The European Commission has released draft guidelines aimed at helping companies determine whether their AI-integrated medical devices qualify as high-risk under the EU's Artificial Intelligence Act.
The guidelines will supplement existing regulations under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), rather than replace them. Nils Lölfing, an attorney specializing in AI, emphasized the importance of these guidelines in clarifying the classification process for AI systems, particularly those influencing human health and safety. The AI Act is set to take effect in late 2027 and 2028 for different categories of high-risk AI systems.
According to the guidelines, the intended purpose of an AI system is crucial in determining its classification as high-risk. For instance, AI systems that serve as safety components or are standalone products will require third-party conformity assessments under the Act. The guidelines also provide practical examples, although they are not exhaustive, to illustrate what constitutes high-risk AI systems.
Efforts to prevent dual regulations are ongoing, with proposals aimed at integrating AI requirements into existing device approval processes. This approach would streamline compliance and reduce redundancy, allowing companies more time to adapt to the new regulations while ensuring that AI in medical devices remains effectively regulated.