As I have written before on this blog, medical devices are spectacularly unregulated by medical devices specific EU legislation when it comes to advertising and marketing. That does not mean however that no rules apply to to advertising and marketing for medical devices. Many general EU statutes regulate advertising and marketing for medical devices one way or the other. At the same time the national approach to advertising differs quite widely. To highlight how companies can deal with this, I decided to organise a seminar about it with the same colleagues as with whom I wrote the article referenced in this post, which was well received and attended by many (especially via the simultaneous webinar). The seminar presentation can be found here. I will post the recording of the webinar when we have finished the remastering.
The first step of course is to determine if the statement a company wishes to make is advertising in the first place. Any statement that is not advertising is information subject to the full protection of Although there is no case law about advertising of medical devices specifically at the EU level, there is plenty about the scope of the concept of advertising and its borderline with information in the field of medicinal products. A recent presentation of mine on the subject is here (sorry, in Dutch only – if enough people request a translation I may translate it).
The most recent case law of the EU court in the field of medicinal products advertising provides some interesting additional pointers (some of the nuances will be lost in the below summary and translation from medicinal products law to medical devices law, so I recommend to always read the referenced cases yourself).
Damgaard – a statement does not necessarily have to come from the manufacturer to be considered (regulated) advertising, and may even originate from a completely independent journalist. Add to this (in my view) patient group, CRO recruiting for a clinical trial, etc. The decisive criterion is its ‘promotional objective’.
MSD – the faithful reproduction of the packaging of the medicinal product as well as the literal and complete reproduction of the package leaflet or the summary of the product’s characteristics, which have been approved by the authorities with competence in relation to medicinal products. Any information relating to a medicinal product which has been selected or rewritten by the manufacturer, which can be explained only by an advertising purpose, is however prohibited. The reproduction of such information on a website is allowed, as long as it is not actively pushed to the consumer.
Novo Nordisk – For advertising aimed at healthcare professionals quoting to stay permitted advertising the information given does not need to be identical to that in the SmPC (or in case of medical devices: label), provided that such information, firstly, may not be misleading and is to encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties. Secondly, it must be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned. Finally, quotations, tables and other illustrative matter taken from medical journals or other scientific works are to be clearly identified and the precise sources indicated, so that health professionals are informed of them and can verify them.
Alter Channel – (not about medicinal products but about cosmetic dental treatment) It doesn’t matter if the promotional statements made (in this case on TV) were paid for or not for them to constitute advertising.
Although none of these cases deal with advertising and marketing of medical devices, consistent application of EU law to similar situations would dictate that the same principles as described above apply.