Our White Paper on the applicability of the AI Act to clinical investigations of AI-based medical devices addresses the critical need for regulatory clarity regarding the intersection of the EU Artificial Intelligence (AI) Act and the Medical Device Regulation (MDR) concerning clinical investigations of AI-based medical devices. The White Paper identifies the current regulatory ambiguity within the European Union, particularly the uncertainty about whether and to what extent the AI Act applies to clinical investigations of AIMD that have not yet obtained CE marking.

This confusion arises due to inconsistencies between the AI Act and the MDR, posing significant challenges for manufacturers, regulators, and healthcare providers involved in the development and deployment of these innovative medical devices. We discuss further in our White Paper which can be accessed here.

Authored by Arne Thiermann and Hannah Wiborg.