B2: Session on regulatory aspects around IVDs

13:15-13:40 Ingrid Blaimaumer: Manufacturers & Notified Bodies: Overcoming IVD Certification Hurdles

Achieving CE certification under the IVDR remains a top priority for IVD manufacturers. However, despite strong efforts, the conformity assessment process can take up to a year, and longer.

This presentation will take a practical look at key factors that influence certification timelines, including clear technical documentation readiness timelines, submission quality, structured dialogue, and project communication. We’ll focus on how manufacturers can actively support and prepare for a smooth and fast assessment process taking a deeper look into technical documentation requirements and submission expectations.

13:40-14:05 Christian Schweiger: Best practice on in-house IVDs: process and examples

My special interests are the role of LDTs in lab. medicine and the influence of IVDR on the changes of the relations between manufacturers and medical labs.

14:05-14:30 Birgit Wahlmüller: IVDR in Practice: Challenges of Sampling, Changing Reviewers and Lessons Learned

Insights from the first sampling after successful certification – navigating regulatory uncertainty and different assessments.