From 1 July 2026, Swissmedic Requires Medical Devices and IVDs to Be Registered in swissdamed

Key Summary

The Swiss Agency for Therapeutic Products (Swissmedic) has announced that, with effect from 1 July 2026, Swiss manufacturers, assemblers of systems and procedure packs, and authorised representatives must register their devices, systems and procedure packs in the swissdamed database. A transition period runs until 31 December 2026.

The requirement is designed to be equivalent to the EU EUDAMED system. Registration can be carried out through an online editor, an XML upload, or a machine-to-machine (M2M) interface. Manufacturers should plan data preparation in advance, as the exercise touches technical documentation, UDI data, labelling and post-market surveillance.

Source and Applicability

Source authority: Swiss Agency for Therapeutic Products (Swissmedic)
Original date: 1 July 2026
Article published: 25 July 2026
Source: Swissmedic public information, https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/produktregistrierung.html

This article is compiled and translated from publicly available Swissmedic information. The latest official publications of the regulatory authority prevail over any summary provided here.

Full Translation of the Official Notice

Registration obligation in the UDI device module

Swiss manufacturers, assemblers of systems and procedure packs, and authorised representatives must register their devices — or, in the case of authorised representatives, the devices they represent as well as systems and procedure packs — in the UDI device module of swissdamed*.

Alignment with the European framework

To ensure equivalence with the European legal framework and to reduce costs for economic operators, Swissmedic has aligned the design of swissdamed with EUDAMED. Device data that an economic operator has already prepared for EUDAMED can, to a large extent, be transferred to swissdamed.

Because there is no interface between swissdamed and EUDAMED, Swissmedic cannot import or synchronise data directly from EUDAMED. Swiss manufacturers, system and procedure pack assemblers, and authorised representatives must actively upload device data to swissdamed. Swissmedic offers the following registration methods:

• Online editor: manual data entry through the user interface.
• XML upload: upload of an XML file in the EUDAMED “GET DEVICE” or “POST DEVICE” format.
• Machine-to-machine (M2M): direct data exchange through a REST API interface using JSON format.

Economic operators should choose the registration method based on their experience with EUDAMED medical device registration. The M2M route is recommended only where the operator has extensive in-house IT expertise or works with an experienced supplier that has such expertise. If a device is already registered in EUDAMED, downloading the XML file and re-uploading it to swissdamed may be the preferred approach. Manufacturers without such experience and without a large product portfolio are best served by the online editor for registering devices in swissdamed.

Deadline for device registration in swissdamed

In Switzerland, registration of economic operators has been in force since 26 November 2021 and has been available in swissdamed since August 2024. Registration of devices, systems and procedure packs becomes mandatory in swissdamed from 1 July 2026, with a transition period until 31 December 2026 (Ordinance of 20 November 2024 amending the Ordinance on In Vitro Diagnostic Medical Devices, AS 2024 742).

Device registration in Switzerland therefore takes effect roughly one month later than in the European Union. Economic operators are advised to take these deadlines into account and to plan the registration of their devices, systems and procedure packs accordingly.

Swissmedic webinar of 28 May 2026

A swissdamed webinar was held on 28 May 2026. During this online training, Swissmedic representatives provided step-by-step guidance on correctly registering and managing medical device data in swissdamed. Those who could not attend the live session, or who wish to review the content, can access the webinar recording here.

Special cases: devices with a technical documentation assessment or type-examination certificate

For high-risk devices covered by a type-examination certificate or a technical documentation assessment certificate (applicable to devices under Article 29(3) of the EU MDR or Article 26(2) of the EU IVDR), the device data must be confirmed by the notified body. At present, this confirmation must be given 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 XML files can be downloaded without prior notified body confirmation. Once that release is published, the announced device registration deadline will also apply to these devices.

If the release is not published in time, Swissmedic will adjust its enforcement of the medical device registration obligation for these devices in line with the longer transition period for designated bodies under Article 123(3)(ea) of the EU MDR.

Territorial scope

*The information below describes the obligations and transitional provisions applicable to economic operators established in Switzerland and to devices placed on the Swiss market. Owing to the customs treaty between Switzerland and Liechtenstein, where devices are placed on the market on the basis of the MedDO/IvDO, “established in Switzerland” and “on the Swiss market” refer to the common market (customs union) of Switzerland and Liechtenstein. (1)

Because of the EEA Agreement and the Liechtenstein–Switzerland customs treaty, two legal frameworks apply in parallel to medical devices in Liechtenstein. Devices may be placed on the market on the basis of the MDR/IVDR or on the basis of the MedDO/IvDO. The Swiss/Liechtenstein common market concerns only devices placed on the market under the MedDO/IvDO. Placing devices on the market in Switzerland solely under the MDR/IVDR is not considered. (2)

AIMEILI Regulatory Interpretation

Determine your role and the responsible legal entity first

For manufacturers established outside Switzerland, the practical starting point is the appointment of a Swiss authorised representative (CH-REP). The authorised representative carries out the economic operator registration in swissdamed (in force since 26 November 2021) and the device registration on behalf of the manufacturer. From 1 July 2026, a device that has not been registered cannot lawfully be placed on the Swiss market. Roles should therefore be confirmed in writing, together with a clear allocation of responsibility for data accuracy and for maintaining the records after registration.

