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From robotic surgery and wearables to connected devices and AI-powered diagnostics, medical technologies are reinventing healthcare. Europe’s medtech sector is making unprecedented investments in research & innovation – and joining the Innovative Healthcare Initiative for the first time. I sense that something big is happening in healthcare research. A tectonic shift in Europe’s health innovation […]

When our partners launched the European Alliance for Cardiovascular Health in September 2021, we were driven by the commitment to share expertise and raise awareness on the burden of cardiovascular diseases (CVDs) in Europe. We knew then, and our Alliances of 17 partners knows today, that cardiovascular diseases understood as a vast group of disorders, […]

We need to start a conversation now about how to prepare our systems and societies for the changes on the horizon. In the second of a two-part mini-series on predictive genomics, Francesco Floridini examines how Europe can accelerate the transition. I believe technology is no longer the key barrier to unlocking the potential of predictive […]

At first sight, EU policy on mergers and acquisitions might not need to concern patients and frontline healthcare workers too much. However, a subtle shift in the rules on whether two companies can agree to become one could have a profound impact on access to medical innovation. To understand why this might be, it’s important […]

The pandemic has changed many aspects of our lives. This is no different for those of us in the medtech space where we were pushed to rethink how we work. In the process, we learned how to find robust alternatives to important processes such as physical audits. These changes also revealed the need for greater […]

On 26th of May 2021 the EU Medical Device Regulation (MDR) became fully applicable. It is a modern piece of legislation that strives to ’establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation’. It further aims ’to ensure the smooth […]

COVID-19 and its impact has been unprecedented. Nowhere is this more visible than in our healthcare sector, where hospital and ICU capacity have been stretched to their limits. Healthcare professionals and other frontline staff have performed heroic yet exhausting feats – delivering superhuman efforts to ensure continuity of care. I’m proud that the MedTech industry […]

The medical technology sector welcomes the European Commission’s 3rd edition of the EU Research and Innovation Days (R&I Days). This event could not have come at a more important time, as this year marks the official launch of Horizon Europe, the EU’s most ambitious research and innovation program to date. The response to the Covid-19 […]

After 4 years of transition period followed by a pandemic year, we reached the date of application of the medical device regulation 2017/745 on May 26, 2021. A lot of uncertainty is still associated with this date and key stakeholders are still questioning the readiness of the system. Twenty notified bodies out of fifty applicants […]