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As of 1 September 2023, the MHRA has required all vigilance be submitted through its web-based system, the Manufacturer’s Online Reporting Environment (MORE).
Further, the MHRA has introduced new Post-Market Surveillance (PMS) requirements under SI 2024/1368. It is effective 16 June 2025 and is applicable for devices marketed in Great Britain* (England, Scotland, Wales). These requirements update vigilance obligations (including serious incident and field safety corrective action reporting) and introduce a proactive PMS system with post-market clinical follow-up and trend reporting.
Due to the above, the MHRA has published updates related to its MORE vigilance portal.
* From a regulatory standpoint, the four UK countries are made up of two territories:
- Great Britain ((GB) England, Scotland, Wales): subject to the UK MDR 2002 (“UKCA”) requirements. The new UK PMS regulation SI 2024/1368 applies.
- Northern Ireland (NI): Due to Brexit negotiations, Northern Ireland will continue to be part of the European Single Market and require CE Marking. The new UK PMS regulation SI 2024/1368 does not apply.
Overview
The MHRA has published/updated the following webpages.
Manufacturer’s Online Reporting Environment (MORE) Guidance (NEW)
- A high-level overview of the MORE platform and how to report.
- Confirmation that the MHRA is updating its processes to align with the new PMS requirements. And that the data schemas for transmission of Manufacturer Incident Reports (MIR) and Field Safety Corrective Action (FSCA) reports are being updated to support GB submissions under the new requirements.
MORE Implementation Guidance (NEW)
- Implementation of data requirements under the new Post-Marketing Surveillance regulations (SUBPAGE)
- Provides a high-level overview of changes made to the MORE platform, due to the updated regulation.
- Important Notes:
- Continued reporting on the existing schema will be permitted until the 16th of October 2025. However, the additional information required to meet the new PMS regulations must be submitted in the existing Manufacturer Incident Report (MIR) and Field Safety Corrective Action (FSCA) report fields.
- The webpage provides tables outlining how manufacturers should include the additional information, should they continue to use the existing forms until 16 October 2025.
- GB MIR and FSCA schema implementation guide (SUBPAGE)
- This is applicable to manufacturers who have a high-volume of vigilance and therefore submit via XML or API transmittal.
Medical devices: post-market surveillance (collection) (UPDATED)
- Links to the above newly created pages were added to this page.
Additional Notes
- If you have already registered in the UK’s MORE platform, you do not need to reregister.
- The Great Britain (GB) data schemas will be live in MORE starting 16 June 2025. The separate EU schema (for Northern Ireland) will be hosted in parallel, and the process will remain unchanged.
- Reporting on the existing GB 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. The above webpages provide guidance on how to do this.
- Vigilance should still be reported per the current (2023) version of the MORE Registration & MORE Submissions user guides. However, the guides “will be updated in line with the new requirements” in the future.
