Life Sciences Blog

What is a UDI label and UDI requirements?

by | Nov 22, 2021

What is UDI?

Unique Device Identification is a globally unique, unambiguous identification comprised of a Device Identifier (DI) and a Production Identifier (PI).  UDI is specific to a device model and version of that device on the market.

How Do You Create the UDI?

The actual product owner is responsible for creating the identifier based on an approved standard.  First step is to generate a device identifier, the mandatory fixed portion that’s always present in the UDI. It identifies the labeler, the actual manufacturer and it points to a particular model version. The second part of the UDI number is a production identifier and it is conditional.  Some production controls may be on the label itself, such as manufacturing date, expiration date, lot or batch number or serial number.  These two identifiers added together comprise the UDI. Sometimes, the production identifier is conditional and may not be included in the UDI at all.

How is UDI presented on a label?

The UDI information is most commonly presented in a linear barcode so the full UDI Device ID first and the Production ID next.  Another option is a two-dimensional matrix as an acceptable standard. The requirement is that the text encoded in that barcode is also presented in human readable form so you can see it on a single line or it can be on multiple lines.  

What are the Industry Issuing Agencies?

GS1,  HIBCC, ICCBA, IFA (Germany-Europe)

If my device already has a UDI and a label, do I need a new label for each regional market or can I use one label universally?

The short answer is yes for UDI, however there can be nuances region to region with labels. See the answer and some examples of different labels based on scenario in this 3 minute Reed Tech Insight.

 

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