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SwissDaMed is Switzerland’s Database on Medical Devices. It is a Swissmedic database for registering economic operators and medical devices, including in vitro diagnostic medical devices, on the Swiss market.
Based on the following roadmap, it is clear that XML uploads are the only method for uploading or adding data to SwissDaMed until it becomes mandatory. If the manual input forms are not in place before SwissDaMed becomes compulsory, companies will face significant issues.
Warning: The creation of XML is either going to be done via a company like ours, EirMed, or downloaded by you from EUDAMED. If you manually attempt to use the bulk download from EUDAMED, you are currently limited to 20 UDIs, and only the first 20 in the search results are supported. If your company has access to EUDAMED M2M, you can download up to 300 UDI DIs per file, resulting in multiple XML files and potentially numerous uploads to SwissDaMed. However, this feature is only available if you have M2M access for EUDAMED.
We, EirMed, offer a solution to convert all your existing EUDAMED uploads to XML format; no effort is required on your part. We even have exclusion lists if you do not want all devices made available in SwissDaMed. We prepare your XML for SwissDaMed uploads and create additional weekly or monthly uploads to ensure your data remains in sync with EUDAMED, while excluding those in the exclusion lists.
1 July 2026 Mandatory
3 – Q4 2025: Formal publication of modules
From now on, Registration is possible voluntarily.
From 1 July 2026: Registration mandatory for products placed on the market in Switzerland. Transition period until 31 December 2026.
No transitional period for products with mandatory reporting (serious incidents, FSCA, trends) – mandatory from 1 July 2026.
Swiss manufacturers, persons who assemble systems and procedure packs, and authorised representatives must register their devices or, in the case of authorised representatives, their mandated devices, as well as systems and procedure packs in the UDI Devices module of swissdamed*.
For reasons of equivalence with the European legal framework, Swissmedic has aligned the design of SwissDaMed with EUDAMED. Economic operators can largely transfer their device data prepared for EUDAMED to SwissDaMed.
Since there is no interface between SwissDaMed and EUDAMED, Swissmedic cannot import or synchronise data from EUDAMED. Swiss manufacturers, persons who assemble systems and procedure packs, and authorised representatives must actively upload device data to SwissDaMed. Currently, an XML file in EUDAMED ‘GET DEVICE’ or ‘POST DEVICE’ format can be used for this purpose. Additional upload methods, such as machine-to-machine, will be available at a later date.
Note: EirMed offers a solution to convert all your existing EUDAMED uploads to XML format; no effort is required on your part. We even have exclusion lists if you do not want all devices made available in SwissDaMed. We prepare your XML for SwissDaMed uploads and create additional weekly or monthly uploads to ensure your data remains in sync with EUDAMED, while excluding those in the exclusion lists.
Download the SwissDaMed Device Manual
The SwissDaMed system will operate in two environments: Production (current data, accessible) and Pre-Production (testing, for sponsors/manufacturers only).
The Production environment is accessible at https://swissdamed.ch/
A Playground environment is accessible at https://playground.swissdamed.ch/
The SwissDaMed home page: https://swissdamed.ch/
At EudaMed.com, we can assist you with all your SwissDaMed needs, from M2M and automated uploads to weekly or monthly syncing with EUDAMED, as well as providing general advice on the requirements. We continue to grow, SwissDaMed, EUDAMED, GUDID, and AusUDID, and more to come. We can give you as much assistance as you need. SwissDaMed, AusUDID, EUDAMED, and regulatory submissions are our speciality; let our experts alleviate your submission challenges.
Contact us to see how our services can benefit you.
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