My Basic UDI-DI Manager from GS1 Belgilux makes publishing to EUDAMED easy, thanks to data validation, a test environment and a direct connection to EUDAMED.
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What is EUDAMED and why is registration mandatory?
EUDAMED is the European database for medical devices, managed by the European Commission. Under the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR), manufacturers must identify and register their medical devices in this database.
If you miss the deadlines below, you risk being non-compliant.
Two important deadlines
for new medical devices
Final date to register new medical devices.
for legacy medical devices
End of the transition period for products that were on the market before 27 May 2026.
Benefits of My Basic UDI-DI Manager
Built-in data validation
Errors are detected before EUDAMED rejects them. No surprises afterwards.
Bulk function
Manage product families and data more efficiently thanks to our built-in features.
Direct connection with EUDAMED
Data flows directly from our tool to EUDAMED. No manual copying.
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Frequently asked questions
Since 26 May 2021 under the MDR and from 26 May 2022 under the IVDR.
View the prices here.
Yes, you can already create an account via My GS1.
You can do this via My GS1.
The Basic UDI-DI is required to identify a medical device as a product family. Basic UDI-DI is a term used by the European Commission. Global Model Number (GMN) is the standard that GS1 has developed for this purpose.
The UDI is the unique product identification and is different for each product with, for example, a different content, language, shape or colour. Using the GS1 GTIN Allocation Rules, you can determine how many product codes you need. A Basic UDI-DI identifies a group of products, in which each product in the group has its own UDI. The UDI must be printed on the product in barcode format; the Basic UDI-DI is not printed on the product packaging.
Yes, thanks to My Basic UDI-DI Manager, you create or modify data in bulk using our different tools.
For the Basic UDI-DI, GS1 has developed the standard Global Model Number (GMN). The manufacturer of the medical device is responsible for creating the Basic UDI-DI. You can calculate this number with the calculation tool. To do this, you need a company number from a GS1 code package. Take the company number from your code package, add an internal model reference to it and the calculation tool will then calculate 2 control characters across the board. For the internal model reference, you can use any digits and letters from Figure 7.11-1 in the GS1 General Specifications. In total, the GMN may not contain more than 25 characters (23 + 2 control characters).
Please consult Med Tech Europe for assignment of Basic UDI-DI
With My Basic UDI-DI Manager, you receive feedback from EUDAMED immediately after publication. You easily resolve error messages and republish. An advantage: you can also do this in bulk for multiple products at the same time.