The new Great Britain vigilance report schema goes live

By Amelia Boldrick and Elizabeth Pugh

The new Great Britain (GB) vigilance report schema goes live on Monday, June 16 in alignment with the timing of the new post-market surveillance (PMS) regulations coming into force. The GB regulator has updated its online guidance hub with resources intended to assist with the implementation of the new schema.

The Medicines and Healthcare products Regulatory Agency (MHRA) has long leveraged the European Union (EU) vigilance report form schema for report intake and submission in their online reporting portal: the Manufacturer Online Reporting Environment (MORE). Data from version 7.2.1 of the EU form will be accepted until October 16.

Due to Brexit, GB was removed from the distribution countries identified in version 7.3.1 of the EU form. Only reports for Northern Ireland will transition to the new version 7.3.1 form in November and, ultimately, submission in the European database for medical devices, EUDAMED, upon completion of the vigilance module. XML files exported from the 7.3.1 template will not validate in MORE.

What this means

Any party that does not wish to enter data into the MORE incident manually and field safety corrective action (FSCA) report webforms after October 16 will need to implement the new schema released by MHRA into complaint management software so that XML data exported from these systems will validate in MORE.

This means that complaint-handling systems will need to be capable of exporting XML data that is compatible with two different sets of schema for reporting in both the EU and GB.

MHRA resources available

In addition to the XSD files necessary for updating complaint management systems to export the Manufacturer Incident Report (MIR) form and FSCA report data that will be validated in MORE after October, MHRA has also published changelogs for both forms, updated help text files for completing both webforms and sample XML files for each type of MIR and FSCA report that can be used to test functionality in MORE.

Concluding remarks

The EU and GB are giving manufacturers no respite in the timing of their respective updates to vigilance from data requirements. We at Emergo by UL recommend that the transition period in both markets be used judiciously to confirm complaint handling systems are compatible with the new forms/web forms.