MHRA Releases New Guidance on Post-Market Surveillance for Medical Devices

The new UK Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 introduce new requirements for manufacturers of medical devices in Great Britain. These requirements are designed to ensure that medical devices continue to be safe and effective throughout their lifetime. The 2024 amendment introduces a new Part 4A to the UK Medical Devices Regulations (MDR) 2002, focusing on post-market surveillance (PMS) for medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices within Great Britain. The regulations outline requirements for incident notifications and preventive and corrective actions after a device is approved for the GB market. 

The regulations apply to all medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices. They require manufacturers to have a plan for post-market surveillance (PMS) of their devices. This plan must include a process for collecting and analyzing data on the safety and performance of the devices. Manufacturers must also report serious incidents to the Medicines and Healthcare products Regulatory Agency (MHRA).

To ensure clarity, the guidance defines several important terms:

• Lifetime of a device : The device lifetime runs from the time of manufacture/production date to the end of the period the manufacturer has validated the device will perform as intended, sometimes referred to as the expected service life. 

• Post-market Surveillance Period: This period begins when the first device of a model is either put into service or placed on the market by the manufacturer and ends at the conclusion of the lifetime of the last device of that model. It’s important to note that many devices continue to be used beyond their defined lifetime, and manufacturers are responsible for gathering post-market surveillance feedback throughout this period. 

• Reportable Side-effects: The guidance provides a definition to help manufacturers identify which side-effects need to be reported under the new regulations (serious incidents). 

The regulations mandate that manufacturers establish a post-market surveillance system that includes:

• Post-market Surveillance Plan: A mandatory plan detailing how post-market surveillance activities will be conducted. It should include
  • Details of procedures for gathering and analyzing data on device performance and safety (ensuring comprehensive real world data obtained) 
  • Assess and mitigate risks identified through post-market surveillance activities 
  • Strategies to address issues identified during post-market surveillance to prevent recurrence.
• Reporting against the Post-market Surveillance plan: The manufacture must produce post market surveillance reports (PMSR) or periodic safety update reports (PSUR) depending on device. 
  • The PMSR or PSUR requirements (Regulations 44ZL and 44ZM) apply to system or procedure packs which contain a medical device which does not bear a UKCA or CE-mark or where the chosen combination of medical devices is not compatible with their approved intended use. These system or procedure packs shall be classified in line with accepted classification guidance, and the PMSR/PSUR requirements apply accordingly. 
  • The manufacturer must make the most up-to-date report available to the MHRA on request within 3 working days. There is no requirement to routinely submit copies of PMSRs or PSURs to the MHRA unless requested to do so. 
  • It further provides details for frequency of update, deadline for preparation of PSUR/PSMR/ The manufacturer must prepare a PMSR within 3 years of the first device being placed on the market or put into service (whichever is sooner), or if already on the market/put into service, within 3 years of this regulation coming into force. The timescales for provision of PSURs vary depending on device risk classifications.
• Reporting Obligations: Manufacturers must report serious incidents, FSCAs, and adverse trends. The reporting templates for each are available in the MORE portal. 
  • Serious incidents are the one that meet all of the 3 criteria:
    • An Event Occurred: An issue is identified, including device testing, accompanying information, or scientific data indicating potential risks.
    • Device Contribution: The manufacturer’s device is suspected to have contributed to the event, even as a side effect.
    • Serious Outcome: The incident led to or could lead to death or serious health deterioration of a patient, user, or others.
  • Adverse trends: Notable rises in incident frequency that could impact device safety or performance. Guidance on determining statistical significance is available in PD CEN ISO/TR 20416 and within the MHRA guidance document.
  • Timelines for Reporting Incidents to the MHRA:
    • Serious Public Health Threat: Report within 2 calendar days of awareness.
    • Death or Unanticipated Serious Deterioration in Health: Report within 10 calendar days of awareness.
    • Unanticipated Deterioration: A situation not covered in the manufacturer’s existing risk analysis documentation.
    • Anticipated Serious Deterioration in Health: Report within 15 calendar days of awareness (changed from 30 calendar days).

Further the guidance provides comprehensive information about reporting, investigating, and addressing adverse incidents involving medical devices, as outlined by the MHRA’s regulations. Key changes include the requirement to submit adverse incident reports via the MORE portal, with specific guidance for registration, report completion, and API integration. Manufacturers must provide all mandatory information in initial reports, including UDI details and data on similar incidents. They are also responsible for thorough incident investigations, including notifying the MHRA before destructive testing. Updates highlight new requirements for trend reports, periodic summary reporting, and responding to safety concerns raised by the MHRA. Field safety corrective actions (FSCAs) and notices (FSNs) are emphasized, with structured processes for communication and effectiveness verification. The guidance introduces tighter timelines for information submission and detailed protocols for managing risks, ensuring compliance with updated regulatory standards.

Conclusion

The MHRA’s guidance provides a comprehensive framework for manufacturers to align with the new post-market surveillance requirements. By adhering to these guidelines, manufacturers can enhance device safety and performance, ultimately improving patient outcomes. It’s imperative for all stakeholders to thoroughly review and integrate this guidance into their operations ahead of the June 16, 2025, implementation date.

For detailed information, please refer to the full guidance document on the MHRA website. GOV.UK