EU Artificial Intelligence Act and its Impact on Medical Device Manufacturers - Keeping abreast of the changing regulatory landscape

According to the Organisation for Economic Co-operation and Development, AI-based medical devices lack trust. Reasons are manifold and range from over fitted models, bias, lack of robustness to inadequate transparency.[i] Often these issues are related to manufacturers having insufficient access to training and testing data and the absence of standards or guidance describing state-of-the-art AI development and test processes. 

To create trust, the European Commission published a new legislative proposal: the Artificial Intelligence Act. The Act provides risk management, quality system, data quality, data governance, human oversight, and performance requirements for high-risk AI systems across different sectors, from AI-based vehicles, financial services to medical devices. 

The Act is currently in the legislative process, being reviewed by the European Parliament and the Council of the European Union. In the slipstream of the AI Act an ecosystem of standards and certification services emerges in support of the AI Act. Depending on the legislative progress, the AI Act could become applicable as early as Q1 2025. Such timelines give manufacturers little time to prepare.

Meanwhile, legislators from various continents are developing guidance for manufacturers and assessors of AI-based medical devices. International standardization bodies are creating standards for AI-based medical devices. The interaction between the horizontal and the vertical level of legislation and standardization becomes increasingly complex. Anticipating regulatory changes has become increasingly important in developing AI-based medical devices that stay ahead of the competition. 

Join us on the 13th of May 2022 when Koen Cobbaert will identify the most critical legislative and standardization initiatives, explain their relevance, and provide helpful cues to best prepare. 

Click here to book your place!


[i] Trustworthy AI in health. Organisation for Economic Co-operation and Development (OECD) 2020. 

Published on Mar 09, 2022 by Koen Cobbaert