IMPORTANT CHANGES TO THE DRAFT EUROPEAN IVD REGULATION

PRODUCT INFO

Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.

In June 2015, the European Council published its much anticipated consolidated draft of the proposed IVD Regulation. This newest draft differs from the previous version in several important ways. These changes will have a significant impact on manufacturers’ plans for implementation of the new regulation. The Commission clarified and re-interpreted several important aspects of the previous proposal, and strengthened Notified Body oversight of lower-risk class devices.

The presentation will discuss the following topics:

Rationale and expected timeline for implementation
Major changes in the Council’s draft
Risk based classification of devices
Routes to conformity
Clinical expectations
Economic Operators

Speaker:
Stefan Burde, PhD
IVD Product Expert
BSI Americas

Contact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 | bakins@q1productions.com

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