Governmental requirements of the
US authorities

Yes. GS1 Denmark has been designated by the U.S. authorities as the issuing agency for medical devices. As a result, we are required to identify which of our members use their GS1 membership specifically for UDI on medical devices marketed in the United States.

ALL our members have to answer yes or no - even though they are not medical devices producers.

It is important that you answer yes or no to if your GS1 Denmark membership is used for UDIs for medical devices that are sold in the U.S. or not.

In that case, it is important that you clarify with your distributor whether the products are marketed in the United States as medical devices, so you can answer the question correctly.

You should only say 'yes' if you sell medical devices in the U.S. If you only sell medical devices outside of the U.S. then you should answer 'no'.

If you answer 'no' to if your GS1 Denmark medlemskab is being used for UDI for medical devices - your company will not be included in GS1's annual report to the FDA in the United States. No further action will be taken.

If you answer yes, you will be asked to provide the name and email address of a contact person. This information will be stored by GS1 Denmark and submitted to the FDA if requested.

GS1 has no influence over the consequences (such as costs, administrative requirements, or enquiries from the U.S. FDA) if your company should have been included on this list but you answered No, or if your company should not have been included but you answered Yes.

If your answer changes, you are required to update it. You can do this in your company profile in My GS1.