Skip to main content
Views on the rules and regulations that govern MedTech.
From here to 2024: personalized medicine for an immediate future
2 Jul 2019
Executive Director, European Alliance for Personalised Medicine
State of play The aim of Europe’s policies and actions in public health is to improve and protect human health, and to support the modernisation of Europe's...
A bold new vision for the medical technology community
15 May 2019
Senior Vice President and President, EMEA - Boston Scientific
20 years ago, I'd have called you foolish if you suggested that the world's largest taxi company would not own any taxis. I'd have called you ill-advised if...
IVDR: an overview of clinical evidence requirements
13 May 2019
Solutions Delivery Manager - Maetrics
Managing Director, Europe - Maetrics
With the updated in vitro diagnostic medical devices (IVD) classification moving at least 80% of IVDs under Notified Body scrutiny (compared to 20% previously...
Notified Bodies are becoming a regulatory bottleneck
13 May 2019
Partner - Hogan Lovells
The new EU regulations on medical devices and in vitro diagnostics (IVDs) share a laudable aim: They seek to modernise the regulatory framework and enhance...
Regulatory affairs: One way of addressing the skill shortage Notified Bodies are facing
24 Apr 2019
Prof. Dr. Folker Spitzenberger
Professor at the University of Applied Sciences, Luebeck, Germany
New EU Regulations on medical devices and in vitro diagnostic medical devices (IVDs) mean all stakeholders, including manufacturers, competent authorities, and...