46 results
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 […]
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 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 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, […]
Posted on 26.11.2015
My 5 predictions for the medical technology industry in 2016
The year 2016 is just around the corner. While there are still weeks before we say goodbye to 2015, I’m going to write a few thoughts on what I think will be the key themes for the medical technology industry next year. I did a similar blogpost last year and I’ve done another round for […]
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 […]
Posted on 22.10.2015
What’s with all the unnecessary complexity on the medical device revision?
In my view, a good legislation needs to be clear and feasible. A regulation that breeds complexity doesn’t help anyone. The medical device discussions are coming to an end with the current trilogue discussion between the European Council, Parliament and Commission. While we welcome the general direction of this regulation, I worry about the unnecessary […]
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 […]