Many companies believe that by simply having the CE mark on their products, they are in position do business in Europe. However, things are not always that straightforward. They tend to forget that the European Union is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with national language requirements. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?
In this audio conference, we discuss these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels. In addition the presentation covers proper language for the intended users in conjunction with risk management.
Industry Update: EU Labeling for Medical Devices is being presented by Jaap Laufer, Vice President, Public & Regulatory Affairs, with Emergo Group and airs on Thursday, March 12th, 2009. For more details or to register for this conference, please visit our site www.fxconferences.com
