Manufacturer’s Online Reporting Environment (MORE)
Source: gov.uk (2025-06-09)

A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.

The Manufacturer’s Online Reporting Environment (MORE) is a digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents. MORE serves as a crucial tool for both the MHRA and manufacturers to ensure the safety and efficacy of medical devices used within the healthcare system. It allows for the efficient submission of medical device reports, providing a centralised database that can be analysed and reviewed to identify potential risks and areas for improvement.

This guidance only applies to manufacturers and those reporting on behalf of manufacturers. Patients, healthcare professionals and other device users should refer to our guidance on Yellow Card reporting for medical devices. (https://yellowcard.mhra.gov.uk/medicaldevices)

How to report to the MHRA

Manufacturers must submit reports to the MHRA relating to adverse incidents for devices occurring in GB or NI via the MORE portal (https://more.mhra.gov.uk/login). The MHRA will not accept any reports received via other routes.

To use the MORE portal, you must register for a MORE account (https://more.mhra.gov.uk/login). See the MORE registration guide (https://www.gov.uk/government/publications/more-registrations-user-reference-guide) for details on how to register.

See the MORE Submissions Guide (https://www.gov.uk/government/publications/more-submissions-user-reference-guide) for guidance about how to use the portal.

If you are interested in setting up an API (application programming interface) to submit your reports directly from your internal IT systems to ours, please contact xxx@xxx.xx (mailto:xxx@xxx.xx) for further information. See the MORE production API guidance (https://www.gov.uk/government/publications/more-platform-api-application-programming-interface-set-up-user-reference-guide) document for more information about how to set up your API.

Great Britain (England, Scotland and Wales)

In 2024, the government put in place legislation to clarify and strengthen the post-market surveillance requirements for medical devices in use in Great Britain. These measures came into force on 16 June 2025 and will facilitate greater traceability of incidents and trends and allow the MHRA to act swiftly when needed, supporting better risk management and containment of safety issues and reducing harm.

Following the passing of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (https://www.legislation.gov.uk/uksi/2024/1368/contents/made), the MHRA has updated its processes and procedures to ensure that trends, patterns or signals that may reveal new risks or safety concerns are identified more efficiently. This will allow both the MHRA and the whole healthcare system to better protect patients.

As part of this work, the data schemas for transmission of Manufacturer Incident Reports (MIR) and Field Safety Corrective Action (FSCA) reports have been updated to support GB submissions under the new requirements. These updates ensure that information is provided in a structured manner facilitating improvements to data quality.

See the MORE implementation guide (https://www.gov.uk/government/publications/more-implementation), Implementation of data requirements under the new Post-Marketing Surveillance regulations (https://www.gov.uk/government/publications/more-implementation/implementation-of-data-requirements-under-the-new-post-marketing-surveillance-regulations) and Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations (https://www.gov.uk/government/publications/documentation-for-implementation-of-data-requirements-under-the-new-post-marketing-surveillance-regulations) for further guidance.

Northern Ireland

The Regulations apply to Great Britain (England, Wales and Scotland). Medical devices placed on the market or put into service in Northern Ireland (NI) must follow the post market surveillance rules set out in EU MDR 2017/745 (https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng) and EU IVDR 2017/746 (https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng) as explained by guidance documents issues by the Medical Device Coordination Group (MDCG) (https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en).

In accordance with these regulations, manufacturers must report serious incidents, FSCAs and trends to the competent authority via the electronic system, Eudamed. Until such time that the Eudamed Vigilance (VGL) module becomes available, competent authorities and economic operators must continue to use national reporting processes.

As the competent authority for NI, manufacturers must report serious incidents, FSCAs and trends to the MHRA.

Manufacturers reporting serious incidents occurring in NI should continue to use the EU forms within MORE.