Global menu

Our global pages


Developing medical AI systems. Overview of MDR and AI legislation implications

  • Poland
  • Technology


Artificial intelligence (AI) systems are increasingly applied in more and more disciplines, one of which is healthcare. When creating AI systems, developers focus first on their functionality and effectiveness. However, another challenge that developers may face is legal uncertainty. This uncertainty is, to some degree, addressed in the proposal for an Artificial Intelligence Act published on 21 April 2022 (the AI Act).(1) Due to its general and broad scope, although the AI Act does not specifically address AI in healthcare, it will also apply to medical devices to which the EU Medical Devices Regulation (MDR) applies. Currently, the AI Act is being discussed in the European Parliament's committees.(2) This article is part of a series on developing medical AI systems.


Click here to read the full article by Jowita Prokop and Malte Scheel (part 1) >

Click here to read part 2 >