MDCG 2024-2: Process & Timing to Add, Amend, Obsolete New EMDN Codes
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New Association Formed in the UK: Team Approved Body (“Team AB”)
February 21, 2024Swissmedic published an update to the Swissdamed launch date.
Background
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 Updated Timing
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:
- Economic Operator module now available “in the 2nd half of 2024”.
- The Medical Device module to follow “4 months after” the Economic Operator module goes live.
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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