GTIN
Colloquially, many know GTIN as a barcode, but technically, GTIN is the number found beneath the barcode symbol itself, and can therefore also be used for other technologies such as 2D barcodes and RFID tags.
Colloquially, many know GTIN as a barcode, but technically, GTIN is the number found beneath the barcode symbol itself, and can therefore also be used for other technologies such as 2D barcodes and RFID tags.
Ensure all your products are registered in EUDAMED before the deadline of 28 November 2026.
GS1 UDI Link gives you one secure, validated channel to all regulatory databases - directly from your existing GDSN flow.
Do you manufacture medical devices? If so, you must report up to 100 UDI attributes to EUDAMED for products already on the market no later than 28 November 2026. The rules apply immediately to new products.
Many manufacturers are already struggling with multiple systems, manual uploads, and the risk of errors - all of which are costly and time-consuming.
GS1 UDI Link has been developed by several GS1 organizations. The module connects your GS1Trade Sync data pool directly to EUDAMED and also includes an FDA GUDID connection.
During 2027, it will also become possible to submit data to the medical device databases AusUDID (Australia) and GUDID (USA).
With GS1 UDI-Link, we have established a structured path from our product data to EUDAMED. Together with GS1, we have worked our way through the entire process, from testing to reporting to EUDAMED.
Having their guidance and support throughout the journey has been invaluable.
EU legislation requires you to register your medical devices in the European database EUDAMED if you manufacture products covered by the EU Medical Device Regulations (MDR and IVDR).
The deadline for submitting data to EUDAMED is 28 November 2026 for products placed on the market before 28 May 2026.
If you have many products to register, the process can be time-consuming and complex. GS1 can help streamline your submission to EUDAMED. Through GS1Trade Sync, you can register your product data and share it with both customers and authorities - including EUDAMED - using GS1 UDI Link.
EUDAMED:
Mandatory use for new products
swissdamed:
Mandatory use for new products
EUDAMED:
The transition for UDI registration is concluding
swissdamed:
The transition for UDI registration is concluding
We have summarized the benefits of GS1 UDI Link in two short documents that you can share within your organization.
One is aimed at management and focuses on business value. The other targets regulatory teams and shows how UDI compliance becomes easier in day-to-day operations.
You can download them below.
These two guidelines help companies get started with UDI registration through GS1 UDI Link for EUDAMED and swissdamed quickly, efficiently, and with confidence.
The user is guided through the entire process, from onboarding and setup to testing, validation, live reporting, and error handling.
The guidelines cover, among other things:
For GS1 UDI Link users, the guidelines provide a practical and structured overview that helps reduce the risk of errors and makes it easier to comply with regulatory requirements.
Tested alongside leading manufacturers and GS1 organizations in several countries.
GS1 Denmark offer you advice on everything from UDI generation to data mapping.
GS1 UDI Link will be expanded to additional countries as regulatory requirements are introduced.
Data submission to medical device registries
With GS1 UDI Link, you can submit your data to EUDAMED.
In the future, additional connections will become available, enabling you to submit data to other registries, for example Switzerland, Australia, the USA, Korea, and China.
Prices for data suppliers
Annual turnover < 5 Mio Euro
30,000 DKK/YEAR
Annual turnover < 20 Mio Euro
50,000 DKK/YEAR
Annual turnover < 100 Mio Euro
80,000 DKK/YEAR
Annual turnover < 500 Mio Euro
100,000 DKK/YEAR
Annual turnover > 500 Mio Euro
Price on request
In addition, a one-time fee is charged at the start
Annual turnover < 5 Mio Euro
15.000 DKK
Annual turnover < 20 Mio Euro
20.000 DKK
Annual turnover < 100 Mio Euro
25.000 DKK
Annual turnover < 500 Mio Euro
30.000 DKK
Annual turnover > 500 Mio Euro
30.000 DKK
Below you'll find some of the questions we've already received about this service, along with our answers.
You may find the information you're looking for here. If not, please don't hesitate to contact us.
From January 2026, you can use GS1 UDI Link to submit data to EUDAMED.
If you would like to use GS1 UDI Link and get started, please fill out the form and we will contact you to arrange a kick off meeting.
