Since 26 May 2021, manufacturers of class I medical devices must comply with the Swiss Medical Device Ordinance (MedDO). As part of market surveillance activities, Swissmedic continuously inspects manufacturers to assess conformity with the applicable regulatory requirements. In March 2023, the Swiss Competent Authority published the results of inspections conducted in Switzerland between August and December 2022. These inspections focused on class I devices as part of a campaign to investigate medical devices exempted from third-party assessments, namely lowest risk devices.
Post-market requirements: PMS plan and report
According to the Swiss Ordinance, medical devices are subject to post-market surveillance. The manufacturer must track and react to incidents involving the devices, mitigate complaints, and verify that no unexpected risks occur. In this sense, manufacturers must draw up a post-market surveillance (PMS) plan for each device on the market and collect the related data in the PMS report.
Inspections’ results: non-conformities among class I manufacturers
The Swissmedic inspections have revealed that class I medical devices are not sufficiently implementing MedDO requirements. Especially, about 70% of post-market surveillance documentation under scrutiny did not meet the legal requirements, and manufacturers could not demonstrate adequate surveillance of their devices on the market. Additionally. the inspections have shown non-conformities also in regard to registration obligations and proof of compliance with the Swiss or EU legislation (updated Declaration of Conformity).
Market surveillance and registration obligation
Swissmedic announced they would continue focussing on class I medical devices’ inspections. Together with adequate technical documentation and PMS activities, manufacturers must fulfil registration obligations. To increase the efficiency and transparency of market surveillance activities, Swissmedic is implementing a new database: Swissdamed. While Swiss manufacturers and their devices must currently register with Swissmedic, they will register with Swissdamed once the database is fully implemented.
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