Views on the rules and regulations that govern MedTech.

96 blogs about the topic


Posted on 02.07.2019

From here to 2024: personalized medicine for an immediate future

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 health systems – which the EU sees both as improving the quality of its citizens’ lives, and as a contribution to goals involving growth and jobs. While the […]

By Denis Horgan Executive Director, European Alliance for Personalised Medicine


Posted on 15.05.2019

A bold new vision for the medical technology community

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 you suggested that the world’s largest hotelier would not own any hotels. I’d have thought you unwise if you suggested that the world’s largest book store could […]

By Eric Thépaut Senior Vice President and President, EMEA - Boston Scientific


Posted on 13.05.2019

IVDR: an overview of clinical evidence requirements

With the updated in vitro diagnostic medical devices (IVD) classification moving at least 80% of IVDs under Notified Body scrutiny (compared to 20% previously!), most manufacturers should now be gearing up to shift from self-certification to notified body oversight as we enter into the third year of the In Vitro Diagnostic Regulation’s transition period. A […]

By David Egbosimba Solutions Delivery Manager - Maetrics


Posted on 13.05.2019

Notified Bodies are becoming a regulatory bottleneck

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 transparency. The goal, shared by all stakeholders, is to enhance patient safety without harming innovations that improve patient outcomes. However, with these two regulations coming into force by May 2020 […]

By Fabien Roy Partner - Hogan Lovells


Posted on 24.04.2019

Regulatory affairs: One way of addressing the skill shortage Notified Bodies are facing

New EU Regulations on medical devices and in vitro diagnostic medical devices (IVDs) mean all stakeholders, including manufacturers, competent authorities, and Notified Bodies – need new knowledge and skills. The Regulations seek to harmonise requirements, capacities and competencies of Notified Bodies and to me, one of the key advances is the new responsibilities for Notified […]

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

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 began to consider the plight of soldiers and generals a century ago. For military leaders, it was impossible to have an overview of what was happening […]

By Ronald Boumans Senior Regulatory Consultant at Emergo


Posted on 02.10.2018

IVDR: The designation issue during the transitional period

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 three-year transition for the EU Medical Devices Regulation), the procedures to designate Notified Bodies (NBs) under each of these two regulations have started at the same time. NBs are […]

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

For me, one of the most intriguing health policy questions of our time is how to encourage citizens to embrace healthy lifestyles. Should we tax and punish bad behaviour or empower citizens with the information they need to make their own decisions?   An interesting ‘league table’ caught my eye recently. Entitled the Nanny State […]

By Denis Horgan Executive Director, European Alliance for Personalised Medicine


Posted on 14.09.2018

What does Brexit mean for Notified Bodies?

With 45% of devices accessing the EU via UK NBs, what would be the impact of a so-called “hard Brexit?” The political landscape is far from clear. However, BSI would concur with the recent MHRA  paper as we fully anticipate remaining part of the EU system for the long term. We also agree that nothing […]

By Gary Slack Senior Vice President Global Medical Devices, BSI Group