Promotion of medical devices. Legal analysis based on pharmaceutical law

“While advertising of pharmaceuticals is highly regulated and fully harmonized in the European Union, there are no specific European rules on advertising of medical devices. The reasoning that led to the adoption of the rules on advertising of pharmaceuticals can nonetheless also be applied to medical devices: The current national rules on advertising of medical devices are widely divergent, hindering the establishment of the internal market of medical devices. Taking this idea as a point of departure, the main objective of the research is to formulate principles to underpin European regulation on advertising of medical devices. The basic assumption is that such regulation should allow a maximum of information to be communicated to the consumer, without compromising on health protection. To discern these principles, medical device law is being compared to pharmaceutical law and European and Belgian law, as well as US regulation are being investigated.”status: publishe