Swissmedic Clarifies swissdamed Registration Requirements: Deadlines, Fees, and What’s Coming Next

On 28 May 2026, Swissmedic held a webinar dedicated to swissdamed, the Swiss Database on Medical Devices, providing manufacturers, authorized representatives, and importers with important updates on registration requirements, fee obligations, and upcoming platform functionality. Below is a summary of the key takeaways.

What Is swissdamed?

swissdamed is a Swissmedic database for registering economic operators and medical devices, including in vitro diagnostic medical devices, on the Swiss market. It was built independently after Switzerland’s Mutual Recognition Agreement with the EU was not updated for MDR/IVDR, leaving Swiss authorities without access to EUDAMED. The guiding principles are straightforward: swissdamed serves as the single source of truth for the Swiss market, and all devices placed on the Swiss market must be registered within it.

While swissdamed shares a largely equivalent data model and business rules with EUDAMED and supports the same registration methods (manual online editor, XML bulk upload, and Machine-to-Machine/M2M), it is independently developed, operates on different timelines, and includes only two modules: the Actors module and the UDI Devices module.

Registration Deadlines: What You Need to Know Now

UDI Devices

Registration in swissdamed is mandatory for all devices, systems, and procedure packs for which individual sales units are placed on the Swiss market as of 1 July 2026. This applies to both regulation and legacy devices.

The transition period applies to all devices placed on the Swiss market before 1 January 2027, including devices first placed on the market after 1 July 2026. This means manufacturers can continue placing devices on the Swiss market throughout 2026 without prior swissdamed registration, provided registration is completed by 31 December 2026.

Beginning 1 January 2027, devices must be registered in swissdamed before they can be placed on the Swiss market.

One important exception: immediate registration is required if a report to Swissmedic becomes necessary due to an incident, Field Safety Corrective Action (FSCA), or trend — regardless of the transition period.

Master UDI-DI

The registration obligation for Master UDI-DIs begins 9 November 2026, with the transition period also ending 31 December 2026. An extended deadline of 1 November 2028 applies specifically for Master UDI-DI assignment and registration for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles.

Note: Master UDI-DI registration in swissdamed is not yet available, but Swissmedic confirmed it will be live on the production environment before the 9 November 2026 obligation enters into force.

swissdamed vs. EUDAMED Timelines

swissdamed’s registration obligation begins more than one month later than EUDAMED’s (28 May 2026). For companies already registered in EUDAMED, this provides additional preparation time. However, there is no interface between the two systems: registration in EUDAMED does not satisfy the swissdamed requirement.

Registration Fees: New Fee Ordinance Effective 1 July 2026

Swissmedic has adopted a new fee ordinance (FeeO-Swissmedic, SR 812.214.5), approved by the Swiss Federal Council, which takes effect 1 July 2026. Fees apply to every UDI-DI with market status “On the market.”

Fee structure per calendar year, per actor or foreign manufacturer:

• The registration fee is a one-time charge per UDI-DI. No fee applies to devices in “draft” status, or new versions/updates of an already-registered UDI-DI. It is important to understand that this is not an annual recurring fee; each device is only invoiced once, in the year of its initial registration.

Billing Schedule

• 31 December 2026 — Fees first assessed based on devices with “On the market” status at that date. Devices marked “No longer placed on the market” as of this date will not incur a fee. First invoices are expected to be issued in January 2027.
• From 31 January 2027 — Invoices issued at the end of each calendar month for devices registered during that month.

Invoices are addressed to the registered actor. For devices of foreign manufacturers, invoices are sent to the Swiss authorized representative.

Source: Swissmedic — Registration fee

The Actors Module: Roles, Mandates, and Management

The Actors module manages the economic operators responsible for devices on the Swiss market. Switzerland-specific actor types include:

• Swiss Manufacturer (MF)
• Swiss Authorized Representative (AR) — responsible for mandates of foreign manufacturers
• Swiss Importer (IM)
• Swiss Single Practice Procedure (SPP) Producer — responsible for registering entities that assemble systems or procedure packs under Swiss requirements

Key Points for Authorized Representatives

ARs must create and manage mandates for each foreign manufacturer they represent. Required information includes the manufacturer’s SRN (if available), address, and a direct email contact for Swissmedic.

If an AR becomes inactive, all associated mandates are considered “not valid,” and devices already “On the market” will lose that status after 30 days unless the mandate is transferred. Swissmedic has introduced a mandate transfer function to handle changes in authorized representative: the current AR initiates the transfer, the mandate entry moves to the new AR (with a new mandate ID), and all registered devices carry over.

Important: manufacturers should not inactivate a mandate when changing ARs, as doing so sets all linked devices to “No longer placed on the market.”

The UDI Devices Module: Registration Methods and Market Status

How to Register

swissdamed supports three registration methods:

• Online Editor — manual entry of data elements per UDI-DI; currently available for MDR and IVDR devices (excluding Master UDI-DI) on the playground, coming soon to production
• XML Bulk Upload — XML files per EUDAMED XSD specifications; supports up to 300 UDI-DIs per upload; EUDAMED exports can be used directly
• Machine-to-Machine (M2M) — REST API upload; most commonly used via third-party providers; available on the production environment from June 2026

Setting Market Status Is the Critical Step

Registration is not considered complete until market status is set to “On the market.” This applies regardless of registration method — M2M, XML upload, or online editor. Market status remains unchanged even if UDI data is updated and is only removed if the UDI-DI is discarded.

Data Accuracy Is the Manufacturer’s Responsibility

Swissmedic emphasized that manufacturers are responsible for uploading correct data and controlling what is submitted. swissdamed device data will be made available for public download by 2027 at the latest, making accuracy especially important.

Importer Linking: Coming Autumn 2026

A new importer linking feature is under development and expected to be available from Autumn 2026. Importers do not register devices themselves; this function will allow them to link their actor profile to the devices they import. Once the feature is live, importers will have until 1 April 2027 to complete their linking.

For MedEnvoy Global customers, no action will be required, as our team will complete the importer linking on your behalf.

What’s Coming Next on the swissdamed Platform

Swissmedic outlined the following features in development:

• Registration fee billing — infrastructure to support the invoicing process described above
• Importer linking — launching autumn 2026
• Device transfer (M&A) — to support transfers of device ownership following mergers and acquisitions
• Public download — device data to be made publicly accessible by 2027

Key Takeaways for Manufacturers and Authorised Representatives

The 31 December 2026 registration deadline is approaching quickly. Companies should prioritise registering their devices now to avoid last-minute pressure and to ensure invoices reflect an accurate device portfolio. With fees assessed on “On the market” status as of 31 December 2026, getting market status set correctly and reviewing any devices that should be marked “No longer placed on the market” is equally important.

To learn more, you can view the recording and presentation slides from Swissmedic’s recent webinar: swissdamed Webinar 28 May 2026.

MedEnvoy is actively preparing for the swissdamed transition and will continue monitoring and sharing guidance from Swissmedic. Contact our team if you have questions or need support with your swissdamed registration.