RAPS Vancouver Chapter: Webcast Breakfast Series #3: EU IVDR Requirements

Program Description

The European Commission published proposals for new regulations of medical devices and in vitro diagnostics in 2012. Now, after years of negotiation within the EU legislative system and with interested stakeholders, the new regulations are expected to be published in 2017. This four-week virtual program draws together industry experts and leading notified bodies who have been closely following the evolution of the proposed regulations, anticipating the final texts, developing positions on what will be required by the regulations, and understanding the impact on manufacturers, devices and systems both new and legacy.

Uniquely, each week provides different perspectives/opinions from different notified bodies and experts on the key significant changes that will impact all medical devices and in vitro diagnostics being placed into Europe under the new European Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). This program will also consider the impact on legacy devices cleared, CE Marked, and under the existing EU Medical Device Directive (MDD) and In Vitro Diagnostics Directive (IVDD).      

Learning Objectives

• Understand the key final requirements of the new EU MDR and IVDR
• Hear the interpretations of leading notified bodies on their expectations under the new final regulations
• Consider the impact of the new regulations on legacy devices cleared, CE Marked and under existing directives
• Be prepared for the changes and begin to understand the impact on regulatory resources needed by manufacturers and notified bodies
• Learning Levels: Basic, Intermediate, Advanced