{"id":34756,"date":"2025-10-22T12:26:18","date_gmt":"2025-10-22T10:26:18","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34756"},"modified":"2025-10-22T16:21:08","modified_gmt":"2025-10-22T14:21:08","slug":"great-britain-greater-certainty-with-the-standard-model-for-post-market-surveillance-reports-pmsr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/10\/22\/great-britain-greater-certainty-with-the-standard-model-for-post-market-surveillance-reports-pmsr\/","title":{"rendered":"Great Britain: Greater Certainty with the Standard Model for Post-Market Surveillance Reports (PMSR)"},"content":{"rendered":"

Translated with AI<\/em><\/strong><\/p>\n

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On September 5, 2025, the MHRA (Medicines and Healthcare products Regulatory Agency)<\/strong> published new guidelines and a model to support manufacturers<\/strong> in preparing their Post-Market Surveillance Reports (PMSR).<\/strong><\/p>\n

This initiative represents a further step towards rigorous post-market surveillance that is compliant with the new UK requirements.<\/p>\n

What is the PMSR and why is it essential?<\/strong><\/h3>\n

With the entry into force, on June 16, 2025, of the amendment The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024<\/em><\/strong><\/a>, Great Britain introduced stricter and more specific standards for the safety and performance of medical devices. The new provisions have made post-market surveillance requirements<\/strong> more stringent, following the path of the European MDR and IVDR Regulations.<\/p>\n

The PMSR<\/strong> is confirmed as the central document<\/strong> of this activity: it is the formal tool through which the manufacturer<\/strong> demonstrates that they have systematically collected and analysed data on the device’s safety and performance after its placing on the market.<\/p>\n

The MHRA Standard Model: Key Points and Advantages<\/strong><\/h3>\n

Manufacturers must prepare the first PMSR<\/strong> within three years<\/strong> from the commercial launch of the device or the entry into force of the amendment, with subsequent updates at least every three years<\/strong>.<\/p>\n

Using this standard model offers a dual advantage:<\/p>\n

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  1. Efficiency for MHRA:<\/strong> a standard format facilitates quick consultation and review, speeding up any corrective actions.<\/li>\n
  2. Clarity for the Manufacturer:<\/strong> a clear checklist defines the minimum contents of the report, reducing uncertainties and the risk of non-compliance.<\/li>\n<\/ol>\n

    Proposing alternative formats is possible but requires rigorous justification; adopting the MHRA model is the safest and most advantageous choice for medical device manufacturers.<\/p>\n

    Structure and Content<\/strong><\/h3>\n

    The PMSR model proposed by the MHRA is divided into three main thematic areas<\/strong> that ensure the alignment and execution of the key aspects of the PMS Plan:<\/p>\n

      \n
    1. Cover page and summary:<\/strong> offers an executive summary of the report and a detailed description of the devices included in the scope of the report (clear identification through UDI and other references).<\/li>\n
    2. Safety and performance data:<\/strong> analytical section that collects data on serious adverse events, Field Safety Corrective Actions (FSCA), non-serious trends, and user feedback.<\/li>\n
    3. Analysis, conclusions, and future measures:<\/strong> strategic part with CAPA assessment, review of the benefit-risk profile, and planning of corrective and preventive actions.<\/li>\n<\/ol>\n

      Particularly relevant is the obligation to immediately detail any deterioration of the benefit-risk profile, accompanied by concrete mitigation initiatives. For complex devices (systems or kits), the PMSR must integrate shared data on the safety and performance of combined use.<\/p>\n

      Proactive Approach<\/strong><\/h3>\n

      This step marks the abandonment of a predominantly reactive approach in favour of a proactive and predictive system<\/strong>, based on robust data collection and systematic analysis.<\/p>\n

      It is also essential to highlight that, if the analysis shows a deterioration in the benefit-risk profile, manufacturers must immediately detail the initiatives planned or already implemented to address and mitigate these risks.<\/p>\n

      Furthermore, for complex devices (such as systems or kits), the PMSR must obligatorily integrate joint information on the safety and performance resulting from the combined use of the components.<\/p>\n

      Next Steps for Manufacturers<\/strong><\/h3>\n

      For manufacturers, the task is not just to compile the report but to ensure that their data collection system is robust and structured to feed the PMSR with high-quality information, in line with the MHRA’s expectation.<\/p>\n

      \ud83d\udc49 Thema, as a UK Responsible Person<\/strong><\/a>, can be your strategic partner for compliance at every stage of the medical device lifecycle, including Post-Market Surveillance.<\/p>\n

      SOURCE:<\/strong><\/p>\n