As per EU MDR and IVDR, PMSR shall be prepared for 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.
Manufacturers of class IIa, class IIb and class III medical devices as well as class C and Class D IVD devices shall prepare a Periodic Safety Update Report (PSUR) by summarizing the results and conclusions of the analyses of the Post-Market Surveillance (PMS) data gathered as a result of the Post-Market Surveillance plan together with a rationale and description of any preventive and corrective actions taken. Periodic Safety Update Report (PSUR) shall be a part of technical documentation for all the categories mentioned above but not for custom-made devices.
Throughout the lifetime of the device, the Periodic Safety Update Report (PSUR) should be updated with the following aspects:
Role of consultant in writing PSUR
We, Maven Profcon Services LLP will take upon the Post-Market Surveillance activities upon request, including Periodic Safety Update Report and Post Market Surveillance Report!!!
How to write a Periodic Safety Update Report for Medical & IVD devices
Writing a Periodic Safety Update Report (PSUR) for medical devices and in vitro diagnostic (IVD) devices involves compiling and analyzing post-market surveillance data to provide an overview of the safety and performance of the device. While the specific requirements and format may vary based on regulatory guidelines and regional standards, here is a general outline of the steps you can follow to write a PSUR for medical and IVD devices:
Understand Regulatory Requirements:
Familiarize yourself with the specific regulatory requirements for PSURs in your region, whether it’s under the European Union’s Medical Device Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR), or other relevant regulations. Ensure that you have a clear understanding of what needs to be included in the report and the reporting frequency.
Gather Post-Market Surveillance Data:
Collect relevant post-market surveillance data, including information on adverse events, complaints, clinical investigations, field safety corrective actions (recalls), post-market clinical follow-up (PMCF) studies, and any other safety-related data. Ensure that you have comprehensive and up-to-date data for the reporting period.
Analyze Data:
Analyze the collected data to identify trends, patterns, and potential safety concerns. Evaluate the device’s benefit-risk profile based on the available data. Assess the impact of any corrective or preventive actions taken during the reporting period.
Prepare the Report:
Organize the report based on the regulatory requirements and guidelines. Include the following sections:
- Executive Summary: Provide a concise overview of the main findings, conclusions, and actions taken during the reporting period.
- Introduction: Introduce the device and provide context for the report.
- Device Description: Describe the device’s intended use, design, and specifications.
- Post-Market Surveillance Methodology: Explain the methods used to collect and analyze post-market surveillance data.
- Adverse Event Data: Present adverse event data, including a summary of reported events, severity, outcomes, and any changes in reporting trends.
- Benefit-Risk Assessment: Evaluate the device’s benefit-risk balance based on the post-market data, clinical experience, and other available information.
- Field Safety Corrective Actions: Detail any recalls, field safety corrective actions, or other measures taken to address safety issues.
- Post-Market Clinical Follow-Up (PMCF): Include the results of any PMCF studies conducted during the reporting period.
- Conclusions and Recommendations: Summarize the main findings, highlight significant safety concerns, and provide recommendations for any necessary actions or changes.
- References: Cite relevant scientific literature, guidance documents, and regulations that support your analysis.
Review and Approval:
Have the PSUR reviewed by cross-functional teams, including regulatory affairs, quality assurance, clinical affairs, and other relevant departments. Ensure that the report is accurate, comprehensive, and aligned with the regulatory requirements.
Submission:
If required by regulatory authorities, submit the PSUR within the specified timeframe and through the appropriate channels. Follow the submission procedures outlined in the regulations.
Remember, writing a Periodic safety update report (PSUR) requires a thorough understanding of the device, its post-market performance, and the applicable regulatory framework. It’s advisable to work closely with regulatory experts and professionals familiar with post-market surveillance to ensure that your report meets all the necessary requirements and accurately reflects the safety and performance of your medical or IVD device.
