AIB 2025-1 / MDCG 2025-6 Interplay between the Medical Devices Regulation (MDR) and In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)

Question-and-answer document with 36 questions on the joint application of the AI Regulation and the regulations on medical devices and in vitro diagnostics. The document introduces the term Medical Device Artificial Intelligence and explains that manufacturers may integrate their AI testing, documentation and reporting procedures into existing Medical Devices Regulation and in vitro Diagnostic Medical Devices Regulation procedures. It is not formally a Commission document and not legally binding, but is endorsed by the AI Board and the Medical Device Coordination Group. The document is dated June 2025, without a specific day.