Recalibrating EU Medical Device Regulation: Deep Dive into the EU MDR / IVDR COM-Proposal

The EU Commission’s proposal for amending the MDR and IVDR marks a pivotal moment in medical device regulation. This Coffee Break provides a structured overview of the upcoming reform: regulatory simplification, reduced administrative burdens, and more efficient conformity assessments. Join us for practical insights into key changes, including new device classifications, “well-established technology” designations, and regulatory sandboxes designed to foster innovation. Discover what these developments mean for manufacturers, notified bodies, and healthcare providers—and prepare for the next phase of compliance in the EU MedTech sector.