Regulatory Open Forum

We are a manufacturer of a class 1 medical device who are printing our own labels in-house (therefore, not using a contract labeler).  We are using a bar code form of AIDC to comply with the FDA UDI requirements.  As such, FDA guidance requires that the bar code should be tested for print quality.  Wondering how other manufacturer's who print their own barcodes comply with this requirement.  Also, does anyone have experience with barcode verifiers, do you use one to measure print quality or are there other methods to measure print quality?

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Sandra Veenstra
Director - Quality Assurance and Regulatory Affairs
Moncton NB
Canada
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Hello Sandra,

There are other methods for confirming bar code quality which are defined in some of the various ISO standards which address bar codes.  Personally, I have used a bar code verifier - yes it is an investment to get one - but they are definitely the best method to verify bar code quality.  Also note there is a difference between bar code readers, calibrators, and verifiers - a bar code verifier is definitely the best for confirming bar code quality and content.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 05-Oct-2022 08:55
From: Sandra Veenstra
Subject: UDI - Barcode Verification

We are a manufacturer of a class 1 medical device who are printing our own labels in-house (therefore, not using a contract labeler).  We are using a bar code form of AIDC to comply with the FDA UDI requirements.  As such, FDA guidance requires that the bar code should be tested for print quality.  Wondering how other manufacturer's who print their own barcodes comply with this requirement.  Also, does anyone have experience with barcode verifiers, do you use one to measure print quality or are there other methods to measure print quality?

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affairs
Moncton NB
Canada
------------------------------

Thank you Richard, we had initially looked into purchasing a barcode verifier and thought it would be more cost effective to use a third party as we are manufacturing in small batches.  Do you have a recommendation or specification of a bar code verifier you could share?

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Sandra Veenstra
Director - Quality Assurance and Regulatory Affairs
Moncton NB
Canada
------------------------------

Original Message:
Sent: 06-Oct-2022 06:14
From: Richard Vincins
Subject: UDI - Barcode Verification

Hello Sandra,

There are other methods for confirming bar code quality which are defined in some of the various ISO standards which address bar codes.  Personally, I have used a bar code verifier - yes it is an investment to get one - but they are definitely the best method to verify bar code quality.  Also note there is a difference between bar code readers, calibrators, and verifiers - a bar code verifier is definitely the best for confirming bar code quality and content.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 05-Oct-2022 08:55
From: Sandra Veenstra
Subject: UDI - Barcode Verification

We are a manufacturer of a class 1 medical device who are printing our own labels in-house (therefore, not using a contract labeler).  We are using a bar code form of AIDC to comply with the FDA UDI requirements.  As such, FDA guidance requires that the bar code should be tested for print quality.  Wondering how other manufacturer's who print their own barcodes comply with this requirement.  Also, does anyone have experience with barcode verifiers, do you use one to measure print quality or are there other methods to measure print quality?

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affairs
Moncton NB
Canada
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Sandra,

We use GS1 and we send the printed label with the matrix and HRI to GS1 for testing. They can advise whether the size and quality of the printed code/matrix provide good readability. First time they normally do for free, after which they may charge you a nominal fee for re-testing if any changes are made.
Original Message:
Sent: 05-Oct-2022 08:55
From: Sandra Veenstra
Subject: UDI - Barcode Verification

We are a manufacturer of a class 1 medical device who are printing our own labels in-house (therefore, not using a contract labeler).  We are using a bar code form of AIDC to comply with the FDA UDI requirements.  As such, FDA guidance requires that the bar code should be tested for print quality.  Wondering how other manufacturer's who print their own barcodes comply with this requirement.  Also, does anyone have experience with barcode verifiers, do you use one to measure print quality or are there other methods to measure print quality?

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affairs
Moncton NB
Canada
------------------------------

Thank you, I am curious whether you send your samples to GS1 Canada, US or other?  Did it matter whether they had generated the barcode that is being verified?

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affairs
Moncton NB
Canada
------------------------------

Original Message:
Sent: 05-Oct-2022 20:59
From: Anonymous Member
Subject: UDI - Barcode Verification

This message was posted by a user wishing to remain anonymous

Hi Sandra,

We use GS1 and we send the printed label with the matrix and HRI to GS1 for testing. They can advise whether the size and quality of the printed code/matrix provide good readability. First time they normally do for free, after which they may charge you a nominal fee for re-testing if any changes are made.
Original Message:
Sent: 05-Oct-2022 08:55
From: Sandra Veenstra
Subject: UDI - Barcode Verification

We are a manufacturer of a class 1 medical device who are printing our own labels in-house (therefore, not using a contract labeler).  We are using a bar code form of AIDC to comply with the FDA UDI requirements.  As such, FDA guidance requires that the bar code should be tested for print quality.  Wondering how other manufacturer's who print their own barcodes comply with this requirement.  Also, does anyone have experience with barcode verifiers, do you use one to measure print quality or are there other methods to measure print quality?

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affairs
Moncton NB
Canada
------------------------------

Hi Sandra,

 

We make a software that allows you to verify Barcodes (any many other items) prior to printing. https://www.schlafenderhase.com/products

 

For verification of printed labels, the most popular solution I have seen in use at my customers is; https://webscaninc.com/applications/udi-compliance/

 

Both of the above can be Validated.

 

Hope this helps!

Peter

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PETER MULLER
Cambridge MA
United States
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Original Message:
Sent: 05-Oct-2022 08:55
From: Sandra Veenstra
Subject: UDI - Barcode Verification

We are a manufacturer of a class 1 medical device who are printing our own labels in-house (therefore, not using a contract labeler).  We are using a bar code form of AIDC to comply with the FDA UDI requirements.  As such, FDA guidance requires that the bar code should be tested for print quality.  Wondering how other manufacturer's who print their own barcodes comply with this requirement.  Also, does anyone have experience with barcode verifiers, do you use one to measure print quality or are there other methods to measure print quality?

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affairs
Moncton NB
Canada
------------------------------

Hi Sandra.

Just a quick question on this - why not simply purchase a barcode scanner that can be used to scan the codes yourself on your product?  They sell these as handheld devices and the readout displays directly on the screen of the device in front of you.  You can then verify: (1) that the code is readable; (2) that the code reads correctly; and (3) that the code on the display matches the code on the package itself.  We used to do this all the time in a company I worked for previously and it worked just fine.

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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
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Original Message:
Sent: 05-Oct-2022 08:55
From: Sandra Veenstra
Subject: UDI - Barcode Verification

We are a manufacturer of a class 1 medical device who are printing our own labels in-house (therefore, not using a contract labeler).  We are using a bar code form of AIDC to comply with the FDA UDI requirements.  As such, FDA guidance requires that the bar code should be tested for print quality.  Wondering how other manufacturer's who print their own barcodes comply with this requirement.  Also, does anyone have experience with barcode verifiers, do you use one to measure print quality or are there other methods to measure print quality?

------------------------------
Sandra Veenstra
Director - Quality Assurance and Regulatory Affairs
Moncton NB
Canada
------------------------------