Medical devices fee

General information

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.

 

Attention: New web form for tax declaration

You can find the declaration form under the following link: https://medprodabgabe.basg.gv.at

The procedure for the fee declaration for the year 2018 will change fundamentally with 01.01.2019. From this date, the self-declaration must be electronically submitted and processed via the web form to the Federal Office for Safety in Health Care. The PDF forms used in recent years will no longer be available for the 2018 tax declaration. At the end of December/beginning of January you will receive a letter from the Federal Office for Safety in Health Care with which you will receive your access data for the web form. Please do not declare your identity until you have received this information letter.

 

medical device fee ordinance

 

Declaration form filling aids

 

Procedure for self-declaration

The procedure for the self-declaration of medical devices has changed with 1.1.2019:

  1. Click on the following URL: https://medprodabgabe.basg.gv.at
  2. Enter your username and password. You received the identification and your password with the information letter. If you have not received an information letter, please register at: medizinprodukteabgabebasg.gvat
  3. Declare your identity using the web form. A guide to declaration can be found here. Please declare even if you have not sold any medical devices to the end consumer.
  4. After completion of the declaration you will receive an email with a PDF document containing the data you have entered.
  5. In the event of a tax liability, please transfer the tax to the account indicated in the letter, stating your procedure number.

In the case of a tax liability, the fee is to be transferred to the following account:

Bank: BAWAG P.S.K. Bank IBAN: AT84 6000000096051434 BIC: BAWAATWW

ATTENTION: The Federal Office for Safety in Health Care (BASG) does not charge you any fees/invoice. This is a fee, the amount of which is determined by the self-declaration and must be transferred from the payer to the above account.

Amount of the fee The medical device fee is defined in the Medical Device fee Ordinance. The medical device fee does not depend on the quantity of products sold, but on the highest class of medical devices sold in Austria and is to be paid by the person who sells medical devices to the final consumer in Austria (classes of medical devices according to applicable directives; e.g. Directive 93/42/EEC):

  • Maximum Class I medical devices: 250 €.
  • Maximum Class IIa medical devices or general IVD: 300 €.
  • Maximum Class IIb medical devices or List B IVD: 350 €.
  • Maximum Class III medical devices or List A IVD or AIMD IVD: 400 €.

Procedure for small enterprises Small enterprises where the annual fee exceeds 1 % of the turnover of medical devices are exempted from payment. The justification for the exemption shall be submitted to the Federal Office for Safety in Health Care using the appropriate form (including the documents for proof).

Example: A company sells medical devices to the end consumer in Austria. The highest class of medical devices sold is class IIb, so the annual fee is 350 €. If the total sales volume of the company's medical devices is less than €35,000, the company may be exempted from payment of the fee.

Procedure for retail chains There are also special regulations for retail chains (chain stores). While for the first branch the medical device fee is fully applicable, for all other branches only 50% of the full amount, with a total maximum value of 10,000 €, is payable.

Example: A retail chain with 10 branches in Austria sells medical devices to end consumers in Austria; the highest class of medical devices is IIa. The annual fee for the first branch is 300 € plus an annual fee of 150 € for branches 2 to 10. 300 + 9x150 = 1,650 € - The annual fee is 1,650 € in total.

Amount of fee

The medical devices fee is fixed in the form of an annual lump sum. The amount or assessment of the medical device fee can be found in the Annex to the Medical Device fee Ordinance. The amount of the fee depends on which medical devices are actually levied: the amount of the fee to be paid is the amount corresponding to the highest class of medical devices levied.

Determination of the amount of the medical device fee
medical device classAnnual net sales achievedAmount of the fee to be paid
Class Imore than 25.000 EUR250,00 EUR
Class IIamore than 30.000 EUR300,00 EUR
Class IIbmore than 35.000 EUR350,00 EUR
Class IIImore than 40.000 EUR400,00 EUR

Thus, if medical devices of different classes, IVD or implantable medical devices are supplied, there is no addition of the respective charges, but only the charge amount of the respective highest class of these products has to be paid. Example: If the (net) revenue threshold of EUR 35,000 (revenue threshold for medical devices in Class IIb) were exceeded, only the medical device levy for Class IIb (EUR 350.00) would have to be paid for the sale of Class I and Class IIb medical devices and not additionally the levy for Class I (EUR 250.00).

