Hello Shivani,
Always remember that UDI is from the customer facing point of view. If a change to the labelling including change to language, adding language, or deleting language, could be perceived to the customer/user as a new product. The wording you will find in regulations and even help guides from Issuing Entities is not too specific, but Valentina's quote is correct that if can impact the safety, identity, or traceability of the product, then a new UDI might be required.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 21-Oct-2022 04:32
From: Valentina Faziani
Subject: Change to UDI-DI
Hi Shivani,
as per Guidance "MDCG 2018-1 Rev.4 Guidance on BASIC UDI-DI and changes to UDI-DI" (April 2021), changes of colour or language might require a new UDI-DI when those changes might lead to misidentification of product or change the product safety/performance.
Specifications of EU designated issuing entity should be used as a reference source to identify other possible examples.
Hope it was helpful.
Best regards
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Valentina Faziani
Regulatory Affairs Specialist
Thema s.r.l.
Italy
Original Message:
Sent: 21-Oct-2022 01:03
From: Shivani Patel
Subject: Change to UDI-DI
Hello,
Will a change in language of label, lead to change in UDI-DI?
Thank you in advance.
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Shivani Patel
Jr Regulator Executive
Ahmedabad
India
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