A Brave New World for Software Medical Devices: EU Regulations on the Horizon

A Brave New World for Software Medical Devices: EU Regulations on the Horizon

November-December 2023, The Journal of Robotics, Artificial Intelligence & Law

The European Commission recently published a number of new legislative proposals that will affect medical devices marketed in the European Union. Among other things, these proposals would introduce new (or add on to existing) pre-market conformity assessment requirements, create ex ante monitoring requirements, and impose transparency and data sharing obligations. In this article, the authors discuss the key obligations in a number of laws and regulations and explain how they may apply to software medical devices, which already are regulated by the Medical Devices Regulation.