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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 […]

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 […]

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 […]

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 […]

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, […]

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 […]

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 […]

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 […]

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 […]