124 results

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Regulation

Posted on 23.09.2021

Global approach needed to remote audits

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 […]

By Emmett Devereux Director Government and Regulatory Affairs, Cook Medical EMEA

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Regulation

Posted on 12.07.2021

Is medical technology innovation leaving Europe?

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 […]

By Julia Steckeler CEO - MedicalMountains GmbH

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Value

Posted on 29.06.2021

Reimagining healthcare delivery in a new era of surgery

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 […]

By Hani Abouhalka Company Group Chairman - Johnson & Johnson Medical Devices Companies Europe, Middle East & Africa (EMEA)

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Research & Innovation

Posted on 23.06.2021

MedTech: a partner in building a research-oriented, innovative, and resilient Europe

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 […]

By Patrick Boisseau Director Research and Innovation, MedTech Europe

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Regulation

Posted on 26.05.2021

MDR enters into full application and challenges remain

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 […]

By Bassil Akra CEO - QUNIQUE GmbH

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Value

Posted on 30.04.2021

Paving the Path Ahead for MedTech: Innovation, Health Equity and Global Collaboration

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 […]

By Ashley McEvoy Executive Vice President, Worldwide Chair, Johnson & Johnson MedTech

R&I in medtech shaping Europe’s heathcare and economyw
Research & Innovation

Posted on 19.03.2020

Horizon Europe: 6 priorities for health Research & Innovation

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. […]

By Patrick Boisseau Director Research and Innovation, MedTech Europe

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Digital

Posted on 10.02.2020

AI in medical technologies: prioritising an ethical approach to deliver better care

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 […]

By Anne-Sophie Bricca Deputy General Counsel - Global Compliance Officer, Terumo BCT

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Regulation

Posted on 19.08.2019

The increased role of Clinical Research Organizations in the context of the new EU regulations on medical devices

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 […]

By Șerban Marius Roșu Associate Professor of Medicine and Pharmacy, University of Timişoara