55 results

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Regulation

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

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Regulation

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

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Regulation

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

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Regulation

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)

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Regulation

Posted on 12.09.2018

New EU regulations: what’s next for Notified Bodies?

It is now circa ten months since any well-prepared Notified Bodies (NB) wishing to undertake conformity assessment under MDR (EU) 2017/745 and IVDR (EU) 2017/746 were able to submit formal applications.  The date of application of the MDR and IVDR, 27th May 2020, is currently 20 months away. I would like to publicly acknowledge the […]

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

Health data can transform our lives – but must be used wisely
Ethics

Posted on 09.07.2018

Health data can transform our lives – but must be used wisely

This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage,How to create and maintain an ethical culture,Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Progress and […]

By Oba Adewunmi Legal Counsel at Verily Life Science

New Medical Device Regulation – an obstacle to progress
Regulation

Posted on 11.06.2018

New Medical Device Regulation – an obstacle to progress

On May 25th, 2017, a new era began. The date marks the beginning of the Medical Device Regulation, the MDR in short. It provides a new framework for the certification of medical devices in Europe and is supposed to increase the transparency of the approval and application of medical devices, as well as to improve […]

By Dr. Meinrad Lugan Member of the Management Board, B. Braun Melsungen AG

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Regulation

Posted on 25.05.2018

IVDR/MDR transition periods: It’s time to talk about time

One year has now passed since the ‘new’ EU IVD and medical devices regulations entered into force. Since Day 1, the medical technology industry has been working at full capacity to achieve and maintain maximum possible readiness.  While I’d love to claim the same for all other essential elements of the new regulatory system, progress […]

By Oliver Bisazza Director Regulations & Industrial Policy - MedTech Europe

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Ethics

Posted on 24.05.2018

Progress and new challenges after 10 years of collaboration

This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage, How to create and maintain an ethical culture, Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Distributors […]

By Bronwen Taylor Vice President, Compliance & Risk Management at Stryker Corporation