Advertising medical devices in Europe is a minefield: even within the EU, the laws are not harmonised as between countries. Social medial marketing campaigns need to be judiciously planned to target different content to users in the different countries to avoid falling foul of the laws in the strictest countries. This article gives you a sense of the legal differences to be aware of before preparing a European social media marketing campaign by comparing the laws in Austria, France, Germany, Poland and the UK.
The basics
There are some basic rules which are uniformly applied in all countries to permitted social media posts as well as to other forms of advertising. Advertisements for medical devices must not make claims that are outside those supported by the IFU. They must also be honest, fair, not misleading and substantiated by objective and robust evidence.
Advertising in any media must not be covert: it must be clear that a paid for feature or promotion is an advertisement. Germany and Poland specifically require that the post is labelled as "advertising". In the UK the use of "Advertisement Feature" is common.
Most countries require that a fear of not using the device is not created and that consumers are not led to believe that a doctor's treatment is unnecessary. Some countries such as Germany specifically prohibit statements that the reader's health will be improved by use of the device.
All countries also prohibit advertising of medical devices directed at children, although the age at which people are considered a "child" for these purposes is quite variable from 18 in Poland, 16 in the UK, 14 in Germany and Austria and undefined in France. Advertising to the parents of children is permitted, although the distinction can be difficult to draw.
Might medical devices be advertised on social media to the public?
Some countries limit the types of medical devices which might be advertised to the public. France is one example. Only devices which are not reimbursed by the French state or which are reimbursable and are lower risk, defined as class I and IIa, might be advertised to the public. Prior authorisation from the ANSM is also required for all advertising for non-reimbursable devices presenting a significant risk to human health. These are listed in a royal decree. Poland and Austria both restrict public advertisement of medical devices to devices which are not designed for professional use/ on prescription, or which require supervision by a healthcare professional.
It is prohibited in France to share a website's promotional page on an open social media network. In France the commentary facilities of such social media advertising must be switched off – whether "like", "comments" or sharing. Interestingly, no other countries mandate the policing of social media responses, although companies would be wise to review responses to and comments on their posts for product complaints to add these to their post-market surveillance system.
France and Austria do not permit comparative advertising of medical devices to consumers.
What are the rules on advertising medical devices to healthcare professionals on social media?
The same basic rules on the content of advertising apply equally to adverts directed at professionals. However, in many European countries medical device advertising directed at healthcare professionals must be accessible only to that group to prevent consumers seeing information about devices that it is prohibited to advertise to them.
The UK is less restrictive in its laws – there are none that prohibit the advertising of specific devices to consumers. If the website is in English and asks the user to say if they are an HCP or a patient and then directs them accordingly, this will be acceptable. Countries with a higher level of restriction on consumer content such as France and Austria would find this solution problematic if the site could be said to be directed to consumers in their country. A site would be considered directed at consumers of a particular country for example, if the website or social media content is in the language of that country and/ or if sales are or can be made to consumers in that country.
Inclusion of mandatory information
Even on social media, mandatory information on the medical device being advertised must be included and prohibited content is to be excluded.
In Poland, the name of the device and information on its intended use together with a statement (in Polish): “This is a medical device. Use it according to the instructions for use and the label”. Some countries such as Germany require that expected risks are outlined to consumers. France requires that the following information is included: the purpose, the instructions for use, the name of the manufacturer and the CE mark, but that reimbursement status must be mentioned.
Use of testimonials/influencers
For permitted consumer advertising, influencers might be used but it must be clear that they are advertising the device, by the word "advertising". In France and Germany "commercial collaboration" might be used in the alternative. In Austria, influencers are not permitted to say that the device brought about their recovery. Both Austria and the UK have general rules on influencers which it is worthwhile following to avoid complaints.
For transparency reasons, influencers must say if they are paid or have received a free of charge device or any other payment in kind. In France there is a public transparency website on which the remuneration of the influencer (whether a healthcare professional or not) exceeding EUR10 including tax must be published. While in the UK, it is required to have a written agreement that is signed and dated by the parties, and which sets out the expenses (if any) to be paid to the influencer. Influencers must be aware of the requirements of decency that apply to the use of physical images of the body, and for those in France and Austria, that "before" and "after" images are not permitted.
Note that Poland does not permit the use of images of heathcare professionals in advertising to the public, which inhibits the use of influencers who are physicians in Poland. In Germany, healthcare providers are subject to professional restrictions on being involved in the advertising of medical devices to consumers.
What is the solution if advertising is not permitted?
For manufacturers of medical devices which cannot be advertised to consumers, there is the option of corporate advertising. In these the company and not its devices, will be advertised. Corporate advertising must not be used for covert device advertising and must otherwise comply with the general laws on advertising.