Do you get an invoice for the tax?

No, the Federal Office does NOT issue an invoice in connection with the medical product fee. The fee declaration shall be regarded as accounting evidence.

Is deductible VAT included in the levy?

No, as the medical device fee is not subject to the Value Added Tax Act (UStG).

Low sales

Please note the following (net) revenue limits in connection with the fee exemption:

The highest fee applies, which means that a different fee threshold has to be taken into account depending on the class of the vehicle concerned.

Example: You sell products in Class I and Class IIb -> the sales revenue threshold is therefore less than 35,000.00 euros.

Highest class as defined in the Annex to the RegulationTotal of all (net) sales of medical devices

acc. to Annex lit. a Class I

< 25.000,00 Euro

according to Annex lit. b Class II a, general IVDs, IVDs for self-testing

< 30.000,00 Euro

acc. to Annex lit. c Class II b, IVDs List B

< 35.000,00 Euro

acc. to Annex lit. d Class III, IVDs List A

< 40.000,00 Euro

Please submit the completed form for the tax declaration even if your total (net) sales revenue from the sale of medical devices is below the de minimis threshold and you are therefore not subject to tax.

Several operating sites

A permanent establishment is a fixed place of business where the activities of an undertaking are wholly or partly carried out. Each payer therefore has at least one permanent establishment. This is referred to as the "main house", since every taxable person owns it, regardless of whether he also has other business premises. The full amount of the medical device fee must be paid for this one and thus first operating facility (the "main building").

If a company has several permanent establishments, the medical device fee for each additional permanent establishment (going beyond the "main building") will only be payable in the amount of 50% of the fee intended for this permanent establishment in each case. Analogous to the "main house" of the taxable person, this amount is measured according to the highest class of medical devices taxed in the specific establishment.

The starting point for the assessment of the amount of the medical device fee for permanent establishments is therefore the individual permanent establishment specifically affected in each case. It is therefore necessary to carry out a case-by-case assessment of the amount of the fee for each establishment.

Example: In addition to the "main building", in which only Class I medical devices are sold, a taxable person has two operating facilities. The two sites supply products in both Class I and Class IIb.

The applicable level of taxation for these two establishments is the level of taxation for Class IIb medical devices (EUR 350). According to § 3 Para. 3 of the Medical Devices fee Ordinance, the full medical devices fee (EUR 250) must be paid for the first establishment (the "main establishment") and for each additional 50 percent of the planned corresponding medical devices fee (EUR 175 per establishment). It follows from this that the total fee amounts to 600 EURO and is thus below the maximum fee of EUR 10,000. The (net) revenue threshold relevant for a tax exemption according to § 5 Medical Devices fee Regulation (Medizinprodukteabgabenverordnung) (for the total sales of medical devices of the main building including all operating facilities) is EUR 35,000.00 in the concrete case.

Time of payment

The corresponding fee shall be payable annually by 30 June of the calendar year following that in which the fee is levied.

Example: For the year 2018, the fee declaration must be repaid by 30.06.2019.

Unless the conditions for fee exemption are met, the fee declared therein must also be paid to the Federal Office for Safety in Health Care by 30 June of the following year. The deadline shall be deemed to have been met if the tax declaration and, in the case of an obligation to pay fee, the amount of fee declared therein has been received by the Federal Office for Safety in Health Care before expiry of the deadline.

Default of payment

If the fee declaration is not submitted or is submitted late (after 30.06. of the following year) and the self-calculation is not carried out even after the Federal Office for Safety in Health has requested it, the Federal Office for Safety in Health Care must issue a fee assessment and prescribe a mandatory medical device fee of EUR 400, plus a 2% surcharge for late payment and a processing amount of EUR 25. The total medical device fee in this case is therefore EUR 433.00 (pursuant to § 12a (5), (7) and (9) of the Medical Device fee Ordinance). A fee assessment notice (on the declared amount of fee plus 2% surcharge for late payment plus processing amount) must also be issued if the duty to pay fee has been declared in a fee declaration but the duty to pay has not been fulfilled by 30 June of the following year.

Am I a dutiable?

Those natural and legal persons who supply medical devices to end consumers in or to Austria in return for payment are subject to duty in the sense of the Medical Devices fee Ordinance.

