Advertising medical devices: lack of harmonisation across Europe

At our recent Spotlight on medical devices event, Taylor Wessing's European team discussed the differing approaches taken to the advertising of medical devices and in vitro diagnostic medical devices (IVDs) across Europe. Partners Alison Dennis (London), Evelyne Friedel (Paris), Daniel Tietjen (Munich), and Senior Associates Christopher Bakier (Vienna) and Bartosz Świdrak explored and compared the different regulatory requirements, restrictions and sanctions in their respective jurisdictions.

The key takeaway was the lack of harmonisation across the approaches taken to medical device advertising across Europe, and a feeling that the failure of the Medical Devices Regulation to introduce advertising rules was a missed opportunity in this regard.

The panel discussed:

Disparities in approach to the advertising of medical devices and IVDs to the public

France has comparatively very detailed and prescriptive guidelines on the advertising of medical devices and IVDs to the public. Advertising prohibition depends upon whether the device is reimbursable, and on the device's classification. There are also requirements that usual social media functions (eg 'likes' and 'comments') are disabled for product pages.

Both Poland and Austria prohibit the advertisement of professional-use only devices to the public, whereas in Germany and the UK this is permitted subject to content restrictions. Images of healthcare professionals (HCPs) are not permitted in Poland in medical device advertising.

Differing definitions of 'children' for the purpose of medical device advertising

All countries represented on the panel prohibit the advertising of medical devices to children. However, the age at which people are considered 'children' for the purpose of medical device advertising varied significantly: Poland considers this under 18, the UK and Spain consider this under 16, Austria and Germany consider this under 14, and The Netherlands and Italy consider this under 12.

France does not clarify the definition of children at all, however it does prohibit advertising materials using elements specifically targeting children, for example images that would appeal to children.

Varied approach to testimonials and influencers

All countries represented on the panel allow influencer advertising.

There are however differing approaches towards whether HCPs can provide testimonials: this is prohibited in France and Poland, but permitted in the UK, Austria and Germany as long as applicable advertising rules are complied with.

Wide variation in sanctions for breach

The sanctions applied for breaching medical device advertising laws/codes vary significantly across Europe. Germany, the UK and France impose criminal sanctions for breaches, with a prison sentence of up to two years in Germany. By contrast, there are no criminal sanctions in Poland or Austria.

The levels of fines also vary widely: unlimited fines are possible in the UK, and a fine of up to EUR1 million may be imposed in France. Fines are subject to a significantly lower limit of up to EUR50,000 in Austria and Germany.

Our European comparison tool for advertising medical devices enables quick and easy comparisons for the different approaches taken to medical device advertising law – check it out here!