EUDAMED M2M Connection

From your existing product database to controlled transmission via the Swissmedic REST API

What has been in effect since July 1, 2026 and why integration is becoming a priority now

SWISSDAMED is Swissmedic's national database for registering medical devices, in vitro diagnostics (IVDs), and the responsible economic operators in Switzerland. Since July 1, 2026, the registration of medical devices, systems, and procedure packs in SWISSDAMED has been mandatory. A transition period applies to affected products until December 31, 2026. Exceptions apply in particular to products involving reportable serious incidents, field safety corrective actions, or trends.

This presents manufacturers and Swiss authorized representatives (CH-REPs) with the task of keeping their regulatory product data complete, correct, and permanently up to date in SWISSDAMED.

Especially with extensive product portfolios or regular changes, manual data maintenance quickly becomes time-consuming.

Swissmedic therefore offers three ways to register products: manual entry via the web portal, XML upload, and automated machine-to-machine integration (M2M).

Which path is right for you depends on the number of products, your existing data sources, and the desired level of automation.

2 SWISSDAMED Modules

3 ways to register products

31 december 2026: End of the transition period

Key deadlines at a glance

July 1, 2026 Product registration mandatory: The registration requirement for medical devices, IVDs, systems, and procedure packs is in effect.For certain reportable vigilance cases, there is no transition period.

October 1, 2026 Importer linking available: Importers can link their CHRN to already registered products that they place on the Swiss market.

December 31, 2026 End of the transition period: Affected products must be registered in SWISSDAMED by this date.

April 1, 2027 End of the transition period for importers: The linking of relevant products with registered importers must be completed by this date.

The three ways to register products

SWISSDAMED offers three different ways to transmit product data. We support you in selecting and implementing the right method.

Web portal (online editor)

MANUAL REGISTRATION

Product data is entered and maintained directly via the SWISSDAMED user interface.

Suitability: Best for companies with few products and infrequent changes. However, for larger portfolios, the manual effort increases significantly.

XML upload

FILE-BASED TRANSFER

Product data can be uploaded to SWISSDAMED as XML files in accordance with the supported EUDAMED specifications. This allows you to largely reuse product data already registered in EUDAMED. A maximum of 300 Basic UDI-DI / UDI-DI pairs are allowed per file.

Suitability: Best for companies that have already prepared their product data in EUDAMED format and prefer file-based transfer.

M2M interface

AUTOMATED TRANSMISSION VIA REST API

The M2M interface allows you to transmit product data directly from existing corporate systems to SWISSDAMED in a JSON-based format. Registrations, updates, market status changes, and processing result queries can all be integrated into an automated process.

Suitability: Particularly suitable for companies with extensive product portfolios, regular changes, and existing ERP, PLM, or regulatory information management systems.

Machine-to-Machine: How the integration works

The M2M connection links your existing data sources with the SWISSDAMED UDI Devices module.

Product data from systems such as SAP, PLM, QMS, or RIM is consolidated, converted into the required data format, and validated against Swissmedic requirements.

Secure transmission then takes place via the REST API. Feedback is automatically queried and processed. Changes to product data or market status can be transmitted to SWISSDAMED using the same process.

adesso supports you in the design, implementation, validation, and operation of this integration.

Benefits at a glance

  • Central database: Use existing product data from your corporate systems instead of manually entering the same information multiple times.
  • Pre-transmission validation: Validate data against the technical API specification and SWISSDAMED business rules to detect incorrect submissions early.
  • Scalable processing: Efficiently register and update even large product portfolios through automated individual transactions.
  • Traceable processes: Document transmissions, feedback, and changes directly within the integration solution.
  • Direct system integration: Connect existing ERP, PLM, and RIM systems and reduce manual data exports.
  • Automated data maintenance: Transmit product changes and market status updates to SWISSDAMED in a controlled manner.

Where the time savings come from

The greatest benefit of the M2M connection comes from automating repetitive tasks.Fewer manual data entries. Product data is pulled from existing systems. This reduces duplicate maintenance and the effort required for transmission to SWISSDAMED.

  • Early error detection. Technical and functional checks identify incomplete or inconsistent data before it is transmitted to Swissmedic.
  • Automated feedback processing. The processing status is queried via the SWISSDAMED API. Failed transmissions can be identified and targeted for correction.
  • Efficient bulk processing. Large product portfolios can be processed via automated API requests without having to enter each UDI-DI manually.
  • Controlled updates. Changes to product data and market status are applied through defined processes and documented traceably.
  • Better predictability. Standardized, repeatable processes help you meet regulatory deadlines and ensure long-term data quality.

