Clinical Investigation in Denmark for MDR

bill.Kal

Starting to get Involved
#1
hi Community!
We are looking into the potential of conducting a clinical investigation for a new medical device with 3 sites in Germany, Denmark. and Netherlands. This will be a new (not an update) software added into an existing and marketed hardware.
Could someone help me find the application we would need to submit to the Danish Medicines Agency? I have been navigating into their webpage but I haven't been able to figure out if the application is available online and they are not replying to my e-mail (or I'm just using the wrong e-mail in the first place). Anyone has any feedback on potential additional requirements than the ones asked by MDR (for Denmark only; we have all the info for Germany and Netherlands)?
Any help will be much appreciated.
Thank you!
 
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Al_Z1

Starting to get Involved
#2
Just to be clear, are the requirements from ISO 14155 not enough? MDR requirements are in compliance with them, as I remember.
 
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