Translated with AI
On September 5, 2025, the MHRA (Medicines and Healthcare products Regulatory Agency) published new guidelines and a model to support manufacturers in preparing their Post-Market Surveillance Reports (PMSR).
This initiative represents a further step towards rigorous post-market surveillance that is compliant with the new UK requirements.
What is the PMSR and why is it essential?
With the entry into force, on June 16, 2025, of the amendment The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, 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 more stringent, following the path of the European MDR and IVDR Regulations.
The PMSR is confirmed as the central document of this activity: it is the formal tool through which the manufacturer demonstrates that they have systematically collected and analysed data on the device’s safety and performance after its placing on the market.
The MHRA Standard Model: Key Points and Advantages
Manufacturers must prepare the first PMSR within three years from the commercial launch of the device or the entry into force of the amendment, with subsequent updates at least every three years.
Using this standard model offers a dual advantage:
- Efficiency for MHRA: a standard format facilitates quick consultation and review, speeding up any corrective actions.
- Clarity for the Manufacturer: a clear checklist defines the minimum contents of the report, reducing uncertainties and the risk of non-compliance.
Proposing alternative formats is possible but requires rigorous justification; adopting the MHRA model is the safest and most advantageous choice for medical device manufacturers.
Structure and Content
The PMSR model proposed by the MHRA is divided into three main thematic areas that ensure the alignment and execution of the key aspects of the PMS Plan:
- Cover page and summary: 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).
- Safety and performance data: analytical section that collects data on serious adverse events, Field Safety Corrective Actions (FSCA), non-serious trends, and user feedback.
- Analysis, conclusions, and future measures: strategic part with CAPA assessment, review of the benefit-risk profile, and planning of corrective and preventive actions.
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.
Proactive Approach
This step marks the abandonment of a predominantly reactive approach in favour of a proactive and predictive system, based on robust data collection and systematic analysis.
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.
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.
Next Steps for Manufacturers
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.
👉 Thema, as a UK Responsible Person, can be your strategic partner for compliance at every stage of the medical device lifecycle, including Post-Market Surveillance.
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