Eudamed data fields

[Sullen-gent]

Hello,

Is there a template or Excel document of all the information that will be requested upon implementation of EUDAMED?

I'm reviewing the guidance documents but wondered if there is an upload template akin to the one MHRA use?

Thanks,

John

 

[duinyk]

Hello, is the device module for product upload available in EUDAMED already? They had a date for May 2021 but I cant find anything in there. Just the actor module seems active.

Thanks

 

[Sullen-gent]

Hello, I have May 2022 scratched down in a note book and some (perhaps all) modules being available from Q3-4 this year (the plan for implementation is definitely available, although how much I believe the dates in it is another thing).

As a company we are quite manual so I was trying to get a head start on getting this information or at least get a feel for how big a hole I need to fill.

 

[Philip B]

Just the actor module available for now I think.

 

[Sullen-gent]

yes that right.

 

[paris]

Hello, is the device module for product upload available in EUDAMED already? They had a date for May 2021 but I cant find anything in there. Just the actor module seems active.

Thanks

not yet