Device registration

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 and to minimise the cost for economic operators, 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 directly from EUDAMED. Swiss manufacturers, persons who assemble systems and procedure packs, and authorised representatives must actively upload device data to swissdamed. Swissmedic provides the following registration methods:

Online editor: manual data input via a user interface
XML upload: XML file upload in EUDAMED “GET DEVICE” or “POST DEVICE” format
Machine to machine: direct data exchange through an interface using a REST API in a JSON format

The registration method chosen by actors should be determined by their experience with EUDAMED medical device registration. Using M2M is only advised if the actor has extensive IT expertise or is working with an experienced provider who has this expertise. If medical devices are already registered in EUDAMED, downloading the XML to re-upload in swissdamed may be the preferred method. Manufacturers who do not have this kind of experience and do not have a vast portfolio may be best advised to use the online editor to register their medical devices in swissdamed.

Deadline for device registration in swissdamed

In Switzerland, the registration of economic operators has been in place since 26 November 2021 and has been available in swissdamed since August 2024.

The registration of devices, systems and procedure packs is mandatory in swissdamed with effect from 1 July 2026, with a transition period until 31 December 2026 (amendment to the Ordinance on In Vitro Diagnostic Medical Devices of 20 November 2024, AS 2024 742).

The device registration requirement in swissdamed therefore takes effect in Switzerland around one month later than in the EU. Economic operators are requested to consider these deadlines and plan the registration of their devices, systems and procedure packs accordingly.

BW630_40_841e_HB swissdamed User Guide UDI Devices Module (PDF, 2 MB, 07.07.2026)

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On 28 May 2026, the swissdamed webinar took place. During this online training, Swissmedic representatives provided step-by-step guidance on the correct registration and management of medical device data in swissdamed.

For those who were unable to attend the live session or wish to revisit the content, a recording of the webinar is available here.

Special case

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. Currently, this confirmation must be made before the device becomes publicly visible and before the XML file can be downloaded from EUDAMED.

With a new release of EUDAMED, it is planned that the XML file can be downloaded without prior confirmation by the Notified Body. After that release has occurred, the published device registration deadlines will also apply to these devices.

If the release is not performed in time, Swissmedic will adapt the enforcement of the medical device registration obligation for these devices to the longer transition periods for confirmation by the Designated Authorities in accordance with Art. 123 para. 3 lit. ea EU-MDR in the EU.

Further links

Questions and answers

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Playground

swissdamed – swiss database on medical devices

MU600_00_016e_MB Obligations Economic Operators CH (PDF, 1 MB, 01.05.2026)

BW630_40_841e_HB swissdamed User Guide UDI Devices Module (PDF, 2 MB, 07.07.2026)

Technical documentation

*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.}

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