RAPS Twin Cities Webcast: Navigating the New IVDR Rule-Based Risk Classification for Your IVD Products
12:00pm - 1:00pm
RAPS Member: FREE
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.
Scott Sepple, MS, RAC, principal regulatory affairs consultant, Fang Consulting, Ltd.
Contact: RAPS Customer Service
Contact Phone: 1-301-770-2920, ext. 200
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