Swissmedic published an update to the Swissdamed launch date.
As reported previously, Swissmedic is launching a new registration database called ‘swissdamed’. It will house Economic Operator and medical device information.
The reason it is necessary is because of the lapsed Mutual Recognition Agreement between Europe and Switzerland, for medical devices. As a result, Swissmedic no longer has Competent Authority access to EUDAMED. Therefore, a Swiss equivalent to EUDAMED is being developed.
The Swissdamed Economic Operator module was supposed to be available in early 2024, with the Medical Device module becoming available in the summer of 2024.
However, Swissmedic published new release dates, postponing its launch. The new timing is:
The reason cited is related to the continued development of IT infrastructure. Until then, swissdamed will be delayed.
As a reminder, in addition to swissdamed going live, the Medical Device & IVD Ordinances must be updated, in order to make its use mandatory.
Until then, manufacturers should continue to follow the current registration requirements.
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