GB MIR and FSCA schema implementation guide
Published 16 May 2025
© Crown copyright 2025
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This publication is available at https://www.gov.uk/government/publications/more-implementation/gb-mir-and-fsca-schema-implementation-guide
Introduction
This document will guide users through the changes being made to reporting manufacturer incident reports (MIR) and field safety corrective action reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
Section 1: Background
Serious incidents involving medical devices which occur in the UK and meet vigilance reporting criteria must be reported to the MHRA by the manufacturer or their UK Responsible Person via the Manufacturer’s Online Reporting Environment (MORE) portal. FSCAs affecting devices in the UK and trends in incidents should also be reported using this portal.
The data standards used to report are updated for reports relating to Great Britain (GB) due to the new set of regulations - The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 which amends the UK Medical Devices Regulations (UK MDR) 2002 by inserting a new Part 4A on post-market surveillance (PMS) requirements for medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices which apply within GB.
Further information on the post-market surveillance requirements can be found here: The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation - GOV.UK.
MORE services
You should continue to refer to the following supporting documents for use of MORE:
These documents will be updated in line with the new requirements.
In the MORE portal, registered users will be able to make submissions via manual data entry via the web forms within MORE portal, XML report upload, or via Application Programming Interfaces (API). The MORE web forms that are available include:
- Manufacturer Incident Report (MIR)
- Field Safety Corrective Actions (FSCAs)
- Trend Reports
- Periodic Summary Reports (PSRs)
- Serious Adverse Events (SAEs)
This document outlines changes to MIR and FSCA schemas. Trend reports, PSRs and SAEs have no changes.
Section 2: Summary of changes to MIR and FSCA
The below table shows a high level summary of the changes made from MIR 7.2.1 and FSCA 2.8 to support the new GB schemas.
| Update | Impacts to xsds | Impacts to xsds |
|---|---|---|
| MIR (all versions) | FSCA (all versions) | |
| xsd Name changes | Yes | Yes |
| Schema text change from EU to GB | Yes | No |
| Removal of ‘EUDAMED Number of NCA’ | Yes | No |
| Removal of ‘Reference number assigned by EUDAMED for this incident’ | Yes | No |
| Removal of ‘FSCA EUDAMED reference numbers’ | Yes | No |
| Enable collection of UK Responsible Person contact details | Yes | Yes |
| Restrict nomenclature to allow GMDN only | Yes | Yes |
| Addition of ‘UK Approved Body (UKAB) ID number(s)’ | Yes | Yes |
| Addition of ‘UK Approved Body (UKAB) certificate number(s) of device’ | Yes | Yes |
| Mandating of IMDRF Annex codes A, B, C, D, E, F, G | Yes | No |
| Addition of ‘UDI Issuing entity’ | Yes | Yes |
| Addition of ‘UDI DI’ | No | Yes |
| Addition of ‘UDI PI’ | No | Yes |
| Addition of ‘Basic UDI-DI’ | No | Yes |
| Addition of ‘Unit of use UDI-DI’ | No | Yes |
| Addition of IMDRF Annex A, B, C, D, E, F, G | No | Yes |
| Addition of field to ask ‘If you think the FSCA is unique and a suitable IMDRF term is missing, briefly explain:’ for IMDRF Annex A, B, C, D, E, F, G | No | Yes |
| Addition of ‘The number of devices placed on the market or put into service in Great Britain’ | No | Yes |
| Addition of ‘The estimated number of users affected in Great Britain’ | No | Yes |
| Restrict ‘Notified body ID number’ type to numbers only | No | Yes |
| Addition of ‘Notified body certificate number’ | No | Yes |
To aid comparison to the existing MIR 7.2.1 schema, the MIR help text has been annotated with the changes to the fields. Any changes between EU MIR 7.2.1 and the GB schema are on the tab named ‘7.2 Help text GB’. Please note that some elements within the xsd will be changed which are not part of the existing help text. Each change to the MIR xsd is provided below.
Please note the PDF is not supported as a submission route and has not been since the current MORE portal was launched in 2022. Submissions must be via MORE, and you can send reports via API, post or webform.
MIR xsd changes
The changes are made to the following MIR xsds:
- Initial
- Combined initial and final
- Follow-up
- Final (reportable incident)
- Final (non-reportable incident)
A detailed summary of each change is provided below.
