Last week, MHRA updated the PMS and Vigilance guidance page. They intend to continue to accept reporting for NI using the EU MIR and will transition to using 7.3.1 as per the EU deadline, however for GB reporting there is a new GB Schema that will be introduced and will need to be used from the date of application of the updated UK PMS 16th June 2025.
Current changes adopted in the GB Schema are for 7.2.1 and not 7.3.1
MHRA are currently reviewing the changes introduced by 7.3.1 and will review if they need to update the GB Schema to incorporate these changes. You can find further information here: Medical devices: post-market surveillance – GOV.UK.
Guidance on the Manufacturers online reporting environment (MORE)
- Manufacturer’s Online Reporting Environment (MORE) guidance
- GB MIR and FSCA schema implementation guide
- Implementation of data requirements under the new Post-Marketing Surveillance regulations
We will have this topic on the agenda for the scheduled UKCA sub group meeting on Tuesday 27th May, so please review and provide any feedback (regulatory@bivda.org.uk) before the meeting so we can discuss any issues.
