18 results
Posted on 05.07.2019
Are you ready for Eudamed?
We all know that the healthcare landscape is undergoing significant transformation. Today’s patients and clinicians are savvy consumers, demanding access to trusted product information to make informed decisions about health care. In parallel, government organisations are supporting patient safety through regulatory mandates around product traceability. To me, one of the biggest changes on the horizon […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]