14 results

Digital

Posted on 17.07.2023

Harnessing the Potential of Artificial Intelligence in Healthcare

The Transformative Power of Artificial Intelligence in Healthcare Artificial Intelligence (AI) can change many industries, such as healthcare. It can help healthcare professionals with tasks, improve patient outcomes, and advance medical knowledge. When AI is used in medical devices and in vitro diagnostics, it must follow specific rules under the Medical Devices Regulation and the […]

By Alexander Olbrechts Director Digital Health, MedTech Europe

Digital

Posted on 22.05.2023

A European Health Data Space for a stronger Europe

Making primary use of health data and electronic health records work for citizens and patients A fundamental belief of the medical technology sector is that the great potential of emerging technologies must be harnessed through a patient-centred approach. The main objective is to deliver high-quality patient care and provide transparent information that builds trust between […]

By Alexander Olbrechts Director Digital Health, MedTech Europe

Digital

Posted on 17.11.2022

Artificial Intelligence pushing the frontiers of healthcare

Working for a company that is at the frontline of digital innovation in medical technologies, I believe that with continued advances in artificial intelligence (AI)-enabled medical devices, the possibility for improving patient lives can reach an entirely new level. AI in healthcare has the potential to solve pressing challenges for European healthcare systems. However, there […]

By Chantal Vets Senior Legal Director, Medtronic

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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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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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Regulation

Posted on 13.05.2019

IVDR: an overview of clinical evidence requirements

With the updated in vitro diagnostic medical devices (IVD) classification moving at least 80% of IVDs under Notified Body scrutiny (compared to 20% previously!), most manufacturers should now be gearing up to shift from self-certification to notified body oversight as we enter into the third year of the In Vitro Diagnostic Regulation’s transition period. A […]

By David Egbosimba Solutions Delivery Manager - Maetrics

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Regulation

Posted on 08.11.2018

The fog of war: crunch time in the regulatory cycle

As I followed the 1,075 km cycling route starting at the Belgium coast and ending in Basel, Switzerland, along the Western Front line of the First World War, I began to consider the plight of soldiers and generals a century ago. For military leaders, it was impossible to have an overview of what was happening […]

By Ronald Boumans Senior Regulatory Consultant at Emergo

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Regulation

Posted on 02.10.2018

IVDR: The designation issue during the transitional period

The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) was published in May 2017. While the IVDR has a five-year transition period (longer than the three-year transition for the EU Medical Devices Regulation), the procedures to designate Notified Bodies (NBs) under each of these two regulations have started at the same time. NBs are […]

By Stefano Dettori Director of IVD Operative Unit of Notified Body 0373 Italian Health Institute (ISS)