As per EU MDR and IVDR, PMSR shall be prepared for a class I medical devices & Class A and B in-vitro diagnostic devices, a post-market surveillance report summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as per the post-market surveillance plan.
This PMSR need not be submitted to notifying body during technical file assessment, however must be prepared and updated periodically and shall always be at the disposal of competent authority when requested.
This PMSR shall contain results and conclusion of the analysis of Post Market Surveillance data against the PMS Plan. It should also describe the rationale and description of number of corrective and preventive actions takes against customer complaints and audit observations. It shall clearly state the number of devices sold and observed non-conformities.
Other than the periodic updates, the PMSR can also be updated if any changes are made to the Class I Medical Device or Class A, B IVDs in scope.
The Post Marketing Surveillance report shall be prepared and updated throughout the lifecycle of medical devices and in-vitro diagnostic medical devices (IVDs).
What Is PMSR and Why It Matters
The Post Market Surveillance Report (PMSR) is a critical document required for medical devices, including Class I devices and Class A and B in-vitro diagnostic devices (IVDs), as per EU MDR and IVDR regulations. This report provides a detailed analysis of the post-market surveillance data, summarizing the results and conclusions in relation to the post market surveillance report plan. PMSR helps ensure ongoing safety and performance of the device by highlighting corrective and preventive actions taken in response to customer complaints and audit findings. It is essential for maintaining compliance and being prepared for regulatory authority requests. Regular updates to PMSR ensure that any changes in the device or its usage are captured accurately.
Key Features of Our Post-Market Surveillance Report Services
Tailored PMSR Templates for Compliance
Tailored Post Market Surveillance Report (PMSR) templates are essential tools for ensuring compliance with EU MDR and IVDR regulations. These templates streamline the process of collecting, analyzing, and documenting post-market data for Class I medical devices and Class A and B in-vitro diagnostic devices. By customizing PMSR templates to meet specific product requirements, manufacturers can ensure they meet regulatory expectations while minimizing the risk of non-compliance. Regularly updating these tailored templates throughout the product lifecycle helps maintain the accuracy of the post-market surveillance report, ensuring that all corrective and preventive actions are properly documented and aligned with regulatory standards.
Data Analysis & Risk Assessment Reporting
Data analysis and risk assessment reporting are essential elements of Post Market Surveillance (PMSR). These processes ensure that any potential risks or issues with medical devices and in-vitro diagnostic devices (IVDs) are identified and addressed. The Post-Market Surveillance Report (PMSR) helps track product performance and identifies areas for corrective and preventive actions. Through thorough analysis, manufacturers can assess risks, improve device safety, and comply with regulatory requirements. Proper documentation and ongoing updates in the PMSR are crucial for maintaining device safety and efficacy throughout its lifecycle.
Adverse Event Monitoring & Documentation
Adverse Event Monitoring & Documentation plays a critical role in post-market surveillance for medical devices and IVDs. It involves systematic tracking and documentation of adverse events that occur after a device is placed on the market. Ensuring timely reporting and detailed documentation of these incidents is essential for updating the post-market surveillance report and enhancing patient safety. Regular monitoring helps identify trends and potential risks, guiding corrective actions to mitigate harm. Proper adverse event management is key to maintaining device quality and regulatory compliance throughout the device lifecycle.
Efficient Corrective and Preventive Actions (CAPA)
Efficient Corrective and Preventive Actions (CAPA) are essential in the post-market surveillance process, ensuring that any issues identified through customer complaints or audits are promptly addressed. A well-structured post market surveillance report format outlines the actions taken, helping manufacturers mitigate risks, improve device performance, and maintain regulatory compliance throughout the lifecycle of medical devices and in-vitro diagnostic devices (IVDs). Regularly updating the CAPA and PMSR ensures proactive risk management and enhances patient safety.
Why Choose Our PMSR Service
Compliance with Global Regulatory Requirements
Compliance with Global Regulatory Requirements is essential for manufacturers of medical devices and IVDs. Adhering to global standards ensures that devices are consistently monitored for safety and performance post-market. A comprehensive Post Market Surveillance Report (PMSR) helps demonstrate compliance with regulatory bodies worldwide. A post market surveillance report sample can serve as a valuable reference for companies to meet the rigorous requirements outlined by authorities like the EU MDR, IVDR, and others. Keeping the PMSR updated ensures continued adherence to evolving regulatory frameworks and fosters public safety.
Accurate and Data-Driven Reporting
A well-structured post market surveillance report template ensures consistency in monitoring Class I medical devices and Class A, B IVDs. By leveraging real-world data, manufacturers can identify trends, implement corrective actions, and enhance patient safety. Regular updates to PMSR support compliance with EU MDR and IVDR, ensuring transparency in post-market surveillance activities.
Our PMSR Service Process
Data Collection & Monitoring
Effective data collection and monitoring in Post Market Surveillance Reports (PMSR) ensure continuous compliance with EU MDR and IVDR. Manufacturers must systematically track adverse events, customer complaints, and non-conformities. Utilizing robust PMS plans, real-time monitoring helps identify trends, implement corrective and preventive actions (CAPA), and enhance device safety and performance.
Risk Analysis & Documentation
Risk analysis plays a crucial role in the Post-Market Surveillance Report (PMSR) by identifying potential safety concerns. Medical device manufacturers must document risk assessments, corrective actions, and non-conformities based on PMS data. Proper documentation ensures compliance with EU MDR and IVDR, reducing adverse events and strengthening device safety throughout its lifecycle.
Report Preparation & Submission
The Post Market Surveillance Report (PMSR) must be systematically prepared and updated as per the EU MDR and IVDR requirements. It should document post-market surveillance data, analysis outcomes, and any corrective and preventive actions (CAPA) taken. While submission to the Notified Body (NB) is not required, it must be readily available for Competent Authorities upon request.
Contact Us for Tailored PMSR Solution
Ensure compliance with EU MDR and IVDR by maintaining an up-to-date Post Market Surveillance Report (PMSR) for Class I medical devices and Class A & B IVDs. Our experts help you analyze PMS data, track CAPA actions, and manage non-conformities effectively. Stay audit-ready – contact us today!
