REGISTRATION CLOSED-Chicago Chapter Webcast: IVDR Notified Body Update

When:  Jun 12, 2020 from 11:00 AM to 1:00 PM (ET)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital now more than ever before. The COVID-19 pandemic shows that we need to stay connected and work to understand the daily impact on our industry. 

To support the community during this crisis, RAPS is offering this webcast for free to members. 

Description

On 5 May 2017, the European Commission adopted the In Vitro Medical Device Regulation (EU IVDR) 2017/746. There is a five-year transitional period, ending in May 2022, after which the regulation will take effect. IVD manufacturers have the duration of this transition period to update their technical documents and processes to meet the standards.

Join this webcast by Dr. Julien Senac, PhD, Global Director, IVD Focus Team, TÜV SÜD, on the EU IVDR State of Implementation. The new regulation introduces more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. 

Learn strategies that can help your company navigate the higher level of scrutiny, including:

  • Key differences between the new regulation and the directives it replaces;
  • Data from clinical investigations vs. literature review;
  • Concept of equivalence;
  • Additional scrutiny in the pre- and post-market phase;
  • How to ensure a smooth transition to IVDR certification.

There will be a Q&A session at the end. 

This event is brought to you by the RAPS Chicago chapter to encourage knowledge sharing and community development. RAC holders may claim 2.0 RAC recertification credits.

This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. 

Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 48 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. Registration will close 48 hours prior to the event. 

Featured Speaker:
Dr. Julien Senac, PhD, global director, IVD Focus Team, TÜV SÜD