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.\u00a0![\"swissdamed](\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank\/_jcr_content\/par\/columncontrols\/items\/0\/column\/image\/image.imagespooler.png\/1754637022691\/2_EN_Grafik_Roadmap.png\" "\\"EUDAMED\\"")
<\/p>\r\n
SwissDaMed\u00a0 <\/strong>Key Dates vs. EUDAMED<\/h3>\r\n\r\n\r\n\r\nSystem<\/strong><\/th>\r\nKey Date in 2025<\/strong><\/th>\r\nKey Date in 2026<\/strong><\/th>\r\nNotes<\/strong><\/th>\r\n<\/tr>\r\n<\/thead>\r\n\r\n\r\n\u00a0SwissDaMed\u00a0\u00a0<\/strong><\/td>\r\n\u00a0August 2025: Devices module is\u00a0 live for XML only uploads<\/td>\r\n \r\n1 July 2026 Mandatory<\/p>\r\n<\/td>\r\n
A transitional period, lasting until the end of 2026, applies to most products.
There is\u00a0no transitional period\u00a0for products with a\u00a0reporting obligation\u00a0(serious incidents,\u00a0FSCA,\u00a0trends) \u2013 the registration obligation\u00a0will apply from 1 July 2026.<\/td>\r\n<\/tr>\r\n \r\n\u00a0EUDAMED\u00a0<\/strong><\/td>\r\n\r\n\u00a03 – Q4 2025: Formal publication of modules<\/p>\r\n<\/td>\r\n
\u00a0Q2 – Q3 2026: Mandatory use of published modules begins<\/td>\r\n \u00a0Gradual rollout, with full functionality targeted for 2027; modules published between January and September 2025.<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\nImportant dates & transitional arrangements<\/h3>\r\n\r\n- \r\n
From now on,\u00a0Registration is possible\u00a0voluntarily.<\/span><\/p>\r\n<\/li>\r\n- \r\n
From 1 July 2026:\u00a0Registration\u00a0mandatory\u00a0for products placed on the market in Switzerland.\u00a0Transition period\u00a0until\u00a031 December 2026.<\/p>\r\n<\/li>\r\n
- \r\n
No transitional period\u00a0for products with\u00a0mandatory reporting\u00a0(serious incidents,\u00a0FSCA,\u00a0trends) \u2013\u00a0mandatory from 1 July 2026.<\/p>\r\n<\/li>\r\n<\/ul>\r\n
Device Registration<\/h3>\r\n
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*.<\/p>\r\n
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.<\/p>\r\n
![\"Data](\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/medizinprodukte-datenbank\/produktregistrierung\/_jcr_content\/par\/image\/image.imagespooler.png\/1754647791375\/3_DE_Grafik_Data%20Elements.png\" "\\"EUDAMED\\"")
<\/p>\r\n
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.<\/p>\r\n
Note:<\/strong> 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.\u00a0<\/p>\r\nDownload the SwissDaMed Device Manual<\/a>\u00a0<\/p>\r\nSwissDaMed Environments<\/h3>\r\n
The SwissDaMed system will operate in two environments: Production (current data, accessible) and Pre-Production (testing, for sponsors\/manufacturers only).<\/p>\r\n
The Production environment is accessible at https:\/\/swissdamed.ch\/<\/a>\u00a0<\/p>\r\nA Playground environment is accessible at https:\/\/playground.swissdamed.ch\/<\/a><\/p>\r\n
1 July 2026 Mandatory<\/p>\r\n<\/td>\r\n
There is\u00a0no transitional period\u00a0for products with a\u00a0reporting obligation\u00a0(serious incidents,\u00a0FSCA,\u00a0trends) \u2013 the registration obligation\u00a0will apply from 1 July 2026.<\/td>\r\n<\/tr>\r\n
\u00a03 – Q4 2025: Formal publication of modules<\/p>\r\n<\/td>\r\n
Important dates & transitional arrangements<\/h3>\r\n\r\n- \r\n
From now on,\u00a0Registration is possible\u00a0voluntarily.<\/span><\/p>\r\n<\/li>\r\n- \r\n
From 1 July 2026:\u00a0Registration\u00a0mandatory\u00a0for products placed on the market in Switzerland.\u00a0Transition period\u00a0until\u00a031 December 2026.<\/p>\r\n<\/li>\r\n
- \r\n
No transitional period\u00a0for products with\u00a0mandatory reporting\u00a0(serious incidents,\u00a0FSCA,\u00a0trends) \u2013\u00a0mandatory from 1 July 2026.<\/p>\r\n<\/li>\r\n<\/ul>\r\n
Device Registration<\/h3>\r\n
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*.<\/p>\r\n
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.<\/p>\r\n
<\/p>\r\n
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.<\/p>\r\n
Note:<\/strong> 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.\u00a0<\/p>\r\nDownload the SwissDaMed Device Manual<\/a>\u00a0<\/p>\r\nSwissDaMed Environments<\/h3>\r\n
The SwissDaMed system will operate in two environments: Production (current data, accessible) and Pre-Production (testing, for sponsors\/manufacturers only).<\/p>\r\n
The Production environment is accessible at https:\/\/swissdamed.ch\/<\/a>\u00a0<\/p>\r\nA Playground environment is accessible at https:\/\/playground.swissdamed.ch\/<\/a><\/p>\r\n
From now on,\u00a0Registration is possible\u00a0voluntarily.<\/span><\/p>\r\n<\/li>\r\n From 1 July 2026:\u00a0Registration\u00a0mandatory\u00a0for products placed on the market in Switzerland.\u00a0Transition period\u00a0until\u00a031 December 2026.<\/p>\r\n<\/li>\r\n No transitional period\u00a0for products with\u00a0mandatory reporting\u00a0(serious incidents,\u00a0FSCA,\u00a0trends) \u2013\u00a0mandatory from 1 July 2026.<\/p>\r\n<\/li>\r\n<\/ul>\r\n 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*.<\/p>\r\n 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.<\/p>\r\n 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.<\/p>\r\n Note:<\/strong> 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.\u00a0<\/p>\r\n Download the SwissDaMed Device Manual<\/a>\u00a0<\/p>\r\n The SwissDaMed system will operate in two environments: Production (current data, accessible) and Pre-Production (testing, for sponsors\/manufacturers only).<\/p>\r\n The Production environment is accessible at https:\/\/swissdamed.ch\/<\/a>\u00a0<\/p>\r\n A Playground environment is accessible at https:\/\/playground.swissdamed.ch\/<\/a><\/p>\r\nDevice Registration<\/h3>\r\n
<\/p>\r\nSwissDaMed Environments<\/h3>\r\n