GTIN & GS1 - what does the law say ?

C

Chani

Registered
Please advise - GS1 has outlined terms for when a new GTIN is required. On their website, they have many triggers for when a new GTIN should be assigned. One of them being adding a conformity mark (such as CE mark ) , surely this is not something that can be enforced? GS1 sells barcodes , and so to me it would make sense that they put systems in place to make you use more barcodes. Additionally, GS1 is not the regulator. Where is the _actual_ regulation guiding new GTIN triggers ? Besides the MDR , I have not seen a legal document outlining this.
 
Enghabashy

Enghabashy

Quite Involved in Discussions
For info only - regarding Egypt- EDA
 

Attachments

  • Egypt EDA -GTIN Decree قرار-499-2021.pdf
    227.1 KB · Views: 7
  • udi-guideline-13-12-2021_ Regarding Egypt.pdf
    584.1 KB · Views: 18
Enghabashy

Enghabashy

Quite Involved in Discussions
*another ref.. for Product Identifiers Under the Drug Supply Chain Security Act;
Questions and Answers-Guidance for Industry,
June 2021 Labeling
 

Attachments

  • U.S. Department of Health-FDA -36653367fnl Product Identifiers Under the DSCSA_041421.pdf
    222.4 KB · Views: 10
B

Billy Milly

Involved In Discussions
In the end, it is pretty simple. MDR requires you to use an approved (b)UDI provider. Whichever you choose, you need to respect their labelling (UDI assignment) rules. They were approved because their rules were assesed as suitable for the (b)UDI management according to MDR.
So, if you use GS1 for UDI and do not respect GS1's labelling standards, you are not complying with MDR's UDI requirements.
 
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