Effective from 16 June 2025, the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 mark a pivotal evolution in the UK’s post-market surveillance (PMS) framework. These amendments, which update the UK Medical Devices Regulations 2002, aim to enhance patient safety and align regulatory practices in Great Britain with internationally recognised standards. This article summarises the core changes introduced by the amendment and provides guidance on what manufacturers must do to comply.

What is changing?

The regulations insert a new Part 4A in the UK MDR 2002, creating more robust and risk-appropriate PMS requirements for medical devices and in vitro diagnostic (IVD) devices. The rules apply to devices placed on the market or put into service in England, Scotland, and Wales from 16 June 2025. (Northern Ireland remains under EU MDR/IVDR requirements.)

These requirements do not apply to devices which are under clinical investigation, performance evaluation or are subject to exceptional use authorisation in Great Britain. Further, they do not apply to medical devices manufactured in-house by healthcare establishments (regardless of whether custom-made).

Key Highlights

1. Post-Market Surveillance System (PMSS)

All manufacturers must now implement and maintain a structured, device-specific PMSS. This system must reflect the risk class of the device and outline:

  • Device lifetime expectations
  • Methods of data collection, analysis, and feedback
  • Performance and safety indicators
  • Corrective and preventive actions processes

A documented PMS plan is mandatory and must be made available to the MHRA on request within three working days.

2. Incident and Field Safety Corrective Actions (FSCAs) Reporting

Manufacturers must continue to report serious incidents using the Manufacturer’s Incident Report (MIR) form, but additional clarity is now provided on timelines and format.

Field Safety Corrective Actions must be supported by a Field Safety Notice (FSN). The FSN must be:

  • Clearly labelled
  • Easily understandable
  • Inclusive of the Unique Device Identifier (UDI) data, where available, in a searchable format
  • Accessible to all impacted parties, including healthcare professionals and patients

3. Periodic Safety Update Reports (PSURs)

    PSURs are now mandatory for Class IIa, IIb, and III devices, and higher-risk IVDs.

    • For Class IIb and Class III medical devices and higher-risk IVDs, the first report must be produced within one year of device placement or use (this means that if the device is already on the market, then that is within one year of the Regulations coming into force).
    • For Class IIa devices, the first report must be produced within two years of device placement or use.
    • For Class IIb and Class III medical devices and higher-risk IVDs, the PSUR must be updated annually until the end of the device’s surveillance period.
    • For Class IIa devices, the PSUR must be updated every two years until the end of the device’s surveillance period.
    • The PSUR should include:
    • PMS data summaries
    • Risk-benefit evaluation
    • Data on sales and usage
    • Trend analyses
    • Description of any preventive or corrective action including FSCAs

    Manufacturers must submit PSURs to the MHRA within three working days on request.

    4. Trend reporting requirements

    A new obligation to monitor and report for trends in incidents which meet the reporting criteria (serious incidents) as well as incidents which do not meet the criteria for individual reporting. This aims to:

    • Enable early detection of emerging risks
    • Identify safety signals based on both the manufacturer’s data and various other sources

    Trend reports to the MHRA are not required for custom-made devices, although the requirement to identify adverse trends still applies.

    5. Use of Data for Similar Devices

    Manufacturers are required to include data from similar devices—those with the same technology and intended purpose—as part of their PMS activities. This ensures a broader safety perspective and supports proactive decision-making.

    6. Patient and Public Engagement

    A progressive addition is the encouragement to integrate feedback from different user groups, including healthcare professionals and patients. This includes complaints, usability concerns, and reactions to product labelling and instructions. While not mandatory for every device, it is highly encouraged, especially for high-risk or widely used products.

    Next Steps for Manufacturers

    By 16 June 2025, manufacturers should:

    • Review and update existing PMS plans and systems
    • Identify which devices require PSURs or trend reporting
    • Train relevant personnel on FSCA, MIR, and FSN protocols
    • Ensure data capture systems can support the required PMS reporting frequency and quality

    The MHRA has issued comprehensive guidance to support implementation, including device-specific guidance for medical devices as diverse as blood glucose meters, intraocular lenses, joint replacement implants, neurostimulators, and even software, to assist manufacturers in implementing the new PMS requirements.

    If you require any further resources and support on guidance for healthcare professionals, please get in touch with our insurance lawyers or your usual brodies contact.

    Contributors

    Lynn Livesey

    Legal Director

    Laura McMillan

    Partner & Director of Advocacy