Purpose and Scope of This FAQ
This FAQ is designed for medical device manufacturers, Swiss Authorized Representatives (CH-REPs), regulatory affairs teams, and other stakeholders responsible for swissdamed compliance.
It provides answers to common questions for organizations preparing, validating, submitting, and maintaining device registrations in swissdamed.
This FAQ focuses specifically on swissdamed device registration, including scope, timelines, responsibilities, UDI data, submission methods, EUDAMED alignment, and record maintenance.
It does not provide comprehensive guidance on broader Swiss medical device regulations, conformity assessment, labeling, or other market-access requirements.
Understanding swissdamed
swissdamed is Swissmedic’s national database for medical devices. It supports the registration and management of information about economic operators and medical devices placed on the Swiss market.
The database is being introduced in modules. The Actors module has been operational since August 2024, while the UDI Devices module became available for voluntary device registration in August 2025 and mandatory registration began on July 1, 2026.
The UDI Devices module is the part of swissdamed used to register medical devices, IVDs, systems, and procedure packs.
It stores medical device information and enables manufacturers and Authorized Representatives to manage device registrations required under Switzerland’s Medical Devices Ordinance (MedDO) and Ordinance on In Vitro Diagnostic Medical Devices (IvDO).
Broadly, yes, although the two databases are separate systems.
Swissmedic has intentionally aligned the design and device data requirements of swissdamed with EUDAMED to maintain equivalence with the European regulatory framework and reduce the burden on economic operators.
As a result, organizations that already maintain EUDAMED-ready device information can reuse much of that data for swissdamed.
No.
There is no interface between EUDAMED and swissdamed that automatically transfers or synchronizes device information.
Manufacturers and Authorized Representatives must actively register applicable devices in swissdamed even if those devices have already been registered in EUDAMED.
swissdamed is designed to increase transparency around medical devices and economic operators in Switzerland. Certain information from the database is publicly accessible, while restricted functionality is available to registered economic operators for managing their own information.
Key Takeaway
swissdamed is Switzerland’s national medical device database and is separate from EUDAMED. Although the two systems are closely aligned, manufacturers and CH-REPs must ensure applicable devices are independently registered in swissdamed.
Compliance Dates and Scope
Registration of applicable devices, IVDs, systems, and procedure packs became mandatory on July 1, 2026.
A transitional period applies through December 31, 2026 for devices subject to the general registration requirement.
Devices, systems, and procedure packs that are subject to the registration obligation and continue to be placed on the Swiss market must generally be registered in swissdamed by December 31, 2026. The transitional period provides economic operators with time to complete registration of existing portfolios following the July 1, 2026 effective date.
Yes.
Devices placed on the Swiss market after the registration requirement entered into force are subject to swissdamed registration. During the 2026 transitional period, registration must be completed no later than December 31, 2026. After the transitional period, applicable devices must be registered before they are placed on the market.
Yes, if additional units continue to be placed on the market after July 1, 2026.
Devices that were placed on the market before July 1, 2026 but continue to be supplied after that date generally need to be registered in swissdamed by December 31, 2026.
Yes, where applicable.
The registration obligation covers devices under the current MedDO and IvDO as well as applicable legacy devices under the former legislation when additional units continue to be placed on the market after July 1, 2026. However, if a device under the current legislation has already been registered in swissdamed, the corresponding legacy device generally does not also need to be registered unless a serious incident or Field Safety Corrective Action (FSCA) involving the legacy device occurs.
Yes.
Beginning July 1, 2026, devices, systems, and procedure packs for which a serious incident, Field Safety Corrective Action, or trend must be reported to Swissmedic must be registered in swissdamed immediately. The general December 31, 2026 transitional period does not apply in these cases.
Yes.
The swissdamed UDI Devices module covers both medical devices and in vitro diagnostic medical devices.
Applicable IVDs under the IvDO, as well as applicable legacy IVDs under the former legislation that continue to be placed on the market, are subject to the registration requirements.
Key Takeaway
Mandatory swissdamed device registration began July 1, 2026, with a general transition period through December 31, 2026. Manufacturers and CH-REPs should use this period to complete registration of applicable current and legacy device portfolios.
Manufacturer and Authorized Representative Responsibilities
Device registration can be performed by applicable economic operators registered in swissdamed, including:
- Swiss manufacturers
- Swiss Authorized Representatives
- Persons who assemble systems and procedure packs
- Foreign manufacturers with an appropriate mandate, where supported by swissdamed
The appropriate permissions within swissdamed must also be assigned to the user performing the registration.
A manufacturer established outside Switzerland must appoint a Swiss Authorized Representative where required under Swiss medical device regulations. For swissdamed, the CH-REP plays an important role in maintaining the manufacturer’s regulatory presence in Switzerland and can register devices covered by its mandate.
The relevant economic operator relationships must be established in the swissdamed Actors module.
Swissmedic uses a Swiss Single Registration Number (CHRN) to uniquely identify registered economic operators, including Swiss manufacturers and Authorized Representatives. Foreign manufacturer relationships are managed through the applicable mandate structure.
