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). The purpose of the FAQ is to provide guidance concerning some of the most common questions regarding the interplay between the Act and the Regulations, including guidance on which provisions of the AI Act reflect related provisions of the IVDR and MDR.

This is helpful in light of the fact that the Regulations and the Act sometime use different terms for the same purpose, e.g., the term "manufacturer" in the IVDR and MDR are confirmed in the Guidance to be equivalent to the term "provider" in the AI Act. The Guidance also provides directions concerning the appropriate steps to incorporate requirements provided in the AI Act into quality management systems and technical documentation developed in accordance with the IVDR and the MDR.

It confirms both that devices without an intended medical purpose listed in Annex XVI of the MDR fall within the scope of the AI Act, and that medical devices and IVDs falling within the health institution exemption provided in both the IVDR and the MDR do not fall within this scope.