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NERAC WEBINAR SERIES | Industry Insights and Analysis
on Business Challenges, Trends and Opportunities
Sign Up Today - Space is Limited!
Thursday, April 30, 2009 from 1:00 to 2:00pm (EST)
Click here to register.
Nerac will hold a FREE, online event titled:
The Changing Directives in the EU Medical Device Market
Are You Prepared for the March 2010 Deadline?
The European Union(EU) has revised their Medical Device Directive, which regulates how products are approved for sale within any of the 27 EU member nations. With a rapidly approaching March 2010 deadline to comply with the revised Medical Device Directive, many medical device manufacturers are faced with an enormous amount of work to complete in a short period of time in order to obtain a CE mark for sale of their products.
At stake is maintaining or increasing share in the growing $86 billion market that accounts for a significant percentage of most U.S. medical device companies’ profits. With nearly 8,000 devices on the EU market, it is possible that a backlog of applications could bottleneck approvals, with serious implications for sales and profits.
Many products that used to rely on substantial equivalence will now require a clinical literature review. Clinical literature reviews constitute an effective alternative to time-consuming and costly clinical trials. In addition, post-market surveillance will now be required for CE mark approval. Companies need to analyze product data now to make certain that they have initiated the required procedures to prevent disruptions to their sales pipelines.
We invite you to attend a free webinar hosted by Nerac which will provide an overview of the changes to the Medical Device Directive and discuss what Notified Bodies are expecting when they receive a clinical literature review or post-market surveillance report.
Be sure to register to attend and mark your calendar!
Thursday, April 30, 2009 | 1:00 to 2:00pm (EST)
There are many questions surrounding the implications and requirements of the new Medical Device Directives. Webinar attendees will learn:
- What are the changes to the EU Medical Device Directive and how do they impact my company?
- How do clinical literature reviews address the new requirements? What are the benefits of using a clinical literature review?
- What other options are available to address the requirements?
- What are the Notified Bodies expecting to see from a clinical literature review?
- What are some common pitfalls in performing a clinical literature review?
- How does the approval process work? How can I streamline the process and maximize our chances for success?
Ensure that your company is positioned to comply with the new requirements before March 2010--Join experts from Nerac and TUV-USA for a powerful discussion designed to give you answers to these questions and more.
Who should attend?
· Engineers, Regulatory and Clinical Medical Device Professionals.
Speakers & Topics
Upcoming Changes to EU Medical Device Directive and Use of Clinical Literature Reviews
Deb Schenberger, Ph.D.
Nerac Analyst
The Clinical Evaluation Process
Jennifer Bromm
Medical Products Manager
TUV-USA
The webinar will be interactive, with the opportunity to submit your questions throughout the presentation. Don't miss this exciting, informative event...register here.
To learn more about this topic, read the Nerac Analyst Report "Clinical Literature Reviews | Changes in EU Medical Device Directive require Immediate Steps." Click here to read the report.
