Artificial Intelligence in Medical Device Legislation

We're pleased to inform you about the in-depth analysis we have conducted at COCIR with regard to Artificial Intelligence in EU Medical Device Legislation. Analysing all aspects of the conformity assessment process and how they would apply to AI-based medical devices with different characteristics, this analysis aims to show how AI can be deployed in a way that is consistent with existing Regulations.

Next to that we would also like to make you aware that we are periodically updating the list of AI Use cases provided by our member organisations which demonstrate how AI is already being used in the healthcare setting: https://www.cocir.org/activities/digital-health/artificial-intelligence-1.html

We hope these documents can contribute to an informed debate on how to build trustworthy AI and how sector-specific approaches may help addressing the legal and ethical issues in a targeted way.

About COCIR

COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries.

Founded in 1959, COCIR is a non-profit association headquartered in Brussels (Belgium) with a China Desk based in Beijing since 2007. COCIR is unique as it brings together the healthcare, IT and telecommunications industries. www.cocir.org