Post-market surveillance is an essential process that allows medical device manufacturers to monitor their products once they’ve been released to the market.
What Is Post-Market Surveillance for Medical Devices?
Post-market surveillance (PMS) is all about keeping a close eye on devices after they hit the market to gather real-world evidence and monitor any potential issues. This means that manufacturers can collect quality, performance, and safety data throughout a device’s lifetime, providing a complete risk/benefit profile. As part of PMS, manufacturers also collect data on related devices from competitors to stay up to date on the latest advancements and continue improving their own products.
One of the key benefits of post-market surveillance is the early detection of adverse events. By monitoring and analyzing customer complaints, failure reports, and adverse event reports, manufacturers can quickly identify any problems and take necessary action.
How Do You Conduct Post-Market Surveillance?
Conducting post-market surveillance is crucial for ensuring the safety and effectiveness of medical devices. Here’s a breakdown of the steps involved:
The new European Union Medical Device Regulation (Article 84) now requires a post-market surveillance plan. This plan is essential for collecting valuable feedback to update important processes and ensure the safety and effectiveness of medical devices in the market.
The PMS plan must cover a range of data elements, including:
- Serious incidents
- Non-serious incidents
- Reportable trends
- User feedback
- Information from literature and databases
Your PMS also needs to address the methods and tools for data collection, assessment, and reassessment, as well as communication with stakeholders and corrective action procedures.
Manufacturers must also include a Post Market Clinical Follow-up (PMCF) plan or a justification why it’s not applicable. This is crucial for ongoing evaluation of device performance.
Having a PMS plan in place is essential for success, and Quality Management System (QMS) software can help you implement it. By automating these tasks, you can save time and resources, allowing your team to focus on more important matters. Plus, with the ability to track progress and receive timely reminders, you can make sure nothing slips through the cracks.
Not only does QMS software simplify your operations, but it also improves accuracy and accountability. With a centralized system in place, everyone involved can access and update relevant information, making communication and collaboration easier.
Various documentation is generated during the PMS process, so manufacturers are required to provide a summary of all the outcomes and decisions made based on the data collected and analyzed. PMS reporting also involves documenting the corrective and preventive actions taken by your company, ensuring the safety and reliability of your device. One key document to include is the Periodic Safety Update Report (PSUR). This report summarizes the findings and conclusions obtained from analyzing the PMS, PMCF, and vigilance data.
A QMS is essential for ensuring the safety and effectiveness of medical devices. But how does post-market surveillance fit into your QMS? Both the FDA’s Quality System Regulation (QSR) and ISO 13485:2016 require companies to incorporate post-market processes into their QMS. These processes include complaint handling, nonconformance management, corrective action, preventive action, and internal auditing. When used correctly, these processes and the data they generate provide a strong foundation for post-market surveillance. By effectively managing complaints, identifying nonconformities, taking corrective actions, and conducting internal audits, you can proactively monitor the performance, safety, and quality of your medical devices after they hit the market.
Learn about how post-market surveillance plays a part in getting a CE certification for medical devices with this guide.
FDA post-market surveillance requires manufacturers to monitor devices even after they’ve been approved. Higher-risk devices are more likely to require PMS, while lower-risk device classifications typically don’t. PMS activities include submitting adverse event reports, which can be done by healthcare professionals and consumers through MedWatch. The FDA also maintains the MAUDE database, where mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters (healthcare professionals, patients, and consumers) can submit medical device reports.
While in the US, PMS is only mandatory for higher-risk devices, the EU MDR post-market surveillance goes a step further by making PMS a requirement for all devices. Annex III of the MDR 2017/745 outlines the specific PMS requirements that manufacturers must comply with. If you’re planning to sell your medical device in the EU, you need to prove that you have performed a PMCF plan or provide a justified reason for its omission.
Looking for guidance in navigating the post-market surveillance process? With over 30 years of medical device manufacturing experience, Remington Medical is here to assist you every step of the way. We understand that staying compliant and ensuring patient safety is of utmost importance to you, and that’s why our team of experts is dedicated to helping you navigate this daunting process. We’ve helped numerous medical device manufacturers like you overcome these daunting hurdles, and Remington takes pride in our ability to simplify complex regulations and ensure your products meet all necessary requirements. Contact us today to learn about our complete contract manufacturing process for medical devices and how post-market surveillance fits into it.
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