Pragmatic Clinical Trial Resources-Europe: Current situation in Europe including IVDR regulations

Europe: Current situation in Europe including IVDR regulations

Video Transcription

Video Summary

Christian Malt explains the EU’s IVDR, a stricter regulatory framework for in vitro diagnostic devices and tests, introduced to improve patient safety, test quality, and consistency across Europe. He highlights that most biomarker-based tests used in clinical trials, especially pragmatic and academic studies, fall under its scope. The rules require risk-based classification, clinical evidence, conformity assessment, technical documentation, and post-market surveillance, increasing cost and time. He warns that academic groups face funding, expertise, and collaboration challenges, but urges training, interdisciplinary support, and early engagement with notified bodies.

Asset Subtitle

Europe: Current situation in Europe including IVDR regulations by Christian Marth

Keywords

EU IVDR

in vitro diagnostic devices

biomarker-based tests

clinical trials regulation

notified bodies