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3 articles
UDI & Labelling
Device identification requirements under EU MDR
Basic UDI-DI vs UDI-DI
Understand the difference between regulatory grouping and device-level identifiers.
Prepare IFU and label source inputs
Provide the warnings, symbols, claims, and language information needed for review.
Prepare EUDAMED and publication inputs
Collect the identifiers and public-facing device information needed for registration and publication.