In the newly published article on Lexology, our lawyers Dr. Ulrich Grau, Dr. Tobias Volkwein and Dr. David Shaverdov discuss AI-based medical devices and the regulatory challenges they pose.
They provide an overview of the current regulations for AI-based medical devices and outline national efforts to implement the European requirements. They also discuss the Commission's far-reaching legislative proposals for the applicability of the AI Act, the simplification of the MDR Regulations and highlight their consequences.
To read the whole essay, click here:
https://www.lexology.com/library/detail.aspx?g=2db7a9df-9432-4c1b-9e4e-25878ff62771


