80 results

Digital Regulation

Posted on 15.09.2022

Should the EU rewrite the rulebook on liability in response to advances in artificial intelligence?

As lawyers we tend to use academic journals to tease out complex legal questions. (See our latest contribution to the literature here). However, today we’re taking the opportunity to discuss a hot topic with a broader audience, as we feel it will have a profound impact on the public, patients and health systems. That topic […]

By Ulrich Juknat Legal Director Regulatory Law

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Value

Posted on 06.12.2021

How can we overcome barriers to homecare?

If the current COVID-19 pandemic has taught us anything, it is that critical hospital capacity can quickly become saturated in times of crisis. On several occasions over the past two years, this has led to delays in standard care to make room for extra capacity in intensive care units (ICU). However, we know that moving […]

By Steven Vandeput Advisor at beMedTech

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Regulation

Posted on 19.11.2021

EU move on mergers threatens innovation

At first sight, EU policy on mergers and acquisitions might not need to concern patients and frontline healthcare workers too much. However, a subtle shift in the rules on whether two companies can agree to become one could have a profound impact on access to medical innovation. To understand why this might be, it’s important […]

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

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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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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