical device manufacturers in preparing for upcoming changes to the reporting requirements for serious safety incidents and field safety corrective actions in Great Britain.

The new implementation guide for the Manufacturers Online Reporting Environment (MORE) outlines the revised data requirements and compliance timelines, ahead of the new post-market surveillance regulations for medical devices taking effect on 16 June 2025.