TÜV SÜD experts cover the regulatory requirements for AI-based medical devices under the EU MDR and the EU AI Act, including classification, risk management, and clinical evaluation considerations for SaMD.
By Dr. Hatem Rabeh · Published April 7, 2026
TÜV SÜD experts cover the regulatory requirements for AI-based medical devices under the EU MDR and the EU AI Act, including classification, risk management, and clinical evaluation considerations for SaMD.
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).