PRELIMINARY PROGRAM DESCRIPTION

Healixia’s Medical Devices Day offers a concise yet comprehensive overview of the latest regulatory developments and practical challenges in the medical devices and IVD sector. Participants will be updated on the evolving MDR and IVDR frameworks and the progress of Eudamed implementation, with a focus on strategic compliance.

The programme explores new national procedures for regulatory advice, the role of clinical investigations in the pre-market phase, and the documentation required for CE marking. A dedicated session addresses the impact of IVDR on clinical trials, highlighting complexities around multi-country applications and combined studies.

Attention is also given to post-market topics such as risk management, materiovigilance, and medical device shortages. Participants gain clarity on the legal obligations of hospitals as potential distributors. The event concludes with a forward-looking discussion on the regulatory implications of AI and connected medical technologies.

Detailed program will follow, but you can already register!