On 14 April 2025, an updated paper from Team-NB has been published, providing an overview of their perspective on the challenges of the AI Act with particular attention to its implementation.
This document offers a comprehensive analysis of the challenges and implications associated with implementing the EU Artificial Intelligence Act (AI Act), particularly concerning the designation and preparedness of Notified Bodies (NBs) for high-risk AI systems.
Key Highlights from the Position Paper
1. Urgency in Designation of Notified Bodies
Team-NB emphasizes the pressing need for a coordinated approach among EU Member States to designate and oversee Notified Bodies for AI systems. The Position Paper warns that delays in national implementations could result in a shortage of designated NBs when the high-risk provisions of the AI Act become applicable on 2 August 2027. Such delays could hinder the timely conformity assessment of high-risk AI systems, potentially impacting their market availability.
2. Challenges in the Designation Process
The paper outlines that existing MDR/IVDR Notified Bodies cannot automatically extend their scope to include AI systems under the AI Act. Instead, they must undergo a separate designation process as specified in Article 31 of the AI Act, which includes meeting stringent requirements related to organizational structure, resource allocation, and technical competence. This additional layer of accreditation is seen as a potential bottleneck, especially given the already limited number of NBs and their stretched capacities.
3. Advocacy for Leveraging Existing Frameworks
Team-NB advocates for utilizing the existing MDR/IVDR authorization frameworks to cover AI requirements, rather than establishing entirely new processes. They suggest that enhancing the competencies of current NBs to assess AI-related aspects would be more efficient. This approach aligns with recommendations from the Medical Device Coordination Group (MDCG), which supports the addition of AI-specific codes to existing NB scopes to streamline the assessment process.
4. Concerns Over Resource Allocation and Expertise
The Position Paper raises concerns about the availability of qualified personnel to assess AI systems, noting that attracting and retaining experts in AI will be a significant challenge. Team-NB underscores the necessity for substantial investments in training and resource development to ensure that NBs can effectively evaluate high-risk AI systems.
5. Implications for Stakeholders
Manufacturers of AI-integrated medical devices should proactively engage with their respective NBs to understand the implications of the AI Act on their products. Given the potential for delays in NB designation and the stringent requirements outlined in the AI Act, early preparation and collaboration with NBs are crucial to ensure compliance and timely market access.
You can read the full document here
