EUROPE IT CONSULTING

◻ ◻ ◻ Software Development & UDI Consulting

  • Solutions
    • Global UDI Submission Portal
    • Global UDI Data Management Solution for SAP
    • GS1 Barcode Generator
  • Services
    • UDI Consulting
      • UDI Consulting for MedTech
      • UDI data submission GUDID and EUDAMED
      • ZEBRA Printer integration in SAP
    • Software Development
      • Outsourcing strategy for your company
      • Software Development
      • SAP Interactive Forms by Adobe
    • Computer System Validation | CSV gemäss ISO 13485
    • Webinars & Trainings
      • SAP Adobe Forms Training
  • UDI
    • Manuell, per XML Bulk Upload oder M2M
    • UDI EUDAMED Overview
      • EUDAMED Database Structure
      • EUDAMED FAQ
      • EUDAMED UDI: Top 25 Returns
      • EUDAMED XML Bulk Upload
      • EUDAMED M2M
      • UDI terms
      • MIR Reporting
      • EUDAMED links and documents
    • Swissdamed: Overview & Introduction
      • eudamed to swissdamed
      • swissdamed Excel Template
      • Authority Links
    • TGA AusUDID
      • AusUDID Excel Template
      • TGA AusUDID Links
    • FDA GUDID
      • FDA GUDID Excel Template
      • eMDR Data Submission
      • UDI Links of the FDA/GUDID
    • UDI Guide
      • UDI Evidence Pack
      • Case Study UDI Management with Excel Template
      • Case Study Implementation of UDI Data Management
      • EU-MDR Whitepaper
      • UDI Webinars
    • UDI World Overview
    • UDI compliance (audit trail & compliant software)
    • UDI barcode & correct UDI labelling
  • News
    • UDI Expert Articles
    • Newsletter subscription
    • EU-MDR Whitepaper
    • News
  • Company
    • Company
    • Partnerboard
    • Customers
    • Disclaimer
    • Privacy Policy
    • GTC
  • Contact
  • English
    • German
    • Turkish
    • Spanish

Authority Links

  • Home
  • Authority Links

swissdamed links: official guides, documentation and support

Which source helps with your next task?

Find annotated links to Swissmedic and swissdamed: from actor accounts, device data and XML to M2M tests and error messages. Sources are organised by task, so you do not have to search across the portal, manuals and technical documentation.

Sources checked: 4 September 2026. Official requirements may change. External links open in a new tab.

Go directly to your task:

  • Understand registration and find access
  • Prepare device data and XML
  • Check M2M and the Playground
  • Errors, changes and support
  • Legal framework and fees

1. Understand registration and find access

swissdamed at Swissmedic

The official starting point for the database and its modules. Useful when you first want to understand the system’s role and implementation status.

swissdamed — production portal

Access to the application and public search. Before making changes, check which actor and environment you are working with.

Actor registration and CHRN

Responsible roles and preparation for actor registration. Do not confuse this with a completed device registration.

Device registration

Tasks of responsible actors, registration methods and deadlines. Note the product-specific exceptions described there.

Information for importers

The importers’ own role and the status of device linking. This task differs from registering a device record.

Looking for a clear explanation with solution options? Use our swissdamed overview.

2. Prepare device data and XML

User manuals, quick guides and training videos

The support page brings together Actor and UDI Devices manuals and videos, including XML upload and setting market status. Choose the guide for your particular role.

Business Rules and UDI Data Dictionary

Official technical documentation with linked rules and a data dictionary. Check field definitions and dependencies; a correctly named field alone is not enough.

XML upload: supported Device services

The same documentation page contains the XML section. Compare the file type and supported structure with your export; not every EUDAMED service is suitable for swissdamed.

FAQ on device data and data scope

Specific questions about identifiers, nomenclature, stored data and special cases. Always read the full answer for your particular use case.

Europe IT supports data preparation with the swissdamed Excel template . Existing EUDAMED data is covered on the EUDAMED → swissdamed page. The template is not a Swissmedic document.

3. M2M, test environment and production

Playground: access and test preparation

Swissmedic explains the test environment and links to its manual. A test is not a production registration.

swissdamed Playground — application

Direct access to the test environment. Use the designated test account and consistently distinguish test data from production records.

M2M REST API: technical documentation

Links to the official API documentation. Use the version that matches your environment and plan the required tests before production use.

Production environment release notes

Check which functions have been released or changed. Availability in a test system does not automatically prove the same status in production.

Building your own client requires technical implementation expertise. If you want to use an existing Europe IT solution, start with GSP or GUDI for SAP. Using a solution and the authority’s interface are different levels.

4. Narrow down errors and find the right help

Swissmedic support for swissdamed

Official contact form and links to login help. For application errors and access problems, this is the authority’s support service, not the Europe IT sales form.

For traceable troubleshooting, have the environment, time, affected task and error message ready. Share only necessary information and no passwords or client secrets.

Your question Where to start
Access to or use of the authority website Swissmedic manuals and support
Understanding files, fields or rules Technical documentation and FAQ
Europe IT template, mapping or project scope Europe IT consulting or your agreed product support

5. Legal framework and fees

Swissmedic registration fees

Official calculation and billing rules. Authority fees are separate from software, template and service prices.

  • Therapeutic Products Act (TPA/HMG) on Fedlex
  • Medical Devices Ordinance (MedDO/MepV) on Fedlex
  • Ordinance on In Vitro Diagnostic Medical Devices (IvDO/IvDV) on Fedlex

The legal links come from the official Swissmedic starting page. This list does not replace checking which provisions apply to your role and devices.

From the right source to the right data process

Found the requirements but need help with data structure, validation or transfer? Europe IT helps connect your device information with the intended technical workflow.

  • Prepare UDI data in a structured Excel template
  • Use existing EUDAMED data for swissdamed
  • Discuss the transfer process and support

Europe IT Consulting GmbH

Development and UDI Consulting

Europe IT Consulting GmbH
Steinentorstrasse 35
4051 Basel-Stadt
Switzerland

ISO 9001 certified company

We are SAP Partner

Copyright © 2025 Europe IT Consulting GmbH. All rights reserved

Thank you for your rating!
Thank you for your rating and comment!
This page was translated from: German
Please rate this translation:
Your rating:
Change
Please give some examples of errors and how would you improve them:
Europe IT Consulting GmbH uses cookies to optimally design the website. By continuing to use the website, you agree to the use of cookies.