As companies review their technical files in preparation for the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), many are seeking to complete Post-Market Clinical Follow-Up (PMCF) studies.
Gordon MacFarlane, PhD, RAC
In the rush to set up and complete PMCF studies, some manufacturers skip a critical step in the planning process ─ to identify the study objective.
This is an important question because if the study is to provide basic supporting clinical evidence, then it is likely to be more extensive (and thus more resource intensive and expensive) than a study designed to address a specific residual risk. Rather than completing a study to check off the PMCF box and hope that prepared you for the MDR transition, we recommend a more targeted approach. The figure below outlines a process for clinical evidence assessment to help guide study development.
Clinical Evidence Assessment Process
If for example, the device CE Mark under the MDD was based on equivalence, it may be necessary to conduct clinical validation studies to demonstrate the performance of the device consistent with the Intended Purpose and product claims. Each of the indications for use or product claims should be supported with clinical data.
For PMCF studies, one would review the safety and performance data from surveillance activities, such as adverse event reports, recalls, and user complaints. The data generated from these activities are used to inform the product risk analysis. The updated risk analysis is then applied to amend the residual risks associated with the product. The revised residual risks will then generate an updated list of unanswered questions of safety or performance which can then be evaluated for an appropriate plan for either clinical investigation or mitigation. Note that not all questions may require a clinical investigation to resolve. At the end of this process, if there are no unanswered questions of safety or performance, then a simple justification can be written to identify why a PMCF study is not warranted. The time and resource investment to complete this exercise can potentially save a company significant time and expense in their MDR transition process.
If you need any assistance with your Post-Market Clinical Follow-Up (PMCF) study or implementing the new guidance, please contact us today.