TEAM-NB Highlights Challenges in Implementing EU AI Regulation for Medical Devices

The European Association of Notified Bodies for Medical Devices (TEAM-NB) has released a revised position paper addressing the EU Artificial Intelligence Regulation (Regulation (EU) 2024/1689), which will apply to medical devices and IVDs starting August 2027. TEAM-NB notes that the three-year implementation timeline is ambitious and raises concerns about the availability of notified bodies across member states to carry out AI-related conformity assessments.

The paper emphasizes the need for a shared understanding of key terms such as AI system, safety component, substantial modification, significant change, and life cycle management. TEAM-NB also highlights challenges in integrating fundamental rights—including privacy, data protection, and non-discrimination—into risk assessments and product design.

Additionally, the group calls for harmonised standards and practical solutions for data use, noting that the European Health Data Space (EHDS) may not fully support high-risk applications.

12-09-2025