Step-by-step plan for a Unique Device Identifier (UDI)

To create a UDI you follow several steps.

Stappenplan

Step 1: Become a GS1 member

BEcome a GS1 member so you can create product codes (UDI-DI) for your products. You will (by becoming a member) gain access to the GS1 platform My Product Manager to be able to create these codes.

For that you need to purchase a code pack. More info

step 2

Step 2: determine the devices

Assign UDIs (Unique Device Identification) to each version or model of the medical device. Create the UDI-DI in My Product Manager with basic information.

Step 3

Step 3: Find the UDI Hero

Determine the people within your organization who are responsible for entering and publishing data.

step 4

Step 4: identify product families as well

Identify product models and/or product families with a Basic UDI.

step 5

Step 5: choose the right barcode

Place a barcode on the products. Use a GS1 DataMatrix or a GS1-128.

stap 6

Stap 6: deel je data

Collect all necessary product data using the field list. It also states which information is mandatory for the MDR or IVDR.

Share your product data with hospitals both in Belgium and other countries, or other partners. You may use My Product Manager, the central place to publish product data.

You need a My Product Manager Share subscription for that. Find all information here

Extend the product data in My Product Manager using the ECHO Data Model and publish to your partners .

step 7

Step 7: Apply for an SRN

 

Apply for an SRN (Single Registration Number) to access EUDAMED