Changes to submitting medical device adverse incidents to the MHRA
07 October 2022
Manufacturers (or their UK Responsible Person/Northern Ireland-based Authorised Representative) must report post-market vigilance reports to the MHRA via the MORE system or by sending an XML output of the Manufacturer Incident Report (MIR) form to AICxml@mhra.gov.uk.
This will change from 21 November 2022. Reports relating to adverse incidents for devices to the MHRA must be submitted via the new MORE portal or via the MHRA’s custom Application Programming Interface (API) for direct submission from your internal systems.
Manufacturers, UKRPs and NI-based ARs will need to register for a new MORE account to be able to use the new MORE portal and/or API. Registration will be available from Thursday 13 October 2022.
From 21 November 2022, you will no longer be able to submit reports via the old MORE portal. You will have read only access and will be able to download existing reports until 30 April 2023.
More information can be found on the gov.uk page below, and the slides and recording from a recent MHRA webinar on the changes are also available.
