Team-NB Position Paper on the European Artificial Intelligence Act

Team-NB published an updated version of its Position Paper on the European Artificial Intelligence Act. It aims to present its members’ position regarding the implementation and application of the AI Act, with a focus on the interface and overlap with MDR and IVDR.

In particular, this document covers:

• The articulation between the AI Act and MDR/IVDR for medical devices incorporating AI;
• Compliance requirements and the role of notified bodies in assessing high-risk devices;
• Areas of regulatory challenges, including definitions and processes to be harmonized.

This Position Paper clarifies the requirements for compliance with the IA Act for manufacturers of medical devices incorporating AI. It helps to anticipate product certification challenges and understand the assessment processes by notified bodies.

DOWNLOAD THE TEAM-NB POSITION PAPER