In Vitro Diagnostics

Regulatory Hurdles to Overcome to Introduce Nanotechnology-based IVD and Medical Devices to the EU Market, A Safe-N-Medtech Concern

Tuesday, October 27, 2020

09:45 – 10:45 CET

Session Leader/Speaker(s)

Luc Van Hove, MD, PhD

CEO
MARACA International bvba
Rotselaar, Vlaams-Brabant, Belgium

Slides Handouts

Speaker(s)

MP

Menno Prins, PhD

Professor
Eindhoven University of Technology, Netherlands
AD

Angel Delpozo, MSC

Deputy Manager of programs strategy
BioKeralty Research Institute
Miñano-, Pais Vasco, Spain
QP

Quentin Pankhurst

Description: Participants will learn from the cases and this interaction between nanotechnology experts and the regulatory community what the potential is of nanotechnology based devices. The discuss will provide an exciting glimpse into the future of new medical devices and IVD. Participants will learn that there are still many unexplored regulatory hurtles. They will also hear that there are possible regulatory solutions and that a path to market introduction as medical device or IVD is possible. Participants will enjoy to be part of defining this regulatory pathway for nanotechnology-based medical devices and IVD.

Learning Objectives:

Upon completion, participant will be able to understand that medical devices and IVD can be developed based on nanotechnology.
Upon completion, participants will be able to identify regulatory issues which need to be address prior to introducing medical devices and IVD based on nanotechnology to the EU market.
Upon completion, participants will be able to propose possible regulatory solutions for the many regulatory hurtles to introduce nanotechnology based devices to the EU market.