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. Further upload methods, for example machine-to-machine, will be possible at a later date.
In the Swiss legal system, the date for the start of the device registration obligation is defined in Art. 17 para. 5 MedDO and Art. 16 para. 5 IvDO (AS 2024 742 - Ordinance on In Vitro Diagnostic | Fedlex). Swissmedic is aware of the further postponement of the applicability of the device registration obligation in the EU and is closely monitoring the development of the corresponding timelines.
MF= Manufacturer (Swiss manufacturer according to Art. 4. para. 1 let. f MedDO / Art. 4. para. 1 let. e IvDO)
AR= Authorised representative (according to Art. 4 para. 1 let. g MedDO / Art. 4. para. 1 let. f IvDO)
PR = System and procedure pack producer (natural and legal person who assembles systems and procedure packs according to Art. 11 MedDO)
IM = Importer according to Art. 4 para. 1 let. h MedDO / Art. 4. para. 1 let. g IvDO
As of 1 July 2026, all devices, systems and procedure packs that are placed on the market in Switzerland from this date must be registered in the swissdamed UDI Devices module.
The registration obligation applies to devices under the existing legislation (MedDO, IvDO) and to devices under the old legislation according to Art. 101 MedDO and Art. 82 IvDO (“legacy devices”), which continue to be placed on the market at the time the registration obligation enters into force.
Devices, systems or procedure packs that are placed on the market after the entry into force of the registration obligation on 1 July 2026:
Devices, systems and procedure packs that were placed on the market before the entry into force of the registration obligation on 1 July 2026 and continue to be placed on the market after the transitional period (31 December 2026):
The registration process shall be in accordance with the provisions of Art. 17 para. 5 MedDO and Art. 16 para. 5 IvDO (AS 2024 742 - Ordinance on In Vitro Diagnostic | Fedlex), which enter into force on 1 July 2026.
* Exception: Immediate registration without a transitional period will apply from 1 July 2026 for devices and systems and procedure packs for which a serious incident, field safety corrective action or trend must be reported to Swissmedic.
In general, all device data registered in swissdamed can be viewed by the public.
Importers do not register devices in swissdamed. According to Art. 53 para. 4 MedDO in conjunction with Art. 13 para. 4 EU-MDR and Art. 46 para. 4 IvDO in conjunction with Art. 13 para. 4 EU-IVDR, they are required to add their own data to a registered device that they place on the market. This is done by linking their actor with the relevant data in swissdamed. The link function for importers is not available at this time. Swissmedic will announce the introduction and mandatory use of the link function when it becomes available.
All information on functions and procedures is described in the User Guide UDI Devices. Further information is published in the technical documentation.
As of 1 July 2026, devices, systems and procedure packs placed on the market in Switzerland must be registered in swissdamed. Voluntary registration is already possible before this date and enables economic operators to familiarise themselves with the database in advance.
Swissmedic levies fees for the licences, controls and services that it provides (Art. 65 TPA). After the registration obligation enters into force, a one-time fee will be charged for registering devices in swissdamed. According to current planning, the first invoicing of the registration fee, for those devices registered in swissdamed by the end of 2026, will take pace in January 2027. Additional information will be available at a later time.
Devices with certificates for the assessment of the Technical Documentation or the type examination
The device data for high-risk devices covered by a certificate for the type examination or for the assessment of the technical documentation (for devices according to Art. 29 para. 3 EU-MDR or Art. 26 para. 2 EU-IVDR) must be confirmed by the notified body before the device can be viewed by the public and the XML file can be downloaded from EUDAMED.
Due to the longer transitional periods for the confirmation by the notified bodies according to Art. 123 para. 3 let. ea EU-MDR, Swissmedic will align the enforcement of the registration obligation for these devices under therapeutic products legislation with this transitional period.
Contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles with a Master UDI-DI
The assignment of a Master UDI-DI for contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles is not yet compulsory. These medical devices cannot be registered in swissdamed at this time. Swissmedic will introduce functions for registering the Master UDI-DI at a later date and announce the relevant timelines. Corresponding ("legacy") contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles according to Art. 101 MedDO without a Master UDI-DI will not be registered in swissdamed.
*The information below describes the obligations and transitional provisions applicable to economic operators established in Switzerland and to devices that are made available on the market in Switzerland.
Due to the customs treaty1 between Switzerland and Liechtenstein, the terms “established in Switzerland” and “on the market in Switzerland” refer to the common market of Switzerland and Liechtenstein (customs union) if the devices are placed on the market based on MedDO/IvDO2.
1 Treaty between Switzerland and Liechtenstein on the Accession of the Principality of Liechtenstein to the Swiss Customs Area (SR 0.631.112.514)
2 Due to the EEA agreement and the Liechtenstein-Switzerland customs treaty, two legal systems apply in parallel to medical devices in Liechtenstein. Medical devices can either be placed on the market based on MDR/IVDR or on MedDO/IvDO. The Switzerland/Liechtenstein common market relates only to placing on the market according to MedDO/IvDO. A placement on the market in Switzerland according to MDR/IVDR only is not contemplated.
