The UK’s MHRA has issued a substantial update to its Manufacturer’s Online Reporting Environment (MORE) portal, in preparation for the Post-Market Surveillance (PMS) regulatory changes that will take effect across Great Britain on June 16, 2025. The June 9 update marks the latest step in the UK’s broader initiative to modernize its medical device oversight regime following the departure from the EU regulatory framework.
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Manufacturers are advised to review the updated portal guidance, understand the new data requirements for incident reporting, and prepare internal systems for compliance with the upcoming enhanced PMS requirements.
Background: The New GB PMS Framework
In 2024, the UK passed new regulations to establish a national Post-Market Surveillance system aligned with global best practices and tailored to the UK’s independent regulatory landscape.
The new PMS regime is designed to:
- Improve the timeliness and accuracy of incident reporting
- Enhance data quality and traceability
- Strengthen the MHRA’s ability to identify trends and safety signals early
- Align reporting workflows more closely with real-world usage and risk
This system will formally come into force on June 16, 2025, but the recent MORE update reflects preparatory changes necessary for implementation.
Key Changes to the MORE Portal
MHRA’s Manufacturer’s Online Reporting Environment (MORE) portal is the mandatory interface for reporting incidents involving medical devices marketed in the UK.
As of the June 9, 2025 update, the portal has been revised to support the new PMS regime with the following key changes:
- Revised Data Schemas for MIR and FSCA
The Manufacturer Incident Report (MIR) and Field Safety Corrective Action (FSCA) forms have been restructured to align with the UK’s updated data requirements. These schemas now capture more granular safety data, clearer incident categorization, and structured follow-up information.
- Enhanced Data Standardization and Submission Guidance
MHRA has issued detailed instructions for completing submissions under the revised schema. The changes aim to ensure consistency and interoperability across device categories and support better regulatory review.
- Expanded System Capabilities
Technical improvements to the MORE portal include enhanced field validation, improved upload workflows, and backend processing designed to support faster assessment and triaging of reported incidents.
Manufacturers are encouraged to integrate these changes into their PMS workflows immediately to avoid disruption when the new regime formally takes effect.
Great Britain vs. Northern Ireland: Diverging Paths Under One System
Although the MORE portal remains a central tool for both GB and Northern Ireland, the regulatory basis for reporting differs significantly due to the application of the Windsor Framework and post-Brexit arrangements.
Great Britain (England, Scotland, Wales)
- Applies UK-specific PMS regulations
- Uses the revised UK-formatted MIR and FSCA templates through MORE
- MHRA is the sole authority for reporting and compliance
- Enhanced monitoring capabilities and proactive signal detection tools will be in full use after June 16, 2025
Northern Ireland
- Continues to follow EU MDR/IVDR, as part of alignment with the EU regulatory system
- Submissions through MORE must still use EU-style templates and formats (mirroring the EUDAMED requirements)
- MHRA remains the reporting authority for NI while the EUDAMED Northern Ireland module is not yet launched
- Once EUDAMED is fully functional, some reporting may transition to the EU portal for NI products
This duality requires manufacturers operating across both GB and NI to maintain two sets of PMS documentation and reporting workflows, tailored to each jurisdiction’s regulatory basis.
Strategic Implications for Manufacturers
These updates represent a significant operational shift for manufacturers marketing devices in the UK. With the new PMS framework and the revised MORE portal now active, organizations must take immediate steps to ensure regulatory readiness:
- Review and update internal SOPs to reflect the new data schema requirements.
- Validate PMS data systems and software to ensure compatibility with updated MIR and FSCA forms.
- Conduct staff training on use of the updated MORE portal, focusing on jurisdiction-specific differences between GB and NI reporting.
- Monitor regulatory developments around EUDAMED readiness for Northern Ireland, which could further change reporting obligations.
Companies not yet aligned with the updated processes risk submission rejections, delayed investigations, or potential enforcement action.
Looking Ahead
The MHRA’s modernization of the MORE portal underscores its broader shift toward data-driven, proactive regulation. Enhanced surveillance capabilities and harmonized reporting frameworks will allow the regulator to identify risks earlier and intervene faster.
This transition also signals MHRA’s intent to diverge from EU systems was beneficial, while still maintaining a parallel structure that allows for dual compliance in NI and GB. As global regulatory regimes continue to evolve, manufacturers should view this as an opportunity to strengthen their PMS infrastructure and digital regulatory operations.
Conclusion
The MHRA’s latest update to the MORE portal marks a critical milestone in the UK’s transition to a modern, post-market surveillance ecosystem. With new PMS regulations going live on June 16, 2025, manufacturers must act now to align systems, processes, and reporting protocols with the revised requirements.
While the regulatory path in Great Britain is increasingly distinct from the EU, the use of MORE for both GB and Northern Ireland underscores the continued complexity of navigating UK compliance. Manufacturers with operations spanning both regions must ensure their teams are well-versed in the differing requirements and that their data infrastructure supports both UK and EU formats.
The update is not just a technical adjustment, it reflects the MHRA’s broader regulatory vision focused on early detection, real-time risk management, and higher standards of device safety.
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