On July 12, 2024, Regulation (EU) 2024/1689 was published in the Official Journal of the European Union. This “Regulation on Artificial Intelligence” or “AI Act” marks a new stage in the certification of medical devices (MDs) using this technology.
The European Commission has chosen a horizontal approach to legislating on artificial intelligence, and medical devices are one of the areas covered by this text. The medical industry is already well prepared, as it is familiar with the approach and requirements: quality management systems, risk management, technical documentation, etc. Preparing for the application of this regulation will therefore involve adapting practices to the new normative and regulatory requirements linked to
artificial intelligence.
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