Skip to main content
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Submitting Adverse Incidents to Medical Devices to the MHRA – enhancements to the MORE portal

By May 26, 2023No Comments

Adverse incidents involving medical devices which occur in the UK are reported to the
MHRA via the MORE portal. The MHRA is in the process of implementing several changes to make the MORE portal automatized and easier to use. These updates are expected from June onwards.

The MHRA have provided the following information:

In our last update, we said that we will let you know about upcoming changes to the MORE portal based on your feedback about your experience of submitting medical device vigilance reports. We are pleased to let you know about the latest enhancements that will be available soon.

Please note that the release of these enhancements will not affect your ability to access the MORE portal or submit reports. Information about new features will be included in the MORE Submissions Guide, available on the GOV.UK website and in the Resources tile within the MORE portal.

Upcoming changes in June

  • We have redesigned the look and feel of the web forms to address your feedback about slow performance and difficulties in identifying mandatory fields.
  • When submitting a report, if the information within a field is not valid or if information is missing from a mandatory field, you will be alerted to this allowing you to address these issues before submission.
  • Within the Report Management tile, the report review screen that displays when selecting an incident report has been updated with a new and improved design and some additional information fields.
  • Organisation details including name, email address and address will be auto-populated when creating a new report via the web-form which will be based on the data held in the MHRA’s Device Registration Database for the organisation you are reporting for, saving you time when completing reports manually and ensuring consistent and accurate data.
  • Submitter details in the MIR forms will be auto-populated when the submitter of the report is selected, saving time when completing reports manually and ensuring consistent and accurate data.

Future improvements planned

  • You will be able to define who receives email notifications from the MORE portal
  • The date that the incident report is submitted will be visible in the PDF version of the report
  • Improvements to language used within the portal to make it clearer and easier to understand.

We welcome any feedback about these improvements and features, as well as any general feedback about your experience using the portal via aic@mhra.gov.uk. We will continue to work on improving the system and will keep you updated about the latest improvements.

Tehelj