Explore the medical device requirements currently available for Switzerland, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Route Dependent
No generic Swiss product-licence expiry for ordinary CE-conforming devices; conformity-assessment certificate validity and legacy transitions apply separately.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Device/actor/mandate database changes are not the same as notified-body significant change.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Manufacturer Mandated Authorized Representative
Swiss Authorized Representative (CH-REP)
Yes For Foreign Manufacturer
Registers Mandated Devices And Represents Manufacturer
Separate Registered Actor Links To Device
Separate Supply Chain Role
May Combine If Each Role Is Registered And Fulfilled
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Swissdamed Mandate Transfer
No Generic Fresh Conformity Assessment
Swissdamed supports mandate transfer; importers link themselves to already registered devices and do not register devices.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
