Dispensing of masks intended to protect against SARS-CoV-2 viruses.

Whether a product is a "medical device" as defined by the Medical Devices Act (MPG) - and thus also falls within the scope of the Medical Devices Dispensing Ordinance - or not, is determined by the intended purpose defined by the manufacturer. Masks that are marketed as medical devices can be identified, for example, by the following markings on the packaging or in the instructions for use:

• CE marking
• Reference to the EN 14683 standard
• Indication of the mask type: Type I, Type II or Type IIR according to the EN 14683 standard.

If the dispenser cannot clearly make the distinction as to whether the masks distributed are medical devices or not, it is recommended to consult with the manufacturer or importer of the product. If masks are marketed as simple mouth-nose protection (MNS), as personal protective equipment (FFP2, FFP3 masks) or as corona virus pandemic respirators (CPA) - ensuring that these do not give the impression that the product is a medical device - they fall neither under the Medical Devices Levy Ordinance nor under the jurisdiction of the BASG.

The medical device levy is set in the form of an annual lump sum. The amount and assessment of the medical device levy can be found in the Annex to the Medical Device Levy Ordinance . The amount of the levy depends on which medical devices are actually dispensed: the levy amount corresponding to the highest class of medical devices dispensed is applied.

The allocation of in vitro diagnostic devices (IVDs), which are a subcategory of medical devices, to the classes I, IIa, IIb and III mentioned in the Medical Devices Levy Ordinance results from 1. the Annex to the Medical Devices Levy Ordinance and 2. Annex II of Directive 98/79/EC on in vitro diagnostic medical devices. In short, IVDs named in List B fall under Class IIb. IVDs named in list A are in class III. All other IVDs are considered class IIa medical devices.

If medical devices of different classes, IVDs or implantable medical devices are supplied, there is no addition of the corresponding duties, but only the duty amount of the highest class of these devices has to be paid. Example: If class I and class IIb medical devices are dispensed and the (net) revenue limit of EUR 35,000 (revenue limit for class IIb medical devices) is exceeded, only the medical device levy for class IIb (EUR 350.00) would have to be paid and not additionally the levy for class I (EUR 250.00).

Do I receive an invoice for the levy?

No, the Federal Office does NOT issue an invoice in connection with the medical device levy. The levy declaration is considered as an accounting document.

Is deductible sales tax included in the levy?

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

Please note the following (net) sales revenue thresholds in connection with the tax exemption:

The highest levy applies in each case, which means that a different levy threshold must be taken into account depending on the class dispensed.

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

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

A permanent establishment is a fixed place of business at which the activities of an enterprise are wholly or partly carried on. Every taxpayer therefore has at least one permanent establishment. This is referred to as the "main establishment", since every taxpayer owns it, regardless of whether it also has other business premises. The full amount of the medical device levy must be paid for this one and therefore first establishment (the "main establishment").

If a company has several establishments, the medical device levy for each additional establishment (beyond the "main establishment") is only 50% of the levy for this establishment. Analogous to the "main establishment" of the person liable to pay the levy, this amount is calculated according to the highest class of medical devices dispensed in the specific establishment.

The starting point for calculating the amount of the medical device levy for establishments is therefore the individual, concretely affected establishment in each case. The amount of the levy must therefore be determined on a case-by-case basis for each establishment.

Example: In addition to the "main facility", in which only Class I medical devices are dispensed, a taxpayer has two production facilities. The two facilities dispense both Class I and Class IIb devices.

The applicable fee for these two facilities is the fee for class IIb medical devices (EUR 350). Pursuant to Section 3 (3) of the Medical Devices Levy Ordinance, the full medical device levy is payable for the first establishment (the "main establishment") (EUR 250), and 50 percent of the intended corresponding medical device levy is payable for each additional establishment (EUR 175 per establishment). This means that the total amount of the levy is EUR 600, which is below the maximum levy of EUR 10,000. The (net) sales revenue threshold relevant for a tax exemption according to § 5 of the Medical Devices Tax Ordinance (for the total sales of medical devices of the main facility including all operating sites) is EUR 35,000 in this specific case.

The corresponding levy must be paid annually by June 30 of the calendar year following the levy.

Example: For the year 2018, the levy declaration must be made by June 30, 2019.

Unless the conditions for a levy exemption are met, the levy declared therein must also be paid to the Federal Office for Safety in Health Care by June 30 of the following year at the same time. The deadline shall be deemed to have been met if the declaration of levy and, in the case of a levy obligation, also the levy amount declared therein is received by the Federal Office for Safety in Health Care before the deadline expires.

If the declaration is not submitted or is submitted late (after 30.06. of the following year) and if the self-calculation is not made up even after a request by the Federal Office for Safety in Health Care, the Federal Office for Safety in Health Care has to issue a levy notice and prescribe a mandatory medical device levy in the amount of EUR 400,-, plus a 2% late payment surcharge and a processing amount of EUR 25,-. In this case, the total amount of the medical device fee is EUR 433,- (according to § 12a Abs. 5, 7 und 9 Medizinprodukteabgabenverordnung). A levy notice (for the declared levy amount plus 2% late payment surcharge plus processing amount) must also be issued if the levy obligation is declared in a levy declaration but the payment obligation has not been fulfilled by 30.06. of the following year.

