Keeping the PMCF documents aligned with the rest of the file
The PMCF plan and report repeat content from the clinical evaluation report, usually follow its revision cycle, and can lead to updates of the summary of safety and clinical performance, the periodic safety update report, the risk management documentation and the post-market surveillance plan. Keeping them aligned depends on how much content they share with the clinical evaluation report, what sets the revision interval, and where the PMCF report sits among the other post-market documents.
Content repeated between the PMCF documents and the clinical evaluation report
Copying sections of the clinical evaluation report into the PMCF plan and report, rather than only summarising them, is easier where it is possible, for instance with parts of the conclusion or the risk-benefit section. One experienced writer holds that it can sometimes be better to keep it simple and focus on the clinical evaluation report's conclusion with regard to the PMCF plan, and in that writer's practice the plan only includes a statement of whether that report concluded that PMCF is needed, with the reason outlined, and copying sections across is avoided where possible.
The first two sections of the report template, the manufacturer contact details and the medical device description and specification, are equivalent to those already in the plan. The first sections of the plan and report templates require repeating much of the sections describing the device, the target users and the like, and this repetition may make it harder to keep every document aligned when one of them changes. One experienced writer holds that this is a problem not only with PMCF plans and reports but with most of the MDR documentation. In that writer's experience the repetition, with a lot of copy-and-paste work, is required, because the documents should be seen as standalone documents: merely referring to other documents is not wanted, and the section itself should be included. Repetition can lead to copy-and-paste errors, and how to align the whole documentation has to be thought through, a problem that often arises when there is a small change, for example in the wording of one document.
How much detail the PMCF report should provide remains a matter of debate. Repeating the information from the PMCF report one by one in the clinical evaluation report seems unnecessary. Some manufacturers only summarise the results of the literature searches, surveys and other PMCF activities in the PMCF report and analyse them in more detail in the clinical evaluation report. That can duplicate effort, especially when the clinical evaluation report is not written immediately after the PMCF report, so a complete analysis and appraisal in the PMCF report with a summary of the results in the clinical evaluation report might be the better choice. The results of the PMCF activities need to be presented in the PMCF report without duplicating the information that will later be presented in the clinical evaluation report.
The revision cycle
The PMCF plan and report are usually revised on the clinical evaluation report's schedule, which is itself usually aligned with the device classification: every five years for class I devices, annually for class III and implantable devices, and every two years for the other devices. A revision outside that cycle can also be considered when there is new information that should be included. In one experienced writer's view, aligning the revision schedule of the PMCF plan and reports with the documents related to established PMCF activities makes things a little easier. Those documents include, as that writer sees it, the clinical evaluation report, but maybe also the risk management documentation and the post-market surveillance activities.
It is important to schedule the PMCF report so that its results and conclusions are available for inclusion in the documents its conclusions are used to update. This requires careful planning for class III devices, whose clinical evaluation report is updated annually.
The PMCF report among the other post-market documents
The PMCF report is part of the clinical evaluation report and the technical documentation. The results of the PMCF activities potentially affect other documents, such as the clinical evaluation report, the risk management file and, if applicable, the summary of safety and clinical performance. The conclusions of the PMCF report are used to update the clinical evaluation, the risk management documentation, the post-market surveillance plan and, if applicable, the summary of safety and clinical performance.
The PMCF report should be evaluated in the clinical evaluation report, which has to conclude whether the technical documentation needs updating, including the summary of safety and clinical performance if applicable to the device. Where a PMCF activity concludes that the clinical evaluation report needs updating, and the clinical evaluation report concludes that the technical documentation needs updating, the summary of safety and clinical performance and the periodic safety update report also have to be updated, and for non-implantable devices the post-market surveillance plan as well. One experienced writer holds that the periodic safety update report should be aligned with the summary of safety and clinical performance.
The periodic safety update report, issued by the manufacturer at defined intervals, provides PMCF data. Its specific requirements include the main findings of the PMCF activities, such as specific literature, hospital registries, patient databases, specific clinical customer surveys and PMCF studies. The PMCF report may be referred to in the periodic safety update report, but enough detail should be given in the periodic safety update report itself.