Fimea current fee schedule, reviewed for 2026, in EUR.
13 fee lines100% exact amountscurrency EURFX rates 2026-08-26reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Annual supervision fee by number of registered devices Tiers: up to 10 devices EUR 500; 11–50 EUR 1,000; 51–100 EUR 2,000; 101–500 EUR 4,000; over 500 EUR 6,000. | EUR 500–6,000 | $583–$7,002 | Per year | Verified |
| Sterilisation-provider annual fee | EUR 1,000 | $1,167 | Per year | Verified |
| Importer annual fee | EUR 500 | $583 | Per year | Verified |
| Distributor annual fee | EUR 500 | $583 | Per year | Verified |
| First registration of a device/manufacturer in the register (2026 only) Introduced by Decree 1344/2025 and chargeable only during 2026. | EUR 355 | $414 | Per registration | Verified |
| Classification decision | EUR 560 | $654 | Per decision | Verified |
| Determination of regulatory scope (is-it-a-device) | EUR 2,240 | $2,614 | Per determination | Verified |
| Exemption permit (MDR Art. 59-type derogation) - MD Class I–IIa / IIb–III Class I–IIa EUR 2,080; Class IIb–III EUR 4,150. IVD equivalents: EUR 1,970 (List A/B) and EUR 3,950 (C/D/other). | EUR 2,080–4,150 | $2,427–$4,843 | Per permit | Verified |
| Clinical-investigation application Class I: EUR 790; Class IIa–III: EUR 1,970. Art. 74(1) applications: EUR 790. IVD performance studies: EUR 1,970. | EUR 790–1,970 | $922–$2,299 | Per application | Verified |
| Substantial modification of a clinical investigation | EUR 335 | $391 | Per modification | Verified |
| Notification using leftover specimens (IVDR Art. 58(2)) | EUR 225 | $263 | Per notification | Verified |
| Authority inspection | EUR 5,600 | $6,535 | Per day | Verified |
| Free-sale certificate Up to four products per certificate; each duplicate product EUR 35. Expedited handling: EUR 340 base plus EUR 65 per duplicate. | EUR 170 | $198 | Per certificate | Verified |
Government fees only — service and testing costs are separate- Fimea also publishes notified-body oversight fees (e.g. EUR 30,600 for designation-related work) charged to the bodies, not manufacturers.
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Exact amounts verified against the Fimea fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:finland:annual-supervision-fee