Natural persons and legal entities who supply medical devices to end users in or to Austria in return for payment are liable for the levy within the meaning of the Medical Devices Levy Ordinance.

The term "end user" refers to all those who do not sell or pass on medical devices in return for payment, whether they are purchased for personal use by consumers, for example, or whether they are used on patients as part of a medical treatment. Thus, end users within the meaning of this provision also include those purchasers of medical devices (hospitals, doctors' practices, laboratories, etc.) who use or apply them themselves within the scope of their operations, etc., and therefore do not sell or pass them on in return for payment. The term "end consumer" is therefore not necessarily the same as the common understanding of a "consumer". In other words, this means that the supply to an entrepreneurial market participant ("B2B") also constitutes a chargeable supply to an end consumer.

The term "dispensing" is to be understood as the transfer or passing on of medical devices in return for payment. Therefore, not only the sale of medical devices but also any transfer of a medical device against payment, such as renting or leasing, is to be understood as dispensing.

The "repair" of medical devices on behalf of a customer is not subject to the duty, as a repair does not constitute the supply of medical devices to the end user against payment.

The duty is payable on the sale of medical devices to end users in or to Austria.

The duty to pay duty exists irrespective of whether the supplier has its registered office in Austria or maintains a permanent establishment in Austria. Therefore, the duty also applies if medical devices are sent - and thus dispensed - to end consumers in or to Austria by a supplier domiciled abroad (EU or EEA member state/third country). Thus, for example, online traders are also subject to the duty to pay duty under the Medical Devices Duty Ordinance when they supply medical devices to end users in Austria.

If medical devices are supplied from abroad to end users in Austria, then it is not the actual "importer" (shipping service provider, forwarder, etc.) who is deemed to be the dispenser within the meaning of the Ordinance, but the seller and shipper (manufacturer or the dispensing (wholesale) dealer).

The duty to deliver applies independently of the manufacturer's responsibility.

Doctors can also be considered as sellers and thus be subject to the duty. This is the case, for example, if physicians do not use medical devices on patients as part of a medical treatment, but sell them to a patient from their medical home pharmacy. Turnover from the sale of medical devices that are used by physicians as part of a medical treatment, such as a therapeutic, diagnostic, prophylactic or analgesic measure, is subject to the tax liability of the person who sells these medical devices to the physician (such as a wholesaler).

Example: If a loose brace is dispensed to a patient, this is to be considered a dispensing to an end consumer within the meaning of this ordinance and the dentist is thus to be qualified as a taxable person. The application of a fixed, individually shaped brace by a dentist does not constitute a supply within the meaning of this Ordinance, but an application within the framework of medical treatment. In the first case, the dentist would be obliged to pay the medical device fee, in the second case, the person who supplies the braces to the dentist.

For orientation purposes, it can be said that if the medical device is firmly attached to the human body and is used within the framework of medical treatment, there is no obligation to pay the levy.

In the area of dental/dental medical devices, a distinction must be made as to whether the medical device is a fixed or a loose medical device. The dentist is always considered to be the end user if a medical device is firmly attached to the patient's body as part of a medical treatment. For all fixed dental/dental medical devices (e.g. fixed braces, bridges, crowns, implant abutments), the obligation to pay the medical device fee therefore arises for the natural or legal person who supplied these medical devices to the dentist and thus for the dental technician.

If loose dental technical/dental medical devices (e.g. loose braces, prostheses) are supplied to a patient, this is a supply to an end consumer within the meaning of the ordinance. For all loose dental technical/dental medical devices (e.g. dental prostheses, loose braces, etc.), the dentist is obliged to pay the medical device levy.

According to the Medical Devices Act, medical devices are only intended for use on humans. If a veterinarian uses a medical device on an animal as part of a medical treatment, this medical device is used outside the manufacturer's intended purpose, but nevertheless remains a product that was sold - and thus dispensed - as a medical device. The person who dispenses such a medical device to a veterinarian is thus subject to the duty to dispense. A veterinarian himself can only be a taxable person in the sense of the Medical Devices Tax Ordinance if he himself (re)sells and thus dispenses medical devices to an end user in Austria.

In principle, pharmacies also sell medical devices to end users in accordance with the Medical Devices Tax Ordinance. However, an agreement has been concluded with the Austrian Chamber of Pharmacists, which stipulates that the Chamber of Pharmacists pays the levy to the Federal Office for Safety in Health Care on behalf of its members (on the basis of Section 12b of the Health and Food Safety Act, Federal Law Gazette I No. 63/2002, as amended). Pharmacies are therefore not obliged to submit a declaration to the Federal Office for Safety in Health Care and the associated payment of the medical device levy.

It is explicitly stated that the list below is by no means complete and that the selected examples can only serve as a first orientation. If you have any questions regarding the actual classification of the medical devices you supply, please contact the manufacturer. The manufacturer is responsible for the correct classification of his products within the framework of the conformity assessment. The classification of a medical device must always be made on a case-by-case basis!

For further information and examples of classification, please refer to the guidance document MDCG 2021-24.