swissdamed is the new Swissmedic database for registering economic operators and medical devices, including in vitro diagnostic medical devices, on the Swiss market.
The new medical devices platform "swissdamed" will be introduced gradually from 6 August 2024. swissdamed is being rolled out in phases. The first release of the "Actors" module enables economic operators to register online.
Economic operators who had already registered with Swissmedic before swissdamed became available have been informed about the next steps via the contact person provided. swissdamed aims to provide an overview of the medical devices, including in vitro diagnostic medical devices, available on the Swiss market and the economic operators responsible for them. In future, the database will gather, process and publish information about medical devices and the companies concerned (e.g. manufacturers). swissdamed will increase transparency by improving the access to information by the public and healthcare professionals.
swissdamed consists of two modules ("Actors" module and "Devices" module) and a public website. For the registration of economic operators with immediate effect and, over the course of 2025, certain medical devices (voluntary registration). In order to preserve equivalence between the Swiss and EU regulations and minimise the effort for economic operators, swissdamed resembles the corresponding modules of the European database EUDAMED.
The second module "Devices" will go live in several phases: after the first release in 2025, it will be possible to register certain devices, specifically "Regulation Devices" (MDR and IVDR), which will be uploaded using XML files in the EUDAMED format. Subsequent releases will complete the Devices module.
Device registration will become mandatory only when swissdamed has been sufficiently developed and relevant amendments have been made to the MedDO / IvDO.
Please refer to the link below for more information.
swissdamed – swiss database on medical devices (swissmedic.ch)
swissdamed – swiss database on medical devices
The first module of the swissdamed medical devices database is online today.
www.swissmedic.ch
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