This Position Paper provides an overview of the Team-NB perspective on the challenges of the AI Act, with particular attention to its implementation in the certification of (in vitro diagnostic) medical devices.
What is new?
Version 2 of this Team-NB Position Paper is a full revision of Version 1 (October 2021) and supersedes the Team-NB Position Paper (December 2022) on the designation of notified bodies under the Artificial Intelligence Act.
The paper discusses the designation and oversight of notified bodies under the AI Act, and the possibility to make use of the existing software-related codes to include AI Act requirements for in vitro diagnostic (IVDs) and other medical devices (MDs). Team-NB expresses its concern that there may otherwise be a shortage of designated notified bodies when the AI Act becomes applicable for MDs and IVDs on 02 August 2027.
The paper stresses the importance of having a common understanding of AI Act definitions such as ‘AI system’, ‘safety component’, ‘substantial modification’, and ‘significant change’. Further, guidance and development of standards are requested to harmonize approaches and expectations on compliance with fundamental rights like privacy, data protection, non-discrimination, and human dignity. Further, Team-NB warns that AI Act and MDR/IVDR requirements for post-market surveillance and vigilance should not lead to duplication of administrative efforts or compartmentalisation of information. Finally, the paper foresees challenges for notified bodies to effectively conduct conformity assessments through GDPR-compliant access to manufacturers’ training and validation data sets and, if necessary, also to high-quality independent datasets for additional testing.
What does it mean to you?
This Team-NB AI Act Position Paperis important for all manufacturers that are developing AI-enabled IVDs or MDs. It provides insight into how notified bodies, designated under MDR/IVDR are preparing to continue certification of such devices under the AI Act and which, mainly administrative, challenges they see in the implementation of the AI Act in the certification process of MDs and IVDs.
About the Author
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
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