Changes to the questions and answers and guidance document on mobile technologies
Swissmedic updated its Q&A and guidance document on mobile technologies.
Swissmedic · Switzerland
Jurisdiction
Switzerland
Switzerland regulates health products through Swissmedic, which authorises medicines and supervises medical devices. As a non-EU country it maintains its own therapeutic products law while tracking EU frameworks such as the MDR and IVDR, and changes to the mutual recognition arrangement have reshaped device market access.
Regulation
Category
Type · Breadth
Date
swissdamed: Mandatory registration of medical devices and in vitro diagnostic medical devices as of 1 July 2026
Mandatory registration of medical devices and in vitro diagnostic medical devices in the Swiss registry (swissdamed) enters into force.
Swissmedic · SwitzerlandUpdating of the information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway
Updated guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway.
Swissmedic · SwitzerlandChecklist for the inspection of medical device vigilance in hospitals
17.07.2026
Swissmedic · SwitzerlandSwissmedic hospital inspections 2025: supervision having an effect, but action still needed
Swissmedic conducted 28 inspections of medical device reprocessing, maintenance and vigilance at 26 hospitals and two service providers in 2025, identifying continued compliance gaps.
Swissmedic · Switzerland
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