IVDR challenge: balancing regulation, innovation, and patient care

This conversation from mid‑2025 captures Christa Cobbaert at a pivotal moment in IVDR evolution. She reflects on the regulation’s origins, unexpected consequences for laboratories and industry, and the missing pathways needed to protect innovation and rare disease diagnostics. She also reveals how BioMed Alliance, MedTech Europe, and EFLM worked behind the scenes to push for change, which led to the EU’s IVDR amendment proposal published in late 2025. This proposal is currently open for feedback, where stakeholder influence continues. After the feedback phase, the proposal will move through the legislative processes of European Parliament and Council.