July 09, 2020 - July 09, 2020
Date: July 9th, 2020
Time: 11am PST/ 2pm EST/ 6pm CEST
Duration: 90 minutes
RAPS Member: FREE
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.
The European Union’s In Vitro Diagnostics Regulation (IVDR) replaces the existing In Vitro Diagnostics Directive (IVDD) beginning 26 May 2022, which is not as far away as it seems. The new regulation’s requirements are much more prescriptive and stringent than the IVDD, so manufacturers will need to begin preparing now to transition their devices to certify under the IVDR. Due to the IVDR’s many classification and conformity route changes, an estimated 90% of all IVD devices would need to be certified under IVDR as opposed to only 20% under IVDD.
With an expected decrease in the number of available IVDR-designated Notified Bodies, new premarket and post-market reporting/documentation requirements, and a dizzying array of regulatory transition timelines, this means that planning, coordination, and budgeting for the new regulation are crucial.
This presentation will provide direction on where your organization should start with implementation preparations for the IVDR. You will need to create a viable transition strategy beginning with senior leadership throughout the organization, as the regulation will impact every segment of your business. We will also review strategies for efficiently collecting and maintaining technical documentation required for new and legacy devices under the IVDR.
At the conclusion of this webcast, attendees will be able to:
- Confidently describe to their organization that, with the transition process and ongoing compliance with the IVDR, manufacturers will require more resources than in the past.
- Outline an IVDR transition strategy for their organization and supply chain.
- Understand how embracing digital transformation of technical documentation and investing in automated, data-driven quality and compliance solutions can reduce IVDR transition effort and time to market for IVD devices in the EU.
A Q&A session will be provided at the end.
This event is brought to you by the RAPS Utah 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. Registration will close 48 hours prior to the event.
Sue Spencer, head of IVD and principal consultant