Understanding the EU AI Act and its impact is crucial for informed boardroom decisions. This session will simplify this complex regulation and provide clear insights tailored for executives. Equip yourself to discuss and implement AI compliance strategies within your organization confidently.

Both MDR (EU)2017/745 and IVDR (EU)2017/746 describe the importance of the existence of an European database on Medical Devices (Eudamed) for all stakeholders involved in de medical device industry. Altough a fully functional Eudamed has not been developed yet, several efforts have been made for the partial implementation of this database. Starting with the voluntary use of the actor, device and certificate module in 2021 and adopting the Regulation (EU) 2024/1860 amending both MDR and IVDR as regards a gradual roll-out of Eudamed. The latter will significantly speed up the timeline for the mandatory use of specific Eudamed modules. The Vigilance and post-market surveillance module (VGL) is considered to be one of the most challenging modules in Eudamed regarding functionality and module interconnectivity. Therefore, in 2024, the initiative was taken by Sweden to setup a Vigilance CA Board, a workgroup to actively test the development of the VGL module being build by the SANTE EUDAMED Team. Together with members from the industry, CA’s have tested different versions of the VGL module focusing on functionality and usability. In this presentation we will discuss the added value of the VGL module from a CA perspective. Furthermore, explain the testing strategy taken by the stakeholders involved, with the purpose of bringing constructive feedback to the SANTE EUDAMED Team, building together a better Eudamed vigilance module.

This presentation examines the challenges of using non-CE marked in vitro diagnostic devices (IVDs) in pharmaceutical clinical trials. It will address the regulatory requirements for performance study applications and notifications in Europe and their impact on trial design and timelines. Participants will learn about key considerations for selecting and integrating non-CE marked IVDs, as well as practical steps to avoid delays in trial start-up. The session will provide a straightforward overview of the most common challenges sponsors face and how to navigate them effectively.