Regulation
Views on the rules and regulations that govern medical technologies.
Posted on 15.05.2019
A bold new vision for the medical technology community
By Eric Thépaut, Senior Vice President and President, EMEA - Boston Scientific
Posted on 13.05.2019
IVDR: an overview of clinical evidence requirements
By Peter Rose, Managing Director, Europe - Maetrics
Posted on 13.05.2019
Notified Bodies are becoming a regulatory bottleneck
By Fabien Roy, Partner - Hogan Lovells
Posted on 24.04.2019
Regulatory affairs: One way of addressing the skill shortage Notified Bodies are facing
By Prof. Dr. Folker Spitzenberger, Professor at the University of Applied Sciences, Luebeck, Germany
Posted on 08.11.2018
The fog of war: crunch time in the regulatory cycle
By Ronald Boumans, Senior Regulatory Consultant at Emergo
Posted on 02.10.2018
IVDR: The designation issue during the transitional period
By Stefano Dettori, Director of IVD Operative Unit of Notified Body 0373 Italian Health Institute (ISS)
Posted on 18.09.2018
The ‘nanny state’ and the case for health literacy
By Denis Horgan, Executive Director, European Alliance for Personalised Medicine
Posted on 14.09.2018
What does Brexit mean for Notified Bodies?
By Gary Slack, Senior Vice President Global Medical Devices, BSI Group
Posted on 12.09.2018
New EU regulations: what’s next for Notified Bodies?
By Gary Slack, Senior Vice President Global Medical Devices, BSI Group
Posted on 11.06.2018
New Medical Device Regulation – an obstacle to progress
By Dr. Meinrad Lugan, Member of the Management Board, B. Braun Melsungen AG
Posted on 25.05.2018
IVDR/MDR transition periods: It’s time to talk about time
By Oliver Bisazza, Chief Executive Officer, MedTech Europe
Posted on 05.03.2018
Invest! Lead! Engage! Let’s Make Europe’s New Regulatory System Work
By Oliver Bisazza, Chief Executive Officer, MedTech Europe

