URPL current fee schedule, reviewed for 2026, in PLN.
7 fee lines100% exact amountscurrency PLNFX rates 2026-08-26reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Free-sale certificate application (Act Art. 30(1)) | PLN 700 | $190 | Per application | Verified |
| Clinical-investigation application (MDR Art. 70(1)) | PLN 6,000 | $1,627 | Per application | Verified |
| Substantial modification notification (MDR Art. 75(1)) | PLN 2,000 | $542 | Per notification | Verified |
| Post-market clinical follow-up investigation application (Act Art. 33(3)) | PLN 6,000 | $1,627 | Per application | Verified |
| Performance-study application (IVDR Art. 66(1)) | PLN 6,000 | $1,627 | Per application | Verified |
| Substantial modification notification (IVDR Art. 71(1)) | PLN 2,000 | $542 | Per notification | Verified |
| Consultations and opinions (Act Art. 52: advertising opinions, borderline determinations, derogation permits) | PLN 80,000 | $21,695 | Per request | Verified |
Government fees only — service and testing costs are separate- Amounts follow the Regulation of the Minister of Health of 26 July 2022 on medical-device fees (Dz.U. 2022 poz. 1582).
- Legacy: pending notifications under the repealed 2010 act pay PLN 300 per device notified, and free-sale certificates on those pending notifications cost PLN 350 (Act of 2024, Dz.U. 2024 poz. 1620, Art. 138).
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Exact amounts verified against the URPL fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:poland:free-sale-certificate