In October 2025, TEAM-NB and NBCG-Med submitted a joint position paper to the European Commission (DG CONNECT) in response to the Call for Evidence on the Digital Omnibus — part of the Commission’s effort to simplify digital legislation, including the AI Act.
Their contribution stresses that simplification should not compromise safety, integrity, or market fairness. Instead, it should strengthen the efficiency and sustainability of the Notified Body (NB) system that underpins the CE-marking framework.
Key recommendations from TEAM-NB & NBCG-Med:
- Maintain the New Legislative Framework (NLF) as the foundation for AI Act implementation — ensuring coherence with MDR/IVDR and other product regulations.
- Promote legal clarity and predictability for economic operators and NBs, avoiding divergent interpretations among Member States.
- Use existing governance structures and NANDO notifications to prevent duplication of assessments or delays in NB designation.
- Ensure economic sustainability of NBs, including potential reimbursement mechanisms for additional workload from incomplete manufacturer documentation or repeated reviews.
- Safeguard patient safety and innovation by avoiding regulatory bottlenecks that could delay market access for AI-based devices.
The statement further calls for uniform assessment of Notified Bodies by Competent Authorities, recognising that fragmentation weakens trust, transparency, and equal conditions in the Single Market.
At Instituto Pedro Nunes we continue to support medical device manufacturers and innovators navigating EU regulatory transitions, we echo the importance of combining simplification with quality, traceability, and sustainability in the evolving AI regulatory landscape. Read the statement here.