IVDR Extension Explained: Tips & Strategies

Watch our webinar, where leading experts from the QbD IVD | Qarad team, renowned for their expertise in In Vitro Diagnostic (IVD) devices, explain the proposal for the IVDR extension and its implications for you as a manufacturer.

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On demand

1h

In Vitro Diagnostics

English

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Description

The journey towards adopting the IVD regulations introduced in 2017 has been ongoing for some time, presenting challenges for many in the industry. Acknowledging the potential disruption that can be caused by devices no longer being available, the European Commission introduced initiatives last year to ensure continuity in devices on the market and minimize the impact on patients. Now, as we enter 2024, they are reinforcing these efforts with new measures to facilitate a seamless transition for specific IVDs.

This session will provide you with the latest updates on the IVDR extension and its impact on your daily operations and long-term strategies. Don’t miss this opportunity to gain valuable insights directly from an expert at the forefront of the field.

Watch the webinar on demand

What you'll learn

• Understanding the proposal
• Understanding the implications of the IVDR extension and the conditions to be met to make use of the new extended transitional provisions
• The impact of the gradual roll-out of EUDAMED
• Information obligation in case of interruption of supply
• Strategic planning for compliance: Learn strategies to navigate the IVDR transition effectively, including tips for adjusting your day-to-day operations and long-term planning
• Expert Q&A to address your specific questions

Speakers

Join us as our expert speakers share valuable insights and practical knowledge drawn from extensive industry experience.

Don’t miss the opportunity to learn and engage with professionals in the field.

Kirsten Van Garsse

Business Unit Manager RA IVD & Representative Services

Kirsten Van Garsse obtained her Master’s degree in Biomedical Sciences in 2002 from the Vrije Universiteit Brussel (VUB) and has amassed extensive experience in the In Vitro Diagnostic Medical Device Industry. She joined Qarad, now part of the QbD Group, a consulting company specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry, at the end of 2017.

In her role as Director of Authorized Representative Services & Manager of IVD Regulatory Affairs, Kirsten applies her wealth of experience to Regulatory Affairs projects, adeptly translating regulations into compliant business processes and applications. Additionally, she oversees the various Representation Services offered by Qarad, ensuring clients receive expert support in navigating regulatory requirements.

Anne Paulussen

Senior Consultant IVD - Regulatory Affairs

Anne Paulussen brings nearly 15 years of experience in the pharmaceutical sector.

Anne’s extensive experience in both the pharmaceutical and in vitro diagnostics (IVDs) sectors has given her a profound understanding of the interplay between pharmaceuticals and diagnostics. With expertise spanning both fields, Anne offers valuable insights that enhance her contributions to the industry, especially in the field of companion diagnostics. Prior to joining Qarad in 2022 as a Senior Regulatory Consultant for IVDs, Anne served as a Global Regulatory Device Leader at Sanofi, working on drug-device combinations. In her current role, Anne leverages her expertise to advise CROs and pharmaceutical companies on IVDR compliance, regulatory intelligence, and comprehensive training for IVD manufacturers across all facets of IVDR implementation.

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