Manufacturer’s Online Reporting Environment (MORE)

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance for medical device manufacturers regarding the Manufacturer’s Online Reporting Environment (MORE) portal. This digital platform is the exclusive channel for reporting adverse incidents and managing device safety in the United Kingdom. Under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, which become enforceable on June 16, 2025, the MHRA aims to strengthen post-market surveillance, improve incident traceability, and enhance patient protection. For devices in Great Britain, manufacturers must utilize the MORE portal or a direct Application Programming Interface (API) to submit Manufacturer Incident Reports (MIR) and Field Safety Corrective Actions (FSCA) using updated data schemas. In Northern Ireland, manufacturers must comply with EU Medical Device Regulations (MDR 2017/745 and IVDR 2017/746), using the MORE portal with EU-specific forms until the Eudamed system is fully functional. To remain compliant, manufacturers are required to register for a MORE account, adhere to new data quality standards, and ensure all reporting follows the mandated digital routes, as the MHRA will no longer accept submissions through alternative methods. These measures are designed to facilitate faster identification of safety trends and more effective risk management across the healthcare system.