Qserve regulatory experts analyze the proposed EU MDR and IVDR revision (MDR 2.0), covering changes to software classification, AI Act interplay, EUDAMED timelines, and what manufacturers should prepare for.
By Dr. Hatem Rabeh · Published April 7, 2026
Qserve regulatory experts analyze the proposed EU MDR and IVDR revision (MDR 2.0), covering changes to software classification, AI Act interplay, EUDAMED timelines, and what manufacturers should prepare for.
The comprehensive free database for medical device companies, FDA-cleared devices, EU Notified Bodies, competent authorities, clinical guidelines, and regulatory resources worldwide — 4,975 companies · 5,064 devices · 53 EU Notified Bodies · 1,129 resources & guidelines. Founded by Dr. Hatem Rabeh (MD, MSc Ing).