UK – Medical Device Post Market Surveillance Requirements

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued comprehensive guidance outlining manufacturers’ obligations for Post-Market Surveillance (PMS) of medical devices in Great Britain. PMS is the ongoing collection and review of experience gained from devices once they are on the market. 

It encompasses monitoring, analysis, and preventive/corrective actions to ensure ongoing device safety and performance.

This guidance aims to provide clarity on the regulatory expectations for PMS, emphasizing the importance of proactive risk management and continuous improvement in device safety and efficacy.

Guidance Overview

Proportionate PMS Systems

Manufacturers are required to maintain a PMS system that is proportionate to the risk class of their device. Higher-risk devices necessitate more robust and detailed PMS activities, while lower-risk devices may have less stringent requirements. 

This approach ensures that the level of surveillance is commensurate with the potential impact of the device on patient safety.

Integration with Regulatory Reporting

PMS data must feed into two key regulatory documents:

1. Periodic Safety Update Reports (PSURs): These are mandatory for higher-risk devices and must be submitted to the MHRA at regular intervals, providing an updated assessment of the device’s safety and performance based on post-market data.
2. Post-Market Surveillance Reports (PMSRs): Required for lower-risk devices, PMSRs offer a comprehensive overview of the device’s performance in the market, including any identified risks and the manufacturer’s actions to mitigate them.

Both reports must be documented, analyzed, and, where necessary, reported to the MHRA to facilitate regulatory oversight and ensure patient safety.

Early Detection and Corrective Actions

An effective PMS system supports the early detection of risks, enabling manufacturers to take timely preventive and corrective actions. This proactive approach helps in identifying potential issues before they lead to significant harm, thereby maintaining the device’s benefit-risk profile within acceptable limits.

Compliance with Legal Obligations

The PMS requirements are embedded within the UK’s regulatory framework, aligning with international standards and practices. Compliance with these obligations is essential for manufacturers to maintain market access and uphold patient safety.

Update History

January 15, 2025

The MHRA first published the standalone PMS requirements guidance, providing manufacturers with a clear framework for post-market surveillance activities. This initial publication laid the groundwork for subsequent updates and refinements.

June 16, 2025

The guidance was updated to reflect the enforcement of The Medical Devices (Post-market Surveillance Requirements) (Amendment) Regulations 2024. These amendments introduced new legal obligations for PMS, aligning with evolving international and EU approaches. 

Key changes included enhanced data collection, shorter timelines for reporting serious incidents, and summary reporting to enable the MHRA and manufacturers to identify safety issues earlier.

September 5, 2025

A significant update was made with the addition of a link to guidance on the standardized format for Post-Market Surveillance Reports (PMSRs). This move towards harmonized reporting templates aims to improve consistency and efficiency in regulatory review processes, facilitating better communication between manufacturers and the MHRA.

Detailed Requirements for Manufacturers

1. Establishing a PMS System

Manufacturers must establish and maintain a PMS system that is appropriate for the risk class of their device. 

This system should include:

• Data Collection: Implementing mechanisms to gather data from various sources, including clinical studies, user feedback, and incident reports.
• Data Analysis: Regularly analyzing collected data to identify trends, patterns, or signals that may indicate emerging risks or safety concerns.
• Corrective and Preventive Actions: Developing and implementing actions to address identified issues, including design modifications, labeling changes, or field safety corrective actions.
• Documentation: Maintaining comprehensive records of PMS activities, including data analyses, decisions made, and actions taken.

2. Reporting Obligations

Manufacturers are required to report certain information to the MHRA, including:

• Serious Incidents: Any event that has led to or could lead to serious injury or death must be reported within specified timelines.
• Field Safety Corrective Actions (FSCAs): Actions taken to correct or mitigate risks associated with a device must be communicated to the MHRA and affected users.
• Periodic Reports: Submission of PSURs and PMSRs at regular intervals, as mandated by the regulations.

3. Risk Management and Benefit-Risk Assessment

An integral part of PMS is the continuous assessment of the device’s benefit-risk profile. 

Manufacturers must:

• Monitor: Continuously monitor the device’s performance in the market to detect any changes in its benefit-risk balance.
• Assess: Regularly assess the cumulative data to determine if the device continues to meet safety and performance requirements.
• Act: Take appropriate actions if the benefit-risk balance becomes unfavorable, such as implementing corrective measures or withdrawing the device from the market.

4. Compliance with International Standards

The MHRA’s PMS requirements align with international standards, including those set by the International Medical Device Regulators Forum (IMDRF) and the European Union Medical Device Regulation (EU MDR). This alignment ensures that manufacturers can maintain compliance across different markets and facilitates global harmonization of regulatory practices.

Standardized PMS Reporting

To streamline the reporting process and enhance regulatory efficiency, the MHRA has introduced a standardized format for Post-Market Surveillance Reports (PMSRs). This format provides a structured approach for manufacturers to present data, facilitating easier review and assessment by the MHRA.

Key features of the standardized format include:

• Structured Sections: Clearly defined sections covering various aspects of PMS, including device description, performance data, risk analysis, and corrective actions.
• Data Presentation: Guidelines on how to present data, including the use of tables, charts, and graphs to illustrate key points.
• Consistency: A consistent format that allows for easier comparison across different devices and manufacturers.

Manufacturers are encouraged to adopt this standardized format to ensure compliance and improve the efficiency of the regulatory review process.

Implications for Manufacturers

The MHRA’s enhanced PMS requirements have significant implications for manufacturers:

• Resource Allocation: Manufacturers may need to allocate additional resources to establish and maintain robust PMS systems, including personnel, training, and technology.
• Regulatory Compliance: Non-compliance with PMS requirements can result in regulatory actions, including fines, product recalls, or suspension of market access.
• Market Access: Adherence to PMS obligations is essential for maintaining market access in Great Britain and other jurisdictions that recognize the MHRA’s regulatory framework.
• Patient Safety: A strong PMS system contributes to patient safety by ensuring that devices continue to perform as intended and that any emerging risks are promptly addressed.

Conclusion

The MHRA’s guidance on Post-Market Surveillance Requirements represents a significant step towards enhancing the safety and performance of medical devices in Great Britain. By establishing clear obligations for manufacturers and introducing standardized reporting formats, the MHRA aims to foster a proactive approach to risk management and continuous improvement in device quality.

Manufacturers are urged to familiarize themselves with these requirements and take the necessary steps to ensure compliance. This proactive approach will not only facilitate regulatory approval but also contribute to the overall safety and efficacy of medical devices, ultimately benefiting patients and healthcare providers alike.

For more detailed information and resources, manufacturers can visit the MHRA’s official guidance page: Medical devices: post-market surveillance requirements