Industry Update: EU Labeling for Medical Devices

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?

This audio conference discusses 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 was presented by Dr. Jaap Laufer, Vice President, Public & Regulatory Affairs, with Emergo Group and aired on 2009-03-12. For more details or to download this event, please visit our site at www.fxconferences.com

EU Device Labeling: Issues and Requirements

For many companies, achieving ISO 13485 certification, applying the CE mark and finally exporting to Europe is a great victory. However, many companies forget that the EU is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with language requirements and the use of symbols for each country. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?

In this presentation, we discuss these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels.

EU Device Labeling: Issues and Requirements was presented by Dr. Jaap Laufer, .P. Public & Regulatory Affairs, with Emergo Group Inc. and aired on 2007-09-06. For more details, or to download this audio conference please visit our site at www.fxconferences.com