We have published new guidance to help medical device manufacturers prepare for changes to reporting requirements for serious safety incidents and field safety corrective actions in Great Britain.
The new implementation guide for our Manufacturers Online Reporting Environment (MORE) clarifies the changing data requirements and timelines for compliance, before the new post-market surveillance regulations for medical devices come into effect on 16 June 2025.
Please review the new guidance here
Manufacturers should be aware of these important dates:
- early June: we will release an updated schema and guidance for Manufacturer Incident Reports (MIRs) and Field Safety Corrective Actions (FSCAs), for the upcoming GB reporting requirements
- 16 June: the new GB MIR and FSCA schema will be available in our MORE system, for manufacturers to use
- 16 October: the latest date that manufacturers must start using the new GB schema to report incidents to MORE [via API (application programming interface) or post eXtensible Markup Language (XML) routes]
Reports for Northern Ireland may continue to be reported to the MHRA using the existing MIR 7.2.1 after 16 June 2025.
Register for email updates to our Medical devices: post-market surveillance web page to keep up to date with all the changes.
