Opening Plenary Session: Evolving Regulatory Frameworks: Access to Innovation and Patient Safety

Wednesday, October 23, 2024

8:30 AM - 10:00 AM CEST

Location/Room: Sagrada familia - 4th fl

Moderator(s)

Jennifer Neff, PhD

Principal Consultant & Head of Medical Devices
Entourage GmbH, Germany
Robert A. van Boxtel, MSc

Principal Consultant
Medical Device Project B.V., Netherlands

Panelist(s)

Donal O'Connor, MD FEBS

Clinical Manager
HPRA
CR

Carmen Ruiz-Villar

Head of Medical Devices Department
Spanish Agency for Medicines and Medical Devices (AEMPS), Spain
Jana Russo, MA

Manager Medical Devices
MedTech Europe
PK

Per Kjaersgaard-Andersen

Chair of BioMed Alliance Medical Device Task Force
Alberto Ganan, PhD

Head of Committees and Quality Assurance Department
European Medicines Agency

Description:

Panellists are welcome to provide their prospective on:
• current regulations and how do they see them evolving.
• also taking into account ongoing non-legislative actions to support the transition and ongoing targeted evaluation of MDR/IVDR.
• and their prospective on right balancing between the risk and benefit for patent, protecting public health but also advancing public health,
• ensuring timely access to high quality, safe and effective medical devices and encouraging innovation.

The MDR and IVDR requirements continue being fine-tuned and clarified. This impacts clinical evaluation, risk management, and postmarket surveillance. Hence the latest knowledge helps regulatory professionals to plan their resources and create stronger strategies and documentation for the current MDR/IVDR compliance.