PROGRAM DESCRIPTION

This full-day conference will provide essential updates on the MDR/IVDR legal framework, Eudamed, and transition periods, delivered by experts from the FAMHP. Dive into pre-marketing strategies, including national regulatory advice, clinical investigations, and the impact of IVDR on clinical trials. Post-marketing topics such as materiovigilance, shortages, and hospitals' obligations under MDR/IVDR will also be addressed. Finally, explore the regulatory challenges and opportunities for AI and connected devices, with insights into the interplay of key legislations like the AI Act, GDPR, and MDR/IVDR. Don’t miss this opportunity to stay ahead in the medtech sector!

Preliminary Timing

• 09h00 - Registration & welcome coffee
• 09h30 - Welcome & introduction - Annabelle Bruyndonckx (Healixia)
• 09h40 - Update from the FAMHP: European perspective, transitions, EUDAMED and others – Alexandre Jauniaux (FAMHP)
• 10h25 - National scientific & technical/regulatory advice: a FAMHP perspective - Christophe Lahorte (FAMHP)
• 11h00 - Coffee break
• 11h25 - Importance of clinical investigations in pre-market process, success factors & best practices for preparing & submitting documents to the FAMHP - Benedicte Nuyttens (FAMHP)
• 11h45 - How IVDR is impacting Clinical Trials? - Kirsten Van Garsse (QBD)
• 12h45 - lunch
• 13h45 - Materiovigilance - Christophe Driesmans  (FAMHP)
• 14h10 - Shortages - Cédric Vandenbroucke (FAMHP)
• 14h30 - Hospitals’ rights & obligations under MDR/IVDR  - Alexandre Jauniaux (FAMHP)
• 15h00 - coffee break
• 15h30 - Regulatory challenges & opportunities for AI & connected devices - Annabelle Bruyndonckx & Alexander Wenzel (Simmons & Simmons)
• 16h30 - Conclusion - Elke Debie (Healixia)