Discover How the EU Artificial Intelligence (AI) Act Will Impact Regulatory Requirements for Medical Products Utilizing AI Technologies
April 12, 2023 | 12:00-2:00 PM ET
The EU Artificial Intelligence (AI) Act is a proposed horizontal legislation that will introduce regulatory requirements for any high-risk product based on machine learning and other artificial intelligence technology, including medical devices and specific health tech.
The Regulation establishes requirements and obligations for providers of high-risk AI systems, including establishing risk and quality management systems, technical documentation, and record-keeping. There are also transparency, human oversight, accuracy, and robustness obligations. E.g., where AI systems use datasets, these will need to be of high quality to minimize risks and avoid discriminatory outcomes.
Notified bodies need to combine the conformity assessment under the medical device regulations with that under the AI Act. Harmonized standards will become available to provide a presumption of conformity; some will likely overlap with existing harmonized standards in support of the Medical Device Regulations.
In this session, Koen Cobbaert will introduce the proposed AI Act, outline the interplay with the Medical Device Regulations, and discuss the implications for medical device manufacturers.
