Medical Devices - Standard Format for Barcoding in EU

[newtothejob]

Has there been any official regulatory developments regarding a standard format for barcoding in EU?
Thanks.

 

[Michael Malis]

Re: medical devices - standard format for barcode

In EU, GS1 keys approved for global use. Most of EU (Spain had their own version) adapted GS1-128 code. Previously known as EAN-128 and is available and use in 2D and 3D format also. Most of the scanners today use standard DataBar but more and more medical folks choose "2D matrix" because if the space considerations.

FDA also is in-process of adapting GS1-128 as part of the UDI (unique device identifier) program.

I hope this helps,
Michael

 

[newtothejob]

Thanks Michael.

From a quick research, I found that HIBC and GS1 bar code are both being prioritized for UDI.
Which are the differences between the two data structures?

Thanks,
Vale