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Austria medical device government fees

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BASG current fee schedule, reviewed for 2026, in EUR.

13 fee lines100% exact amountscurrency EURFX rates 2026-10-11reviewed 2026-08-25
Fee lineOfficial amountUSD equivalentFrequencyProvenance
Annual medical-device levy (Medizinprodukteabgabe) - Class I
Only the highest class placed on the market is levied; a second establishment of the same operator pays 50%; total levy is capped at EUR 10,000 per year; due by 30 June.
EUR 250$280Per yearVerified
Annual medical-device levy - Class IIaEUR 300$336Per yearVerified
Annual medical-device levy - Class IIbEUR 350$392Per yearVerified
Annual medical-device levy - Class IIIEUR 400$448Per yearVerified
Default official-act assessment fee (administrative charge plus VAT)
EUR 400 base plus 2% and a EUR 25 flat component as published for 2026.
EUR 433$485Per official actVerified
Clinical-investigation application (MDR Art. 62/70)
The tariff publishes EUR 8,352 and EUR 3,036 for this act (initial and each further assessment).
EUR 3,036–8,352$3,402–$9,359Per applicationVerified
Clinical-investigation notification (CE-marked device, MDR Art. 74)
The tariff publishes EUR 5,315 and EUR 2,278 for this act.
EUR 2,278–5,315$2,553–$5,956Per notificationVerified
Clinical-investigation post-market/report reviewEUR 949$1,063Per reviewVerified
Substantial change to a clinical investigation
Other (non-substantial) changes: EUR 949.
EUR 1,392$1,560Per changeVerified
Authority inspectionEUR 1,709$1,915Per half-dayVerified
IVD performance-study application (IVDR Art. 58/66)
The tariff publishes EUR 4,036 and EUR 2,278 for this act. Companion-diagnostic aspects: EUR 949; substantial change EUR 673; other changes EUR 429.
EUR 2,278–4,036$2,553–$4,522Per applicationVerified
IVD performance-study notification (CE-marked IVD)EUR 949–2,278$1,063–$2,553Per notificationVerified
Free-sale certificate
Tiered by number of products covered: EUR 660 / 854 / 1,054 / 1,253.
EUR 660–1,253$740–$1,404Per certificateVerified
Government fees only β€” service and testing costs are separate
  • Device-placement acts other than the levy follow the BASG tariff effective 1 January 2026; all other official acts are charged per the default assessment.
  • The annual levy exempts operators whose previous-year device turnover is below 100 times the levy amount.
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Exact amounts verified against the BASG fee schedule Β· full review 2026-08-25 Β· row IDs are stable β€” cite as government-fees:austria:annual-mpa-class-i