AI explained: AI and the impact on medical devices in the EU

Regulatory lawyers Cynthia O’Donoghue and Wim Vandenberghe explore the European Union’s newly promulgated AI Act; namely, its implications for medical device manufacturers. They examine amazing new opportunities being created by AI, but they also warn that medical-device researchers and manufacturers have special responsibilities if they use AI to discover new products and care protocols. Join us for an insightful conversation on AI’s impact on health care regulation in the EU.  ----more---- Transcript:  Intro: Hello, and welcome to Tech Law Talks, a podcast brought to you by Reed Smith's Emerging Technologies Group. In each episode of this podcast, we will discuss cutting-edge issues on technology, data, and the law. We will provide practical observations on a wide variety of technology and data topics to give you quick and actionable tips to address the issues you are dealing with everyday. Cynthia: Welcome to Tech Law Talks and our new series on AI. Over the coming months, we'll explore the key challenges and opportunities within the rapidly evolving AI landscape. Today, we're going to focus on AI and life sciences, particularly medical devices. I'm Cynthia O’Donoghue. I'm a Reed Smith partner in the London office in our emerging technology team. And I'm here today with Wim Vandenberghe. Wim, do you want to introduce yourself? Wim: Sure, Cynthia. I'm Wim Vandenberghe, I'm a life science partner out of the Brussels office, and my practice is really about regulatory and commercial contracting in the life science space. Cynthia: Thanks, Wim. As I mentioned, we're here to talk about the EU AI Act that came into force on the 2nd of August, and it has various phases for when different aspects come into force. But I think a key thing for the life sciences industry and any developer or deployer of AI is that research and development activity is exempt from the EU AI Act. And the reason it was done is because the EU wanted to foster research and innovation and development. But the headline sounds great. If, as a result of research and development, that AI product is going to be placed on the EU market and developed, essentially sold or used in products in the EU, it does become regulated under the EU AI Act. And there seems to be a lot of talk about interplay between the EU AI Act and various other EU laws. So Wim, how does the AI Act interplay with the medical devices regulation, the MDR and the IVDR? Wim: That's a good point, Cynthia. And that's, of course, you know, where a lot of the medical device companies are looking at kind of like that interplay and potential overlap between the AI Act on the one hand, which is a cross-sectoral piece of legislation. So it applies to all sorts of products and services, whereas the MDR and the IVDR are of course only applicable to medical technologies. So in summary, you know, the medical, both the AI Act and the MDR and IVDR will apply to AI systems, provided, of course, that those AI systems are in scope of the respective legislation. So maybe I'll start with the MDR and IVDR and then kind of turn to the AI Act. Under the MDR and the IVDR, of course, there's many AI solutions that are either considered to be a software as a medical device in their own right, or they are part or component of a medical technology. So to the extent that this AI system as software meets the definition of a medical device under the MDR or under the IVDR, it would actually qualify as a medical device. And therefore, the MDR and IVDR is fully applicable to those AI solutions. Stating the obvious, you know, there's plenty of AI solutions that are already now on the market and being used in a healthcare setting as well. Well, what the AI Act kind of focuses on, particularly with regard to medical technology, is the so-called high-class risk AI systems. And for a medical technology to be a high-class AI system under the AI Act, it's essentially it's a twofold kind of criteria that needs to apply. Firs