1. xsd name changes
| Summary of change | EU MIR schema 7.2.1 | GB schema 7.2.1 |
|---|---|---|
| xsd name change | incident-Initial-v7.2.1.xsd | incident-InitialGB-v7.2.1.xsd |
| incident-InitialFinal-v7.2.1.xsd | incident-InitialFinalGB-v7.2.1.xsd | |
| incident-Followup-v7.2.1.xsd | incident-FollowupGB-v7.2.1.xsd | |
| incident-FinalRep-v7.2.1 | incident-FinalRepGB-v7.2.1 | |
| incident-FinalNonRep-v7.2.1 | incident-FinalNonRepGB-v7.2.1 |
2. Text change to the schema description
| Impacted schema | EU MIR schema 7.2.1 | GB schema 7.2.1 |
|---|---|---|
| incident-InitialGB-v7.2.1.xsd | Schema for INITIAL reports about Incidents for EU vigilance exchange. | Schema for INITIAL reports about Incidents for GB vigilance exchange. |
| incident-InitialFinalGB-v7.2.1.xsd | Schema for COMBINED INITIAL AND FINAL reports about Incidents for EU vigilance exchange. | Schema for COMBINED INITIAL AND FINAL reports about Incidents for GB vigilance exchange. |
| incident-FollowupGB-v7.2.1.xsd | Schema for FOLLOW-UP reports about Incidents for EU vigilance exchange. | Schema for FOLLOW-UP reports about Incidents for GB vigilance exchange. |
| incident-FinalRepGB-v7.2.1 | Schema for FINAL REPORTABLE reports about Incidents for EU vigilance exchange. | Schema for FINAL REPORTABLE reports about Incidents for GB vigilance exchange. |
| incident-FinalNonRepGB-v7.2. | Schema for FINAL NOT REPORTABLE reports about Incidents for EU vigilance exchange. | Schema for FINAL NOT REPORTABLE reports about Incidents for GB vigilance exchange. |
3. Removal of ‘EUDAMED Number of NCA’
| Impacted schema | EU MIR schema 7.2.1 | GB schema 7.2.1 |
|---|---|---|
| All five MIR schemas | Field exists for ‘EUDAMED Number of NCA’ | ‘EUDAMED Number of NCA’ field removed |
4. Removal of ‘Reference number assigned by EUDAMED for this incident’
| Impacted schema | EU MIR schema 7.2.1 | GB schema 7.2.1 |
|---|---|---|
| All five MIR schemas | Field exists for ‘Reference number assigned by EUDAMED for this incident’ | ‘Reference number assigned by EUDAMED for this incident’ field removed |
5. Removal of ‘FSCA EUDAMED reference numbers’
| Impacted schema | EU MIR schema 7.2.1 | GB schema 7.2.1 |
|---|---|---|
| All five MIR schemas | Field exists for ‘FSCA EUDAMED reference numbers’ | ‘FSCA EUDAMED reference numbers’ field removed |
6. Enable collection of UK Responsible Person contact details
| Impacted schema | EU MIR schema 7.2.1 | GB schema 7.2.1 |
|---|---|---|
| All five MIR schemas | Allowed values: -Manufacturer -Authorised Representative -Other, please specify |
Allowed values: -Manufacturer -Authorised Representative -Other, please specify -UKRP |
7. Restrict nomenclature to allow GMDN only
| Impacted schema | EU MIR schema 7.2.1 | GB schema 7.2.1 | |
|---|---|---|---|
| All five MIR schemas | Medical terminology – allowed values: -EMDN -GMDN -UMDNS(ECRI) -GIVD/EDMS -Other, please specify |
Medical terminology – allowed values: -GMDN |
8. Addition of ‘UK Approved Body (UKAB) ID number(s)’
| Impacted schema | EU MIR schema 7.2.1 | GB schema 7.2.1 |
|---|---|---|
| All five MIR schemas | No field for ‘UK Approved Body (UKAB) ID number(s)’ | New field for ‘UK Approved Body (UKAB) ID number(s)’ |
9. Addition of ‘UK Approved Body (UKAB) certificate number(s) of device’
| Impacted schema | EU MIR schema 7.2.1 | GB schema 7.2.1 |
|---|---|---|
| All five MIR schemas | No field for ‘UK Approved Body (UKAB) certificate number(s) of device’ | New field for ‘UK Approved Body (UKAB) certificate number(s) of device’ |
10. Mandating of IMDRF Annex codes
| Impacted schema | EU MIR schema 7.2.1 | GB schema 7.2.1 | Comments |
|---|---|---|---|
| All five MIR schemas | Annex A – minimum of one IMDRF code required | No change to Annex A – minimum of one IMDRF code required | If appropriate IMDRF code cannot be found then the following advice is given: Annex A: If a specific term can not be classified please select code A27 |
| All five MIR schemas | IMDRF Annex B - optional | IMDRF Annex B – minimum of one IMDRF code must be included | Annex B: If a specific term can not be classified please select code B21 or B22 as appropriate |
| All five MIR schemas | IMDRF Annex C - optional | IMDRF Annex C – minimum of one IMDRF code must be included | Annex C: If a specific term can not be classified please select code C22 |
| All five MIR schemas | IMDRF Annex D - optional | IMDRF Annex D – minimum of one IMDRF code must be included | Annex D: If a specific term can not be classified please select code D15, D16 or D17 as appropriate |
