Medical Device Post-Market Surveillance and PSUR Planning
Post-market surveillance turns information from device use into decisions about safety, performance and the quality system. A periodic safety update report is one reporting output for devices to which the relevant requirement applies. Establish the information flow before choosing the report format.
Build a usable collection and review process
Identify the sources available to your organization, such as complaints, service experience, literature and clinical follow-up. Define collection frequency, responsibilities and how records are linked to the product or family. Use consistent definitions so changes in coding or exposure do not masquerade as changes in performance.
Connect analysis with action
Review information for new risks, changes in known risks and evidence relevant to existing conclusions. Route individual reportability questions promptly through the reporting process. Record whether findings call for investigation, CAPA, updated clinical evaluation or changed surveillance activities. Where a PSUR is required, organize the relevant period’s data and analysis around justified conclusions, not a raw compilation of numbers.
Practical checklist
Identify products, markets and applicable reporting outputs.
Define data sources and collection owners.
Document coding and exposure measures.
Assess findings and escalation needs.
Record conclusions and resulting actions.
Example
A higher complaint count after sales double may mean something different from the same increase with stable sales. Examine event severity, timing and relevant exposure before interpreting the trend; an important individual event still needs prompt assessment.
Common mistakes
Avoid assuming every device has the same PSUR obligation or update interval. Determine the applicable requirements from device classification and the current regulatory framework, and document the rationale.
Choose the relevant A.P. Lyon documents
Use the PMS procedure to organize collection, evaluation and links to risk management, clinical evaluation and quality action.
Use the PSUR procedure and reporting documents when preparing the applicable periodic safety update output.
Review the product page, document previews and any content list before choosing. Adapt the selected documents to your device, processes and applicable requirements; the organization must generate and review its own implementation evidence.
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