JAZMP current fee schedule, reviewed for 2026, in EUR.
16 fee lines100% exact amountscurrency EURFX rates 2026-10-10reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Notified-body annual fee | EUR 50,000 | $56,030 | Per year | Verified |
| Notified-body evaluation and (re)designation | EUR 70,000 | $78,442 | Per procedure | Verified |
| Notified-body scope extension Minimum EUR 5,000. | EUR 1,000 | $1,121 | Per code | Verified |
| Manufacturer annual fee by net revenue and risk class Class I/A vs higher class: 800/1,500 (0–60k), 1,200/2,500 (60–350k), 2,000/5,000 (350–700k), 4,000/8,000 (700k–4M), 6,000/10,000 (4–8M), 8,000/14,000 (over 8M). | EUR 800–14,000 | $896–$15,688 | Per year | Verified |
| Authorised-representative annual fee by net revenue EUR 2,000 (0–1M), EUR 4,000 (1–10M), EUR 8,000 (over 10M). | EUR 2,000–8,000 | $2,241–$8,965 | Per year | Verified |
| Custom-made-device manufacturer annual fee Exempt if revenue from the activity is below EUR 20,000. | EUR 800 | $896 | Per year | Verified |
| Distributor annual fee by net revenue 350 / 800 / 1,500 / 2,500 / 3,500 / 4,500 by revenue band. | EUR 350–4,500 | $392–$5,043 | Per year | Verified |
| Importer annual fee by net revenue 800 / 1,400 / 2,500 / 3,000 / 4,000 / 5,000 by revenue band. | EUR 800–5,000 | $896–$5,603 | Per year | Verified |
| Combined importer+distributor annual fee by net revenue 1,100 / 2,000 / 3,000 / 4,000 / 5,000 / 7,000 by revenue band. | EUR 1,100–7,000 | $1,233–$7,844 | Per year | Verified |
| Single-use-device reprocessor annual fee | EUR 3,500 | $3,922 | Per year | Verified |
| Health-institution in-house production annual fee | EUR 2,500 | $2,801 | Per year | Verified |
| Free-sale certificate Each additional certificate: EUR 50. Priority handling (10 days): EUR 250 first, EUR 80 additional. | EUR 150 | $168 | Per certificate | Verified |
| Clinical-investigation application EUR 2,000 (Art. 62(a) MDR-type) / EUR 4,175 (Art. 62(b)-type), higher by EUR 2,000 if the device incorporates a medicinal substance or human/animal tissue. Substantial modification: EUR 800 / 1,900. Art. 74 application: EUR 2,000 (change 800); Art. 26 ZMedPri-1: EUR 2,000 (change 800). Re-application after rejection 50% lower; lapsed/rejected applications charged at 15%. | EUR 2,000–4,175 | $2,241–$4,678 | Per application | Verified |
| IVD performance-study application EUR 2,000 (Art. 58(a) IVDR-type) / EUR 4,175 (point (b)); substantial modification EUR 800 / 1,900; re-application 50% lower; lapsed/rejected 15%. | EUR 2,000–4,175 | $2,241–$4,678 | Per application | Verified |
| Decision in a manufacturer/notified-body dispute | EUR 5,000 | $5,603 | Per decision | Verified |
| Exceptional-approval handling 50% advance; listing a device on the reprocessing list is also EUR 150 per hour. | EUR 150 | $168 | Per hour | Verified |
Government fees only — service and testing costs are separate- The Tarifa JAZMP entered into force on 31 January 2026 and replaced the Pravilnik o pristojbinah (UL RS 24/19, 40/25).
- In the first year, annual fees are levied pro rata at 1/12 per month of activity.
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Exact amounts verified against the JAZMP fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:slovenia:nb-annual-fee