FAQ on the Interplay Between the AI Regulation and the IVDR and MDR
The Medical Device Coordination Group (MDCG) and the Joint Artificial Intelligence Board (JAIB) have recently published a FAQ concerning the interplay between the AI Act and the in vitro medical devices Regulation (IVDR) and the Medical Devices Regulation (MDR).
Commission publishes Guidelines on the definition of an artificial intelligence system established by the AI Act
The European Commission has published Guidelines on the definition of an artificial intelligence system established by Regulation (EU) 2024/1689 (AI Act) file:///C:/Users/ewright/Work%20Folders/Downloads/Guidelines_on_the_definition_of_an_artificial_intelligence_system_established_by_AI_Act_VJp35Ve5WA4XFrpUSFj5ohfaBco_112455.pdf