Debbie1228
Registered
Hello everyone,
I’m looking for perspectives on a UDI/GTIN and labeling strategy question in an IVD / CDx context.
We are trying to design a future-state variant and labeling model that avoids unnecessary SKU proliferation while remaining regulatorily defensible and auditable.
Context:
Outside the EU, is it considered acceptable in practice to:
I’m looking for perspectives on a UDI/GTIN and labeling strategy question in an IVD / CDx context.
We are trying to design a future-state variant and labeling model that avoids unnecessary SKU proliferation while remaining regulatorily defensible and auditable.
Context:
- Same physical IVD kit (same reagents, same composition)
- Chemical hazard (GHS/CLP or equivalent) differences are already understood to force physical kit splits
- Intended use / clinical indication may expand over time and may be approved at different times in different non-EU markets
- EU IVDR is out of scope for this question
Outside the EU, is it considered acceptable in practice to:
- Maintain a limited number of physical kits / GTINs (driven primarily by hazard regime differences), and
- Manage country-specific intended use differences via controlled IFUs (paper or eIFU),
- Provided that traceability is robust (i.e. clear evidence of which IFU and intended use was placed on which market for a given GTIN and lot)?Or, in your experience:
- Do intended-use differences typically force a new regulatory identity / GTIN, even when the physical product is unchanged?
- How regulators outside the EU tend to view this (e.g. Health Canada, ANVISA, TGA, Singapore HSA, etc.)
- How companies define the decision point between “same GTIN + IFU variation” vs “new GTIN / variant”
- Any audit or inspection experiences where this approach was accepted
