A new UDI-DI (GTIN) shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI (GTIN): name or trade name, device version or model, labelled as single-use, packaged sterile, need for sterilization before use, the quantity of devices provided in a package, critical warnings or contra-indications: e.g. containing latex or DEHP.
IMPORTANT: The EU MDR and IVDR requirements supersede the GS1 Healthcare GTIN allocation rules and GS1 General Specifications.
You can find through the links below the MDR and IVDR UDI and device data sets to provide in EUDAMED (NOT FINAL, subject to change). Changes in one of these data attributes would trigger a new UDI-DI (GTIN) and/or Basic UDI-DI (GMN).
https://ec.europa.eu/docsroom/documents/35241
https://ec.europa.eu/docsroom/documents/35242
A change of UDI-DI does not automatically trigger a change of Basic UDI-DI. Please check the list of data attributes that trigger a new Basic UDI-DI in the links provided.
The European Commission has provided and is regularly updating guidance on the UDI-DI/Basic UDI-DI changes.
To find the latest information, please regularly check the Medical Device Coordination Group documents here: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
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