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.