What is Post Market Clinical Follow-up?
PMCF is an active collection of data on clinical experience with your device after market release. These activities can range from an analysis of data from existing device registrations to performing a new clinical investigation. European and American regulatory requirements advise medical device manufacturers to consider PMCF as part of their Post Market Surveillance Plan. Why? Because clinical data gathered in the pre-market phase may be too limited to identify rare events or incidents. Post Market Clinical Follow-up is crucial to identify new and unknown risks.
Updating your Clinical Evaluation Report (CER)
Results of the PMCF, as well as vigilance and complaints, will have to be analyzed by the medical device manufacturer and reported in an updated Clinical Evaluation Report. This way the CER will reflect the current understanding of the benefits and risk of the medical device.
Qserve can determine the PMCF strategy for your medical device and assist in factoring in marketing considerations, like country-specific reimbursement requirements. Qserve can provide CRO support for setting up PMCF clinical investigations, which are in fact run similarly to any clinical investigation project.