MHRA Publishes Guidance on Updated Schema for Incident and FSCA Reports in MORE

By Amelia Boldrick and Elizabeth Pugh

The Medicines & Healthcare products Regulatory Agency (MHRA) unveiled new guidance outlining the implementation of new manufacturer incident (MIR) and field safety corrective action (FSCA) report XML schema definitions (XSD) for Great Britain (GB) for the Manufacturer’s Online Reporting Environment (MORE) reporting system. This timing is aligned with the European Union (EU) MIR version 7.3.1 release and Swissmedic guidance on the update.

As our Emergo by UL experts reported previously, the new Post-Market Surveillance (PMS) regulations bring manufacturer vigilance and PMS requirements in GB in closer alignment with the European Medical Devices Regulation 2017/745 (MDR). As also mentioned last December, the statutory instrument incorporating the new requirements will come into force on June 16.

New regulations, new XSD

MORE currently accommodates submission of MIR and FSCA reports in three ways: via manual data entry, upload of XML report data and direct submission through Application Programming Interface (API).

This will still be the case after June 16, however, updates to the MIR and FSCA report XML schema definitions (XSD) will structure and define information collected in MORE specifically for the GB market. For example, changes include removing references to EUDAMED, collecting contact information for the UK Responsible Person, and identifying the UK Approved Body ID and certificate numbers.

The guidance includes a high-level overview of specific changes to both forms. No changes to the trend, periodic summary (PSR) or serious adverse event (SAE) report schema used currently in MORE are expected.

Regulatory convergence and report form divergence

Although many schema updates were unsurprising in light of Brexit, some changes to the FSCA report are noteworthy.

For example, as is the case now for Swiss FSCA report forms, GB FSCA reports will include fields to collect IMDRF coding, the number of devices distributed in GB and the estimated number of affected users. These updates convey an intent for MHRA to closely monitor FSCAs that impact the GB market under the new regulations.

Concluding remarks

MHRA indicates supporting documentation will soon be available in the Resources module of MORE. In addition to an overview of changes made, the new resources will include an updated MORE submissions guide, a bridging document for the EU MIR help text, updated XSD files and sample XML data. There will also be a transition period allowing for submission of reports under either the EU or UK schema from June 16 to October 16.

May is a busy month for markets using EU forms for vigilance reporting. We look forward to sharing further updates on the new EU version 7.3.1 form and GB report schema as additional information and resources become available.