EUDAMED device registration

[justinabm]

Hi Everyone,
I am trying to understand the meaning of the following statement from the EUDAMED device registration form:

“Member State where the Device is to or has been first placed on the EU market:”

Does it mean:

1. The country where the device was imported to for the very first time? Which might be a long time ago and probably not recorded anywhere.
2. The country in the EU where each instance/shipment of the device will enter first before getting distributed elsewhere in the EU. We have multiple importers in different EU countries importing the same device. Which country should I select?

Any clarity would be greatly appreciated

 

[BusyBee]

Hi, I have registered on EUDAMED and you can tick any country in EU that you import to and then additionally add all the others that apply. I ticked all, as we may end up in any EU country,
Hope that helps.

 

[Orca1]

Hi Everyone,
I am trying to understand the meaning of the following statement from the EUDAMED device registration form:

“Member State where the Device is to or has been first placed on the EU market:”

Does it mean:

1. The country where the device was imported to for the very first time? Which might be a long time ago and probably not recorded anywhere.
2. The country in the EU where each instance/shipment of the device will enter first before getting distributed elsewhere in the EU. We have multiple importers in different EU countries importing the same device. Which country should I select?

Any clarity would be greatly appreciated


View attachment 29429

The statement "Member State where the Device is to or has been first placed on the EU market" in the EUDAMED device registration form refers to the country within the European Union where the medical device is first made available on the market. This could be the country where the device is imported for the first time or the country where each instance/shipment of the device enters the EU before being distributed to other EU countries.

In your case, since you have multiple importers in different EU countries importing the same device, you should select the country where the device was first made available on the EU market. This may not necessarily be the country where the device was imported for the very first time, but rather the country where the device was first placed on the market within the EU.