Post-Market Surveillance (PMS) is the process of ongoing monitoring of medical devices after they have been released in the market. The goal is to make sure they are safe and work well for patients. PMS helps identify any problems that may occur with the devices, so that the MedTech companies can take any corrective or preventive actions to improve them. This process is critical for ensuring high-quality, safe, and effective medical devices to ensure enhanced patient care. Currently in effect, EU MDR, places a strong emphasis on PMS to minimize the risks to human health and safety.
Understanding the purpose of post-market surveillance
The absence of a PMS system can have serious consequences including:
- Adverse events and patient harm may go unnoticed and uncorrected
- Product quality and effectiveness may decline over time
- Public trust and confidence in medical devices may be eroded
- Financial costs associated with product recalls and lawsuits may increase
- Opportunities for continuous improvement may be missed
Hence, the need of a well-designed PMS system is essential in detecting and mitigating potential safety and performance issues, ensuring patient safety, regulatory compliance, and improving the quality and effectiveness of medical devices over their entire lifecycle.
Post-market surveillance also helps in achieving post-market success for medical device companies. The medical equipment and devices through timely risk identification, continuous monitoring and ongoing improvement become more efficient, promote patient safety, and support the long-term success of medical devices in the market.
MDR and post-market surveillance
The PMS system is a collection of feedback loops and the requirements for post-market surveillance are stated under the article 83 of MDR for every medical device in the market. The PMS system must be documented in a PMS plan and regularly updated based on the analysis of collected data.
The information collected through PMS feedback can be used in different ways including the following:
- Updating the benefit-risk profile of the device by assessing the frequency and severity of device-related harms
- Improving the risk management processes
- Optimizing device safety and performance by updating the device design, instructions for use, and labels
- Updating the clinical evaluation of the device
- Identifying the need for preventive and corrective actions or field safety corrective actions
MDR demands Post-Market Clinical Follow-Up (PMCF) for medical devices. Manufacturers of general medical devices are now required to conduct PMCF according to current regulations. PMCF is an ongoing process of gathering and examining clinical data from the actual use of the device by patients, throughout the device's expected lifespan.
Five Imperatives for an Effective PMS System
For ongoing post market surveillance activities, MedTech manufacturers should incorporate these 5 essential elements in their surveillance system:
- The plan
- Standards & procedures
- Record of post market surveillance activities
- The Postmarket Surveillance and Periodic Safety Update Reports-PMSR & PSUR
- PMCF-Post market clinical followup and feedback System
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Why Post-Market Surveillance is Often Misunderstood in the Medical Device Industry?
Post-Market Surveillance (PMS) is often misunderstood in the medical device industry for several reasons:
- Complex regulatory requirements: The regulatory requirements for PMS can be complex and constantly changing, leading to confusion and misinterpretation among industry stakeholders.
- Lack of standardization: There is a lack of standardization in PMS practices across the industry, which can lead to misunderstandings about the purpose and importance of PMS.
- Limited resources: Medical device companies may have limited resources dedicated to PMS, making it difficult to fully understand and comply with the requirements.
- Misaligned incentives: There may be misaligned incentives between medical device companies, regulators, and healthcare providers, leading to a lack of understanding and cooperation in the PMS process.
- Limited understanding of PMS benefits: PMS can be seen as a compliance burden, rather than as a tool to improve patient safety and quality of care, leading to a lack of investment and understanding in the PMS process.
The Advantages of an Effective Post-Market Surveillance System in the MedTech Industry
A robust PMS solution can ensure the continued safety and performance of medical devices, thereby reducing the risk of harm to patients. It can provide valuable insights into the real-world use of medical devices and can be used to identify areas for improvement. Finally, it can help medical device manufacturers demonstrate their commitment to quality and patient safety, which can help to build trust with healthcare providers and regulators.
Conclusion: PMS system is mandatory to ensure safety and comply with MDR
Post-Market Surveillance (PMS) is a critical component of the medical device industry as it helps to ensure that medical devices are safe, effective, and of high quality. The EU MDR requires MedTech manufacturers to document their PMS plans and regularly update them based on collected data. PMS is often misunderstood due to many factors complex regulatory requirements, limited resources, misaligned incentives, and limited understanding of its benefits etc., Despite these challenges, implementing an effective PMS solution can provide numerous benefits to medical device companies including reducing the risk of harm to patients, providing valuable insights into the real-world use of medical devices, and helping to build trust with healthcare providers and regulators.