Post Marketing Clinical Followup
Post-Market Clinical Follow-up (PMCF) actively collects data on a medical device's clinical experience after market release, ranging from literature analysis to new post-market investigations. This is vital as pre-market data may not sufficiently identify rare events or represent real-world usage. PMCF is critical for detecting emerging or residual risks and confirming the device's long-term safety and performance. By continuously assessing clinical data through PMCF, manufacturers can proactively address any remaining risks, ensuring enhanced risk management throughout the device's lifecycle.
PMCF Services
PMCF Survey Plan
Clinical investigations aren't the sole method for clinical data collection. Post-market clinical follow-up (PMCF) surveys can address data gaps and serve as valuable tools. User surveys, gathering user feedback, are considered valid for post-market data collection as per MDR. PMCF surveys can be entirely remote, eliminating the necessity for onsite visits to hospitals and no need for direct patient contact.
Endpoints & Residual Risk determination
In PMCF of medical devices, establishing endpoints, as the specific outcomes or measurements to evaluate the device's performance, safety, and effectiveness, is crucial.
Residual risk determination in PMCF involves assessing any potential risks that may still exist even after the device has been granted regulatory approval.
​
Summary of Safety and Clinical Performance
Under MDR, the Summary of Safety and Clinical Performance (SSCP) is pivotal. It centralizes safety and performance data for class IIb and III devices, ensuring transparency, informed healthcare decisions, and continuous oversight throughout a device's lifecycle.
