Introduction to new EU regulations on Medical and In Vitro Diagnostic devices (Two Courses)

Omschrijving

Delegates participating in this course will:

• Gain an overview of the critical changes with EU MDR and EU IVDR, and their implications
• Find out about implementation timescales and their impact on resources
• Discover what EU MDR and EU IVDR mean in practice

Doelstellingen

About the EU MDR and EU IVDR

The EU MDR and EU IVDR were published in the Official Journal of the European Union on May 5, 2017 as Regulation (EU) 2017/745 and Regulation EU (2017/746). The new rules will apply after a transition period of three years for MDR and five years for IVDR. These two eLearning courses will help medical device and In Vitro diagnostic device manufacturers understand the complex new regulations.

Doelgroep

This course is intended for, but not limited to, regulatory personnel, managers, CEO, CFO, or any medical device or IVD field personnel who want to learn about the new regulations.