[Emergo, UL] MHRA Publishes Guidance on Updated Schema for Incident and FSCA Reports in MORE

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.

 

 

MHRA Publishes Guidance on Updated Schema for Incident and FSCA Reports in MORE | Emergo by UL

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