Swissmedic Highlights Post-Market Surveillance Obligations for Legacy Devices

The Swissmedic review focused on Periodic Safety Update Reports (PSURs). These reports are crucial for proactively identifying potential risks and ensuring continued device safety and effectiveness.

Key Findings and Implications

The Swissmedic review highlighted several key areas needing improvement among manufacturers. While the specific details of these shortcomings are outlined in the full Swissmedic report, the agency is using the review to remind manufacturers of their obligations.

EU and Swiss Regulations Demand PMS for Legacy Devices

The announcement serves as a timely reminder that both European Union (EU) regulations and Swiss regulations require manufacturers to meet comprehensive PMS requirements for Legacy Devices. Despite these devices being on the market for some time, manufacturers are not exempt from the responsibility of actively monitoring their safety and performance. This includes:

• Systematic data collection: Gathering data from various sources, including user feedback, complaints, and scientific literature.
• Proactive risk assessment: Regularly evaluating potential risks associated with the device and taking appropriate corrective actions.
• Transparent reporting: Submitting timely and accurate PSURs to regulatory authorities.

Manufacturers who fail to meet these PMS requirements risk facing regulatory action, including device recalls and market withdrawals. Swissmedic emphasizes its commitment to ensuring patient safety and will continue to actively monitor compliance with PMS regulations.

Link to the Swissmedic Report: EN_Schwerpunktaktion_PSUR-final.pdf