UDI Label Verification - How do we ensure the barcode is correct and prove it?

C

cabjerk

#1
Hello,

From the FDA view point "how do you ensure that barcode will print out correct each and every time?" Our systems have been validated, but how do we ensure the barcode is correct and prove it?

If this has been asked before please send me the link. Did a search and could not find anything.

Any feedback on this will be great?

Thank you,
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
Here are links to few previous threads:

UDI (Unique Device Identification) Verification Requirements



820.120 UDI (Unique Device Identification) Labeling Verification Requirements


UDI (barcode, datamatrix) Verification Solutions

As I recall, there was no consensus, other than that the safest (and, of course, most expensive) option is to invest in some sort of automated equipment. Every single barcode need not necessarily be checked, but perhaps the first and last off a batch might be a suggestion, depending on product/volume/capabilities...

MM.
 
Last edited:
J

JJLit

#3
The direction that we took was to buy a calibrated verification unit. For our purposes, scanning each barcode works very well. The unit produces a report with the barcode quality grade. You can automate these units in any way that you want.
 

Haddad9921

Starting to get Involved
#4
Hi,
I don't know if this is the right place to ask this question. I am looking for a barcode challenging procedure to test for accuracy of readability. This is a requirement for food packaging manufacturers. Let me know if you have one you can share or if you can direct me to where I can find one.
Thank you
 

Mark Meer

Trusted Information Resource
#5
Suggest checking the links to other threads I posted previously here (Post #2), where this has been discussed.

I'd attempted to justify a more simplified procedure that does not involve specialized equipment...but I think the general consensus is that some sort of dedicated barcode verification equipment/scanner is necessary. How often you want to verify is up to you. You can setup an automated system that checks every label off the production line, or setup a system of spot-checking (for example, maybe the first and last label for every batch).
 
#6
I apologize for resurrecting' a 4 year old thread but this has come up recently in my company I wonder if anyone has more input. We purchased an expensive verifier back in 2016 when we implemented the UDI. It cost about $10,000 and required annual calibration of $1500. The verifier is outdated and we are presented with the need to purchase another one or stop verifying this way. As people have mentioned in this thread and others, these verifiers are the most "compliant" way to go but I am having a hard time justifying this kind of expense. Also, I was just reading the FDA's final guidance document on UDI that was issued July 7 2021, it doesn't even mention verification. Does anyone have a work around for not using a verifier and how did they justify it?
 

LUFAN

Involved In Discussions
#7
I apologize for resurrecting' a 4 year old thread but this has come up recently in my company I wonder if anyone has more input. We purchased an expensive verifier back in 2016 when we implemented the UDI. It cost about $10,000 and required annual calibration of $1500. The verifier is outdated and we are presented with the need to purchase another one or stop verifying this way. As people have mentioned in this thread and others, these verifiers are the most "compliant" way to go but I am having a hard time justifying this kind of expense. Also, I was just reading the FDA's final guidance document on UDI that was issued July 7 2021, it doesn't even mention verification. Does anyone have a work around for not using a verifier and how did they justify it?
I had a customer that wanted us to use a verifer but we pushed back and said that getting a barcode report that grades its did not add any value to us and we could not justify the cost. Instead, we worked out an arrangement that we would send first articles to them so that they could perform one with their equipment. I really don't think its necessary at all, and instead I'd argue the requirement is nothing more than the transmission of the human-readable information on the label. To me, and everyone auditor/other customer I've worked with, they want to scan a barcode and confirm that the information matches. I think as far as an inspection goes, that's meets the requirement assuming the data is correct.
 

DitchDigger

Starting to get Involved
#8
A small Class I company I was at couldn't handle the amount of time and money it would have taken to do in-house verification scanning activities for every run of UDI-carrier labels they printed themselves. They went the route of validating the controlled process of printing UDI-carrier labels instead of scanning the outputs each time. Labels were still getting visually inspected during final release as they were before for inaccuracies and defects (now including looking for scoring or smudging on the barcode), but didn't include any scanning.

