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Important Changes to the Draft European IVD Regulation
Important Changes to the Draft European IVD Regulation

Our Price: $395.00

Product Code: WB-7189

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About the Product
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

Stefan Burde, PhD
IVD Product Expert
BSI Americas

Participants that will find this webinar most beneficial will be those involved in diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
  • Regulatory Affairs
  • Legal Counsel
  • Compliance Officers

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