The recent agreement on the AI Act confirms that AI-enabled medical devices and in vitro diagnostics (IVDs) are classified as “high-risk.”
This classification follows the political consensus reached on the Digital Omnibus on AI, which clarifies that these devices, already regulated under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will also be subject to the AI Act’s stringent requirements. Specifically, an AI system qualifies as high-risk if it is either a product or a safety component that necessitates third-party conformity assessments, a requirement applicable to most AI-enabled medical devices and IVDs.
Key aspects of the agreement include a lack of a sector-specific compliance pathway, meaning that AI-enabled devices will adhere to both the AI Act and existing medical regulations. Additionally, the application date for high-risk AI in regulated products has been postponed to August 2028, providing manufacturers with extra time to prepare for compliance. However, this should not be interpreted as a delay in action; companies are encouraged to integrate the AI Act’s requirements into their existing quality management systems without creating separate compliance structures.
The agreement also introduces a mechanism to avoid duplicative requirements, allowing the Commission to limit AI Act obligations where equivalent requirements already exist under the MDR/IVDR. Furthermore, AI systems that serve non-safety-related functions will not automatically be classified as high-risk, which could ease regulatory burdens for certain ancillary features. As the landscape continues to evolve, it will be crucial for manufacturers to stay informed about regulatory updates and harmonized standards to ensure compliance.