Please be advised that MHRA have published the Guidance on Standardised PSUR format.
It is guidance, and members may exclude irrelevant sections or present data in formats different than in the guidance, but it identifies the data they expect to see in the PSUR submitted to meet the updated UK PMS SI requirements that applied from 16th June 2025.
The format can be adapted to include the requirements for reporting EU PSUR as well as to meet the GB PMS requirements. GB specific data is required to be presented to meet the GB requirements.
Also remember that Northern Ireland PMS data continues to follow the Requirements set out in the EU IVDR 2017/746.
