Multi-jurisdlctional advertising of medical devices - the legal framework in Germany, the Netherlands and the UK

摘要

Unlike the EU directive on medicinal products, the directives on medical devices do not regulate the promotion of medical devices per se. Consequently, the legal landscape for the promotion of medical devices in Europe is fragmented and derives from a variety of disparate sources. The primary requirement of the Medical Devices Directive (93/42/EEC), as amended by Directive 2007/47/EC, is that a medical device must have a CE mark if it is to be placed on the market. In this context, a medical device may only be promoted for its intended purpose as set out in the instructions for use, labelling and promotional materials. While there are limited exceptions for exhibiting at trade fairs, exhibitions and demonstrations, a visible sign displayed at those events must clearly indicate that the device cannot be marketed until the device is validly CE-marked.