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The advertising of medical devices in Austria
In every jurisdiction the advertising of medical devices comes with certain national peculiarities. The following article explains in more detail what needs to be considered if you intend to market medical devices to the Austrian market.
The definition of advertising
Advertising in the medical field is strictly regulated in Austria. This includes the advertising of pharmaceutical products and medical devices. The aim pursued by the legislator with these very precise regulations is to protect the public’s health.[1] To further elucidate the term “advertising of medical devices”, it is necessary to refer to different legal foundations. Relevant provisions can be found at European level, within Union law, and in national legislation. At a European level, the Medical Devices Regulation (2017/745, hereinafter “MDR”) and at national level the Medical Devices Act (“MPG”) are relevant. In this context, it should be noted that there is no specific definition of the term “advertising of medical devices” either at a national or European level. Therefore, the general definition of advertising outlined in Directive 2006/114/EC on misleading and comparative advertising should be applied. The concept of “advertising” is defined in Art 2 (a) as “the making of a representation in any form in connection with a trade, business, craft or profession in order to promote the supply of goods or services, including immovable property, rights and obligations”. At national level, this directive was implemented by the Federal Act against Unfair Competition (hereinafter “UWG”). The concept of advertising is congruent with Article 86 of the Directive on the Community code relating to medicinal products for human use 2001/83 EC, Sec 50 Medicinal Products Act (“AMG”) and Sec 2a UWG. Due to the comparability, Austrian literature and jurisdiction refer to the aforementioned provisions to also define the term of medical device advertising.
consumer advertising vs professional advertising
Article 7 of the MDR contains a ban on misleading advertising, which applies directly in each member state and, thus, requires no implementation into national law. “In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by:
a) ascribing functions and properties to the device which the device does not have;
b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.”
This very explicit, but also very general, provision on medical device advertising in the MDR is primarily intended to protect consumers and patients from misleading information regarding the intended purpose, safety and performance of medical devices. In addition, this provision obliges economic operators to provide objective information.[2]
The MPG differentiates between consumer advertising (lay advertising) and professional advertising. Based on this distinction, different requirements are placed on the respective advertising. Since the term “consumer” is not specifically regulated in the MPG, consumer is defined as anybody who is not defined as a healthcare professional under law. Thus, an advertising measure is aimed at the consumer if it is intended to influence the consumer’s willingness to purchase.[3]
According to Sec 71 MPG, consumer advertising is not permitted for
- medical devices that are subject to prescription in accordance with a medical prescription pursuant to Sec 67 MPG;
- medical devices that are exclusively intended to be used by healthcare professionals on or for the patient; and additionally
- for medical devices that may only be used by consumers in connection with medical or dental treatment or monitoring based on the instructions for use.
Moreover, medical device advertising intended for consumers must be designed in such a way that the advertising character is clear, and the medical device is clearly presented as a medical device (Sec 72 MPG). In particular, consumer advertising may not contain the following information in accordance with Sec 73 MPG:
- information suggesting that the effect of such medical device is equivalent or superior to another treatment or medical device,
- information intended exclusively or primarily for children,
- information making a medical treatment appear superfluous, because such information can lead to a false self-diagnosis, or recommend treatment by correspondence,
- information referring to certificates of convalescence, and
- information use pictorial representations of changes in the human body due to diseases, injuries or disabilities or the effect of a medical device on or in the human body.
In addition, advertising aimed directly at consumers must contain the following information in accordance with Sec 74 (1) MPG:
- The designation of the medical device
- A brief description of the intended purpose of the medical device
- The information essential for the appropriate use of the medical device, and
- A clearly perceptible warning if the medical device can also cause undesirable effects or if its use requires special safety precautions.
These regulations, which set minimum content requirements on the one hand and identify elements on the other hand that shall not be included in consumer advertising, are intended to ensure that consumers are informed objectively and factually about medical devices.[4]
Therefore, medical device advertising targeted at consumers is more strictly regulated under Austrian law than in other EU jurisdictions. Medical device companies entering the Austrian market or advertising on the Austrian market should, thus, critically examine if advertising measures for their medical devices in Austria or targeted at Austrian consumers are in line with the detailed Austrian regulations on medical device advertising.
Cross-border issues through social media
Advertising in social media and on the internet in general is not specifically regulated in the MPG.[5] Rather, any advertising on the Austrian market or targeting Austrian consumers, irrespective if such advertisement is in newspapers, magazines, television, radio or social media/ the internet is deemed advertising. The current lack of specific regulations for medical device advertising on social media or on the internet has also been repeatedly criticized at a national level.[6] However, currently all advertising measures for medical devices remain solely regulated by the MPG. Medical device companies should, thus, be especially cautious when advertising on social media. It is important to bear in mind, that complications may arise, especially when various regulations come into effect due to cross-border advertising. Thus, when using social media as an advertising platform companies should make sure that advertising for consumers is in line with the laws of all jurisdictions in which such social media advertising can be seen or make sure to implement geographical restrictions so that social media advertising can only be seen by consumers in certain jurisdictions.
Authors: Francine Brogyányi and Theresa Zekert, DORDA Rechtsanwälte GmbH
[1] Brogyànyi, Seling in Anderl (ed.), Praxishandbuch UWG (2021) 219.
[2] Wagner in Rehmann/wagner (ed.), MP-VO4 art 7 Rz1.
[3] Cerha in Cerha/Heissenberger/Steinböck (eds.), AMG § 51 Rz 4.
[4] Semp in Aigner/Kletečka/Kletečka-Pulker/Memmer, Handbuch Medizinrecht Chapter V.1.9.1.
[5] Daniel Larcher/Lukas Beiglböck, The new Austrian Medical Devices Act 2021, RdM 2021/242.
[6] Daniel Larcher/Lukas Beiglböck, The new Austrian Medical Devices Act 2021, RdM 2021/242.