16 results

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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

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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Regulation

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 Director Regulations & Industrial Policy - MedTech Europe

MTV
Value

Posted on 11.01.2018

The Butterfly Effect: when minute changes to our regulatory and payment systems impact the fragile medtech innovation ecosystem

Nadim Yared is President and Chief Executive Officer of CVRx and Chairman of the AdvaMed’s Board of Directors, our sister organisation in the United States. He is a speaker at the MedTech Forum 2018 and his sessions include: CEO #NOFILTER and The MedTech Europe Code as a Business Enabler, both on Thursday 25th of January. […]

By Nadim YARED CEO - CVRx

heikki
Regulation

Posted on 06.09.2017

The challenges of a MedTech startup in the land of scattered Regulatory Information

According to the preliminary results of a study* aimed at the Finnish medical device industry, regulatory compliance pops up as the second biggest challenge burdening the industry. This, according to the study, comes in the wake of challenges for establishing effective international distributor channels. To me, this only verifies what I have experienced working in […]

By Heikki Pitkänen CEO & Founder

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Regulation

Posted on 23.08.2017

Feeling lost? Find your direction with the new IVD/MD regulations training

MedTech Europe and IVDR & MDR training: a contribution There has been a lot of noise in the MedTech community on the recently adopted in vitro diagnostic medical devices regulation (IVDR) and the medical devices regulation (MDR). These new regulations were some 10 years in the making, yet many details still have to be clarified […]