Post Market Surveillance: What You Need to Know to Ensure Patient Safety

In short, almost 60% of FDA citations between FY22 and FY24 were related to PMS issues, making this an issue that companies cannot afford to take lightly. It is critical for patient safety, to comply with regulatory requirements, and it makes manufacturers accountable.

Post-market surveillance serves as a vital mechanism for tracking the real-time performance and safety of medical devices once they are in use. Initial tests and clinical trials are incredibly insightful but do not always capture the full spectrum of potential issues in diverse, everyday environments. Post-market surveillance seeks to fill this gap, offering a broader, more fluid perspective by analysing real-world usage data and experiences.

This ongoing monitoring is critical to validating medical devices’ practical safety and utility. It provides a pathway for manufacturers to receive and integrate user feedback, crucial for refining and advancing their products. Beyond enhancing device quality, this surveillance is essential for regulatory compliance, aligning with governing bodies such as the FDA in the United States, the European Commission in the European Union, and Health Authorities globally.

Post-market surveillance is regulated in the United States, the European Union, and globally. Look at the specific regulations manufacturers must comply with for successful US and European market operation.

United States: FDA Regulations

The FDA regulates post-market surveillance activities for medical devices through 21 CFR part 822 in the United States of America. This regulation outlines the requirements for medical device manufacturers to ensure the safety and effectiveness of their products. Section 522 states post-market surveillance is required for specific devices potentially posing serious health risks.

PMS is mandatory for class II and class III medical devices that meet any of the following criteria:

1. Failure of the device would be reasonably likely to have serious adverse health consequences.
2. The device will be implanted in the human body for over a year.
3. The device can support or sustain life outside a user facility.
4. The device is expected to have significant use in paediatric populations.

Compliance with these regulations is essential for medical device manufacturers to demonstrate their commitment to patient safety and meet the FDA’s requirements and ongoing device performance monitoring.

Some additional Post Market Surveillance requirements apply to all classes of medical devices and stem from:

• The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA
• 21 CFR Part 7 contains requirements for conducting an effective recall.
• 21 CFR Part 806, Medical Device Corrections and Removals contains reporting requirements and maintenance of records for corrections and removals.
• 21 CFR 820.198 Complaint Files

European Union: MDR Requirements

In the European Union, post-market monitoring for medical devices is governed by the Medical Device Regulation (MDR), released in 2017. The MDR emphasises post-market surveillance to ensure the safety and performance of medical devices in the EU market.

MDR requires manufacturers to have a post-market surveillance system that is commensurate with the risks associated with their devices. This system should include the following:

• A post-market surveillance plan,
• Post-market surveillance procedures,
• Post-market surveillance reporting (such as Post-Market Surveillance Reports (PMSRs) or Periodic Safety Update Reports (PSURs)).

Compliance with the MDR’s post-market monitoring requirements is essential for manufacturers to obtain and maintain the CE marking, which indicates that their devices meet the necessary safety and performance standards for sale in the European market.

Post-market surveillance is of paramount importance for several reasons. Why should manufacturers prioritise and invest in an effective PMS system?

Post-market surveillance plays a crucial role in maintaining the safety and efficacy of medical devices once they are available to the public. While pre-market testing offers significant insights, it often falls short in sample size and duration compared to real-world usage. New risks, adverse events, or performance issues that were not apparent during initial testing may emerge in real-life scenarios. Therefore, continuously monitoring these devices after-market release is essential for manufacturers to swiftly identify and address issues, thereby enduring ongoing patient safety.

The process of collecting user feedback is an integral aspect of post-market surveillance. This feedback from real-world use is invaluable for understanding how devices are used, identifying potential problems, and implementing necessary enhancements. By actively engaging with users and listening to their experiences, manufacturers can align their devices more closely with the needs of patients and healthcare professionals.

Regulatory authorities, such as the FDA in the United States and the European Commission, mandate that medical device manufacturers establish robust systems for post-market surveillance. Meeting the regulatory requirements is crucial for obtaining and maintaining market authorisations, including the FDA’s 510(k) clearance and the CE mark in Europe. Failure to adhere to these regulations can lead to serious repercussions, including regulatory non-compliance, fines, and product recalls.

Post-market monitoring goes beyond regulatory compliance; it catalyses business growth and innovation. By analysing data from post-market activities, manufacturers can unlock the potential for new applications for their devices, uncover market gaps, and innovate to meet these unmet needs. Additionally, by maintaining a pulse on how their devices perform and user feedback, manufacturers can fine-tune their products, improve customer satisfaction, and sharpen their competitive edge.

Creating an effective post-market surveillance system requires a methodical and structured approach. Let us explore the critical steps involved in setting up a PMS system.

CAPAs should collect, analyse, identify, and investigate issues impacting quality systems. In this instance, quality teams must begin by ensuring that the CAPA system procedure is aligned with quality system requirements. In short, they should correct the issue and prevent it from happening again.

CFR 21 820.100 outlines the corrective and preventive actions that manufacturers need to take for implementing CAPAs. They include:

1. Analysing processes, work operations, audit reports, quality records, and other documents to identify recurring quality problems.
2. Investigating the cause of nonconformities
3. Identifying the actions that need to be taken.
4. Verifying and validation the actions that need to be taken in the CAPA.
5. Implementing changes in methods to prevent reoccurrence.
6. Disseminating relevant information to those responsible for assuring product quality
7. Submitting the CAPA and the quality problem to management for review.

Medical Device Reporting (often referred to as MDR – which is distinct from the EU MDR, which related to medical device regulations) is mandatory for manufacturers as well as device user facilities, and importers. They are required to submit reports of adverse events and product problems to the FDA. The Medical Device Reporting Regulation (21 CFR Part 803) outlines how manufacturers should report back to the FDA.

“Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or severe injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur” (Source FDA).

Reports need to be submitted promptly. This is an area where many companies do not have sufficient expertise or resources. Regardless of a company’s ability to manage this, the FDA expects reports within thirty days. Again, this is an area where NSF’s specialists have considerable experience through their experiences within the industry and as ex-FDA regulators. It is an area where we have worked extensively with medical device manufacturers to ensure that they comply with 21 CFR 803.

Recalls are a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws are an integral part of Post Market Surveillance and need to follow very specific requirements outlined by the FDA. Recalls are classified by their severity and degree of health hazard and are governed by 21 CFR Part 7. These need to be performed in a careful and methodical manner and can trigger unannounced inspections and follow-up activities from the FDA.

21 CFR Part 806, Medical Device, Reports of Corrections and Removals outlines the regulatory reporting requirements for device corrections and removals, records that need to be maintained, and reporting timelines. These are also an integral part of the Post Market Surveillance programme.

Post-market surveillance is a vital aspect of medical device manufacturing. Ensuring devices remain safe and effective. It allows manufacturers to gather essential user feedback and comply with regulatory requirements. Manufacturers can quickly identify and resolve potential issues by implementing an effective post-market surveillance system, enhancing device performance, and fostering innovation. Success lies in thorough planning, robust data collection and analysis, prompt responses, and a dedication to continuous improvement. This approach not only prioritises patient safety but also ensures device quality.

NSF Medical Device Consulting and Training services offer comprehensive solutions for medical device manufacturers seeking expert guidance in post-market surveillance and regulatory compliance. Their team of subject matter experts can aid in developing and implementing effective PMS systems, ensuring device safety, and driving business growth.

Remember, post-market surveillance is more than a regulatory checkbox. It is an opportunity for manufacturers to underline their commitment to patient safety, propel innovation, and build market trust. When embraced as a proactive tool for continuous improvement, it positions medical devices for success in the dynamic healthcare industry.

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