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?

Incident reports

Professional users can report incidents to Fimea either with through the Fimea electronic interface used by the organization or sending a PDF form below to: [email protected].
- Medical Device Professional User’s Incident Report (pdf)
In urgent cases, the notification can first be made by phone (029 522 3341). However, the notification must also be submitted in a written format without delay.

Further information: Laitteet sosiaali- ja terveydenhuollossa – Vaaratilanteista ilmoittaminen (Social and health care devices – Reporting of incidents, in Finnish only)
The requirements of the incident reporting procedure for medical devices depend on the type of the medical device concerned and the regulatory basis on which the device was placed on the market. Adverse incidents according to MDD/IVDD and the serious incidents according to MDR/IVDR shall be notified to FIMEA via MIR-form.
- Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD), comission webpage
- Instructions for filling out the form: Helptext
- Hint: if the form does not open in your browser, download it on your computer and open it with a PDF reader.
Other incident reports for manufacturers can be found under “Manufacturer's incident reporting procedure”.

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?