COCIR Analysis on AI in medical Device Legislation – May 2021

The analysis explains the characteristics of AI relevant for regulatory discussions, including possible approaches to
the management of changes in software. Then, the crucial topic of ethics is addressed – especially the distribution
of responsibilities between the AI developer and user, as well as the AI deployer/operator (in healthcare often health
institutions and public authorities) needs to be clearly defined. The concept of trust is explored in its different dimensions,
offering tools to increase trust in AI. The document also delves in more detail into the conformity assessment process
under the EU Medical Device Regulations. The analysis presents how the existing risk management, life-cycle approach
and testing requirements are fitted to AI-based medical devices. International standards are an essential building block
of the medical device regulatory system. An overview of on-going standards development activities relevant for AI is
provided.