swissdamed vs. EUDAMED: Alignment and Key Differences

For medical device manufacturers already preparing and submitting device information to the European Database on Medical Devices (EUDAMED), Switzerland’s swissdamed will look particularly familiar. That is intentional.

Swissmedic has explicitly aligned the design of swissdamed with EUDAMED to maintain equivalence with the European regulatory framework and reduce the burden on economic operators. As a result, manufacturers can largely reuse device data already prepared for EUDAMED when registering devices in swissdamed.

But alignment does not mean the two databases are interchangeable.

swissdamed is a separate Swiss regulatory database, governed by Swiss requirements and operated independently by Swissmedic. There is no direct interface between EUDAMED and swissdamed, meaning information registered in EUDAMED is not automatically transferred or synchronized with Switzerland.

This distinction has become particularly important in 2026. EUDAMED’s UDI/Device registration module became mandatory on 28 May 2026, while device registration in swissdamed became mandatory on 1 July 2026, subject to the applicable transitional provisions.

For manufacturers operating in both markets, the opportunity is clear: reuse the significant alignment between EUDAMED and swissdamed without treating Switzerland as simply an extension of the EU submission process.

The Common Foundation: Where swissdamed and EUDAMED Align

The close relationship between the two systems reflects the broader alignment between Switzerland’s medical device regulatory framework and the EU MDR and IVDR.

swissdamed has been designed to resemble the corresponding EUDAMED modules, and Swissmedic states that economic operators can largely transfer device data prepared for EUDAMED to swissdamed.

This alignment extends to many of the fundamental concepts manufacturers already manage for EUDAMED, including:

• Basic UDI-DI
• UDI-DI
• Package UDI-DI
• Master UDI-DI for applicable devices
• legacy device identifiers
• device and packaging relationships
• systems and procedure packs

Swissmedic also supports EUDAMED DI and EUDAMED ID as replacement identifiers for applicable legacy devices that do not have a Basic UDI-DI or UDI-DI.

The technical alignment is also significant. swissdamed supports XML files based on EUDAMED’s GET DEVICE and POST DEVICE formats, allowing organizations with EUDAMED device data to reuse that information as part of their Swiss registration process.

swissdamed vs. EUDAMED at a Glance

Area	EUDAMED	swissdamed
Regulatory authority	European Commission / EU competent authorities	Swissmedic
Primary regulatory framework	EU MDR and IVDR	Swiss MedDO and IvDO
Geographic scope	European Union	Switzerland
Database structure	Six interconnected modules and public website	Actors and UDI Devices modules plus public search
Actor identifier	Actor ID / Single Registration Number (SRN)	Swiss Single Registration Number (CHRN)
Device identification	Basic UDI-DI, UDI-DI and applicable packaging identifiers	Closely aligned with EUDAMED UDI structure
Device data model	EUDAMED requirements	swissdamed requirements designed for substantial alignment with EUDAMED
Automated submission	EUDAMED M2M via AS4	REST API using JSON
Mandatory UDI/Device registration date	28 May 2026	1 July 2026, with applicable transition period

The similarities are substantial, but manufacturers should pay particular attention to where the two systems diverge.

Key Difference #1: swissdamed is a Separate Swiss Regulatory Database

The most important distinction is also the simplest: registration in EUDAMED does not constitute registration in swissdamed.

Although swissdamed was designed around EUDAMED concepts, Swissmedic operates its own database to support the Swiss medical device regulatory framework.

There is currently no interface between EUDAMED and swissdamed, so Swissmedic cannot automatically import or synchronize device information registered in EUDAMED. Economic operators subject to Swiss registration requirements must actively register their device information in swissdamed.

This creates an important operational distinction for manufacturers selling the same devices in the EU and Switzerland.

A successful EUDAMED submission may provide much of the data required for Switzerland, but it does not eliminate the need for a separate Swiss registration process.

The objective should therefore be to reuse and augment EUDAMED-ready data with Swiss-specific requirements and validate against swissdamed rules for successful registration in Switzerland.

Key Difference #2: Different Economic Operator Registration and Identifiers

Both databases require economic operators to be registered, but the registrations are jurisdiction-specific.

EUDAMED’s Actor Registration module provides an Actor ID / Single Registration Number (SRN) as an EU-wide identifier for applicable economic operators. The module became mandatory to use on 28 May 2026.

Switzerland operates its own actor registration framework through swissdamed and uses the Swiss Single Registration Number (CHRN). Swissmedic’s Actors module covers Swiss manufacturers, authorised representatives, importers and persons assembling systems or procedure packs.

For foreign manufacturers, the role of the Swiss authorised representative is particularly important. Swissmedic states that Swiss manufacturers, persons assembling systems and procedure packs, and authorised representatives must register the applicable devices or mandated devices in swissdamed.

This means manufacturers cannot simply extend their EUDAMED actor identity into Switzerland. They need to ensure that the correct Swiss economic operator structure, registrations, mandates and user permissions are established before device registrations are managed in swissdamed.

