A Proactive and Systematic Process
Manufacturers must mitigate the risks associated with their medical devices in their risk management to help ensure safety and performance, which serves the overarching goal of patient safety.
In the phase after a product has been placed on the market, further risks may arise (e.g. in daily use by professional or in a real-life population). With PMS, these risks must be identified proactively and systematically in practical use. Moreover, the performance of the product and previously unrecorded product safety issues must be recognized, and thus risk mitigation measures can be applied accordingly (risk management).
A key piece of the PMS is the Post-Market Clinical Follow-up (PMCF) for MDs and the Post-Market Performance Follow-up (PMPF) for IVDs, where manufacturers must systematically record and evaluate clinical data regarding the safety and performance of their product.
Additionally, a new position introduced by the regulations is the `Person responsible for Regulatory Compliance´ (PRRC). This position is responsible for compliance with the PMS process, among other obligations and is relevant for all manufacturers.
Kalms Regulatory team offers support in the development of a suitable PMS strategy, setup of a PMS-Plan, CRO pre-selection for PMCF-/PMPF studies planning and setup, creation of required reports like the Post Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP), Manufacturer Incident report (MIR), Periodic Summary reports, Trend reports and Flied Safety Corrective Actions and Notice (FSCA).