Before the launch of the Eudamed database, applications and notifications are submitted to Fimea using the application form which can be found in MDCG 2021-08. If several devices are used in a clinical investigation, provide device information by copying pages in Section 3 and 4 as attachments and notifying information separately for each additional device.
Notifications and applications concerni ...
Applications concerning clinical investigations are sent electronically through Fimea’s secure mail service to: laitetutkimus@fimea.fi
P.O. Box 55
00034 Fimea