Notifications and applications
Fimea’s Medical Devices Unit is responsible for supervising the regulatory compliance of medical devices and for promoting their safe use. Central tools in the supervisory work are the statutory notifications or applications. Below is a list of notifications and applications filed in respect of devices. In principle, a fee is charged for all notifications made to Fimea. More information can be found on the “Fees” page.
Incident reports
Before sending an incident report, please check the following:
- Does the observed event meet the definition of an incident?
- Who should be notified of the incident?
- What form should be used for reporting the incident?
Notification of a medical device operator and a device
Before selling medical devices, placing them on the market or making them available on the market, an operator liable to submit a notification must notify Fimea of their operation and the devices. The notification can be made to the CERE register or the Eudamed register. Any amendments concerning the notification or ceasing of operations must be made to the same register as the notification.
You can find more information about submitting a notification on the “Device registrations” page.
In questions concerning registration, please contact Fimea at: [email protected]. In case of problems, errors or bugs in EUDAMED, please contact the Eudamed support team: [email protected].
E-submissions for medical devices
Fimea uses e-submissions for the CERE register, but everything cannot yet be managed in the e-service. Some of the notifications must still submitted to the register using PDF or excel forms. Before submitting the notification, check the section "Where do I report my information; to the CERE or EUDAMED register?", see if you can you submit the notification in e-submissions or should you use forms to submit the notification to CERE or EUDAMED?