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Views on the rules and regulations that govern MedTech.
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...
The fog of war: crunch time in the regulatory cycle
8 Nov 2018
Senior Regulatory Consultant at Emergo
As I followed the 1,075 km cycling route starting at the Belgium coast and ending in Basel, Switzerland, along the Western Front line of the First World War, I...
IVDR: The designation issue during the transitional period
2 Oct 2018
Director of IVD Operative Unit of Notified Body 0373 Italian Health Institute (ISS)
The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) was published in May 2017. While the IVDR has a five-year transition period (longer than the...