Regulatory and Practical Implications of e-Labeling for IVDs in Europe

is being presented by Dr. Dirk Stynen, Founder & Principal Consultant, of Qarad and airs on Tuesday, October 12th, 2010. For more details or to register, please visit our site at www.fxconferences.com

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

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