Medical device operator: Check your registered information to confirm the supervision fee for 2025

Fimea collects an annual supervision fee from the medical device operators subject to the reporting obligation in accordance with section 50 of the Medical Devices Act (719/2021). The supervision fee is charged from each of the registered roles separately. For example, if you act as a distributor and manufacturer, you will receive an invoice with two supervision fees.

Operators are obliged to notify Fimea of any relevant changes in the information they have provided. Please ensure that the information in the register is up to date by 31 December 2024, as we will determine the supervision fee to be confirmed for 2025 on the basis of the information reported to the register by the end of 2024. We will charge the supervision fee unless the operator has submitted a notification of the termination of registered activities electronically to the CERE register or the EUDAMED database by 31 December 2024. The notification to CERE can also be submitted to Fimea in writing. However, no supervision fee will be charged if Fimea has otherwise found that the activities have ceased by 31 December 2024.

This is why we remind operators to check the information in the registers before the turn of the year. 

Device and operator notifications to EUDAMED 

Device and operator notifications to CERE 

Fimea’s old device register discontinued

Fimea also announces that the old device register is no longer in use. Device notifications made to the old device register have been removed with the register. Operators must submit all necessary notifications of their activities and devices to the CERE register or the EUDAMED database (section 49 of the Medical Devices Act (719/2021) (Finlex, available in English) and Fimea regulation 2/2021 (Finlex, in Finnish)).