# Documentation for implementation of data requirements under the new Post-Market Surveillance regulations

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/c61ccfb6-c102-4cec-a896-20c2920c1768
Type: Guidance
Published: June 8, 2025

> The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update following the implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. This regulatory framework mandates significant enhancements to how medical device safety is monitored after products enter the market. The primary focus of this guidance is the refinement of internal processes to more effectively detect trends, patterns, or signals indicating emerging risks or safety concerns. Unlike specific company inspection reports, this update establishes broad requirements for the entire healthcare sector to ensure patient protection. The MHRA’s revised procedures aim to streamline the identification of potential hazards, allowing for a more proactive response from both the regulator and the wider healthcare system. Under these new regulations, manufacturers and stakeholders are expected to adhere to more rigorous data collection and reporting standards. The objective is to shift toward a more data-driven approach to safety monitoring, ensuring that any negative impacts on patient health are addressed swiftly. While the document does not cite specific violations or individual company audits, it serves as a directive for all medical device entities operating within Great Britain to align their surveillance protocols with the 2024 amendments. This initiative reflects a systemic move toward heightened transparency and efficiency in post-market safety oversight.

---

## Content

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.

## Attachments

- [Field Safety Corrective Action Report (FSCA) 2.8 changelog](https://assets.publishing.service.gov.uk/media/690478fc20da736e65913192/Field_Safety_Corrective_Action_Report__FSCA__2.8_changelog.pdf)
- [Manufacturer Incident Report (MIR) 7.2.1 changelog](https://assets.publishing.service.gov.uk/media/69047907e2ebc0fb39a52058/Manufacturer_Incident_Report__MIR__7.2.1_changelog.pdf)
- [Helptext for Field Safety Corrective Action Report (FSCA) 2.8](https://assets.publishing.service.gov.uk/media/6841878e58bd5a53d0211cdd/Helptext_for_FSCA_GB_2.8.xlsx)
- [XML Files for Testing](https://assets.publishing.service.gov.uk/media/684187f0578282a4b102c082/XML_Files_for_Testing.zip)
- [Helptext for Manufacturer Incident Report (MIR) 7.2.1](https://assets.publishing.service.gov.uk/media/684187bd578282a4b102c081/Helptext_for_MIR_GB_7.2.1.xlsx)
- [GB XSD files](https://assets.publishing.service.gov.uk/media/684187dad5f6bf75703e8786/GB_XSD_Files.zip)