CHRN stands for Swiss Single Registration Number.
It is assigned by Swissmedic to applicable economic operators registered in Switzerland, including:
- Manufacturers
- Authorized Representatives
- Importers
- Manufacturers of systems and procedure packs.
The CHRN identifies the economic operator, and is not a device identifier and does not represent certification or approval of the manufacturer’s devices.
A mandate establishes the relationship between a foreign manufacturer and its Swiss Authorized Representative within swissdamed. The mandate allows the CH-REP and appropriately authorized users to manage device information associated with that manufacturer.
Users responsible for device registration require the appropriate UDI Editor permissions. For Authorized Representatives, UDI Editor permissions can be assigned in relation to the applicable manufacturer mandate, allowing authorized users to manage devices for that manufacturer.
Applicable Master UDI-DIs can be uploaded by:
- Swiss manufacturers
- Authorized Representatives
- Foreign manufacturers with an applicable mandate.
The user performing the registration requires the appropriate UDI Editor role.
No.
Importers do not independently register devices. Instead, they link themselves as an importer to an existing device registration using the UDI-DI.
The device must first have been registered by the applicable manufacturer, Authorized Representative, or other permitted party.
Key Takeaway
Successful device registration depends on establishing the correct actor, mandate, and user-permission structure first. For foreign manufacturers, close coordination with the CH-REP is particularly important because the Authorized Representative plays a central role in Swiss device registration.
UDI and Device Data Requirements
swissdamed stores the UDI and device information defined in the swissdamed UDI Data Dictionary.
This includes information associated with the Basic UDI-DI and UDI-DI, together with applicable device characteristics, classification, nomenclature, packaging, and other regulatory data.
Yes. For devices subject to the applicable MDR/IVDR-aligned requirements, swissdamed uses the Basic UDI-DI as an important identifier connecting devices that share the same intended purpose, risk class, and essential design and manufacturing characteristics.
Where UDI requirements apply, individual devices and applicable packaging levels must be identified in accordance with the relevant UDI requirements and issuing entity rules. The UDI-DI is then included in the device registration maintained in swissdamed.
Yes.
swissdamed supports Master UDI-DI registration for device categories subject to these requirements.
For example, contact lenses requiring a Master UDI-DI must be registered using the Master UDI-DI beginning November 9, 2026. For spectacle frames, spectacle lenses, and ready-to-wear reading spectacles, the Master UDI-DI registration requirement begins November 1, 2028.
swissdamed recognizes UDIs issued by the following four issuing entities:
- GS1
- HIBCC
- ICCBBA
- IFA
These are the same UDI issuing entities designated for EUDAMED. Manufacturers should assign and maintain their UDIs according to the requirements of their selected issuing entity and applicable Swiss regulations.
The data structures are closely aligned but not completely identical.
Swissmedic designed swissdamed to allow economic operators to largely reuse data prepared for EUDAMED. However, organizations must still validate the data against the current swissdamed UDI Data Dictionary and Business Rules. Certain EUDAMED data elements are not stored or used by swissdamed, while Swiss-specific requirements can also apply.
Device registrations must satisfy swissdamed’s applicable data requirements and business rules.
Invalid values, missing required information, incorrect relationships, or other validation errors can prevent a record from being successfully registered. Manufacturers should therefore validate their source data against swissdamed requirements before attempting high-volume submissions.
UDI-DI records remaining in Draft status are automatically deleted after 30 days unless the record’s status is changed during that period.
Organizations should therefore avoid using Draft status as a long-term repository for incomplete device data.
Key Takeaway
swissdamed is highly aligned with EUDAMED, but EUDAMED-ready does not automatically mean swissdamed-ready. Device data should be validated against Swissmedic’s current Data Dictionary and Business Rules before registration.
EUDAMED Alignment and Data Reuse
Yes.
This is one of the most important efficiencies available to manufacturers operating in both the EU and Switzerland.
Swissmedic deliberately aligned swissdamed with EUDAMED so organizations can largely reuse device information already prepared for EUDAMED rather than maintaining completely independent datasets.
No.
There is no automatic data exchange or synchronization between EUDAMED and swissdamed.
Even if the same device is registered in EUDAMED, the manufacturer or its CH-REP must ensure the device information is separately submitted to swissdamed.
Yes.
swissdamed accepts XML files based on EUDAMED specifications.
Swissmedic supports the EUDAMED GET DEVICE and POST DEVICE XML formats, enabling organizations to leverage EUDAMED-compatible data for swissdamed registration.
Yes.
For devices already registered in EUDAMED, an organization can download applicable device information in XML format and use it as the basis for registration in swissdamed.
Swissmedic specifically identifies this as a practical registration approach for organizations already managing devices in EUDAMED.
Potentially, yes.
swissdamed supports EUDAMED-compatible XML structures, allowing organizations that generate their own EUDAMED XML to leverage those files for Swiss registration.
However, the data should still be checked against the swissdamed Data Dictionary and Business Rules because the two systems are aligned but not identical.
No.