Key Difference #3: The Data is Highly Aligned, but Not Identical

swissdamed’s close alignment with EUDAMED creates a major advantage for manufacturers already managing EU device data. But manufacturers should not interpret that alignment as complete data equivalence.

Swissmedic maintains a dedicated swissdamed UDI Devices data model, and some EUDAMED data elements are not stored in swissdamed. Swissmedic identifies exclusions including certain EUDAMED-specific certificate links, clinical investigation links, authorised representative fields and market information, as well as language restrictions.

This means an EUDAMED record should be treated as the starting point for swissdamed, rather than as an automatically identical Swiss record.

Organizations should identify:

• Reusable data – attributes that can flow from the same authoritative source into both systems.
• Swiss-specific data – information or relationships required specifically for Switzerland.
• Transformable data – information based on the same source but requiring different formatting or processing.
• EUDAMED-only data – attributes that should not be carried into swissdamed.

For manufacturers managing large product portfolios, this mapping provides the foundation for maintaining one governed source of device information while supporting both regulatory destinations.

Key Difference #4: EUDAMED and swissdamed Support Different Submission Methods

While swissdamed is designed to facilitate the reuse of EUDAMED device data, the two databases have distinct submission methods and technical interfaces. Manufacturers therefore need to determine how their existing EUDAMED processes can be adapted for swissdamed rather than assuming the same submission mechanism can be used for both.

Swissmedic currently provides three primary methods for registering device data in swissdamed:

1. Online Editor – manual entry directly in swissdamed, generally suited to organizations with smaller device portfolios.
2. XML Upload – upload of XML files using the EUDAMED GET DEVICE or POST DEVICE format.
3. Machine-to-Machine (M2M) – automated submission through a REST API using JSON.

The XML upload option creates an important point of alignment with EUDAMED. Because swissdamed accepts EUDAMED-compatible XML, manufacturers can reuse device data exported from EUDAMED rather than recreating records manually for Switzerland.

However, this should not be confused with direct integration between the two databases. EUDAMED and swissdamed do not automatically exchange or synchronize device records. Manufacturers remain responsible for transferring the applicable data to swissdamed and completing the Swiss registration process.

For organizations requiring greater automation, swissdamed also provides an M2M option through a REST API using JSON. This represents a different technical interface from EUDAMED and should be treated as a separate integration when designing automated regulatory submission processes.

Key Difference #5: EUDAMED Has a Much Broader Regulatory Scope

Perhaps the biggest structural difference between the two databases is their overall scope. EUDAMED is designed as a comprehensive European medical device information system spanning the device lifecycle. It consists of six interconnected modules:

1. Actor Registration
2. UDI/Device Registration
3. Notified Bodies and Certificates
4. Clinical Investigations and Performance Studies
5. Vigilance and Post-Market Surveillance
6. Market Surveillance.

As of 28 May 2026, Actor Registration, UDI/Device Registration, Notified Bodies & Certificates and Market Surveillance are mandatory to use, while the remaining modules are still progressing toward implementation.

swissdamed currently has a more focused structure comprising an Actors module and UDI Devices module, together with public search capabilities.

This difference matters strategically. Manufacturers should not assume that every regulatory process or dataset managed through EUDAMED has an equivalent swissdamed module. The strongest alignment today is around actor and device registration, which is also where manufacturers have the greatest opportunity to reuse their existing EUDAMED capabilities.

swissdamed Compliance Timelines

Device, system and procedure-pack registration in swissdamed became mandatory on 1 July 2026, approximately one month after the EUDAMED requirement. A transitional period runs until 31 December 2026 for applicable existing registrations.

There is an important exception: devices and systems/procedure packs associated with a reportable serious incident, field safety corrective action or trend are subject to immediate registration from 1 July 2026 without the general transitional period.

Milestone	EUDAMED	swissdamed
Mandatory device registration begins	28 May 2026	1 July 2026
General transition deadline for applicable device registrations	27 November 2026	31 December 2026

Manufacturers operating in both markets should therefore manage the EU and Swiss deadlines independently even when most of the underlying device data is shared.

Building on Your EUDAMED Investment

For manufacturers already managing EUDAMED compliance, swissdamed should not require building another UDI compliance process from the ground up.

The close alignment intentionally created by Swissmedic provides a strong foundation for reuse. Manufacturers can leverage existing Basic UDI-DIs, UDI-DIs, device attributes, packaging structures and EUDAMED-ready data while accounting for Swiss-specific actors, data requirements and registration processes.

The most effective strategy is to:

1. Reuse EUDAMED-ready device data wherever requirements align.
2. Map EUDAMED and swissdamed requirements to identify the differences that need to be managed.
3. Avoid duplicating master data by maintaining common device information from authoritative enterprise sources.
4. Choose the appropriate swissdamed submission method based on portfolio size and IT capabilities.
5. Manage both databases as separate regulatory destinations from a common and governed UDI data foundation.