Select the registration route that matches your existing data

Where a device is already registered in EUDAMED, downloading the XML file and re-uploading it to swissdamed is normally the most efficient option, because the two systems have been aligned in design and no direct interface exists. Operators with a complex portfolio or limited IT capacity should use the online editor, which is more robust for small volumes. The M2M route based on a JSON REST API is appropriate only for organisations with substantial in-house IT capability or a specialised service provider. The technical approach should be decided early, since it determines the data format, validation workflow and internal resources required.

Technical documentation and UDI data must be consistent

Registration requires UDI-DI information, device identification data and the Basic UDI-DI. These elements must already exist in the technical documentation and must be consistent with the data held in EUDAMED. Where discrepancies exist between the technical file, labelling and the regulatory database, they should be corrected before submission rather than after the record becomes publicly visible.

High-risk devices: notified body confirmation

For devices covered by a type-examination certificate or a technical documentation assessment certificate under Article 29(3) of the EU MDR or Article 26(2) of the EU IVDR, data confirmation by the notified body is currently still required before the record becomes publicly visible and before the XML file can be downloaded from EUDAMED. Manufacturers should monitor the planned EUDAMED release that would remove this step, and should build contingency time into their Swiss registration schedule in case the release is delayed and enforcement is adjusted accordingly.

Labelling, instructions for use and combined products

The registration obligation does not in itself require changes to labelling, but the UDI information printed on labels and packaging must match the data entered in swissdamed. Assemblers of systems and procedure packs must identify and register the combined product as placed on the market as a whole, which requires management of the UDI data of the constituent devices.

Quality system and post-market maintenance

Maintaining registration data is part of post-market surveillance. Manufacturers should establish a documented process, with a named responsible person and periodic review, to update swissdamed records when certificates change, designs are modified, devices are discontinued or other relevant changes occur. A stale record can result in an invalid registration or a finding of non-compliance.

Business Impact

• Market access risk from 1 July 2026: Swiss distribution depends on a completed device registration. Exporters and their Swiss authorised representatives should treat the deadline as a hard gate for new placements and as a priority task for the existing installed base.
• Transition period is not a buffer for inaction: the window to 31 December 2026 should be used for remediation of data quality, not for deferring the project start.
• Leverage EUDAMED investment: companies that have already completed EUDAMED registration can transfer data by XML and avoid duplicate data entry; companies that have not should plan full manual entry and the associated resource load.
• Two parallel regimes: the Swiss and EU frameworks operate independently. A CE mark and an EUDAMED record do not by themselves satisfy the Swiss registration requirement, and Swiss market status should not be assumed from EU status.
• Portfolio-wide exercise: device lists, UDI data, certificates, authorised representative mandates and internal data-ownership processes should be reviewed across the full Swiss portfolio, including systems and procedure packs.

Frequently Asked Questions

Can this update be used directly as a basis for regulatory submission?

No. This article is intended for preliminary understanding and project assessment only. Any formal submission must be based on the latest requirements of the target regulatory authority, the concluded classification of the product, and the actual documentation held by the company.

What should companies do first after seeing this update?

Companies should begin with a documentation gap assessment to determine whether the update affects the registration route, technical documentation, labelling, the quality management system or post-market maintenance obligations, and then assign responsibilities and a timeline accordingly.

Which documents should be prioritised in the review?

Priority should be given to the intended purpose, the classification rationale, ISO 13485 certification, risk management documentation, performance verification data, clinical evaluation or clinical evidence, labelling and instructions for use, authorisation documents and existing registration certificates.

What are the common risks?

Common risks include unclear classification decisions, an incomplete evidence chain, labelling and instructions for use that have not been localised, unclear responsibilities of the authorised representative, and insufficient arrangements for post-market maintenance.

Content review and scope

Author: AIMEILI Regulatory Editorial Team
Professional review: AIMEILI International Medical Device Registration Project Team
Source principle: official regulatory authorities, international organisations, standards bodies and published regulations are prioritised; industry media and project experience are used only as supporting judgement.
Scope: this article supports preliminary understanding, documentation preparation and project planning. It does not replace the formal requirements of the target regulatory authority, testing conclusions or legal advice.