MHRA Quarterly Summary Report Template Update

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released an important update that builds upon previous changes announced in early July. The latest development involves the introduction of a new MHRA Quarterly Summary Report (QSR) template, version 1.1, which replaces the previous version published in January 2024.

This updated template reflects significant changes to streamline the reporting process for clinical investigations involving medical devices.

MHRA Quarterly Summary Report key modifications in version 1.1 include:

• • Removal of Distinction Between Annual and Quarterly Reports: The new template eliminates the need to differentiate between annual and quarterly reporting, simplifying the process for manufacturers and stakeholders.
  • Elimination of Annual Reports Requirement for Q4: The requirement to submit annual reports specifically for the fourth quarter has been removed, reducing the administrative burden on reporting entities.
  • Change in Submission Process: With the transition to the MHRA’s MORE portal, there is no longer a need to cc reports to an MHRA email address. All submissions are now to be made directly through the MORE portal.

These changes align the QSR template with the latest guidance available on the UK government’s website for notifying the MHRA about clinical investigations for medical devices. The updated template is available in PDF format and can be accessed here.

These updates are expected to improve the efficiency and clarity of the reporting process for medical device manufacturers and other stakeholders involved in clinical investigations, and the changes in the template now match this guidance.

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