The Swiss medical device database – swissdamed has gone live this month and actor registrations are open for Swiss entities. For foreign manufacturers to be associated with their CH-REPs, Swissmedic recommends including mandates in the swissdamed system as soon as possible, even though it is not yet mandatory. This early mandate registration will ensure a smoother transition when the ‘Devices’ module becomes available in 2025. The registration of the mandates by the CH-REP is a prerequisite for future device registrations.
Starting in 2025, the ‘Devices’ module registration will become available for certain devices, more specifically ‘Regulation Devices’ (MDR and IVDR). Preparing now will help you stay ahead of the curve and avoid potential disruptions.
Don’t miss the opportunity to be among the first to have your mandate listed in the public database. Contact us today!