With more than 20 official languages in the European Union, manufacturers often encounter challenges when providing paper instructions for use by traditional means. In MEDDEV 2.14/3, the European Commission gives guidance to manufacturers of in vitro diagnostic devices regarding the supply of instructions for use, which can now be provided by alternative means such as a dedicated website. However, there are strict conditions which apply to such websites, including the requirement that the manufacturer also provide a toll-free telephone number for customer support.
In this conference, our speaker details the IVD e-labeling requirements as defined in the MEDDEV guidance, and explains the challenges posed by the implementation of e-labeling solutions that comply with those requirements.
Regulatory and Practical Implications of e-Labeling for IVDs in Europe is being presented by Dr. Dirk Stynen, Founder & Principal Consultant, Qarad and airs on Tuesday, September 8, 2009. For more details, please visit our site at www.fxconferences.com
