UK MHRA’s MORE System: Enhancing Post-Market Surveillance of Medical Devices
- Sharan Murugan
- 3 hours ago
- 3 min read
In a regulatory landscape that continually evolves to ensure public health and safety, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pivotal update: "Manufacturer’s Online Reporting Environment (MORE)". This digital platform modernizes the post-market surveillance (PMS) system for medical devices in Great Britain.
With the implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, the MHRA aims to streamline how manufacturers report adverse incidents and field safety corrective actions (FSCAs).
Manufacturer’s Online Reporting Environment (MORE): A secure digital portal developed by MHRA, enabling manufacturers of medical devices to submit post-market vigilance reports electronically. It is a centralized system for handling incident reports, field safety corrective actions (FSCAs), and periodic safety updates.
Post-Market Surveillance (PMS): The ongoing process conducted by manufacturers to monitor the safety and performance of medical devices after they have been made available on the market. This includes collecting, analyzing, and reacting to information about device-related incidents and user feedback.
Guidance: MHRA Guidance on the MORE System
The MHRA’s official guidance outlines how the MORE system is a modern, user-friendly interface for manufacturers to fulfill their vigilance reporting obligations. The platform accommodates submissions related to:
General medical devices
In vitro diagnostic (IVD) devices
Custom-made devices
Through the MORE portal, manufacturers can submit various types of reports, including:
Manufacturer’s Incident Reports (MIRs) for serious incidents
FSCA reports when a safety-related corrective action is implemented
Periodic Summary Reports (PSRs) for trends and recurring incidents
The platform requires users to register securely and assigns access based on user roles within an organization. The reporting interface is integrated with structured templates that ensure all required data fields—such as device identifiers, incident details, and action plans—are captured comprehensively. MHRA has also provided a PDF-to-XML converter tool, which assists in transforming manually completed forms into machine-readable formats compatible with the MORE portal.
Manufacturers are encouraged to thoroughly review the guidance documents, train their reporting staff, and regularly validate the completeness and accuracy of submitted data.
The 2024 amendment to the Medical Devices (PMS Requirements) Regulations brings the UK’s vigilance reporting practices in line with international standards, increasing the level of detail required in safety reports and enhancing traceability through Unique Device Identifiers (UDI).
Key updates include:
Enhanced Reporting Forms: The new templates now require additional fields such as detailed device descriptions, UDI data, incident chronology, root cause analysis, and risk-benefit evaluations.
Improved Data Quality: The system ensures structured data input that facilitates signal detection, trend analysis, and timely regulatory interventions by MHRA.
Transition Support: MHRA is providing user manuals, training materials, and technical support to assist manufacturers in transitioning from legacy reporting systems to MORE. This includes instructions on completing new forms and using updated templates.
Regulatory Alignment: These changes bring UK regulations closer to the expectations set by the European Union Medical Device Regulation (EU MDR), supporting the principle of global regulatory harmonization and reinforcing the UK’s commitment to robust post-market monitoring.
The MHRA also emphasizes that the timely and accurate submission of reports through MORE is not only a legal requirement but also a critical element in safeguarding public health by facilitating early detection of device-related issues.
By embracing these changes, manufacturers not only meet their legal obligations but also contribute meaningfully to a safer healthcare environment in Great Britain.
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