Labeling and Instructions For Use (IFU) for Medical Devices and In-Vitro Diagnostics

This seminar will look at the current regulatory environment and future developments for labeling of medical devices and in-vitro diagnostics (IVDs). It will provide guidance on labeling standards and the use of symbols. The important issues surrounding instructions for use (IFUs) will be discussed and advice will be given on how to provide IFUs to users. A comprehensive overview of the national language requirements will be discussed and advice provided on what to consider when establishing a translation process. In addition, Unique Device Identifiers and barcoding will be addressed and the important and complex area of identifying the manufacturing site and country of origin on your labeling will be covered.