Team-NB, the European association of Notified Bodies, has reinforced the importance of issuing certificates with conditions under the European Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). This approach allows innovative or orphan medical devices to obtain certification under specific conditions, such as more frequent post-market assessments, restriction of use to certain population groups or marketing limited to specialized medical institutions. Team-NB encourages Notified Bodies to apply this strategy to balance innovation and patient safety, ensuring faster access to new medical technologies.

MDCG 2024-2 Rev.1 ushers in a new era for the European Medical Device Nomenclature (EMDN), establishing dynamic procedures that ensure innovation, safety, and efficiency in the medical device sector. This revision, aligned with the MDR and IVDR regulations, introduces annual updates and ad-hoc requests to meet rapid technological changes and growing market demands. With a focus on collaboration between stakeholders, the update reinforces trust between manufacturers, healthcare professionals and patients, ensuring that device classification is accurate, relevant and safe.

Artificial Intelligence (AI) is transforming the healthcare sector, presenting itself as an essential tool for achieving global equity, improving operational efficiency, and driving innovation in healthcare. According to the World Economic Forum report, The Future of AI-Enabled Health: Leading the Way, the adoption of AI solutions requires addressing challenges related to fragmented governance, lack of strategic alignment, and the need for effective public-private partnerships. This document also highlights six key transitions to ensure that AI reaches its full potential in the digital transformation of healthcare, promoting a smarter and healthier future.