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Episode 13: Updates on the IVDR
Manage episode 414316065 series 3456927
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In this episode of the RAQA Café Podcast, our host engages with Warren Jameson (NAMSA’s Sr. Manager, Regulatory & Quality) and Christele Perrin-East (NAMSA’s Sr. Regulatory Consultant, IVD), to explore the extension of the EU IVDR deadline and its implications for the industry.
Our experts highlight the importance of maintaining progress towards IVDR compliance and registration despite the delay. The discussion also reflects on lessons learned from the EU MDR and examines how the IVDR extension might impact both new product registrations and updates to existing products previously regulated by the EU IVDD.
“I think manufacturers have to be very careful when they look at the dates. It's not actually that far, because if you work backwards, like 2025 is actually. If you can't 12 or 18 months period to get a technical file reviewed, you have to send your technical file like almost right now.”
-Christelle Perrin-East, Sr. Regulatory Consultant
Key Discussion Topics:
- The IVDR Extension
- Lessons from the MDR
- Negative Impact of the IVDR Extension
- Impact on Existing Products Covered by the IVDD
Links:
Blog – Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR
Blog – MDCG 2022-11Rev 1: Urgency for MDR and IVDR Compliance
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