Uncertainty or questions on the subject of ‘How and where do I obtain a UDI’ regularly come to us. In a brief and clear form, we show you a possible way and provide you with further links for more in-depth information
What is the meaning of a UDI?
The Unique Device Identification enables the identification and traceability of medical devices. For example, it improves the effectiveness of safety-related activities (incident reports) and applies to all devices placed on the market (exceptions are customised products and investigational devices).
In the following, we illustrate a possible situation as an explanatory example for you.
Your initial situation
You are a manufacturer of a Class I medical device. The next steps for you would be as follows (using GS1 as an example - this can also be done similarly with one of the other notified bodies):
Actor Registration and SRN
You can register as a manufacturer under the following link and apply for the SRN (Single Registration Number).
There you will also find further information on the required documents to be submitted and on the Local Actor Administrator (LAA).
The UDI system
The UDI system to be implemented basically consists of 4 steps:
- Application for the basic UDI-DI at a designated allocation centre (this must be implemented relatively promptly so that the 2nd step can take place)
- Indication of the assigned Basic UDI-DI in your declaration of conformity
- Indication of the assigned Basic UDI-DI with the product registration in the UDI database of EUDAMED (possible as soon as the EUDAMED UDI database goes ‘live’)
- Attachment of UDI tags, machine and human-readable codes in accordance with the UDI system (with product and production-specific parts UDI-DI/UDI-PI on the devices and/or their packaging; ; to be implemented for Class I devices by 25 May 2025 at the latest)
- The UDI consists of two parts: the UDI-DI and the UDI-PI
- UDI-DI: product identifier specific to the manufacturer and the product; Device Identificator
- UDI-PI: DI production identifier; Production Identifier
The basic UDI-DI as well as the UDI-DIs can be applied for and obtained via the following allocation centres (it is up to you which one you choose) :
What we know about this:
With the help of the manufacturer ID assigned there, the basic UDI-DI(s) can be generated directly via their website and, in addition, GTINs/EANs can be issued as UDI-DIs (in the form of barcodes) via their ‘GTIN Manager’ in accordance with the requirements of the UDI system.
You may already be a customer of one of the allocation centres, which would simplify the procedure.
You can also find more information on the UDI system directly from the allocation centres mentioned above. Many are with GS1 and have the ‘GS1 Complete“.
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