33 results


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 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


Posted on 05.06.2018

Can screening decrease lung cancer mortality rates?

This blog is part of the Early Diagnosis campaign #BeFirst Early diagnosis and care can prevent illness from developing and slow disease progression. Lab tests, genetic tests, tests for chronic diseases and modern lab diagnostics can help facilitate earlier intervention and improves outcomes for patients and are increasingly valuable in informing treatment choice.  Read the other […]

By Jo Van den Broeck Marketing Director EMEA - Disease State Management - Lung Health - Medtronic


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 Chief Executive Officer, MedTech Europe


Posted on 05.03.2018

Invest! Lead! Engage! Let’s Make Europe’s New Regulatory System Work

We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike. Last week, at the Association of the […]

By Oliver Bisazza Chief Executive Officer, MedTech Europe


Posted on 19.09.2017

How diagnostics can shape the future of healthcare

As Germany goes to the polls, the VDGH, which represents in vitro diagnostics companies in Germany, has published a new policy paper on the future of healthcare. VDGH Managing Director Martin Walger tells Gary Finnegan why this is a crucial moment for health policy The paper was released just ahead of federal elections in Germany […]

By Gary Finnegan Journalist, editor, author


Posted on 13.04.2016

Finding solutions to notified bodies challenge is crucial

It is important that the medical technology sector functions within a healthy ecosystem. Our sector needs an environment that is open, supportive and free from unnecessary bureaucracy in order to innovate and provide patients safe and effective solutions to their condition. Within the product lifecycle of a medical technology product, we work with patients, doctors, […]

By Serge Bernasconi Chief Executive Officer, MedTech Europe


Posted on 10.11.2015

During Trilogue, IVD and MD files should be treated on their own merits

A month ago, the trilogue on the medical devices (MD) and in-vitro diagnostics (IVDs) regulation proposals have started.This discussion between the Council of the European Union, European Parliament and European Commission is one of the last steps of the process to land a consolidated text for the regulation. It’s almost the end of the road […]

By Serge Bernasconi Chief Executive Officer, MedTech Europe


Posted on 24.06.2015

Turning innovation into value that stays in Europe

The medtech industry in Europe is made up almost uniquely of Small and Medium-sized Enterprises (SMEs). These have brought incredible innovations to patients, healthcare systems, the economy and society, and will continue to do so in the future. But if we put ever more data demands on these companies, in return, they need to be […]

By Serge Bernasconi Chief Executive Officer, MedTech Europe