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February 5, 2026
Approximately 5 minutes
Annual Medical Devices Fee in Austria
Annual Medical Devices Fee in Austria
1. Legal Basis
The medical devices fee is regulated by the Medical Device Levy Ordinance issued by the Federal Office for Safety in Health Care (BASG). This ordinance applies regardless of registration in the medical device register. Source: BASG Medical Devices Fee Page https://www.basg.gv.at/en/medical-devices/medical-devices-fee Full text: Medical Device Levy Ordinance https://www.basg.gv.at/fileadmin/redakteure/02_Ueber_Uns/Gesetzliche_Grundlagen/Medizinprodukteabgabenverordnung_300722.pdf
2. Who Must Pay and Declare
Any natural or legal person (in Austria or abroad, including online retailers) who supplies medical devices to end users in Austria is obligated. End users are those acquiring devices for non-dispensing purposes (e.g., patients, physicians). Dispensing includes sales, renting, or leasing for payment. Specific cases:
- Physicians: Liable only if selling devices.
- Dentists: Liable for loose devices to patients or fixed devices to other dentists.
- Veterinarians: Liable only for resale.
- Pharmacies: Exempt (paid collectively by Austrian Chamber of Pharmacists).
- Repairs: Not considered dispensing. Source: BASG Medical Devices Fee Page https://www.basg.gv.at/en/medical-devices/medical-devices-fee
3. Fee Calculation
The fee is a lump sum based on the highest class of devices dispensed, if net annual turnover exceeds the threshold for that class. Only the highest applicable fee is paid.
| Medical Device Class | Net Annual Turnover Threshold | Fee Amount |
|---|---|---|
| Class I | > €25,000 | €250 |
| Class IIa | > €30,000 | €300 |
| Class IIb | > €35,000 | €350 |
| Class III | > €40,000 | €400 |
For IVDs: List A = Class III, List B = Class IIb, others = Class IIa. Source: BASG Medical Devices Fee Page https://www.basg.gv.at/en/medical-devices/medical-devices-fee
4. Exemptions and Reductions
- Below threshold: No payment required (but declaration mandatory).
- Small companies: Exempt if fee >1% of turnover (justify with proof).
- Multiple sites/chains: Main site full fee; additional sites 50% each (total capped at €10,000).
- Pharmacies: Fully exempt. Source: BASG Medical Devices Fee Page https://www.basg.gv.at/en/medical-devices/medical-devices-fee
5. Declaration and Payment
Annual declaration due by June 30 for the previous year, even if zero or exempt. Use the web form at https://medprodabgabe.basg.gv.at (access data sent by BASG in December/January). Payment: Self-initiated by June 30 to specified bank account, referencing procedure number. No invoice issued. Late payment: Minimum €400 notice plus surcharges. Source: BASG Medical Devices Fee Page https://www.basg.gv.at/en/medical-devices/medical-devices-fee
6. Contact
Email: medizinprodukteabgabe@basg.gv.at Source: BASG Medical Devices Fee Page https://www.basg.gv.at/en/medical-devices/medical-devices-fee
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