About this event
This informative webinar is designed for manufacturers, particularly those new to the field, seeking to initiate the IVDR CE marking process for their in vitro diagnostic (IVD) devices.
Key Topics Covered:
- Device Classification: Understand the risk classification under the new regulation
- Conformity Assessment Requirements: Explore the specific requirements based on risk classification
- IVDR Transitional Period: Gain insights into the latest amendment regarding the transitional period for devices
Why Attend?
Participants will gain basic knowledge essential for navigating the complexities of IVDR compliance. This session will empower you to:
- Identify the classification of your device and understand its implications.
- Prepare for the necessary conformity assessment processes.
- Stay updated on recent regulatory changes affecting your products.
Target Audience
This webinar is ideal for manufacturers and startups focused on IVD products.
We look forward to your participation!
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Hosted by
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Guest speaker
Ellen van Loon DEKRAG
Ellen van Loon joined DEKRA Certification B.V. in 2022 and is currently a qualified Technical File Reviewer for IVDR. She holds a degree in Biomedical Sciences and earned her PhD in Medical Sciences, where she researched the role of transporters in the kidney. Following her PhD, Ellen worked as a project leader, developing technical dossiers, and later as a Quality Control Manager at an IVD company specializing in genetic tests
DEKRA
On the safe side.DEKRA is a global expert organization dedicated to safety, with over 48,000 employees in around 60 countries. They provide a wide range of independent expert services for safety in transportation, workplaces, and homes.
