The UK’s Medical Devices (Post-market Surveillance Requirements) (Amendment) Regulations 2024 introduce significant changes to the Post-Market Surveillance (PMS) landscape for medical devices. These changes aim to strengthen the PMS system in the UK, ultimately improving patient safety. In this article, we will provide a detailed breakdown of these changes and what they mean for you.
Introduction to the Mandatory PMS Plan
One of the most significant changes is the mandatory requirement for manufacturers to have a PMS plan in place. This plan, which outlines the methods for gathering and analysing device performance and safety data throughout the device’s lifecycle, is a crucial component of the updated regulations.
The PMS plan should include:
- Objectives of the PMS system
- Processes to gather information, ensuring comprehensive real-world data is obtained
- Methods of data analysis
- Processes for fulfilling vigilance reporting obligations
- Links to preventive and corrective action as part of a risk management process
Manufacturers must review the actions taken according to the PMS plan at regular intervals and document the review in a Post-Market Surveillance Report (PMSR) or Periodic Safety Update Report (PSUR), as appropriate.
Enhancing Patient and Public Engagement
The regulations underscore the significance of gathering feedback directly from patients and the public. This inclusive approach ensures that their experiences and perspectives are considered.
This includes obtaining feedback on the device’s usability and the adequacy of the instructions for use. Depending on the device type, manufacturers need to assess and document the extent to which this is relevant and achievable.
Focusing on Similar Devices
To improve signal detection, manufacturers must collect data on their devices across all markets and review publicly available information on the safety of similar devices offered by competitors.
The regulations define similar devices as those based on the same or similar technology and with the same or similar intended purpose.
Taking Preventive and Corrective Actions
The regulations require manufacturers to take preventive and corrective actions to address potential safety or conformity issues with their devices. This includes cooperating with the Medicines & Healthcare products Regulatory Agency (MHRA) on any actions taken.
Preventive actions should be taken before the manufacturing process is completed, while corrective actions should be taken after the devices have been manufactured.
Understanding Reporting Requirements
Manufacturers must submit PMSRs or PSURs to the MHRA, depending on the device classification. The PSURs must follow a standardised format and be updated at set intervals.
The PMSR or PSUR should provide a comprehensive and critical analysis of the device’s risk-benefit balance and include a summary of the analysis and conclusions from the review of the PMS data gathered since the last report.
Incorporating Vigilance Reporting
The regulations outline the requirements for reporting serious incidents, Field Safety Corrective Actions (FSCAs), and adverse trends to the MHRA. This includes specific timelines for reporting and the use of the MHRA’s Manufacturer’s Incident Report (MIR) form.
A serious incident is defined as one that directly or indirectly led to, or could have led to, death or serious deterioration in the state of health of a patient, user, or another person.
Communicating Field Safety Notices (FSNs)
Manufacturers must communicate FSCAs to affected customers using FSNs. The FSNs must include Unique Device Identifier (UDI) information where available and be sent in a searchable format. The MHRA encourages manufacturers to host a copy of the FSN on their website for transparency.
The FSN should clearly communicate the risk and the actions taken to mitigate it. Manufacturers should take reasonable steps to ensure that all affected end-users receive and understand the FSN.
FSCAs Outside Great Britain
If a manufacturer undertakes an FSCA outside Great Britain that affects the same type of devices supplied in Great Britain, they must notify the MHRA within three UK working days of the FSN being circulated, even if the devices in Great Britain are not affected.
This requirement is in place to provide transparency and avoid confusion by clarifying why the FSCA does not affect the UK.
Additional Important Changes
The update also amends the following:
- Clarification of Important Terms: The regulations define key terms, such as “lifetime” and “PMS period,” to ensure consistency and clarity.
- Reportable Side Effects: The regulations clarify the definition of reportable side effects to include any negative impact on the health of the patient, their care, or wider public health.
- Self-Administered Treatment: The regulations clarify that interventions to prevent serious deterioration in health include self-administered treatment.
- Use Errors: The regulations specify that use errors do not need to result in serious deterioration in health to be reportable; the risk of occurrence is sufficient.
- UDI Information: The regulations require the inclusion of Unique Device Identifier (UDI) information in incident reports and FSNs where available.
- Trend Reporting: The regulations require manufacturers to submit trend reports for incidents that are reportable individually, as well as those that do not meet the criteria for individual reporting.
- Custom-Made Devices: The regulations clarify that trend reports are not required for custom-made devices.
Conclusion
The UK’s Medical Devices (Post-market Surveillance Requirements) (Amendment) Regulations 2024 represent a significant step towards strengthening the PMS system for medical devices. By clarifying requirements, enhancing patient engagement, and focusing on proactive risk mitigation, these regulations aim to improve patient safety and ensure the continued effectiveness of medical devices in the UK market.
If you need to speak to an expert to understand more about what this update might mean for you, contact us to arrange a free, no-obligation discussion.
