Introduction
This page guides you step by step through the entire UDI onboarding process. The aim is to provide you with clear guidance so that you can carry out the onboarding largely independently, efficiently and in compliance with the regulations – from preparation through to ongoing data maintenance.
Overview and Introduction
Implementation timeframe
Typical duration for the complete UDI onboarding process:
Simple scenario (clear data, small product range): approx. 2–4 weeks
Medium complexity (multiple products, coordination required): approx. 4–8 weeks
High complexity (many products, data gaps, multiple departments): 8–12+ weeks
The duration depends primarily on data availability – not on the tool. The technical steps (capture, validation, submission) can usually be carried out swiftly once the data is complete and accurate.
If you have right from the start:
defined clear responsibilities
adopted a structured approach (plan)
and worked first in the test environment (relevant for Stage 3 of the Guideline)
→ the process can be significantly accelerated and rework avoided.
Time planning at a glance
Preparation & planning (approx. 1 week)
- Work through the Submission Guideline
- Define the team
- Set out responsibilities and timetable
Stage 1: Onboarding (approx. 1–2 weeks)
- Carry out initial configurations in accordance with the Guideline
- Establish technical and organisational prerequisites
- Prepare for implementation in test and production environments
Stage 2: Attribute analysis (approx. 2–4 weeks)
- Identify and verify relevant UDI attributes
- Clarify data sources within the organisation
- Identify and close data gaps
- Document the results (e.g. in the Profiles Overview)
Stage 3: Test submission (approx. 1–3 weeks)
- Enter attributes into firstbase (learn how to enter data correctly)
- Send test submissions to the UDI database and learn how to deal with errors
Stage 4: Data entry (approx. 1–2 weeks)
- Check and validate data
- Ensure data quality
Stage 5: Going live (ongoing)
- Submit data to regulatory databases
- Analyse and process CIC feedback
- Establish data maintenance processes
- Carry out regular quality assurance
Put together a team
Before you begin the actual UDI onboarding process, it is important to put together a suitable internal team. The collection and maintenance of UDI data involves several departments and requires close collaboration.
Objective:
Ensure that all relevant expertise is involved and that clear responsibilities for UDI data are defined.
What to do:
- assemble a central team for UDI data
- involve relevant departments (e.g. Regulatory Affairs, Quality Management, Master Data Management, IT)
- define clear responsibilities and points of contact
- ensure that collaboration between the parties involved is properly organised
Result:
A clearly defined, accountable team that ensures the collection, maintenance and quality of UDI data in firstbase and supports regulatory compliance.
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Use the GS1 UDI Connector Submission Guideline
The Submission Guideline forms the technical and organisational basis for the entire UDI onboarding process. It provides a step-by-step guide on how to correctly set up and use the UDI Connector in firstbase.
Objective:
Ensure that all responsible persons understand the regulatory requirements, process steps and system specifications in order to implement the onboarding correctly and efficiently from the outset.
What you need to do:
- read the GS1 UDI Connector Submission Guideline in full
- familiarise yourself with the process, the requirements and the individual steps
- clarify any outstanding questions internally before you begin implementation
- use the Guideline and the ‘GS1 UDI Connector Profile Overview’ as central reference materials during the onboarding process
Result:
A shared understanding of the requirements and approach, which prevents errors and lays the foundation for complete, consistent and successful UDI data transmission.
Practical guidance
- Allow sufficient time to fully understand the Guideline before you begin.
- Keep the Guideline and the ‘GS1 UDI Connector Profile Overview’ to hand throughout the onboarding process so that you can look up specific steps and quickly clarify any uncertainties.
Create an onboarding plan
After reading through the Submission Guideline, draw up a detailed onboarding plan. This serves as the central basis for implementing onboarding in a structured and efficient manner.
Objective
Provide a clear overview of tasks, responsibilities, sequence and dependencies so that eyerybody involved can work in a coordinated and focused manner.
What you need to do:
- define who is responsible for which tasks during the onboarding process
- determine which steps are to be carried out and when
- determine the sequence of the individual activities
- coordinate the plan with all the relevant departments
Result:
A coordinated and transparent onboarding plan that clearly structures the process, makes targeted use of resources and enables a smooth start to the onboarding process.
