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Policymakers spent years on agreeing on one of the most modern medtech rules in the world – this should not be undermined by revisions to horizontal legislation. As Brussels powers down for a short summer lull, I find myself in a reflective mode. The pandemic has transformed our lives – suffice to say that we […]

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 […]

One of the strongest trends I have observed in healthcare over the past decade has been the growth of patient power. Patients are actively shaping their care like never before. In response, health systems and companies are increasingly focused on the outcomes and experiences that matter to patients. The voice of patients is also becoming […]

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 […]

When it comes to people, one size does not fit all. It is no shock to hear that we all have different shapes and sizes. But then why do we turn to standard equipment and approaches for every patient in our hospitals today? Let’s take a step back and imagine a world where personalised treatments […]

Did you know that every day, some 5,000 people die from cardiovascular diseases (CVDs), amounting to 1.8 million deaths every year? This, unfortunately, makes cardiovascular disease – including heart failure, stroke-related atrial fibrillation, heart valve disease and coronary heart disease – the number one killer in Europe.  The COVID-19 pandemic has radically changed the way we […]

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 […]

More than a year ago, COVID-19 swept across the world, sending us all into lockdown as we battled the pandemic. Today, as we gradually emerge from the impact and experiences of the past year, I am proud and inspired by how resilient we have been and our ability to find new ways of connecting with […]