Name
Session 6 | Market Surveillance / Vigilance
Date & Time
Wednesday, September 9, 2026, 10:30 AM - 11:15 AM
Speakers
Ludger Moeller | Chair, EAAR / Member of the Stakeholder Group of the EU Commission's MDCG working group, MDSS GmbH
Corentin Vermeiren | Inspector in Medical Devices, Federal Agency for Medicines and Health Products (FAMHP)
Hanim YASSIN | Seconded National Expert, European Commission (DG SANTE)
Corentin Vermeiren | Inspector in Medical Devices, Federal Agency for Medicines and Health Products (FAMHP)
Hanim YASSIN | Seconded National Expert, European Commission (DG SANTE)
Description
Market surveillance and vigilance remain important components of the MDR and IVDR framework. This session will explore perspectives on post-market activities, EUDAMED, Competent Authority expectations, and the role of Authorised Representatives.
Key discussion topics include:
- Vigilance
- Post-market surveillance (PMS)
- EUDAMED
- Competent Authority perspectives
- Authorised Representative perspectives
- Audience Q&A
Session Type
Session