Attention medical device operators: check the information submitted to the register by 31 December 2025

Medical device operators are obliged to notify Fimea of any relevant changes in the information they have provided. Please ensure that your organisation’s operator information is up to date in Fimea’s CERE register or the European Commission’s EUDAMED database by 31 December 2025 at the latest. 

The supervision fee for 2026 is based on the information available in the register on 31 December 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 to be confirmed for 2026 will be determined based on the information submitted to the register by the end of 2025. 

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.

We will charge the supervision fee unless the operator has submitted a notification of the termination of registered activities via e-submission to the CERE register or the EUDAMED database by 31 December 2025. 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 operator’s activities have ceased by 31 December 2025.

More information about submitting information to the register:

Device and operator notifications to Eudamed (European database on medical devices) 

Device and operator notifications to CERE (national register of medical device operators and their devices maintained by Fimea) 

For more information, please contact:

Sari Tuomaala, coordinator, control and registration of medical devices,
tel. +358 29 522 3280

Operator and device registration: [email protected]

Email addresses are in the format [email protected]