EU PMS Field Safety Corrective Action (FSCA) Reporting
In the European Union, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) are mandatory requirements for medical device manufacturers. PMS and PMCF are ongoing processes designed to monitor the safety and performance of medical devices throughout their lifecycle.
As part of these requirements, manufacturers must report certain events related to their devices to the competent authorities. These events include serious incidents, including deaths or serious injuries, which may be related to the device. The reporting of such events is referred to as Field Safety Corrective Action (FSCA) reporting.
The FSCA reporting requirements are outlined in the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). Under these regulations, manufacturers must report incidents that occur within their territory or involve their devices, regardless of where they occur.
Manufacturers must also report incidents that occur outside the EU if the device has been placed on the market in the EU and the manufacturer is aware of the incident. Reports must be submitted within specific timeframes based on the severity of the event.
The competent authorities in each EU member state are responsible for receiving and reviewing FSCA reports. They may also take action to address any safety issues identified in the reports, such as requiring the manufacturer to take corrective actions or issuing a product recall.