Page Last Updated: 19 September 2023
As of September 1, 2023, the MHRA has a new process for medical device and IVD vigilance reporting. The process is outlined: HERE
Manufacturers must create an account in the new version of the MHRA vigilance reporting platform MORE, to report adverse incidents or initiate field safety corrective actions (FSCAs).
We reviewed the MHRA’s 43-page user guide and outlined the key steps to create a new account.
The new Manufacturer’s On-Line Reporting Environment (MORE) system became mandatory for vigilance reporting starting 1 September 2023. As of this date, the old vigilance email (AICxml@mhra.gov.uk) no longer accepts new vigilance reports.
The old version of the MORE platform has been obsoleted. You will need to create an account in the new MORE platform.
No new vigilance could be submitted into the old MORE portal after 21 November 2022. From then onward, it was ‘read-only’ until 30 April 2023.
Any information you had in the old MORE platform has not been, and will not be, migrated to the new MORE platform. Instead, manufacturers must have downloaded any information from the read-only version prior to 30 April 2023.
Vigilance Requirements Tool
EU, UK and Switzerland: vigilance contacts, links to forms, reporting process and reporting timeframes
We have outlined the key steps below. The MHRA has also issued a 43-page user guide, available: HERE
Send to: AIC@mhra.gov.uk
Subject: MORE registration supporting documentation – MANUFACTURER NAME
Dear AIC team,
Please see attached validation documentation for MORE registration.
Registration was completed using the email address EMAIL on DATE for organisation MANUFACTURER NAME.
ATTACHMENT: Letter from the CEO
If this is of interest, you must contact the MHRA at: email@example.com
The MORE platform API set-up user guide is available: HERE