The quick-pace rollout of AI and genAI has caused both excitement and controversy. While this technology has revolutionized once tedious, time-consuming processes (i.e. drug discovery, R&D, massive data analysis, vaccine development), skeptics question how these algorithms are generating results—and whether or not they can be trusted.

To put parameters around the use of AI in healthcare and quash qualms of potential prejudicial bias or privacy risks associated with it, the EU recently introduced the Artificial Intelligence Act (AI Act). Having been passed this May by the Council of the European Union, the AI Act is pushing medtech leaders to question not only how these stipulations affect tools already in circulation within healthcare systems, but what it means for a future where AI is at the root of the industry.

In this report, discover:

• The aims of the AI Act, its stipulations, and the risk classifications it proposes for medical devices
• How the AI Act interacts with pre-existing regulations Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR)
• A future outlook on what medtech leaders can expect in a post-AI Act era