Step 1: Select your main UDI contact person
Determine who is responsible for managing the UDI-DI (Unique Device Identification) and Basic-UDI in your organisation. Especially for creating, inserting and publishing UDI-DI & Basic-UDI data.
Step 2: Estimate how many barcodes you need
How many codes do you need? Think carefully about how many variations and packaging there will be. You must purchase a code pack depending on the number of UDI-DI you will need. Better too much than too little!
Step 3: Order your product package & become a GS1 member
Get a membership to My Product Manager Identify to start using the GS1 standards, GS1 barcodes and the My Product Manager platform. You will be able to create product codes / GTIN (UDI-DI) for your products or any identification keys (GLN, GSRN, GRAI,...) you need.
It's important to understand that each variation of each product you sell requires a unique barcode. You’ll need to determine exactly how many barcodes you need before you fill out the application. You can follow the example on the left.
Each product must have its own unique code. If you sell different products, for example a medical device in different types, sizes and packaging, each type, size and packaging will have its own unique product code.
It's not always immediately clear how many product codes you will need. Think on the long term: you can always order another package later.
UDI-DIs must be assigned at all levels of the packaging. Even if you have only 1 or 2 products, we recommend that you buy at least a pack of 100 codes. Check the rates in My Product Manager.
Step 4: Follow a training
GS1 offers useful training courses.
If the date doesn't suit you, you can always follow a tailor-made training.
Step 5: Register your GTIN (UDI-DI) in My Product Manager
Assign UDI-DIs to each version or model of the medical device as well as to all different packaging levels. Create the UDI-DI in My Product Manager with basic information.
Step 6: Choose the right barcode and/or identification key
Put a barcode on your products. Choose a GS1 Datamatrix or a GS1-128.
Other useful standards are also provided by GS1, find the right identification keys that suits your needs.
Step 7: Apply for a SRN
Apply for a SRN (Single Registration Number) to access EUDAMED.
Step 8: Assign a Basic UDI-DI (only for Europe)
Identify product models and/or product families with a Basic UDI. This can be done in 2 ways, directly in Eudamed via the Eudamed pages or by using My UDI manager (part of My Product Manager Share)
Step 9: Exchanging product data in the healthcare sector
Share your product data with hospitals or other partners both in Belgium and other countries. The central place to publish product data is My Product Manager with a My Product Manager Share subscription. Expand your data using the ECHO data model. In addition you can register your Basic UDI in Eudamed (see step 10).
Step 10: Register your UDI-DI in Eudamed
This can be done in 2 ways.
- Directly in Eudamed via the Eudamed pages.
- By using My UDI Manager.
My UDI-Manager is part of the My Product Manager Share platform.
Create your Basic UDIs and enter the needed information as well as the link to the UDI-DI you have already created in My Product Manager. When all data is ready and complete, you can send it to EUDAMED.
This product is still under development and will only be available for our members.