Onboarding process
The UDI onboarding process is divided into preparatory work and sequential stages. During the preparatory work, you lay the organisational and technical foundations for onboarding. Building on this, you implement the individual stages in a structured manner in accordance with the Submission Guideline until your UDI data has been successfully submitted.
Registration for the introductory webinar
We recommend attending one of our UDI webinars. The webinars will be held in German. They provide a structured overview of the UDI onboarding process, how to use the GS1 UDI Connector, and practical tips for successful implementation. Only customers with an active licence for the UDI Connector will be admitted.
New dates for the onboarding webinars:
17.12.26 - 09:00 Uhr
approx. 45 minutes
The webinars will be held in German.
5 steps of onboarding
Stage 1: Onboarding
In this phase, you will begin the practical implementation of the onboarding process in accordance with the Submission Guidelines. You will lay the technical and organisational foundations upon which all subsequent steps will be built.
Objective:
Establish a properly set-up foundation so that the subsequent stages can be implemented in a structured and secure manner, without the need for later corrections.
What you will do:
- implement the first steps in accordance with the Submission Guideline
- ensure that all necessary prerequisites are met
- carry out the configurations in the test environment first
- create a firstbase login for the test environment
- register the participants for the UDI Database Playground/test environment
- M2M set-up and configuration in UDI Connect
- prepare the implementation for the production environment
- work in accordance with the defined plan and the assigned responsibilities
Result:
A properly set-up test environment and a prepared production environment, which serve as a stable foundation for attribute analysis, data collection and subsequent data transfer.
Stage 2 Carry out attribute analysis
In this phase, you will systematically analyse which UDI attributes are relevant to your products. The attribute analysis forms the technical basis for correct data capture and successful regulatory data submission.
Objective:
Fully identify all required UDI attributes using the «GS1_UDI_Connector_Profile_Overview», assign them correctly and identify any data gaps at an early stage in order to ensure high data quality.
What you need to do:
- define the scope of the relevant device types (MDR, SPP, IVDR, MDD/AIMDD, IVDD)
- check the mandatory and optional fields for each device type
- compare these requirements with the assigned attributes in the GDSN profile
- assess the applicability of each attribute based on the manufacturer’s internal device data in the source systems
- clarify the respective data sources and responsibilities
- identify potential gaps where internal data may not fully meet the requirements
- document the results in a structured manner (e.g. in the Profiles Overview)
- repeat the same steps for the code list mapping
- coordinate the analysis with the relevant business departments
Result:
A comprehensive and documented overview of attributes that clearly defines which data is required, where it comes from and how it is mapped to the products – providing a solid foundation for data capture in firstbase.
Stage 3: Data collection and test submission
In this phase, you will enter the previously analysed UDI attributes into the firstbase test environment. The aim is to map the data completely and in a structured manner within the system.
Objective:
Enter the relevant UDI data correctly into the firstbase test environment to create a consistent and high-quality data foundation.
What you will do:
- enter the identified UDI attributes into the firstbase test environment
- ensure that all mandatory fields are completed in accordance with the «GS1_UDI_Connector_Profile_Overview»
- check the data for completeness, consistency and plausibility
- coordinate with the relevant departments if necessary
- send the test submission to the UDI database (firstbase UDI Connector GLN 4399902421386)
- learn how to handle error situations (see CIC messages: meaning and handling)
Result
UDI data has been recorded completely and correctly in the firstbase test environment and is ready for validation and submission to the regulatory databases in the production environment.
Stufe 4: Capturing data
In this phase, you capture, check and validate the UDI data in the production environment before it is transmitted to the regulatory databases. Careful checking is crucial to avoid rejections and rework.
Objective:
Ensure that all UDI data is recorded completely, correctly and consistently, and complies with regulatory requirements, so that it can be successfully submitted.
What you do:
- enter the data into firstbase PROD based on the test submission
- check the recorded UDI data for completeness and accuracy
- validate the data using the available validation functions
- correct or supplement the relevant data as required
Result:
Successfully validated and submitted UDI data that has been accepted by the regulatory databases and forms the basis for the compliant registration of your products.
