The MHRA has updated the MORE system and the underlying reporting requirements for medical devices in the UK. These changes come into force on June 16, 2025, and are a direct result of the new Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
The aim is to improve the traceability of incidents and trends. Manufacturers can submit the following reports electronically via MORE:
- Medical device incidents
- Field Safety Notifications (FSNs)
- Updates and Final Reports
Key changes include the introduction of UK-specific fields (e.g., for UK Approved Bodies and UK Responsible Persons), the restriction of nomenclature to GMDN, and the requirement to provide IMDRF Annex codes and more detailed UDI information. Manufacturers who have integrated their systems via APIs must update their XSDs. The MHRA has provided a transition period until October 16, 2025, during which reporting using the existing scheme is permitted, provided all additional information required under the new PMS regulations is submitted in the existing reporting fields.
