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UDI – In a Nutshell

Uncertainty and questions in regards to „How and where do I obtain a UDI“ have been frequently brought to us in recent months. In a short overview we will show you a possible way and provide you with relevant links to for further reading.

What does UDI mean?

Unique Device Identification (UDI) enables the identification and traceability of medical devices. For example, it improves the effectiveness of safety-related activities (incident reports) and applies to all products placed on the market (exceptions are custom-made products and test products).

With the following explanatory example we will illustrate a possible scenario.

Context

You are a manufacturer of a class I medical device. The next steps for you would be as follows (e.g. GS1 – this can also be done similarly at one of the other named allocation offices):

Actor Registration and SRN

You can register as a manufacturer under the following link and apply for the SRN (Singe Registration Number).

Registration

There you will also find further information on the documents required and to be submitted as well as on the Local Actor Administrator (LAA).

The UDI System

The UDI system to be implemented basically consists of 4 steps:

  1. Application for the basic UDI-DI at a designated allocation office (this ought to be implemented relatively promptly, so that the 2nd step can take place)
  2. Specification of the assigned Basic UDI-DI in your Declaration of Conformity
  3. Specification of the assigned Basic UDI-DI with the product registration in the UDI regulatory database of EUDAMED (possible, as soon as the EUDAMED UDI database goes „live“)
  4. Attaching UDI data carriers, machine – and human readable codes in accordance with the UDI system (with product- und production specific parts UDI-DI/UDI-PI on the product and/or its packaging; for class I products to be implemented until May 25th, 2025 at the latest)
  • The UDI is made up of two parts: the UDI-DI and the UDI-PI
  • UDI-DI: manufacturer and product specific UDI-product identifier; Device Identifier
  • UDI-PI: DI-manufacturing identifier; Production Identifi
UDI Barcode

Image source: UDI barcode example GS1-128

 

The Basic UDI-DI but also the UDI-DIs can be requested and obtained from the following allocation offices (which one you choose is up to you) :

What we know about this:
With the help of the manufacturer ID astigen drehe, the Basic UDI-DI (s) can be generated directly via their website and las via Thera „GTINsManager“ GTINs / EANs conforming to the requirements of the UDI system as UDI-DIs can be issued ( in the form of barcodes).
You may already be a customer of now of the allocation offices, which would simplify the procedure.

Further information on the UDI system can also be found directly at the allocation offices mentioned above. Many manufacturers are at GS1 and have the „GS1 Complete“ there.

 

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