ŠÚKL current fee schedule, reviewed for 2026, in EUR.
7 fee lines100% exact amountscurrency EURFX rates 2026-08-26reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Distributor registration decision (item 96.1.56) EUR 450 when the filing is fully electronic. Paid via eKolok within 30 days. | EUR 500 | $583 | Per registration | Verified |
| Clinical-investigation authorisation proceedings (item 96.1.57) Not refunded on rejection. | EUR 500 | $583 | Per application | Verified |
| Notification of substantial change to a clinical investigation (item 96.1.58) | EUR 500 | $583 | Per notification | Verified |
| Notification of a clinical investigation of a CE-marked device (item 96.1.59) | EUR 500 | $583 | Per notification | Verified |
| Free-sale certificate for devices and IVDs (item 152 aj) Paid via eKolok payment order per filing, not in advance (MP 148/2025). | EUR 300 | $350 | Per certificate | Verified |
| Registration of an SR-seated manufacturer/EC representative Per the ŠÚKL Sadzobník výkonov a služieb (service price list), invoiced after the service; payment is a condition of registration and non-refundable on refusal. | EUR 750 | $875 | Per registration | Verified |
| Technical-documentation assessment of each additional device under the same registration | EUR 430 | $502 | Per additional device | Verified |
Government fees only — service and testing costs are separate- Administrative fees follow the schedule annexed to zákon č. 145/1995 Z. z. as amended; SR-seated manufacturer registrations follow the separate ŠÚKL service price list.
- Separate service-list fees also apply to device notification filings, change reports, and ŠÚKL code creation/update.
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Exact amounts verified against the ŠÚKL fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:slovakia:distributor-registration