Proactive and Reactive Post-Market Surveillance: Implementation Tips

In the ever-evolving landscape of medical devices, ensuring the safety and performance of products post-market is paramount. The recent webinar titled “Proactive and Reactive Post-Market Surveillance: Implementation Tips” provided valuable insights into the intricacies of post-market surveillance (PMS) and its implementation. This article distills the key points from the webinar, offering a comprehensive guide for professionals in the field.  

Understanding Post-Market Surveillance  

Post-market surveillance is a systematic process carried out by legal manufacturers in cooperation with other economic operators (i.e., authorized representatives, importers, and distributors) to collect and analyze data on the performance and safety of medical devices once they are on the market. PMS involves proactive and reactive activities to identify and address potential issues with the device and immediately apply any necessary corrective and preventive actions.  

The Importance of Proactive Surveillance  

Proactive surveillance is crucial in the European Union. It involves activities such as literature screening, surveys, and social media monitoring to gather information on the performance and safety of the device (family) under evaluation and/or similar devices. These activities help legal manufacturers identify potential device risks and take preventive actions before issues escalate.  

Building an Efficient PMS Plan  

A robust PMS plan is the cornerstone of effective PMS. The scope of the PMS plan is based on the outcome of the risk management and clinical evaluation processes leading to both proactive and reactive activities. It should also encompass the device’s lifetime, from production to final decommissioning and disposal.  

Key components of listing a proactive or reactive PMS activity in the PMS plan  

1. Defining the objective: The objective is connected to the scope of the PMS plan and is, therefore, aligned with the risk management and clinical evaluation documentation  

1. Description of the method: It should be clear what type of data and how it will be collected.   

1. Analysis: Up front, it already needs to be decided how the data will be analyzed (e.g., root cause analysis, tools, statistically significant method, measurable acceptance criteria). It might also be relevant to consider the possible techniques and protocols to communicate effectively with Competent Authorities, Notified Bodies, other economic operations, and/or users.   

1. Establish a threshold: The indicators for actions or threshold should also be determined by current procedures (e.g., complaint handling, vigilance, CAPA) and the acceptability criteria as defined in the risk management plan.   

1. Trend analysis: Trend analysis does not apply to all regulatory activities but must at least be addressed for reactive PMS activities such as vigilance.   

Implementing Post-Market Clinical Follow-Up (PMCF)  

PMCF is a critical component of PMS, focusing on the proactive collection and evaluation of clinical data from the end users of CE-marked devices within its intended purpose. PMCF is to confirm the safety and performance throughout the device’s expected lifetime, ensure the continued acceptability of identified risks, and detect emerging risks based on factual evidence (e.g., unknown side effects, systemic misuse, off-label use, emergent risks). For setting up a PMCF plan, a business-balance approach is key, and therefore, the following steps are essential:   

1. Evaluate current state: Understand the available clinical data and determine the gaps.  

1. Review available data: It is essential to ensure cross-functional team integrations, especially to add efficiencies across product portfolios (i.e., overlapping PMCF needs, endpoints, product bundling). Take into account expectations from Notified Bodies and/or Competent Authorities, and consider what type of data is required, the availability of resources, and the cost versus the sales of the devices.   

1. Develop PMCF strategy: The strategy should be tailored to business needs and include all general and specific activities, with rationale and appropriate methods and procedures leading to particular objectives to be addressed by PMCF and carried out over a specific period.    

Different PMCF activities, which usually raise cost, time, and data requirements, include performing a literature review, collecting feedback, database and/or registrations, and conducting clinical investigations.   

Generating a PMS report or Periodic Safety Update Report (PSUR)  

A PMS report must be prepared for Class I devices, and a PSUR is essential for higher classes. The frequency of PSUR generation depends on the device class and can be carried out as planned if the predefined thresholds of the individual proactive and reactive activities are not reached. Both the PMS report and PSUR lead to a rationale and description of any preventive and corrective actions to be taken while addressing the conclusions of the benefit-risk determination, the main finding of the PMCF, and the volume of sales of the device and an estimated evaluation of the size and other characteristics of population using the device and, where practicable, the usage frequency of the device.  

Conclusion  

Proactive and reactive systematic PMS is vital for ensuring the safety and performance of medical devices and may also enhance the quality of devices. By implementing a robust PMS plan, conducting (if needed) thorough PMCF activities, and generating a PMS report or PSUR with clear conclusions if any other update or action is required, legal manufacturers can maintain compliance with regulatory requirements and enhance the overall quality, safety, and performance of their products. The insights from the webinar provide a valuable roadmap for professionals seeking to navigate the complexities of PMS.