| All five MIR schemas | IMDRF Annex E - optional | IMDRF Annex E – minimum of one IMDRF code must be included | Annex E: If a specific term can not be classified please select code E2401, E2402 or E2403 as appropriate |
| All five MIR schemas | IMDRF Annex F - optional | IMDRF Annex F – minimum of one IMDRF code must be included | Annex F: If a specific term can not be classified please select code F24 or F28 as appropriate |
| All five MIR schemas | IMDRF Annex G- optional | IMDRF Annex G – minimum of one IMDRF code must be included | Annex G: If a specific term can not be classified please select code G07001 or G07002 as appropriate |
11. Addition of ‘UDI Issuing entity’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All five MIR schemas | No field for ‘’UDI Issuing entity’ | New field for ‘’UDI Issuing entity’ Allowed values: - GS1 - IFA - HIBCC - ICCBBA |
FSCA xsd changes
The following changes are made to FSCA xsds. Where the change differs per schema the changes are provided per schema. Where the change is identical in the different schemas this is shown.
- Initial
- Follow up
- Final
12. xsd name changes
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| xsd name changes | FSCA_InitialEU_v2.8.xsd | FSCA_InitialGB_v2.8.xsd |
| FSCA_FollowupEU_v2.8.xsd | FSCA_FollowupGB_v2.8.xsd | |
| FSCA_FinalEU_v2.8.xsd | FSCA_FinalGB_v2.8.xsd |
13. Enable collection of UK Responsible Person contact details
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All three FSCA schemas | Allowed values: -Manufacturer -Authorised Representative -Other, please specify |
Allowed values: -Manufacturer -Authorised Representative -Other, please specify -UKRP |
14. Restrict nomenclature to allow GMDN only
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All three FSCA schemas | Medical terminology – allowed values: -EMDN -GMDN -UMDNS(ECRI) -GIVD/EDMS -Other, please specify |
Medical terminology – allowed values: -GMDN |
15. Addition of ‘UK Approved Body (UKAB) ID number(s)’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All three FSCA schemas | No field for ‘UK Approved Body (UKAB) ID number(s)’ | New field for ‘UK Approved Body (UKAB) ID number(s)’ |
16. Addition of ‘UK Approved Body (UKAB) certificate number(s) of device’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All three FSCA schemas | No field for ‘UK Approved Body (UKAB) certificate number(s) of device’ | New field for ‘UK Approved Body (UKAB) certificate number(s) of device’ |
17. Addition of ‘UDI Issuing entity’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All three FSCA schemas | No field for ‘’UDI Issuing entity’ | New field for ‘’UDI Issuing entity’ Allowed values: - GS1 - IFA - HIBCC - ICCBBA |
18. Addition of ‘UDI DI’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All three FSCA schemas | No field for ‘UDI DI’ | New field for ‘’UDI DI’ |
19. Addition of ‘UDI PI’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All three FSCA schemas | No field for ‘UDI PI’ | New field for ‘’UDI PI’ |
20. Addition of ‘Basic UDI-DI’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All three FSCA schemas | No field for ‘Basic UDI DI’ | New field for ‘’Basic UDI DI’ |
21. Addition of ‘Unit of use UDI-DI’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 | |
|---|---|---|---|
| All three FSCA schemas | No field for ‘Unit of use UDI-DI’ | New field for ‘’Unit of use UDI-DI’ |
22. Addition of IMDRF Annex A, B, C, D, E, F, G
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 | Comments |
|---|---|---|---|
| All three FSCA schemas | No field to collect IMDRF Annex A | Addition of field to collect IMDRF Annex A. Addition of field to ask ‘If you think the FSCA is unique and a suitable IMDRF term is missing, briefly explain:’ Minimum of one IMDRF code required. |
If appropriate IMDRF code cannot be found then the following advice is given: Annex A: If a specific term can not be classified please select code A27 |
| All three FSCA schemas | No field to collect IMDRF Annex B | Addition of field to collect IMDRF Annex B. Addition of field to ask ‘If you think the FSCA is unique and a suitable IMDRF term is missing, briefly explain:’ Minimum of one IMDRF code required. |
Annex B: If a specific term can not be classified please select code B21 or B22 as appropriate |
| All three FSCA schemas | No field to collect IMDRF Annex C | Addition of field to collect IMDRF Annex C. Addition of field to ask ‘If you think the FSCA is unique and a suitable IMDRF term is missing, briefly explain:’ Minimum of one IMDRF code required. |
Annex C: If a specific term can not be classified please select code C22 |
