Today, 13 March 2024, the European Parliament approved the text of the Artificial Intelligence Act. In December 2023, Members of the Parliament endorsed the AI Act with 523 votes in favour, 46 against and 49 abstentions. The new law introduces obligations for AI applications based on their related potential risks and impact level, e.g., based on their potential harm to health, safety, fundamental rights, environment, democracy, and the rule of law.
AI Act impact on medical devices
The AI Act classifies AI systems into four categories, according to their level of risk. AI-Medical device software will fall under the second-highest risk category (high-risk).
Article 3 (1) of the new AI Regulation defines an AI system as “a machine-based system designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.”
AI medical device software will require the intervention of a notified body in their conformity assessment according to the MDR and IVDR. The notified body will also verify compliance with the applicable requirements set by the AI Act. The conformity assessment will include the assessment and reduction of risks, maintenance of use logs, and the guarantee of transparency, accuracy, and human oversight.
Our Library of documents dedicated to MDR and IVDR special categories includes all relevant AI-related publications.
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