UK – Medical Device Post Market Surveillance Requirements

The Medicines and Healthcare products Regulatory Agency (MHRA) has established comprehensive post-market surveillance (PMS) requirements for medical devices in Great Britain through the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024/1368). Passed into law on 22 October 2024 and coming into force on 16 June 2025, these Regulations amend the UK Medical Devices Regulations 2002 by inserting a new Part 4A on PMS requirements. These are now active, enforceable legal obligations, not forthcoming guidance

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.

February 2026

The MHRA launched a consultation in February 2026 on indefinitely extending CE mark recognition for Great Britain, with the consultation closing April 10, 2026. The outcome will fundamentally influence market access strategy for the majority of manufacturers currently on the Great Britain market. While this does not directly modify PMS obligations, it is directly relevant to any manufacturer planning their UK market access strategy in parallel with PMS compliance planning.

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.

The MHRA introduced a standardized format for PMSRs from September 2025. The full suite of MHRA guidance on the new PMS requirements is categorized into four areas: guidance on implementation of the Regulations; supplementary guidance on a manufacturer’s vigilance system (with focus on FSCAs, templates for Field Safety Notices, and the MHRA’s approach to receiving FSCAs); guidance on Periodic Safety Update Reports; and device-specific vigilance guidance.

Manufacturers should review all four guidance areas, not just the implementation guidance, as the vigilance system supplementary guidance contains FSCA templates and procedural details that are directly relevant to operational compliance. The standardized PMSR format’s structured sections cover device description, performance data, risk analysis, and corrective actions, with guidelines on presenting data through tables and charts for reviewer clarity.

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.

The new post-market surveillance regulations are now in force as of June 2025. Compliance is not optional and should already be embedded in quality management systems. Manufacturers that have not yet established written PMS Plans, updated serious incident reporting processes to the 15-day timeline, or prepared PSUR/PMSR documentation aligned with the new standardized format should treat this as an immediate remediation priority, not a future planning exercise.

Conclusion

The MHRA’s post-market surveillance framework, now fully in force since June 2025, represents the most significant structural change to UK medical device regulation since Brexit. Mandatory PMS Plans, a 15-day serious incident reporting timeline, class-specific PSUR obligations, standardized reporting formats, and enhanced FSCA notification requirements collectively raise the bar for what compliant post-market oversight looks like in Great Britain.

For manufacturers, 2026 is not a preparation year; it is a compliance year. Organizations that have not yet embedded the June 2025 requirements into their quality management systems should treat this as an immediate priority. With the MHRA’s CE mark recognition consultation potentially reshaping market access dynamics later in 2026, building a strong PMS compliance foundation now is both a regulatory obligation and a strategic investment in long-term GB market access.

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

FAQ

Q: When did the new MHRA post-market surveillance requirements come into force in Great Britain?

A: The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024/1368) came into force on 16 June 2025, amending the UK Medical Devices Regulations 2002 by inserting a new Part 4A on PMS requirements. Devices placed on the GB market after 16 June 2025 must fully comply with the new regime. Compliance with the new regime will generally satisfy the older existing regime as the new requirements are more stringent. These are fully active legal obligations; manufacturers should already be operating in compliance.

Q: What is the new serious incident reporting timeline under the MHRA PMS Regulations?

A: Serious incidents must now be reported within 15 days, reduced from the previous 30-day requirement. If an FSCA is taken outside Great Britain for devices also distributed in Great Britain, the MHRA must be informed within 3 working days, even if the action originates elsewhere. Manufacturers must have triage and escalation processes embedded in their QMS before an incident occurs to meet these timelines consistently.

Q: Is a written PMS Plan now mandatory for all device classes in Great Britain?

A: Yes, the 2024 Regulations introduce the requirement for a documented and risk-proportionate Post-Market Surveillance Plan (PMS Plan) for all devices, across all risk classes. The PMS plan must include requirements for feedback from patients and the public on the device. The MHRA can request the PMS Plan and, if applicable, the PSUR at any time, manufacturers must maintain documentation in a state of readiness rather than treating it as a periodic submission exercise.

Q: How do PSUR requirements differ across device risk classes?

A: PSURs are required for higher-risk devices (Class IIa, IIb, III, and certain IVDs) with frequency based on risk classification. PSURs must be provided to the MHRA on request within three working days. For Class I devices, a Post-Market Surveillance Report (PMSR) is required with updates at least every three years. Class III and implantable devices must update PSURs annually; Class IIa and IIb every two years. All PSURs and PMSRs should follow the MHRA’s standardized format published in September 2025.

Q: How do the MHRA PMS requirements differ for devices sold in Northern Ireland versus Great Britain?

A: The MHRA PMS Regulations apply to Great Britain: England, Scotland, and Wales. For Northern Ireland, incident reports should be submitted using EU forms available on MORE, with the MHRA still acting as the competent authority. Manufacturers distributing across both GB and Northern Ireland must maintain two parallel reporting workflows: EU-format reporting for Northern Ireland and the UK PMSR/PSUR framework for Great Britain making this one of the most operationally complex compliance requirements for pan-UK distributors.