Medical device advertising might not be the first thing manufacturers think about when developing a new device, but it is also a part of the medical device industry. And it can often be easy for manufacturers to “advertise” without realizing it.
As in all fields, there are some specifics to keep in mind when it comes to advertising for medtech manufacturers. This article will explain what is and what isn’t permitted.
The term “advertising” has a much broader definition than a lot of companies think. EU Directive 2006/114/EC concerning misleading and comparative advertising defines advertising as follows:
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
Source: Art. 2(a) of EU Directive 2006/114/EC concerning misleading and comparative advertising
It's not just the definition that is broad, the term is also often interpreted broadly by case law.
It is important to understand it's not just classic TV or magazine ads that are considered “advertising.” Any business contact intended to promote a sale is included. So, this also includes, for example:
Competition law sets the general limits for advertising. The most important regulations in this regard in Germany can be found in the “Gesetz gegen den unlauteren Wettbewerb,” or UWG for short.
The UWG includes a list of prohibited commercial practices in the annex to Section 3(3). This annex lists specific advertising practices that are always illegal when directed at consumers. The list includes, for example, advertising disguised as information and false statements in advertising material.
In addition, there are numerous other regulations on specific topics. However, the most important advertising rules can be summarized as follows:
Misleading advertising according to Section 5 UWG includes any misleading commercial practice that may cause market participants to take a decision they would not otherwise have taken. In other words, companies can win people over with arguments but not by deception.
The following are, for example, considered misleading:
Comparisons with specific competitor products are not prohibited as such. However, they cannot be used if they are unfair according to Section 6 UWG. A comparison is considered unfair, for example, if it:
In the medical field, in particular, courts also regularly require claims to be based on scientific evidence.
It is not uncommon for companies that have involuntarily appeared in other companies’ advertising to take legal action. So, before using comparisons in their advertising, manufacturers should find out what they need to pay attention to and consider whether it's really the smartest way to go.
In addition to these general rules, there are also specific requirements that apply to medical devices.
The German Heilmittelwerbegesetz (Therapeutic advertising act) applies to medicinal products and according to Section 1(1)(1a) also to medical devices as defined by the MDR and IVDR.
This law applies to the advertising of...
Medical devices as defined in Article 2(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117 of May 05, 2017, p. 1; L 117 dated May 03, 2019, p. 9; L 334 dated December 27, 2019, p. 165), amended by Regulation (EU) 2020/561 (OJ L 130 dated April 24, 2020, p. 18) in its current version, and as defined by Article 2(2) of Regulation 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117 dated May 5, 2017, p. 176; L 117 dated May 3, 2019, p. 11; L 334 dated December 27, 2019, p. 167) in its current version.
Source: Section 1(1)(1a) HWG
Although there are fewer restrictions with regard to medical devices than for medicinal products in the HWG, not every form of advertising is permitted for medical devices. However, the HWG distinguishes between advertising for laypersons and advertising for professionals.
Several provisions in the HWG do not apply to advertising directed at “professional groups.” The act defines these “professional groups” as follows:
Professional groups within the context of this Act are members of the healthcare professions or healthcare industry, institutions serving human or animal health, or other persons who legally trade in medicinal products, medical devices, procedures, treatments, objects or other instruments, or use them in the exercise of their profession.
Source: Section 2 HWG
This means “professional groups” primarily refers to professionals in the medical industry: physicians, hospital staff, pharmacists, etc.
If companies target their advertising mainly at hospitals, primary care centers and/or laboratories, there are fewer restrictions to pay attention to than when targeting patients directly.
The MDR and IVDR also contain a specific prohibition on deception when it comes to medical device advertising materials, which the regulations link to the device’s intended purpose.
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.
Source: Art. 7 MDR/IVDR
Therefore, all medical device promotional materials must:
Are there differences for professional groups?
The MDR and IVDR do not differentiate between advertising aimed at laypersons and advertising aimed at medical professionals. However, accompanying information such as instructions for use must be adapted to the target group (more on this in our article on instructions for use).
Manufacturers who market their devices throughout Europe should also be careful: while in Germany less stringent regulations apply to advertising aimed at professional groups, this is not necessarily the case in other European countries. Manufacturers should make sure to familiarize themselves with national regulations.
Neither the MDR nor the IVDR say anything about advertising on social media. Similarly, there is nothing per se in German law prohibiting the advertising of medical devices on social media. But in practice, you need to be very careful.
So-called influencer marketing, in which a third party advertises a product on social media, is only permitted if the corresponding post is clearly marked as advertising.
In practice, this is usually done by displaying “sponsored post” or “advertisement” and a reference to the sponsor of the post. It is important that the post can be recognized as advertising immediately and that the sponsor and conditions (for example, in the case of competitions) are easy to identify. In practice it is better to point out the promotional nature once too often than to risk trouble with the authorities or competitors.
If advertising on websites is aimed at professional audiences, access to these pages generally has to be restricted. Simply asking “Are you a professional medical expert?” is not enough. In practice, a lot of companies use special control and registration methods.
Breaches of the above regulations may result in claims for damages, fines or even prison sentences. In extreme cases, you may even be considered liable for fraud under the German Criminal code (StGB) with correspondingly severe penalties.
Three employees from a company in Pliezhausen (German) recently found out what can happen to you if you make misleading statements about medical devices. The company had marketed a bioscanner for analyzing health data that in reality had absolutely no medical benefit at all. The company's three executives were sentenced to several years in prisonand heavy fines for commercial fraud and violation of the HWG.
No industry, including the medical device industry, can survive without advertising. However, manufacturers have to maintain high standards, particularly with regard to the accuracy of the information they are disseminating. When in doubt, it's better to not get carried away when advertising the benefits of your medical device than to end up as a headline in the media. This is also publicity, but probably not the type you want.