Artificial Intelligence in Medical Devices - the Perspective of Notified Bodies

The European Association of Notified Bodies for Medical Devices (TEAM-NB) publishes position papers at regular intervals. These position papers serve to promote harmonisation in the medical device sector. Currently, there is a position paper on artificial intelligence. What does it say?

The European Commission's Regulation on Artificial Intelligence (AI Regulation) (Regulation (EU) 2024/1689) came into force in August 2024. From August 2027, medical devices and in vitro diagnostics (IVDs) will also be covered by this regulation, depending on their risk class. Team NB has therefore outlined its thoughts on this topic in this position paper. According to Team NB, the three-year timeframe for implementing the AI Regulation is relatively tight. Team NB sees difficulties in ensuring that there are enough notified bodies available to assess medical devices in relation to artificial intelligence - and is particularly sceptical when looking at all member states. It considers a common understanding of the definitions in the AI Regulation to be particularly important. The following terms are explicitly mentioned

• AI system 
• Safety component 
• Substantial modification
• Significant change  
• Life cycle management 

Team NB sees difficulties in implementing fundamental rights such as privacy, data protection, non-discrimination and human dignity, which arise from the AI Regulation and must therefore also be incorporated into manufacturers' risk assessments and products.

Team NB hopes for a fully implemented European Health Data Space (EHDS), which could be helpful but is unlikely to be fully applicable to high-risk areas in the AI Regulation. In this respect, Team NB sees the need to find timely and practical solutions to these data challenges. There is also a lack of harmonised standards that could be helpful in addressing the issue of implementation. There are fears of compliance problems in the absence of harmonised standards.

The position paper is a revision of an older document on this topic.

Conclusion: There is still work to be done to ensure that the AI Regulation can also be implemented in the medical device sector.

Further details can be found in the position paper itself on the Team Notified Body page.