About the webinar
Navigating the EU's regulatory framework for In Vitro Diagnostic Regulation (IVDR) remains challenging!
On 21 February 2024, the EU Council endorsed the European Commission's proposal to revise the IVDR timelines, aiming to mitigate shortages of critical in vitro diagnostic medical devices, particularly Class D devices.
Despite the IVDR entered into force in 2017, the regulatory infrastructure, including Notified Bodies, Legal Manufacturers, EURLs, and MDCG, has struggled to keep pace, posing a risk of shortages in IVDs. Alongside regulatory bottlenecks, the impact of recurring transitional delays on innovation, maintaining state-of-the-art legacy IVDs, and ensuring the reliability of a stable regulatory framework needs to be considered.
In a collaborative webinar hosted by TÜV SÜD and Entourage, our experts will delve into optimal IVDR transition strategies. Participants will gain insights into navigating the conformity assessment process within the proposed new IVDR timelines and how to use the significant change and sampling concepts to ensure a seamless transition.
Join us to get invaluable insights from our world-class experts on how to overcome the IVDR transition challenges.
Webinar outline
Topic 1: Conformity Assessment Process – 7 years after IVDR entry into force – where do we stand?
Topic 2: IVDR transition: New IVDR timelines!
Topic 3: Significant vs substantial changes – what is the difference?
Topic 4: Sampling Concept – how to make the most of it?
Conclusion & Q&A
Speakers & moderator
Speaker
Dr. Heike Möhlig-Zuttermeister
Director Expertise Management & Segment Manager - IVD, TÜV SÜD
