Guidance

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

Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) 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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 9 June 2025

Documents

Field Safety Corrective Action Report (FSCA) 2.8 changelog

PDF, 99.6 KB, 1 page

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Manufacturer Incident Report (MIR) 7.2.1 changelog

PDF, 98.3 KB, 1 page

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Helptext for Field Safety Corrective Action Report (FSCA) 2.8

MS Excel Spreadsheet, 22.7 KB

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Helptext for Manufacturer Incident Report (MIR) 7.2.1

MS Excel Spreadsheet, 22.3 KB

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GB XSD files

ZIP, 646 KB

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XML Files for Testing

ZIP, 52.1 KB

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Details

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.

Published 9 June 2025