The term "final consumer" refers to all those who do not sell or pass on medical devices against payment, whether they are purchased for personal use by consumers, for example, or whether they are used on patients as part of medical treatment. Final consumers within the meaning of this provision are therefore also those purchasers of medical products (hospitals, doctor's surgeries, laboratories, etc.) who use or use these products themselves within the scope of their business, etc., and who therefore do not sell or pass them on against payment. The concept of 'final consumer' is therefore not necessarily the same as the common understanding of a 'consumer'. In other words, the fee on a business operator ('B2B') also constitutes a chargeable fee on a final consumer.

The term "dispensing" refers to the provision or transfer of medical devices against payment. Therefore, not only the sale of medical devices, but also any paid transfer of a medical device, such as rental or leasing, is to be understood as a transfer.

Online trader

The sale of medical devices to end consumers in or to Austria is subject to a fee.

The obligation to pay the fee applies irrespective of whether the transferor is domiciled in Austria or maintains a permanent establishment in Austria. It therefore also arises when medical devices are shipped - and thus delivered - to final consumers in Austria by a supplier domiciled abroad (EU or EEA country/third country). Thus, for example, online retailers in Austria are also subject to the obligation to pay the medical device fee in accordance with the Medical Device fee Ordinance when they supply medical devices to end consumers.

If medical devices are delivered from abroad to end consumers in Austria, then it is not the actual "importer" (shipping service provider, forwarding agent, etc.) who is deemed to be the seller within the meaning of the regulation, but the seller and sender (manufacturer or the selling (wholesale) dealer).

The obligation to pay the fee applies irrespective of the manufacturer's responsibility.

Physicians

Yes, doctors can also be regarded as providers and are therefore subject to the obligation to pay fees. This is the case, for example, when doctors do not use medical devices as part of a medical treatment for a patient, but sell them to a patient from their doctor's dispensary. Revenues from the sale of medical devices used by physicians in the course of medical treatment, e.g. therapeutic, diagnostic, prophylactic or analgesic measures, are subject to the tax liability of the person who sells these medical devices to the physician (e.g. a wholesaler).

Example: Where loose braces are supplied to a patient, this must be regarded as a supply to a final consumer within the meaning of this Regulation and the dentist must therefore be classified as a taxable person. The fitting of fixed, individually shaped braces by a dentist does not constitute a charge within the meaning of this Regulation but an application in the context of medical treatment. In the first case the dentist would be obliged to pay the medical device fee, in the second case the one who gives the braces to the dentist.

As a guide, it can be said that if the medical device is firmly connected to the human body and this is used in the context of medical treatment, there is no obligation to pay fees.

Dental technician

In the field of dental technical/dental medical devices, a distinction must be made between fixed and loose medical devices. The dentist is always considered the final consumer when a medical device is firmly attached to the patient's body as part of a medical treatment. For all fixed dental technical/dental medical devices (e.g. fixed braces, bridges, crowns, implant superstructures), the obligation to pay the medical device fee therefore arises with the natural or legal person who has handed over these medical devices to the dentist and thus with the dental technician.

If loose dental technical/dental medical devices (e.g. loose braces, prostheses) are delivered to a patient, this is a delivery to a final consumer within the meaning of the regulation. The dentist is obliged to pay the medical device fee for all loose dental technical/dental medical devices (e.g. dental prostheses, loose braces, etc.).

Veterinarians

According to the Medical Devices Act, medical devices are only intended for use on humans. When a veterinarian applies a medical device to an animal as part of a medical treatment, that medical device is used outside the manufacturer's intended purpose, but still remains a product that has been sold - and thus delivered - as a medical device. The person who hands over such a medical device to a veterinarian is thus subject to the obligation to pay the fee. A veterinarian himself can only be a taxable person within the meaning of the Medical Devices fee Ordinance if he himself sells medical devices to a final consumer in Austria.

Pharmacies

Yes, pharmacies generally also sell medical devices to end consumers in accordance with the Medical Devices fee Ordinance. However, an agreement was concluded with the Austrian Chamber of Pharmacists in which it is regulated that the Chamber of Pharmacists shall pay the fee to the Federal Office for Safety in Health Care for its members (on the basis of § 12b Health and Food Safety Act, BGBl. I No. 63/2002, as amended). Pharmacy businesses are therefore not required to submit a fee declaration to the Federal Office for Safety in Health Care and the associated payment of the medical devices fee.

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