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Medical technology needs to communicate better about its value. Some people think it is the same as pharmaceutical healthcare. It is not. Medical technology has a different innovation approach, timeline and model. The European Union needs to communicate better about its value. Some people think it is the same as the national entities that make […]

The new EU regulations on medical devices and in vitro diagnostics (IVDs) share a laudable aim: They seek to modernise the regulatory framework and enhance transparency. The goal, shared by all stakeholders, is to enhance patient safety without harming innovations that improve patient outcomes. However, with these two regulations coming into force by May 2020 […]

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 […]

As ABHI celebrates its 30th anniversary today, Peter Ellingworth, Chief Executive of the association discusses the past, present and future.  1.  In the 30-year history of ABHI, what have been the biggest changes? Our industry has changed significantly over the last 30 years, from being simply product based, to delivering value-based service solutions and increasingly […]

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 […]

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 […]

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 […]