Notified Body Position Paper: Timeframes to Implement New Guidance Documents
28 September 2022
UKCA Marking: Fact Sheet for Medical Devices & IVDs
18 October 2022On 24 April 2023 the MHRA stated it would continue to accept vigilance submitted by email until 31 August 2023. This is an update from the below statement from the MHRA, which stated they would no longer accept vigilance submitted by email after 30 April 2023. So companies have a little more time to create their new account in the MORE vigilance reporting platform.
The MHRA announced “Changes to the Incident reporting system”, available: HERE
Current Process
Incident reports can be submitted:
1) Through the MHRA’s Manufacturer’s On-line Reporting Environment (MORE) portal; or
2) by emailing an XML output of the Manufacturer Incident Report (MIR) form to the MHRA.
New Process
Starting 21 November 2022, incidents must be submitted:
1) Through the new version of the MHRA’s MORE portal, which allows upload of an xml report or submission via the portal’s webform; or
2) via the MHRA’s new Application Programming Interface (API) for direct submission from the submitter’s internal system.
Anyone interested in option two (API connector) should contact the MHRA directly to establish this process.
Important Notes
The old version of the MORE portal will not accept new incident report submissions after the above date.
Previous reports remain available in the old MORE system only until 30 April 2023. i.e., manufacturers should ensure to download those records by April 2023, if needed.
The MHRA has advised that they will not migrate any data from the old system. This means that any draft reports saved in the old system, must be re-created in the new system.
To help with a smoother transition process, the MHRA will allow incident reports to be emailed until 30 April 2023. After that time, the mailbox will no longer accept submissions. Instead, industry must follow the new practice. Note that any emailed incident reports will not appear in your new MORE account.
The MHRA published a webinar on the new process if of interest, located: HERE
Next Steps
Registration for the new MORE system is available starting 17 October 2022. The MHRA released a User Reference Guide on how to register, located: HERE
