-
What triggers a new UDI-DI (GTIN) under MDR and IVDR? Does a new UDI-DI (GTIN) automatically trigger a new Basic UDI-DI (GMN)?
-
ISO and GS1 date convention is different, what convention should I use?
-
How to identify a configurable device under EU MDR and IVDR?
-
How do I identify a software as a medical device under the EU UDI requirements?
-
How to identify a kit/system or procedure pack under UDI requirements in the EU and the US?
-
Is it possible to continue selling medical devices that are already on the EU Market after the MDR/IVDR application deadlines?
-
Should GTINs and Application Identifiers (AI) be included in the Human Readable Information (HRI) of the data carriers of the UDI as well as in the machine-readable format?
-
Are there any exemptions allowed?
-
It seems that several GS1 MOs are requesting their own GUDID (US FDA UDI regulatory database) accounts, is this practice part of the FDA policy?
-
As barcode verification is hard on small ampules when the label is on the product, can verification be done before?