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NAMSA Webinar: How to Select the Right EU Notified Body for IVDR Compliance
April 30, 2019 @ 10:00 am - 11:00 am
Join BioOhio member NAMSA for a webinar on How to Select the Right EU Notified Body for IVDR Compliance on April 30 at 10am EST.
The objective of this webinar is to provide manufacturers who intend to market in vitro diagnostic (IVD) products in the European Union (EU) and/or Canada with general guidance on identifying, selecting and approving a designated EU Notified Body, in accordance with the regulatory requirements of the various current Medical Device Directives and the recently published European In Vitro Diagnostic Regulation (IVDR 2017/746).
Topics to be covered during this webinar include:
- The role of an EU Notified Body overseeing the IVD Regulation (2017/746);
- Current challenges Notified Bodies are facing during the rollout of the pending IVD Regulation;
- How these challenges affect IVD Manufacturers outside of the EU looking to gain EU access for their IVD products; and
- How a manufacturer can select the most appropriate Notified Body when facing the above challenges.
Time will also be allotted for Q&A.