Hello Anon
Fimea instructions are here (in English):
https://fimea.fi/en/medical-devices/registrations
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Anne LeBlanc
United States
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Original Message:
Sent: 08-Mar-2024 11:55
From: Anonymous Member
Subject: MD registration - Denmark & Finland
This message was posted by a user wishing to remain anonymous
Hello RAPS Community,
Do Finnish and Danish manufacturers have to register the medical device, independently of a class of the device, in their own national database or is it sufficient to do it in EUDAMED?
If registration is required to be done in Finnish and Danish national databases as well, who is the registration body in those countries?
And how to proceed in terms of legacy devices?