Swissmedic published the results of its 2025 market surveillance focus campaign on medical device importers on 30 January 2026. Inspections of 30 importers and 232 devices identified deficiencies in 22% of devices, with higher non-compliance among legacy MDD devices than MDR devices. Key issues included importer labelling, product verification, and storage and transport conditions, highlighting the continued need for compliance improvements.
On 30 January 2026, Swissmedic published the results of its 2025 market surveillance focus campaign targeting importers of medical devices in Switzerland. The campaign evaluated importer compliance through inspections of 30 importers and the review of 232 medical device samples, assessing how effectively importer obligations are being implemented under the Swiss regulatory framework aligned with the EU MDR.
The results indicate only minor improvements compared to the 2023 focus campaign, showing that importer compliance remains an area requiring continued regulatory attention.
Swissmedic’s inspections focused on core importer responsibilities, including formal product verification, correct importer identification, and appropriate storage and transport conditions. The campaign covered a broad range of device types and regulatory statuses to reflect real-world market conditions.
Of the 232 devices reviewed, more than half were still legacy devices placed on the market under the former Medical Devices Directive (MDD), while the remainder were MDR-compliant devices.
Swissmedic reported that 57% of the devices reviewed were legacy “MDD” devices, while 43% were “MDR” devices. Although MDR devices demonstrated better overall compliance, the authority noted that the difference between the two groups remains relatively modest.
This finding suggests that while the MDR framework is having a positive impact, importer processes are not yet consistently robust across all product categories.
Overall, Swissmedic identified deficiencies in 22% of the devices reviewed. Non-compliance was more common among legacy devices, where approximately one quarter showed deficiencies. In contrast, around one sixth of MDR devices were found to have compliance issues.
These deficiencies were not isolated incidents but reflected recurring gaps in importer controls and verification practices.
At the importer level, Swissmedic observed that more than half of the inspected importers had deficiencies related to at least one of the following areas:
Notably, 30% of importers were unable to ensure that their importer details were correctly indicated on the device itself or on accompanying documentation. This is a critical shortcoming, as importer identification is a fundamental regulatory requirement.
Swissmedic concluded that there is an ongoing need for improvement in several key areas, particularly:
The limited progress since the 2023 focus campaign indicates that importer obligations are still not fully embedded into routine operational processes.
These findings reinforce that importers remain a priority target for market surveillance activities in Switzerland. Deficiencies in importer obligations may result in increased inspections, corrective actions, or enforcement measures, especially for legacy MDD devices that continue to be placed on the market.
Swissmedic’s results suggest that authorities will continue to closely scrutinise importer compliance as part of ongoing market surveillance.
In response to the findings, importers should:
Proactive corrective actions can significantly reduce regulatory risk during future Swissmedic inspections.
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