MHRA - MHRA Publishes Standardised Format for Medical Device Post-Market Surveillance Reports

9th September 2025

MHRA Publishes Standardised Format for Medical Device Post-Market Surveillance Reports

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a standardised format for post-market surveillance (PMS) reports for medical devices in Great Britain. The template aims to streamline the collection and reporting of safety and performance data from manufacturers, ensuring consistent and high-quality submissions. It covers requirements for reporting adverse events, device performance, and corrective actions, aligning with regulatory expectations under the UK Medical Devices Regulations. By providing a structured approach, the MHRA seeks to enhance patient safety and support regulatory oversight while helping manufacturers comply efficiently with post-market obligations.

Medical Devices: Standardised Format for the Post-Market Surveillance Report

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