Medical Devices (includes IVDs)

Opening Panel on EU MDR and IVDR

Monday, September 14, 2020

10:00 AM – 11:30 AM EDT

Moderator(s)

Gert Willem Bos, FRAPS

CTO, Executive Director & Partner at Qserve Group
Qserve Group Inc.

Panelist(s)

Bassil Akra, PhD

CEO
QUNIQUE GmbH
Philippe Auclair, Pharma Dr, PhD , FRAPS

Senior Director Regulatory Strategy EMEA
Abbott
Oliver Bisazza

MedTech Europe
Erica Conway, PhD

Global Head - In Vitro Diagnostic Medical Devices
BSI (London)
Laura de Vries, PhD

Coordinating/Specialist Inspector
Dutch Health and Youth Care Inspectorate
Sabina Hoekstra-van den Bosch, PharmD, FRAPS

Regulatory Strategy Principal
TUV SUD Product Service GmbH

Slides
Armin Ritzhaupt, PhD, MPH

Scientific Administrator
European Medicines Agency
Sue Spencer

IVD Lead/ Principal Consultant
Qserve Group (United Kingdom)
John Wilkinson, MBA

Chair of the Board of Trustees
Global Medical Devices Nomenclature

The essence of being is to learn as you move along. So, what have we learned from MDR implementation sofar? What is clear, and where is more clarity needed. Is there anything new ahead, additional legislation, guidance documents etc. And how are we dealing with the complexities of the EUDAMED delay, and with the MDR sections on economic operators and PMS that kick in on 26 May 2020 for all products, including legacy products under MDD/AIMD grace period. The panel will bring several key opinion leaders from various stakeholders to bring the latest interpretations fresh from Brussels. An interactive session to look forward to!

Learning Objectives:

Interpret key elements of EU MDR and EU IVDR.
Describe the latest development in EU regulatory landscape.
Modify MDR / IVDR transition schemes to the latest knowledge on notified body and regulator processes and expectations.