CE Marking: Pitfalls and Best Practices for IVD Directive Language Requirements

Back in 2002, the $9 billion U.S. in vitro diagnostics (IVD) industry was ill prepared to meet the strict new regulations contained in the European Union's IVD Directive. IVD manufacturers were realizing that translation is critical to earning the CE mark.

Manufacturers that lacked effective plans for complying with the language requirements of the directive risked losing revenue and market share. Translation quality control, global labeling strategies and in-country reviews presented new challenges for the majority of in vitro diagnostics manufacturers who were dealing with non-English texts for the first time.

This audio conference is presented by Andres Heuberger of ForeignExchange Translations. To learn more, visit www.fxconferences.com.

IVD Directive Compliance: Understanding Labeling and Language Requirements

With the introduction of the In Vitro Diagnostic Directive (IVDD) in Europe in 2003, multilingual labels and instructions are required for the diagnostics industry to comply with E.U. regulations.

Companies are faced with the dilemma of providing the appropriate and required information in a multilingual format while making the information readable on a variety of label sizes. The use of internationally recognized symbols as a substitute for text has been actively promoted to provide users with a uniform method of obtaining product information. Yet many diagnostics companies are struggling with the issues that surround multilingual label design and international symbology.

This audio conference is co-presented by John Webster of Medical Device Consultants and Andres Heuberger of ForeignExchange Translations. To learn more, visit www.fxconferences.com.