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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 […]

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 […]

What key health questions should EU Research & Innovation (R&I) funding aim to address? The Horizon Europe (2021-2027) Health Cluster has provided an answer – well, six answers – which will shape R&I for most of the coming decade. This will also drive my own work in leading the R&I Partnership Policy of MedTech Europe. […]

Artificial intelligence (AI) has enormous potential to improve patient outcomes and reduce their variability, making health systems more efficient. But we must take an ethical approach to ensure sustainable implementation and public trust.   As leaders in the medical technology sector, we are playing our part in ensuring that our industry develops advanced data-driven technologies […]

In 2017 the European Commission changed and updated the legal framework regarding the medical devices, superseding the existing directives, with two new regulations which added new responsibilities for European Medicines Agency and national regulatory authorities. The two new regulations, the MDR 2017/745 on medical devices and IVDR 2017/746 on in vitro diagnostic devices are scheduled […]