Fees for medical devices

Fees for medical devices

The Ministry of Social Affairs and Health has issued a decree on the fees chargeable under public law by the Finnish Medicines Agency Fimea. The current Decree (1282/2023) is in force until 31 December 2024. Fimea’s expenditure is mainly covered by fees generated by supervisory and service activities.  

The fees specified in Sections 5, 7, 11 and 12 of the Annex to the Decree on fees chargeable by the Finnish Medicines Agency apply to Fimea’s supervision activities concerning medical devices. 

In addition to the above Decree, the national Medical Devices Act 719/2021 defines annual supervision fees. Supervisions fees payable to Fimea apply to operators registered in the Eudamed or CERE register.

Fees for medical devices

Fees for medical devices

Authorisations and notifications concerning medical devices

Fees for medical devices

Fees for medical devices

Fees for clinical investigations of medical devices

Chargeable performances

Fees for medical devices

Fees for medical devices

Performances free of charge

According to Section 2 of the Decree on fees chargeable by the Finnish Medicines Agency, no fees are charged for processing and reviewing a notification or authorisation application relating to clinical trials on a medical device or performance evaluation studies on in vitro diagnostic medical devices conducted by an individual investigator, a trial group, a university department, a university hospital clinic, the veterinary teaching hospital or the Finnish Institute for Health and Welfare if the trial has no outside financing or is financed by a non-profit organisation.