Twin Cities Webcast: Navigating the New IVDR Rule-Based Risk Classification for Your IVD Products

RAC Credits
Tuesday, 07 July 2020 (12:00 PM) - Tuesday, 07 July 2020 (1:00 PM) Central Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.


Although most manufacturers have focused on preparing themselves for the new Medical Device Regulations in Europe, the date of application for the new IVD product regulations is 26 May 2022, which will be here in no time. The new rule-based risk classification in IVDR will have a substantial impact on Notified Body involvement for CE Mark of most IVD products. Being adequately prepared ahead of the 2022 date is crucial in ensuring that your products maintain CE Mark and meet the requirements of IVDR.

This session will focus on the rule-based classification in IVDR compared to the current Directive and what this change means to manufacturers, especially those whose products will require Notified Body involvement for the first time. Attendees will come from the presentation with an understanding of how the classification changes for IVDR will impact their IVD products and how to begin preparing for IVDR. 

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

This event is brought to you by the RAPS Twin Cities Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

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 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured Speaker:
Scott Sepple, MS, RAC, principal regulatory affairs consultant, Fang Consulting, Ltd.