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.

This audio conference covers:

• Regulatory aspects of e-labeling in the EU
• Hurdles for implementing e-labeling
• Requirements for an e-labeling website
• Requirements for the toll-free (freephone) service
• Practical solutions for implementing e-labeling in practice

About the speaker:

Dirk Stynen, PhD, is Founder and Principal Consultant of Qarad, a consulting company specializing in EU regulations and quality systems for IVD companies. Before founding Qarad, Dirk was R&D Manager at Sanofi Diagnostics Pasteur, and also worked with Innogenetics, where he led the department responsible for quality assurance, quality control, regulatory affairs and labeling.

Dirk participates in the European Commission’s Technical Group for IVDs and has extensive experience with the implementation of e-labeling.

Who should attend?

• Manufacturing Managers
• Regulatory Affairs Managers
• Quality Assurance Managers
• Marketing Managers
• Labeling Managers