Whether an FDA auditor would have an issue with this approach is still up in the air as far as I can tell. And in my experience, the amount of scrutiny a process validation gets depends on the auditor.
 
#9
The direction that we took was to buy a calibrated verification unit. For our purposes, scanning each barcode works very well. The unit produces a report with the barcode quality grade. You can automate these units in any way that you want.
Can you tell more about this tool, like the brand or manufacturer etc?
 
Thread starter Similar threads Forum Replies Date
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
Pmarszal Label Printing: Medical Device related UDI Requirements - GUDID Aspects Other US Medical Device Regulations 0
J Adding a UDI Compliant Label to previously manufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R UDI dates EUDAMED EU Medical Device Regulations 0
I UDI in Europe and US EU Medical Device Regulations 3
G UDI in EU vs FDA EU Medical Device Regulations 1
G UDI or not? EU Medical Device Regulations 0
M UDI IVD - before submission? US Food and Drug Administration (FDA) 2
N UDI for OTS Components Other US Medical Device Regulations 1
J Assigning UDI's for own brand products EU Medical Device Regulations 11
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
E UDI on product/packaging levels EU Medical Device Regulations 7
O 14-digits UDI EU Medical Device Regulations 3
L Looking for SOP Template for UDI under MDR EU Medical Device Regulations 4
P MDR Article 27 - UDI - Keeping records of UDIs EU Medical Device Regulations 1
S BASIC UDI-DI for a class IIa device marketed in a Procedure kit EU Medical Device Regulations 1
C UDI assignment and labeling. EU Medical Device Regulations 4
C Labelling and UDI Requirements - Implications of serial numbers US Medical Device Regulations 1
D Basic udi-di to not appear on IFU? EU Medical Device Regulations 4
R Legacy Device UDI Requirements EU Medical Device Regulations 5
R UDI Requirement at home patient use EU Medical Device Regulations 2
P UDI on devices exclusively intended for retail point of sale EU Medical Device Regulations 3
J UDI and Labelling hierarchy and requirements for separate device components EU Medical Device Regulations 7
M UDI barcode quality EU Medical Device Regulations 3
C How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)? Other US Medical Device Regulations 4
C Issues with UDI-DI and LAA/LUA registration in Eudamed EU Medical Device Regulations 2
Watchcat Mobile app - Different UDI for different smartphones? Other US Medical Device Regulations 7
Watchcat One UDI per country? ISO 13485:2016 - Medical Device Quality Management Systems 3
Watchcat UDI Timeframes? Other US Medical Device Regulations 7
A UDI-PI for IVDs used in house EU Medical Device Regulations 5
G SRN, Basic UDI, Legal Manufacturer EU Medical Device Regulations 6
A Basic UDI and UDI-DI for hip implant systems EU Medical Device Regulations 1
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
R UDI Number Identification EU Medical Device Regulations 5
I Eudamed UDI-Module EU Medical Device Regulations 9
L Configurable UDI mdr EU Medical Device Regulations 0
L UDI implementation in Saudi Arabi (KSA) Other Medical Device Regulations World-Wide 1
L UDI-DI - Device will be sold by itself in a box EU Medical Device Regulations 2
P Basic UDI-DI and Legacy Devices EU Medical Device Regulations 19
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 7
K UDI for two units with different S/N on the same package/case Other US Medical Device Regulations 10
C Validation of process for releasing the UDI EU Medical Device Regulations 4
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
L UDI needed when we submit to ON? EU Medical Device Regulations 5
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
A UDI for product already packed up EU Medical Device Regulations 0
M Brand owner or manufacturer responsible for Basic UDI-DI and UDI-DI? EU Medical Device Regulations 8
Aymaneh UDI-PI Software CE Marking (Conformité Européene) / CB Scheme 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0

Similar threads

Top Bottom