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Post-Market Surveillance for Medical Device
What is Post-Market Surveillance?
Post-market surveillance of medical devices is the ongoing process of monitoring and assessing the safety, performance, and effectiveness of devices after they are on the market. It involves reporting adverse events, tracking device performance, identifying trends, and updating risk assessments. This helps detect issues, ensure patient safety, and maintain regulatory compliance. The process gathers real-world evidence, informs corrective actions, and fosters transparent communication among manufacturers, regulators, healthcare providers, and patients.
Post-market Surveillance Regulations
PMS is a regulated activity in the United States by the Food and Drug Administration (FDA) and in the European Union (EU) by the European Commission (EC). Over the years, regulations have shifted to more emphasis on PMS activities and this is likely to continue in markets across the world.
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21 CFR part 822 in the United States
The FDA’s 21 CFR part 822 outlines the PMS requirements for medical device manufacturers in the U.S. Referencing Section 522 of the Federal Food, Drug, and Cosmetic Act, the FDA states that post-market surveillance is required for certain devices that present a potential for serious risk to health.
PMS is required for class II and class III medical devices that meet any of the following criteria:
(a) Failure of the device would be reasonably likely to have serious adverse health consequences;
(b) The device is intended to be implanted in the human body for more than 1 year; or
(c) The device is intended to be used outside a user facility to support or sustain life.
MDR in the European Union (EU 2017/745)
In 2017, the European Union released the Medical Device Regulation (MDR), which featured an increased focus on post-market surveillance. The post-market surveillance system must be commensurate with the risks associated with the device and include:
– A post-market surveillance plan
– Post-market surveillance procedures
– Post market surveillance reporting such as PMS reports (PMSRs) or Periodic Safety Update Report (PSURs)
Creating a Post-market Surveillance System
Now that we’ve reviewed PMS in general, let’s take a look at how you can build an effective PMS system. Your system’s goal is to collect data on the safety and performance of your medical device. There are many different ways to set up a PMS system, but all systems should include some basic elements:
- Planning: This includes creating a PMS plan and setting up a process that enables your feedback gathering to be effective. Begin with identifying who will be responsible for PMS activities (this is usually a quality manager or quality team member).
- Data collection: Establish channels for collecting data from users, such as customer feedback, product complaints, and post-market studies.
- Data analysis: After collection, take action if necessary. After reviewing and trending data, this might involve conducting post-market studies, modifying product labeling, or issuing a recall.
- Training: Train the relevant staff on your PMS procedures, so valuable feedback isn’t lost or ignored.
- Risk management: This includes taking action to reduce the risks associated with your device. This might involve implementing PMS procedures or field safety corrective actions. It’s important to note that PMS activities should be ongoing and continuous, not just a one-time event.
Why is Post-market Surveillance Important?
- Adverse Event Detection: Identifies unexpected side effects and safety issues not caught in pre-market trials.
- Long-Term Safety: Monitors product safety over extended periods and in diverse real-world settings.
- Effectiveness Confirmation: Validates how well products work outside controlled clinical trials.
- Rare Event Identification: Detects infrequent adverse events that might only emerge with broader usage.
- Product Quality: Ensures consistent manufacturing standards and prevents defects.
- Regulatory Compliance: Regulatory agencies mandate post-market surveillance to ensure ongoing safety.
- Label Updates: Enables timely updates to product information based on new safety or efficacy data.
- Risk Management: Facilitates interventions to mitigate identified safety concerns.
- Public Trust: Demonstrates commitment to safety and fosters confidence in medical products.
- Continuous Improvement: Informs future product development for enhanced safety and effectiveness.