Who is affected by SWISSDAMED obligations?

Registration and administrative obligations vary depending on the role of the economic operator. The registration requirements also apply to internationally active manufacturers who place medical devices or IVDs on the Swiss market. The role in registration is key: Swiss manufacturers register their products themselves; for foreign manufacturers, this is generally done under a mandate via the Swiss authorized representative (CH-REP).

Swiss manufacturers of medical devices and IVDs

  • Registration as an economic operator in the Actors module with a CHRN
  • Registration of the affected products in the UDI Devices module
  • Maintenance of Basic UDI-DI, UDI-DI, and relevant product information
  • Updates to product data and market status
  • Registration of affected legacy devices

Foreign manufacturers of medical devices and IVDs

  • Registration of products intended for the Swiss market under a mandate with a Swiss authorized representative (CH-REP)
  • Provision of complete and up-to-date Basic UDI-DI, UDI-DI, and other required product data
  • No separate CHRN as a foreign manufacturer; the Swiss authorized representative requires a CHRN
  • Opportunity for authorized employees of the foreign manufacturer to upload products themselves within the assigned mandate (user profile "UDI Editor")
  • Reuse of product data already prepared for EUDAMED, provided that the SWISSDAMED requirements are met

Swiss authorized representatives (CH-REP)

  • Registration as an authorized representative with a CHRN
  • Management of mandates from foreign manufacturers
  • Ensuring the registration and management of products within the respective mandate
  • Coordination of data transmission with the represented manufacturers; if required, assignment of "UDI Editor" permissions at the mandate level
  • Ensuring up-to-date and correct registration data within the area of responsibility

System and procedure pack producers

  • Registration as the corresponding economic operator
  • Registration of the affected systems and procedure packs
  • Maintenance of the required identification and product data
  • Updates to the market status

Swiss importers

  • Registration as an importer with a CHRN
  • Linking of their own CHRN with the already registered UDI-DIs of the imported products
  • Maintenance of up-to-date actor and contact data
  • Ensuring correct product linking by April 1, 2027, at the latest

The two SWISSDAMED modules at a glance

Actors module: Registration of economic operators

STATUS: ACTIVE SINCE AUGUST 2024

Relevant for Swiss manufacturers, Swiss authorized representatives, Swiss importers, and system and procedure pack producers. Foreign manufacturers are registered within the scope of the mandates of their Swiss authorized representatives.

The Actors module is used to register and manage economic operators and their mandates.

Swissmedic issues the Swiss Single Registration Number (CHRN). This forms the basis for assigning roles and responsibilities.

The registration and management of actors takes place via SWISSDAMED.

UDI Devices module: Registration of medical devices

STATUS: MANDATORY SINCE JULY 2026

Relevant for Swiss manufacturers, Swiss authorized representatives, foreign manufacturers under a CH-REP mandate, and system and procedure pack producers.

The UDI Devices module is used to register and maintain medical devices, in vitro diagnostics, systems, and procedure packs.

Data recorded includes the Basic UDI-DI, UDI-DI, packaging identification, and the required regulatory product data.

In addition to manual entry, the module supports XML uploads and automated registration via a REST API.

This is where the M2M solution from adesso comes in.

Already registered in EUDAMED? Use your product data for SWISSDAMED too

Companies distributing medical devices in both the EU and Switzerland must meet the respective registration requirements. This applies in particular to foreign manufacturers whose products must be registered in Switzerland via a CH-REP.

SWISSDAMED is based on the product data structures of EUDAMED. Previously prepared data can therefore largely be reused.

However, there is no direct interface between the two databases. Swissmedic does not automatically import EUDAMED data.

adesso helps you make existing product data usable for both databases.

Through a shared database and appropriate interfaces, information can be prepared, validated, and provided for both EUDAMED and SWISSDAMED via the supported transmission paths.

This reduces duplicate data entry and additional manual maintenance effort.

We support you with your SWISSDAMED integration

Whether it's initial product registration, importing existing EUDAMED data, or setting up a permanent M2M interface: We help you build a suitable and sustainable process for your regulatory data transmission.

From analyzing your existing data landscape, mapping, and technical integration to validation and ongoing operations, we guide you through the entire implementation.

Learn more about our EUDAMED M2M integration

We support you with the M2M connection

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