In a significant move towards improving patient safety and product oversight, the UK has introduced new post-market surveillance (PMS) requirements under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. These regulations, effective from 16 June 2025, amend the UK Medical Devices Regulations 2002 by adding a new Part 4A, which outlines comprehensive PMS requirements for medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices.
New Legal Foundations for PMS
Manufacturers are required to have a post-market surveillance (PMS) system and plan, which involves gathering feedback from users, monitoring similar devices, and taking preventive and corrective actions.
| Regulation | Topic | Summary |
| 44ZC | Definitions | Sets out key definitions for terms used in Part 4A. |
| 44ZE | Post-Market Surveillance System | Requires manufacturers to establish and maintain a PMS system for each device, proportionate to its risk and type, to collect and analyze data throughout the device’s lifetime. |
| 44ZF | Post-Market Surveillance Plan | Mandates that the PMS system be based on a PMS plan detailing processes for data collection, analysis, communication with stakeholders, and post-market clinical follow-up. |
| 44ZG | Preventive and Corrective Actions | Obligates manufacturers to take appropriate preventive and corrective actions, including field safety corrective actions, based on data from the PMS system. |
| 44ZH | Initial Reporting of Serious Incidents | Requires manufacturers to report serious incidents to the MHRA within specified timeframes: 15 days for most incidents, 10 days for deaths/unanticipated deterioration, and 2 days for public health threats. |
| 44ZI | Investigation & Final Reporting | Mandates thorough investigation of serious incidents and submission of a final report to MHRA, including conclusions and actions taken. |
| 44ZJ | Field Safety Corrective Actions (FSCAs) | Requires FSCAs to be reported to MHRA before implementation (unless urgent) and communicated through Field Safety Notices (FSNs). |
| 44ZK | FSCAs Outside Great Britain | Requires notification to MHRA within 3 UK working days of FSCAs taken outside GB, if similar devices are placed on the GB market. |
| 44ZL | Post-Market Surveillance Report | Requires manufacturers of Class I and IIa devices to prepare a PMS report summarizing the results and conclusions of the PMS data analysis, to be updated as necessary. |
| 44ZM | Periodic Safety Update Report (PSUR) | Mandates that manufacturers of Class IIb and III devices prepare a PSUR, providing a comprehensive analysis of the device’s safety and performance, to be updated at least annually. |
| 44ZN | Trend Reporting | Requires manufacturers to report significant increases in the frequency or severity of incidents involving the device, based on the statistical methodology in the PMS plan. |
| 44ZO | Reports Received by the Secretary of State | Outlines MHRA duties upon receiving reports – evaluation, public health action, and stakeholder communication. |
| 44ZP | Analysis of Information Received | Mandates that the MHRA analyze received data to detect trends, reassess benefit-risk, and determine necessary actions. |
| 44ZQ | Retention of PMS Documentation | Requires manufacturers to retain PMS documentation for at least 10 years (15 years for implantable devices) after the last device has been placed on the market. |
| 44ZR | Requests for PMS Documentation | Allows the MHRA to request PMS documentation from manufacturers, who must provide it within the specified timeframe. |
Post-Market Surveillance Requirements: What’s New?
- Mandatory PMS System and Plan
Manufacturers are now required to establish a PMS system supported by a detailed PMS plan. The plan should include:
- Procedures for data collection and analysis
- Risk-benefit re-evaluation
- Post-market clinical follow-up (if applicable)
- Stricter Incident Reporting Timelines
Reporting timeframes have been shortened significantly:
- Serious incidents: within 15 days (previously 30)
- Unexpected deaths or serious deterioration: within 10 days
- Public health threats: within 2 days
Trend reports—covering both individually reportable and non-reportable incidents—are now required for devices except custom-made ones. These must include detailed data, including Unique Device Identification (UDI).
Timelines and content requirements for post-market surveillance reports (PMSRs) and periodic safety update reports (PSURs) based on device classification.
| Device Class | PMSR Submission Frequency | PSUR Submission Frequency | Content Requirements |
| Class I | Annually | – | PMS activities Incidents Adverse trends CAPA |
| Class IIa | Annually | Every 2 Years | PMSR content as above Summary of incidents FSCA Benefit-risk analysis |
| Class IIb | Annually | Annually | |
| Class III | Annually | Annually |
Role of UKRPs and UKABs in the post-market surveillance process
UK Responsible Persons (UKRPs): They are responsible for ensuring that the manufacturer complies with the post-market surveillance requirements. This includes facilitating communication between the manufacturer and the Medicines and Healthcare products Regulatory Agency (MHRA) regarding post-market surveillance activities and reporting.
UK Approved Bodies (UKABs): They play a role in the assessment and surveillance of medical devices. In the context of post-market surveillance, UKABs may be involved in evaluating the manufacturer’s post-market surveillance system and activities to ensure compliance with regulatory requirements.
Incident Investigation & Information Sharing
When serious incidents occur, manufacturers are expected to:
- Conduct a root cause analysis
- Perform a risk assessment
- Update the PMS plan and take corrective action (including FSCAs, if needed)
Additionally, manufacturers must respond to MHRA information requests within 3 UK working days or provide valid justification for delays.
The Takeaways for Manufacturers
- Be Proactive: PMS is no longer just a box-ticking exercise—it’s an ongoing lifecycle responsibility.
- Update Your Systems: Manufacturers need to review and revise existing PMS processes to align with the new regulations.
- Prepare for Scrutiny: Both UKRPs and UKABs will play a greater role in holding manufacturers accountable for PMS.
- Stay Ahead of Timelines: With shortened reporting deadlines, it’s essential to have fast internal escalation procedures.
The new PMS regulations represent a significant step forward in ensuring medical devices on the UK market remain safe and effective throughout their lifecycle. Manufacturers should act now to integrate these changes and ensure they remain compliant in this evolving regulatory landscape.
