Medical Device Advertising in Germany and the EU – What is Allowed and What Isn’t

1. What is classed as “advertising”?

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: 

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:

• Social media posts intended to generate sales
• Referral emails (“Tell a friend...”)
• Product reviews on your  company’s website
• Advertising phrases in the footer of an otherwise non-promotional email (according to a Berlin Higher Regional Court decision of September 15, 2021 (reference 5 U 35/20). Specifically, the case was about the short phrase “XXXXX. Organizes, thinks, gets it done. Use www.XXXXX.de” that was included in an email footer).

2. What are the general limits of advertising?

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:

a) No misleading advertising

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: 

• Untrue information
• Statements that are designed in such a way that they can be misunderstood
• Advertising with self-evident facts (companies cannot advertise that their product comes with a two-year guarantee if this is actually required by law)
• Advertising with “small print” (for example, all the positives are accentuated, and the disadvantages are barely legible on the back)

b) Be careful when making comparisons to other products

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:

• makes a comparison with products not intended for the same purpose.
• makes a subjective assessment of the competitor product.
• takes advantage of the good reputation of a competitor product or damages its reputation.

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.

3. Which regulations apply to medical devices?

In addition to these general rules, there are also specific requirements that apply to medical devices.

a) Heilmittelwerbegesetz (HWG)

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...

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.

Layperson or professional audience?

Several provisions in the HWG do not apply to advertising directed at “professional groups.” The act defines these “professional groups” as follows:

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. 

• Advertising to patients: 
  The HWG lists the conditions under which this is permitted, mainly in Section 11. For example, you cannot suggest that their health will deteriorate if they do not use a particular product or use testimonials that could be misleading. Section 12 also prohibits the advertising of medical devices relating to certain diseases.

• Advertising to professional groups:
  Professional groups are exempt from numerous regulations, such as the list of prohibitions in Sections 11 and 12 of the HWG. However, this doesn’t mean that everything is permitted when advertising to medical professionals. Above all, any information in the advertisement must be true (scientific evidence is required) and there is a restriction on donations.

b) MDR and IVDR 

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:

Therefore, all medical device promotional materials must:

• correspond to the intended purpose. No other use may be suggested.
• be truthful.
• be realistic with regard to benefits and risks.

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.

4. Which regulations apply to advertising on the Internet?

a) Can you advertise a medical device on social media?

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.

• The general regulations, particularly those of the UWG, Telemediengesetz (Telemedia Act) and HWG, must be observed.
• Advertising on social media is sure to raise the suspicion of “surreptitious advertising” (which is not permitted). A link to a device or a non-labeled reference is often enough. Advertising has to be clearly recognizable as such.

• The guidelines of the social media platforms themselves also have to be followed. For example, LinkedIn restricts advertising of medical devices.
• Influencer marketing also has to be accurately marked as advertisement  at all times. 

Be careful with influencer marketing

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.

b) Which regulations apply to websites?

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.

5. What can happen if you don’t respect the limits?

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.

6. Conclusion

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.