55 results

Digital

Posted on 31.03.2022

How strong data protection can help drive digital health

It’s hard to think of information that feels more personal than data about our own health. Yet we’re generating and monitoring more health data now than ever before. From specific technology designed to help manage certain medical conditions to home monitoring tools, there are more and more digital options to help manage patient health. The […]

By Boris Arendt Data Protection Officer at Biotronik

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Regulation

Posted on 27.07.2021

This is no time to further unsettle EU medtech legislation

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 […]

By Serge Bernasconi Chief Executive Officer, 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 17.03.2021

MedTech Slovenia: building the future together

  The next chapter in the story of Slovenia’s medical technology industry has begun – and it is being co-written by leaders from the in-vitro diagnostics and medical devices sectors. SIEDMA and SLO-MED have formally merged to become MedTech Slovenia. Together, we are combining our expertise to speak for our diverse industry with one voice. […]

By Peter Bratusek President, MedTech Slovenija

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COVID-19

Posted on 26.11.2020

In vitro diagnostics at risk: Covid-19 delays progresses towards the new European regulations

In order to keep them available to the health care system and to patients, more than 85% of IVDs will need to be updated in view of the new in vitro Diagnostic Regulation (IVDR) which is at risk due to the ongoing COVID-19 pandemic. The remaining IVDR transition time is not sustainable and requires attention […]

By Natale Bova Chair of the Regulatory IVD Forum of Confindustria Dispositivi Medici

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Bones, Joints & Muscles

Posted on 01.04.2020

5 ways innovation is changing orthopaedics

Innovation is the driving force behind the evolution of orthopaedics, continually delivering advances in surgical techniques and products. Now, technology improvements and data open up a world of new possibilities. Here are the top 5 areas where I believe innovation is transforming the field.  1.  Co-creation: addressing unmet clinical, demographic and environmental needs We already […]

By Martyn Inwood Vice President DePuy Synthes EMEA

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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

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Regulation

Posted on 05.07.2019

Are you ready for Eudamed?

We all know that the healthcare landscape is undergoing significant transformation. Today’s patients and clinicians are savvy consumers, demanding access to trusted product information to make informed decisions about health care. In parallel, government organisations are supporting patient safety through regulatory mandates around product traceability. To me, one of the biggest changes on the horizon […]

By Lionel Tussau Director Business Development, Atrify

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Regulation

Posted on 15.05.2019

A bold new vision for the medical technology community

20 years ago, I’d have called you foolish if you suggested that the world’s largest taxi company would not own any taxis. I’d have called you ill-advised if you suggested that the world’s largest hotelier would not own any hotels. I’d have thought you unwise if you suggested that the world’s largest book store could […]

By Eric Thépaut Senior Vice President and President, EMEA - Boston Scientific