Implementation of data requirements under the new Post-Marketing Surveillance regulations
Published 16 May 2025
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This publication is available at https://www.gov.uk/government/publications/more-implementation/implementation-of-data-requirements-under-the-new-post-marketing-surveillance-regulations
Following the passing of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, 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. The Manufacturer’s Online Reporting Environment (MORE) will soon be updated with the new schemas in the user acceptance testing (UAT) environment to support familiarisation and testing of the changes to GB schemas. This will include updates to the webform, as well as xsd changes for posting xmls and API submissions of MIR and FSCA reports for GB.
For those that provide individual reports to MORE, the new GB data schemas will be live within the MORE production environment from 16th June, allowing industry to report under the new GB regulations when the new regulations come into force. Please note that GB schemas will be hosted alongside existing EU schemas, allowing continuation of reporting for non-GB submissions in an unchanged way.
For those that have integrated their system to send MIR and FSCAs to MORE via API, the xsds for GB submissions will require updating. Following publication of the new schemas within the UAT MORE environment, manufacturers must ensure they have updated their systems and procedures to align to the new schemas for submission of MIR and FSCA reports for GB.
We appreciate that updates to systems and procedures take time and are working closely with industry to support adoption and smooth implementation of the new requirements.
The continued reporting on the existing schema will be permitted until the 16th of October 2025, provided any additional information required to meet the new PMS regulations is submitted within existing MIR and FSCA report fields.
This approach supports industry to meet their regulatory obligations while providing additional time to ensure system readiness. Where no existing schema field for the information is available, the additional information can be added as described in Table 1 and Table 2.
Table 1. Provision of additional information in within existing MIR fields until 16th October 2025
| New Field | Current Field |
|---|---|
| UKAB ID Number | Add to ‘general comments’ field |
| UKAB Certificate Number | Add to ‘general comments’ field |
| UDI Issuing Entity | Add to ‘general comments’ field |
| UK Responsible Person contact details | If submitter is the UKRP: Enter “other” in submitter of report field Enter UKRP in “other reporter” field Enter UKRP details in submitter details fields If submitter is not UKRP, no requirement to include in report |
| Mandating IMDRF B,C,D,E,F,G | Manufacturers must provide relevant IMDRF reporting codes relating to their incident |
Table 2. Provision of additional information in FSCA report fields until 16th October 2025
| New Field | Current Field |
|---|---|
| UKAB ID Number | Add to ‘general comments’ field |
| UKAB Certificate Number | Add to ‘general comments’ field |
| UDI Issuing Entity | Add to ‘general comments’ field |
| UDI DI | Add to ‘comments’ field (if applicable) |
| UDI PI | Add to ‘comments’ field (if applicable) |
| Basic UDI-DI | Add to ‘comments’ field (if applicable) |
| Unit of use UDI-DI | Add to ‘comments’ field (if applicable) |
| The number of devices placed on the market or put into service in Great Britain | Add to the ‘Background information and reason for the FSCA’ field |
| The estimated number of users affected in Great Britain | Add to the ‘Background information and reason for the FSCA’ field |
| UK Responsible Person contact details | If submitter is the UKRP: Enter “other” in submitter of report field Enter UKRP in “other reporter” field Enter UKRP details in national contact point details OR authorised rep field if there is also a national contact point for the mfr who is different to UKRP |
| Addition of IMDRF Annex A, B, C, D, E, F, G | Add to the ‘Background information and reason for the FSCA’ field |
| Addition of ‘Notified body certificate number’ | Add to comments field |
Supporting documentation
Supporting documentation will be provided for users of MORE to support the implementation of PMS regulations. Documentation provided will include an overview of the changes made, an updated MORE submissions guidance document, a bridging document for MIR helptext, updated xsds and example xmls.
Support will be available via aic@mhra.gov.uk for any questions relating to these changes. Please use the subject heading “PMS implementation information request:Entity Name”.