What Is Post-Market Surveillance
for Medical Devices?
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Following years of research, development, and testing, bringing a medical product to market is a significant accomplishment. However, once a device or equipment is made available to the public, manufacturers must ensure that it continues to work as intended and that it addresses the needs and requirements of patients and healthcare professionals.
Post-Market Surveillance Explained
Post-market Surveillance (PMS) is the process of evaluating the safety and efficacy of medical devices after the product’s commercial release. This includes gathering usage data, assessing data related to performance and safety, and taking appropriate action to address and correct issues when necessary. While medical devices are subjected to rigorous testing and clinical trials, this is only done on a limited number of patients. PMS helps ensure the continued safety of medical gadgets and equipment in the real world, utilizing a robust system to collect feedback from the public.
The importance of post-marketing surveillance is to ensure that medical devices continue to be safe and effective and that action is taken if the danger of continued use outweighs the benefit. Manufacturers are required to assess each medical device and notify regulatory authorities in a timely manner.
What Are The Elements of a PMS System?
What is a PMCF plan? A Post-Market Clinical Follow-up Plan (PMCF) is a technical document that is a component of PMS activities. It outlines the method and strategies to collect information and feedback on the real-world experiences of patients using these medical devices. The objective of a post-market surveillance plan is to promptly identify any device usage issues or design flaws.
Clinical data needs to be collected throughout the product’s lifecycle. There are numerous data collection strategies for post-market surveillance, such as user surveys, product registries, post-market clinical follow-up studies, and product complaint systems. The procedure varies depending on the device type, patient group, and clinical context.
Systematically collecting and storing information is critical for data gathering. You must assess the data collection and management strategies thoroughly. Be aware that oftentimes collecting PMS data becomes compartmentalized, especially with customer-facing teams. Consequently, the appropriate parties may miss post-market data from field-based personnel who work directly with patients or by not thoroughly examining post-market data. Maintaining close collaborations with groups that have contact with consumers, whether support or field personnel, is essential for identifying complaints and taking action.
In May 2021, the full implementation of EU MDR mandated that PMCF activities be undertaken as part of medical device surveillance programs. Manufacturers are required to plan and execute PMCF activities, such as collecting clinical data needed to confirm the safety and effectiveness of certain high-risk devices.
After collecting post-market surveillance data, it is essential to examine the information to find issues or new uses for the medical device. The analysis should include a review of the data, a statistical analysis to discover trends, and a literature review to locate any prior reports of similar issues.These activities are expected to be performed on a continuous and proactive basis by the manufacturer.
It is important to take action on any detected issues. Evaluating complaints for feedback helps uncover risks you may not be aware of. New information learned from your PMS activities should be used to update risk management files frequently and systematically and make any necessary modifications. Risk mitigation may involve modifying the device’s design or manufacturing process, providing users additional training, issuing corrective and preventive actions (CAPAs), or undertaking post-market clinical follow-up studies. Post-market surveillance should be regarded as an ongoing aspect of the product life cycle.
Manufacturers must submit periodic reports on the performance and safety of their products, including adverse events and challenges. The EU Medical Device Regulation (MDR) introduced the Unique Device Identification (UDI) system to identify and trace devices throughout the supply chain. This enables improved device monitoring and speedier identification in the event of a recall or safety problem.
Reporting mandates differ by region, but data analysis and a summary of the remedial and preventive actions are typically included in most reports. In the U.S., the FDA requires a Periodic Adverse Drug Experience Report, while in Europe, low-risk Class I devices must create a post-market surveillance report (PMSR). Manufacturers of Class IIa, Class IIb, and Class III devices must provide a periodic safety update report (PSUR).
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Who Regulates PMS?
PMS is monitored and regulated by the Food and Drug Administration (FDA) in the United States and the European Commission (EC) in the European Union (EU). Over the years, there has been a greater emphasis on PMS activities, and this trend is likely to continue on a global scale.
Part 822 of the FDA’s Code of Federal Regulations (CFR) 21 defines the PMS standards for U.S. medical device makers. The FDA asserts that post-market surveillance is required for specific devices that pose a potential substantial health risk.
In 2017, the European Union published the Medical Device Regulation (MDR) to ensure that medical devices sold to the public are safe to use. It monitors and evaluates their safety, efficacy, and performance. PMS systems identify medical device issues after regulatory bodies like the European Medicines Agency (EMA) or EU Member States’ National Competent Authorities (NCA) have approved them for commercial use.