AIB 2025-1/MDCG 2025-6: Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)
The MDCG has released a guidance document concerning the interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA). This document offers an initial set of answers to the most frequently asked questions concerning the joint application of the Artificial Intelligence Act (AIA) and ...
