EU MDR & IVDR: What to Know to Stay Ahead

Wed, Nov 11, 2026 · 11:00–11:30 AM CET Regulatory Strategy Stage, Koelnmesse

About this session

Ensuring compliance with the EU MDR & IVDR while fostering innovationOngoing challenges and proposed reforms to the MDR / IVDRImpact of the draft Biotech Act and the AI Act on product developmentAddressing delays and inconsistencies in device and diagnostic approvalsNavigating market access and competitiveness in Europe

Speakers

Hilary Jones

VP Legal, Regulatory and Commercial Law · Consultant and formerly BioNTech

Speaker
Olga Van Grol-Lawlor

Global Regulatory Policy & Advocacy Associate Director · Boston Scientific

Speaker