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GuidanceMHRA

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.

First published: Jun 8, 2025Last updated: Jun 8, 2025Changes: 1

Latest change: First published.

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