National penalties for breach of medical device advertising rules

We are often asked what are the penalties in Europe for breach of advertising laws for a medical device or in vitro diagnostic (IVD). Even within the EU, enforcement is a matter for national law and national regulatory agencies. Advertising of medical devices is mentioned in Article 7 of the EU Medical Device Regulations 2017/745 or In vitro Diagnostic Medical Device Regulations 2017/746, but is often also the subject of separate national legislation. Actions can be instigated by or through the acts of competitors. If they want to hit hard and have the resources, competitors will take action in several countries. This can require as little as a letter to a regulator. Manufacturers might expect therefore for there to be multiple actions and multiple sanctions. 

Penalties can be administrative fines, criminal fines, but also damages for unfair competition from competitors in some civil law countries. A summary of sanctions and penalties that might apply in different countries for breach of advertising laws for medical devices and IVDs is set out below. 

Dealing with such claims can be expensive and time-consuming, taking up valuable resources. This makes it worthwhile for companies trying to comply with local advertising laws, with verification of all claims by their legal and clinical teams.  These reviews might be used to build a claims bank which facilities future reviews. This, combined with the provision of clear guidance for teams developing advertising and marketing materials for each country, will go a long way to avoiding the imposition of sanctions. It will also mean that if the company complains about another manufacturer's advertising, they are less likely to suffer from retaliatory action for their own advertising.