Important note on data validation
Before submission, please ensure that all UDI data is complete and correct. Certain attributes cannot be amended, or can only be amended with considerable effort, once they have been submitted to the UDI database. Incorrect data may therefore lead to time-consuming correction processes.
Careful checking and validation prior to submission is crucial to avoid subsequent rework and delays.
Stage 5: Going live (live data transmission and error handling)
Once your UDI data has been successfully submitted, you will have completed the onboarding process. At the same time, your ongoing responsibility for maintaining and ensuring the quality of your UDI data begins.
Objective:
Ensure that the submitted UDI data is correctly registered and that a sustainable process for future data maintenance is established.
What you need to do:
- publish the data to the UDI database (firstbase UDI Connector GLN 7609999484735)
- check the status and feedback from the regulatory databases
- ensure that all submitted data has been processed correctly
- define an internal process for the ongoing maintenance of UDI data
- establish procedures for handling product changes, new products and corrections
- establish clear responsibilities for the ongoing maintenance of data
- plan regular quality checks of the data
Result:
A successfully completed onboarding process and an established maintenance process that ensures consistently high data quality and long-term regulatory compliance for your UDI data.
CIC notifications: meaning and handling
CIC messages (Catalogue Item Confirmation) are system-generated responses from the UDI Connector. They inform you about the status of your submitted UDI data and indicate whether it has been successfully processed or whether adjustments are required.
Aim of this section
Provide transparency regarding the status of UDI data and enable a structured approach to handling feedback, thereby ensuring long-term data quality.
You should:
- regularly check incoming CIC messages
- analyse the content and cause of each message
- identify the products and attributes affected
- correct or supplement the relevant data in a targeted manner
- re-validate the adjustments and resubmit the data if necessary
Result:
Correctly processed, high-quality UDI data with traceable feedback and a significantly reduced error rate in regulatory data submission.
Depending on the CIC status received, the submission was either successful or not. The following scenarios apply:
- “CIC ACCEPTED” is only set “internally” as soon as data has been sent. No “external” responses have yet been received from the UDI Connector or the UDI database.
- “CIC RECEIVED” is sent by the UDI database immediately after successful transmission. The item may temporarily be in “Submitted” status and has not yet been updated.
- “CIC SYNCHRONISED” is sent by the UDI database (with a delay) as soon as the final status is reached there. These items are fully “Registered” in the UDI database. Updates can now be made.
- “CIC REVIEW” is sent immediately if an error occurs during transmission through the UDI Connector or[ to the UDI database. The error can be viewed in detail under “View in Synclist” and, if necessary, corrected in the data record.
Practical guidance
- Always handle CIC messages in the context of the affected products and attributes.
- Process messages in a structured manner, ideally by priority and severity.
- A consistent approach to handling CIC messages supports both onboarding and ongoing data maintenance.
Conclusion & next steps
This section summarises what the successful completion of onboarding entails and what responsibilities remain afterwards.
Completion of the onboarding process
Once your UDI data has been successfully validated and submitted, check the feedback from the regulatory databases. If the data has been processed correctly, the onboarding process is formally complete.
This ensures that your products are registered in accordance with the regulations and that the UDI data is correct.
Ongoing data maintenance as a regulatory responsibility
UDI data is not a one-off submission; it must be kept up to date throughout the entire product lifecycle. Changes to products, new products or corrections to existing data must be captured promptly and accurately in firstbase and resubmitted.
Continuous data maintenance is crucial for ensuring long-term regulatory compliance and avoiding feedback or corrections from regulatory authorities.
GS1’s role following onboarding
Even after the onboarding process is complete, GS1 Switzerland remains your point of contact. We are here to assist you with any queries regarding the use of the firstbase UDI Connector, to help you understand feedback, and to address any procedural or technical uncertainties that may arise during day-to-day operations.
Result
A successfully completed UDI onboarding process and an established process for the ongoing maintenance of your UDI data – forming the basis for long-term, stable and compliant UDI data management.