Swissmedic, the Agency for Therapeutic Products in Switzerland, just published the results of their recent market surveillance activities. The overview published on 17 February 2025 concerns Swissmedic assessment of post-market surveillance documentation of medical devices.
MedDO requirements on post-market surveillance apply from 26 May 2021. Nonetheless, the recent findings pointed out that manufacturers are not adequately implementing the Medical Devices Ordinance (MedDO) requirements.
Swissmedic assessment of medical devices post-market surveillance
Manufacturers must monitor their medical devices after the launch to identify trends that emerge over time. They must establish a post-market surveillance system, create surveillance plans, and document findings in their safety reports.
Swissmedic selected a sample of 30 high-risk legacy devices (class IIa and higher) on Swiss market, with 28 devices from foreign manufacturers. Non-conformities were found in 20 out of 30 cases, totaling 85 non-conformities across multiple MedDO articles.
Main non-conformities with PMS requirements
With regard to safety reports, the data show that the most common non-conformities concern:
- Estimate of population size using the device
- Characteristics of the population using the device
- Frequency of device usage
- Conclusions of analyses according to the PMS plan
Other non-conformities found in the safety reports that should have been covered: frequency of update, total sales volume of the device, CAPAs, and PMCF findings.
Swissmedic states to follow up on the rectification of the non-conformities and impose additional measures. Manufacturers are required to review their post-market surveillance processes and documentation against the MedDO requirements.
How to sell legacy devices in Switzerland
Switzerland aligns with the EU extensions for legacy medical devices and IVDs. If a manufacturer filed an MDR or IVDR application with a notified body and have a compliant Quality Management System (QMS) according to the deadlines, Switzerland recognises the extended legacy period.
Is your PMS documentation compliant with Swiss requirements? Ask your questions here.
Simona Varrella
Regulatory Intelligence & Innovation
17/02/2025
Reference:
Swissmedic (2025). Medical Devices – Swissmedic assessment of post-market surveillance documentation. Retrieved on 17/02/2025.
Fedlex (2020). Medical Devices Ordinance. Retrieved on 17/02/2025.
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