Medical Devices Fee

Medical Devices Fee

Distributors of correctly CE-marked medical devices are not obliged to register themselves at the Austrian Medical Devices Register (manufacturers register) – but a voluntary registration is possible.

Regardless of registration, according to the “Medical Devices Fee Ordinance” every person or company delivering medical devices to end users in Austria is obliged to pay an annual fee to the Federal Office for Safety in Healthcare (BundesAmt für Sicherheit im Gesundheitswesen).

According to the Medical Devices Fee Ordinance “end user” is any person or company who does not intend to resell or trade the medical devices – therefore typically patients or medical doctors.

Every person or company delivering medical devices to end users in Austria has to declare itself liable for payment of the fee or submit to the Federal Office for Safety in Healthcare the reasons for exemption of the general payment obligation. This declaration has to be submitted annually (as the kind of devices and/or sales volume might change) by 30 June of the following year the latest.

Medizinprodukteabgabenverordnung

FAQ zur Medizinprodukteabgabenverordnung

Wenn Sie Fragen zur Medizinprodukteabgabe haben, kann Ihnen vielleicht bereits unsere FAQ Sammlung weiterhelfen.

Ausfüllhilfen zum Deklarationsformular

 


The filled out form has to be sent to our dedicated email address:
medizinprodukteabgabeagesat

or by mail to:


Federal Office for Safety in Healthcare

Business Development
Traisengasse 5
1200 Vienna
Austria

The fee shall be transferred to the following bank account:
Bank:
  BAWAG P.S.K. Bank
IBAN:  AT84 6000000096051434
BIC:  BAWAATWW

Please include the reason for payment: “Medizinprodukteabgabe YYYY” or “Medical Device Fee YYYY” (e.g. for the year 2015: “Medical Device Fee 2015”).

1.1.    Fee Amount:

The annual fee is defined in the “Medical Devices Fee Ordinance”.The annual fee does not depend on the amount of devices sold, but solely depends on the highest class of medical devices sold in Austria and is payable per company selling to end users in Austria:
- if the highest class is Class I MDD: 250 €
- if the highest class is Class IIa MDD or common IVD: 300 €
- if the highest class is Class IIb MDD or List B IVD: 350 €
- if the highest class is Class III MDD or List A IVD or AIMDD: 400 €

1.2.    Special Procedure for Small Companies:

For (small) companies where the annual fee would exceed 1 % of the sales volume with medical devices, the company can be exempted from the payment. The reasons for exemption have to be submitted to the Federal Office for Safety in Healthcare using the declaration form and accompanied by verifying documents.
Example: A company is selling medical devices to end users in Austria. The highest class of devices sold is IIb MDD, thus the annual fee would be 350 €. If the complete sales volume with medical devices is below 35.000 € the company can be exempted from payment of the fee.

1.3.    Special Procedure for chain store Companies:

Additionally there is a special regulation for chain store companies. While for the first branch the full amount is applicable, any additional branches are obliged to solely pay 50%  of the full amount, with a total maximum of 10.000 € altogether
Example: A chain store company with 10 branches in Austria sells medical devices to end users in Austria, the highest class being IIa MDD. The annual fee for the first branch would be 300 € plus an annual fee of 150 € for branches 2 to 10  300 + 9 x 150 € = total sum of 1.650 €.

Created: 04.11.2014 | Page last modified: 21.02.2018

© Austrian Federal Office for Safety in Health Care
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