| All three FSCA schemas | No field to collect IMDRF Annex D | Addition of field to collect IMDRF Annex D. Addition of field to ask ‘If you think the FSCA is unique and a suitable IMDRF term is missing, briefly explain:’ Minimum of one IMDRF code required. |
Annex D: If a specific term can not be classified please select code D15, D16 or D17 as appropriate |
| All three FSCA schemas | No field to collect IMDRF Annex E | Addition of field to collect IMDRF Annex E. Addition of field to ask ‘If you think the hazard is unique and a suitable IMDRF Code is missing, briefly explain:’ Minimum of one IMDRF code required. |
Annex E: If a specific term can not be classified please select code E2401, E2402 or E2403 as appropriate |
| All three FSCA schemas | No field to collect IMDRF Annex F | Addition of field to collect IMDRF Annex F. Addition of field to ask ‘If you think the hazard is unique and a suitable IMDRF Code is missing, briefly explain:’ Minimum of one IMDRF code required. |
Annex F: If a specific term can not be classified please select code F24 or F28 as appropriate |
| All three FSCA schemas | No field to collect IMDRF Annex G | Addition of field to collect IMDRF Annex G. Addition of field to ask ‘If you think the component is unique and a suitable IMDRF term is missing, briefly explain:’ Minimum of one IMDRF code required. |
Annex G: If a specific term can not be classified please select code G07001 or G07002 as appropriate |
23. Addition of ‘The number of devices placed on the market or put into service in Great Britain’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All three FSCA schemas | No field for ‘The number of devices placed on the market or put into service in Great Britain’ | New field for ‘The number of devices placed on the market or put into service in Great Britain’ |
24. Addition of ‘The estimated number of users affected in Great Britain’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All three FSCA schemas | No field for ‘The estimated number of users affected in Great Britain’ | New field for ‘The estimated number of users affected in Great Britain’ |
25. Update type for field ‘Notified body ID number’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 | Comments |
|---|---|---|---|
| All three FSCA schemas | Notified body ID number allows 50 characters including text | Notified body ID number will only allow numbers | Aligning FSCA with MIR standard |
26. Addition of ‘Notified body certificate number’
| Impacted schema | EU FSCA schema 2.8 | GB FSCA schema 2.8 |
|---|---|---|
| All three FSCA schemas | No field for ‘Notified body certificate number’ | New field for ‘Notified body certificate number’ |
Implementation Steps
Please use the resources available [to be released soon] to update your systems and processes in line with the GB xsd schemas to ensure compliance with the PMS requirements. Submissions under PMS legislation for GB should be reported using the GB schemas, and xml submissions should include the correct schema within the xml header. Reports for Northern Ireland can continue to be submitted in line with EU requirements.
If you need to provide a new submission to a previously submitted MIR or FSCA, you should update the schema in line with the new requirements, and it will be linked on the MHRA system as usual. Explicitly, it is acceptable to have a first submission using EU schema, and a second submission using GB schema.
During the transition period you can submit using the EU schema or new GB schemas. After the end of the transition period, you must use the GB schema to fulfil your reporting requirements under the PMS legislation.
Resources
Additional documentation to support the implementation of the GB schema will be provided within the resources tile and 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.
You will also be able to access these resources within MORE via the ‘Resources’ tile on the dashboard or left-hand side burger menu.
Glossary
| Acronym | |
|---|---|
| API | Application Programming Interfaces |
| FSCA | Field Safety Corrective Action |
| IVD | In Vitro Diagnostic |
| UK MDR | UK Medical Devices Regulations |
| MHRA | Medicines and Healthcare Products Regulatory Agency |
| MIR | Manufacturer Incident Report |
| MORE | Manufacturer’s Online Reporting Environment |
| PMS | Post-Market Surveillance |
| PSR | Periodic Summary Report |
| SAE | Serious Adverse Event |
| UKRP | UK Responsible Person |
Help and Contact Details
Support will be available via aic@mhra.gov.uk.
Please use the heading “PMS implementation information request:Entity Name”.