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‘swissdamed’ Actor Registration Module: Live Starting Today

6 August 2024

The swissdamed Actor registration module went live on 6 August 2024, and its use is now mandatory.

Only Swiss-based economic operators have access to register in the Actor module, i.e., if you are a non-Swiss based manufacturer, your Swiss Authorized Representative must enter your company details into swissdamed on your behalf.

Swissdamed was developed because of the lapsed Mutual Recognition Agreement between Europe and Switzerland. As a result, Swissmedic no longer has Competent Authority access to EUDAMED and developed its own equivalent to EUDAMED.

This is the first of two swissdamed modules under development: 1) Actors & 2) Devices

More information is available here.

Details

Organizer

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Legislation
Swiss MedDO, Swiss IvDO
Region
Switzerland