Because the databases are independent, changes made in EUDAMED do not automatically propagate to swissdamed, and vice versa.
Manufacturers therefore need a process for identifying relevant device-data changes and maintaining both regulatory databases.
Key Takeaway
The most efficient approach for many manufacturers is EUDAMED-ready data → Swiss-specific validation and augmentation → swissdamed registration. The goal should be maximum reuse of common device data while maintaining separate regulatory submissions and ongoing synchronization processes.
Registering Devices in swissdamed
Swissmedic currently supports three primary registration methods:
| Method | Typical Use |
|---|---|
| Online Editor | Manual registration for smaller portfolios |
| XML Upload | Bulk registration and reuse of EUDAMED-compatible data |
| Machine-to-Machine (M2M) | Automated registration for larger portfolios |
Organizations should select a method based on portfolio size, existing UDI submission processes, technical capabilities, and desired level of automation.
The Online Editor allows users to manually create and maintain device records directly in swissdamed. It guides users through the required fields and is generally best suited to organizations with smaller portfolios or limited technical integration requirements.
XML Upload allows organizations to upload EUDAMED-compatible XML files into swissdamed.
This is particularly useful for manufacturers that:
- Already register devices in EUDAMED
- Maintain EUDAMED-compatible regulatory data
- Need to register multiple devices
- Want to avoid manually re-entering the same information.
Yes.
swissdamed supports Machine-to-Machine (M2M) data exchange using a REST API with JSON.
This provides an automated option for organizations managing larger device portfolios or integrating swissdamed registration into enterprise regulatory data-management processes.
Swissmedic recommends M2M primarily for organizations with sufficient technical expertise or those working with an experienced technology provider. M2M is most appropriate when registration volumes and ongoing data-maintenance requirements justify automated integration.
Yes.
Swissmedic provides a Playground environment that organizations can use to become familiar with swissdamed and test relevant processes separately from the production environment.
Technical documentation, including applicable Business Rules and the Data Dictionary, supports both production and Playground use.
Yes.
Beginning July 1, 2026, device registration is subject to Swissmedic fees.
The current fee structure is:
- CHF 200 for the first device registered per manufacturer per year
- CHF 20 for each additional device
- Maximum CHF 10,000 per year per manufacturer or person assembling systems/procedure packs.
Updates to existing device data are not subject to an additional registration fee. Fees are calculated by manufacturer rather than by CH-REP.
For the initial 2026 implementation, fees are assessed based on UDI-DIs with the status On the market as of December 31, 2026.
Devices marked No longer placed on the market by that date are not charged under the initial 2026 fee assessment.
For foreign manufacturers, invoicing is issued to the applicable CH-REP.
Key Takeaway
swissdamed provides manual, EUDAMED-compatible XML, and automated M2M submission options. Manufacturers should select an approach based on portfolio size and existing infrastructure, while also accounting for Swissmedic’s per-device registration fees.
Maintaining Compliance After Registration
No.
Device registration creates an ongoing obligation to maintain accurate device information.
Manufacturers and Authorized Representatives need processes for managing relevant changes to device data, regulatory status, identifiers, and market status throughout the device lifecycle.
Yes.
Because EUDAMED and swissdamed do not automatically synchronize, organizations should evaluate relevant EUDAMED device changes to determine whether corresponding swissdamed records also need to be updated.
This makes cross-regulatory data governance particularly important for manufacturers operating in both markets.
swissdamed provides functionality for discarding applicable device records.
Organizations should use the applicable swissdamed process and business rules rather than assuming a regulatory record can simply be permanently deleted.
swissdamed does not retain successfully processed XML upload files.
Successfully uploaded XML files are deleted immediately. XML files that cannot be successfully uploaded or generate errors are automatically deleted after 14 days.
Organizations should therefore maintain their own source files and submission records where needed for internal traceability.
Key Takeaway
swissdamed compliance continues after initial registration. Manufacturers and CH-REPs need sustainable processes for monitoring device changes, keeping Swiss records aligned with authoritative product data, managing EUDAMED/swissdamed differences, and maintaining evidence of regulatory submissions.
Conclusion
Mandatory device registration in swissdamed represents a significant product data-management obligation for manufacturers supplying medical devices in Switzerland. With the requirement already in effect as of July 1, 2026 and the general transitional period ending December 31, 2026, manufacturers and Swiss Authorized Representatives should now be focused on completing registration of applicable device portfolios and establishing sustainable processes for ongoing compliance.
For manufacturers already submitting device information to EUDAMED, the close alignment between the two databases provides an important opportunity to reduce duplicate effort. However, because EUDAMED and swissdamed remain separate systems with no automatic synchronization, compliance requires more than simply having EUDAMED-ready data. Organizations need to reuse common regulatory data where possible, apply Swiss-specific requirements and validations, submit it independently to swissdamed, and keep both regulatory records aligned as device information changes. The most scalable approach is therefore to establish a trusted regulatory device data foundation that can support both EUDAMED and swissdamed, while accounting for the requirements, data validation rules, submission processes, and lifecycle obligations specific to each database.
