84 results

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Ethics

Posted on 25.03.2021

New training video boosts global compliance – and public confidence

Bringing innovative medical technology to patients around the world is a priority for the medtech industry. This task often relies on a wide network of third-party intermediaries and distributors. While third parties provide valuable local knowledge, logistics and skills, it is important to appreciate that everyone working on behalf of medtech companies is bound by […]

By Aline Lautenberg General Counsel and Director General Legal & Compliance, MedTech Europe

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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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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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Value

Posted on 15.07.2019

Medical technology and the new European institutions

Medical technology needs to communicate better about its value. Some people think it is the same as pharmaceutical healthcare. It is not. Medical technology has a different innovation approach, timeline and model. The European Union needs to communicate better about its value. Some people think it is the same as the national entities that make […]

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

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Ethics

Posted on 11.07.2019

Digital medtech: Rising to the GDPR opportunity

I believe that data has the power to transform patient care. But do the legal and regulatory landscapes in Europe and around the world pose some sort of obstacle to digital health innovation in the medical technology sector? This is a hot topic right now as patients – indeed, all citizens – become increasingly aware […]

By Shannon Zeigler Coordinator Legal & Compliance, MedTech Europe

VBP blog series
Value Based Procurement

Posted on 24.06.2019

Can procurement deliver the ‘best value’ for money?

To my mind, the overarching challenge of modern healthcare systems is to increase the value and outcomes of care, not just to control costs. As someone keenly interested in procurement, this leads me to question what it all means for how health systems buy the technologies they need. In a competitive healthcare system, like the […]

By Hans Bax Senior Advisor MEAT Value-Based Procurement

VBP blog series
Value Based Procurement

Posted on 17.06.2019

Procurement is on a journey to a ‘value-based’ future

The essence of travelling, either by foot, train or plane, is replacing one’s existing location for another more desired or needed one. But why do we do it? Sometimes it’s the appeal of a new destination – perhaps a ski resort or a tropical island. On other occasions, the decision to move away is driven […]

By Hans Bax Senior Advisor MEAT Value-Based Procurement

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Ethics

Posted on 13.05.2019

Data Protection: If It ain’t broke, don’t fix it?

On May 25, 2018, the GDPR became effective across the EU, simultaneously resulting in a ‘consistent and homogenous application’ of data protection rules across the Union (per Recital 10 of the Regulation). For data protection professionals at medical technology companies, the clarity brought by the GDPR has meant that resources can be redirected towards ensuring […]

By Peter Blenkinsop Partner - Drinker Biddle & Reath LLP

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Ethics

Posted on 13.05.2019

Building synergies between the business and compliance communities

This year, GMTCC is fully part of the MedTech Forum. By joining forces to build synergies between the business and compliance communities, the industry is sending a clear message: compliance is part of the business! I have always been in favour of having the compliance officer seen as a true business partner. Indeed, compliance programmes […]

By Anne-Sophie Bricca Co-chair of MedTech Europe’s working group on Ethical AI, and a Deputy General Counsel at Terumo BCT