Product Identifiers: 2D Matrices vs. Barcodes

M

mr.mike

#1
Hi :bigwave:

Just reading over the current EU recommendations on unique device identification and the FDA final UDI rulings:

EU ((2013/172/EU): http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:099:0017:0024:EN:pDF

FDA: https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system


Neither prescribe a particular system or standard, which is great in that new methods (hopefully) won't be stifled.
...but it's also makes choosing difficult, as there are a lot of options...

At this point, I'm leaning towards a 2D-encoding system such as the GS1 DataMatrix.
It seems the most flexible, and least invasive in terms of taking up limited label-space...

Does anyone have any experience will product identification (either with EU or FDA regulatory), based solely on a 2D matrix system (i.e. NOT a barcode)? Is it accepted? ...or is the technology still too new?

Any input much appreciated!
MM.
 

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M

mr.mike

#2
Update:

Done a fair bit of internet research on the subject...

Although I haven't yet come across any explicit testimonials of companies confronting regulatory agencies with 2D matrices in lieu of barcodes, it seems that the general thinking is that these types of coding is acceptable.

Not only acceptable, but potentially the future industry standard. The amount of information you can store in a small area far surpasses barcodes...

So my conclusion is as follows:
The 2D-matrix type identifiers (e.g. GS1 DataMatrix) are here to stay. There is nothing in the FDA nor EU regulatory device identification requirements that would question use of this technology over standard barcodes.

...still though, if anyone has experience and can confirm...

MM.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
We appreciate your letting us know what you have found out.

Thank you!
 

Wes Bucey

Quite Involved in Discussions
#4
I went through a similar research years ago and settled on the 2D system. What turned the corner for me was a visit to a UPS test lab where we were testing new packaging materials and configurations (FREE service of UPS!:applause:) and got into a conversation with the head of the lab who waxed eloquently on its virtues. We discussed this with our customers and suppliers and those few customers using bar code readers to read our shipping labels and documents said, "Bring it on! we're ready to move forward."

Our suppliers were not ready to come with us into the new age and thus we had readers and software to interpret both bar and 2D.

We did NOT barcode our individual parts, but we would have if it had been a customer requirement. I've seen some relatively inexpensive laser writers which seemed to provide elegant solutions. All our bar codes and 2D were printed with either laser jets on documents or special label stock using Zebra printers. The special materials suggested by Zebra resisted smearing from handling, weather, and "some" solvents.
 
M

mr.mike

#5
You didn't label the individual devices?

Maybe it's the type of product, but for us the product is medical electrical systems, and I was under the impression that it was a regulatory requirement that the device labels themselves each bear identificaton...

I could be mistaken, however...
 

Wes Bucey

Quite Involved in Discussions
#6
We didn't make the device, we made components, except for titanium bone screws - engraved serial number per customer requirement, not bar code. Even then, we were custom manufacturers on ALL our products - the design was made and owned by the customer, BUT we did do "value added" concurrent engineering with suggestion to customer for improvements to make for more efficient manufacturing. If customer accepted and incorporated our suggestions, it was still HIS design.
 
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