Best practices vital to navigating medical device post-market surveillance
Manufacturers of medical devices must put in place a wide range of processes and documentation to meet post-market surveillance requirements. While this means more work, Belinda Dowsett of PharmaLex* explains that these requirements do give manufacturers better insight into the performance of their devices.
After some notable medical device recalls and compliance issues — such as silicone breast implants and metal-on-metal hip implants — regulators increased their scrutiny of post-market surveillance processes and activities. Regulatory authorities globally have put in place stricter post-market requirements, particularly in the EU, with the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The hope, and expectation, is that these processes will reduce risk from the outset; however, it’s inevitable that issues will occur with medical devices once they are on the market, particularly in the case of high-risk and innovative devices.
The World Health Organization defines post-market surveillance (PMS) as “a set of activities conducted by manufacturers to collect and evaluate experience gained from medical devices that have been placed on the market and to identify the need to take any action”.1 While the level of stringency differs across global jurisdictions, following the industry best practice with PMS is highly recommended. This helps to ensure regulatory requirements are met and also gives manufacturers a better understanding of how their device is performing in the market so they can more rapidly address any safety concerns.
Documenting the PMS journey: the PMSP
The EU has taken the lead in terms of documentation requirements through the MDR and IVDR. Depending on device classification, required documentation includes a post-market surveillance plan (PMSP); a PMS report (PMSR) or periodic safety update report (PSUR); a post-market clinical follow-up plan (PMCFP), report and summary of safety and clinical performance (SSCP) for medical devices; and the post-market performance follow-up (PMPF) plan, report and summary of safety and performance (SSP) for IVDs.
The PMSP should define processes used to collect post-market information, including what that information is, the dataset, how it will be collected, and all methods and processes used to analyse and assess the collected data. The plan must be effective, which means that the activities defined should meet the principal objective of identifying actual or potential issues and determining the need to take action. The processes should also be appropriate for the type and risk of the device — the higher the classification or the more novel or innovative the device, the more rigorous the PMSP documentation.
To enable regulators to identify and verify the data and sources, manufacturers must ensure the data captured is clear, organised, searchable and unambiguous. Methods and processes used to assess collected data, protocols for statistical analysis of incidents, and the methods of communicating with relevant parties should also be defined. And manufacturers should clearly reference how they are meeting their obligations to trace devices where corrective actions were necessary.
Manufacturers with products in all major markets must also summarise the results and conclusions of their PMS analysis in a report (PMSR). The report must be made available to regulators according to relevant regulations.
Higher classification medical devices and IVDs require a PSUR. This is a more comprehensive report than the PMSR, summarising the results and conclusions of the analysis of PMS data, and must be updated either annually or every two years, depending on the class of the device.
Clinical oversight throughout
The MDR specifically requires manufacturers to have a PMCFP to provide input to the review and revision of the clinical evaluation report. This is a continuous process which confirms the safety and performance of the device throughout its expected lifetime. This is a vitally important piece of documentation that is afforded great importance by the notified body to supplement the data presented within the clinical evaluation report. The PMCF should also identify previously unknown side effects and monitor those to ensure the benefit-risk ratio remains in alignment with the clinical evaluation documentation.
There are certain cases where PMCF is mandatory, including but not limited to:
- innovative products or those replacing current clinical practice;
- where the product has undergone significant changes, such as a change in material for a prosthesis or new technology for an infusion pump;
- where there are higher product-related risks, or risks due to its anatomical use, such as for the heart, or a more vulnerable population.
The PMCF process must include both a report and a plan, which, like the PMS activities, must be continuous, proactive, scheduled, appropriate and justified. The plan should establish the methods, procedures, specific objectives and timelines for follow-up.
Any reference to technical documentation, clinical evaluation and risk management reports, as well as reference to relevant consensus standards, harmonised standards, and regulatory and guidance documents, should also be included in the report. The report will form part of the clinical evaluation report and the device’s technical documentation.
A continuous process
Information gathered through all these processes is fed back through the post-market surveillance system to ensure continuous updates to the clinical evaluation plan and risk management plan. Indeed, clinical and risk evaluation processes tightly intersect with all PMS activities.
The PMS processes are also integral for updating and improving the device’s design specifications and technical documentation. Throughout the life cycle of a product, the PMS will lead to specific actions that the manufacturer must take, such as corrective and preventive actions, field safety corrective actions and communications with key stakeholders.
Ultimately, with the implementation of the European Database on Medical Devices (EUDAMED), the objectives of PMS will be more fully realised thanks to improved transparency through better access to information for the public and healthcare professionals, as well as for manufacturers and regulators.
Following best practices with PMS processes, systems and documentation will help identify and mitigate issues that will inevitably arise with medical devices. With the right PMS processes in place, manufacturers are in a better position to facilitate compliance with regulatory requirements as well as to identify any early issues and potentially prevent the devastating recalls that have led to this more demanding regulatory oversight.
1. Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics, WHO, https://www.who.int/publications/i/item/9789240015319
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