Authorized Representation & UDI Submission for Medical Devices
Your Central Partner for EU MDR, Switzerland, EUDAMED and swissdamed
Are you a medical device manufacturer outside Europe – for example from China – looking to place your products on the European Union or Swiss market?
Europe IT Consulting GmbH supports international medical device manufacturers with structured market access to Europe: from regulatory representation and UDI data management to the technical submission of your product data to EUDAMED, swissdamed, FDA GUDID and TGA AusUDID.
We combine Regulatory Affairs, Authorized Representation and IT-based UDI Submission in one centrally managed solution.
European Market Access for Non-EU Medical Device Manufacturers
For manufacturers outside the European Union, access to the European market is linked to clear regulatory requirements. Chinese medical device manufacturers in particular need a reliable regulatory structure, clean UDI data and a technical solution for submitting data to the relevant authority platforms.
Key requirements include:
- EU Authorized Representative / EC-REP for the European Union
- Swiss Authorized Representative / CH-REP for Switzerland
- MDR- and IVDR-compliant product and manufacturer data
- correct Basic UDI-DI and UDI-DI structures
- technical data submission to EUDAMED
- registration and data submission to swissdamed
- structured UDI data for FDA GUDID and TGA AusUDID
Europe IT Consulting helps you implement these requirements efficiently and transparently.
One Solution for Authorized Representation and Global UDI Submission
Many manufacturers work with several different service providers: one consultant for Regulatory Affairs, one Authorized Representative, one IT provider for XML files and another provider for UDI data maintenance.
This often leads to media breaks, delays, unclear responsibilities and errors in data submission.
Our approach is different: We combine regulatory understanding, technical UDI expertise and international submission experience in one centralized process.
For you, this means:
- one central point of contact
- clear project structure
- reduced error sources
- improved data quality
- efficient preparation of your UDI data
- traceable submission to authority platforms
- support for ongoing lifecycle management
Authorized Representation Setup: EC-REP and CH-REP
For many medical device manufacturers outside Europe, an Authorized Representative is legally required in order to make products available in the EU or Switzerland.
Europe IT Consulting supports you in coordinating and implementing the required representation setup in a structured way.
EC-REP for the European Union
For the EU market, we support the coordination of the EC-REP setup in connection with the requirements of the EU MDR and EU IVDR.
In particular, we consider:
- manufacturer information
- product groups
- regulatory documentation
- responsibilities
- communication channels
- relevant registration requirements
- interfaces to UDI data submission
CH-REP for Switzerland
For the Swiss market, we support the coordination of the CH-REP setup and the related regulatory requirements.
This is especially relevant for manufacturers outside Switzerland who want to make medical devices available on the Swiss market.
In particular, we consider:
- Swiss Authorized Representative requirements
- swissdamed registration
- CHRN-related structures
- product data requirements
- UDI data for Switzerland
- technical submission options
UDI Data Submission for EUDAMED, swissdamed, FDA GUDID and TGA AusUDID
UDI data is a central part of modern regulatory requirements for medical devices. The challenge is not only the regulatory interpretation, but especially the correct technical implementation.
Europe IT Consulting specializes in UDI data management, data validation and technical submission processes for international authority platforms.
We support you with:
- EUDAMED UDI Submission
- swissdamed UDI Submission
- FDA GUDID Data Submission
- TGA AusUDID preparation
- Basic UDI-DI and UDI-DI data models
- XML structures
- M2M data transmission
- validation logic
- data cleansing and mapping
- error analysis and correction processes
Data Cleansing, Mapping and Validation
Many manufacturers already have product data in ERP systems, Excel files, PLM systems or regulatory documentation. However, this data is often not directly usable for EUDAMED, swissdamed or other UDI databases.
We analyze your existing data sources and bring your UDI data into the required structure.
This includes:
- identification of missing mandatory fields
- checking inconsistent data
- mapping to regulatory target structures
- preparation of Basic UDI-DI and UDI-DI data
- validation against target system requirements
- preparation for XML or M2M submission
- support with corrections and re-submission
Machine-to-Machine Submission and Technical Interfaces
Manual entries in authority portals are time-consuming, error-prone and difficult to scale efficiently for larger data volumes.
Europe IT Consulting supports manufacturers with structured technical data transmission using suitable interfaces, XML processes and M2M logic.
This allows UDI data to be prepared, submitted and monitored efficiently.
Especially for larger data volumes, this approach offers significant advantages:
- fewer manual entry errors
- better traceability
- faster data processing
- structured validation
- clear transmission protocols
- efficient lifecycle management
Our Process for International Manufacturers
1. Initial Assessment
We review your initial situation, target markets, existing product data, regulatory documentation and current systems.
2. Authorized Representation Setup
We support the coordination of the required EC-REP or CH-REP setup for your target markets.
3. UDI Data Preparation
Your product data is analyzed, cleansed, structured and prepared according to the requirements of the relevant target platform.
4. Validation & Correction
Errors, data gaps and inconsistencies are transparently identified and systematically corrected.
5. Technical Submission
The validated UDI data is submitted to the relevant authority platforms using suitable technical procedures.
6. Monitoring & Lifecycle Management
After the initial submission, we support you with updates, product changes, corrections and further regulatory data obligations.
Why Europe IT Consulting GmbH?
Europe IT Consulting GmbH combines Regulatory Affairs, UDI data management and technical submission expertise.
Our particular advantage lies in the combination of regulatory understanding and IT expertise. We understand not only the requirements of EUDAMED, swissdamed, FDA GUDID and TGA AusUDID, but also the technical structures behind them: XML, M2M, data models, validation rules and interface processes.
For international manufacturers – especially Chinese medical device manufacturers targeting the European market – this creates a clear advantage: one central partner for regulatory structure, UDI data quality and technical submission.
Europe Market Access for Chinese Medical Device Manufacturers
Europe IT Consulting supports Chinese medical device manufacturers with EU MDR, Swiss market access, EC-REP, CH-REP, EUDAMED UDI submission, swissdamed registration and global UDI data submission.
If you are a manufacturer from China and want to place medical devices on the European or Swiss market, we help you structure your regulatory data, prepare your UDI information and manage the technical submission process.
Your Next Step
Would you like to place medical devices on the EU or Swiss market and need support with Authorized Representation, UDI data management or technical submission?
Talk to Europe IT Consulting GmbH.
We support you from the initial data analysis through to successful UDI submission.
