Primary source: Registration fee
The introduction of mandatory registration in swissdamed from 1 July 2026 replaces prior notification procedures for medical devices and IVDs.
This regulatory change enhances market surveillance and ensures that medical devices comply with safety standards before entering the market.
Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Introduction of mandatory device registration in the swissdamed UDI Devices module; replacement of class I notifications; immediate registration required for vigilance-reportable incidents.
MAHs and manufacturers must use swissdamed for device registration and vigilance-related reporting (incidents, FSCAs, trends) from 1 July 2026 without a transitional period.
Manufacturers must adapt their processes to ensure registration before market placement.
Mandatory registration of medical devices in swissdamed
Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.
From 1 July 2026, all medical devices and in vitro diagnostic medical devices must be registered in the swissdamed UDI Devices module. A transitional period allows for registration until 31 December 2026 for most devices, while immediate registration is required for incidents reportable to Swissmedic. The new rules replace class I notifications and introduce a fee structure for registrations. Fees include CHF 200 for the first device and CHF 20 for additional devices, with a maximum of CHF 10,000 charged annually per manufacturer.
What changed: The introduction of mandatory registration in swissdamed from 1 July 2026 replaces prior notification procedures for medical devices and IVDs.
Why it matters: This regulatory change enhances market surveillance and ensures that medical devices comply with safety standards before entering the market.
Practical implication: Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.
Published from the Firecrawl policy change extraction pipeline.
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