61 results

Regulation

Posted on 27.08.2024

A vision for Europe’s medtech future: Safeguarding Europe’s access to medtech and innovation

The EU medical technology regulations need a rethink to boost competitiveness that better safeguards patient access to innovation  Europe has a strong and diverse medical technology sector and some of the best health services in the world. However, a serious crisis is on the horizon, which threatens our shared progress. We must address this challenge […]

By Dr Emer Sherry Senior Executive, Irish Medtech & Vice Chair of the MedTech Europe MDR Advocacy Working Group

Digital

Posted on 01.08.2024

The landmark AI Act, its ripple effects on the medical technology industry and the challenges yet to be tackled

As we witness the AI Act entering into force, MedTech Europe applauds the European Commission and the co-legislators for taking a leading role in this momentous endeavour. The AI Act represents the first supranational framework aimed at regulating the safety and quality aspects of AI applications across sectors and domains. While it is a landmark […]

By Alexander Olbrechts Director Digital Health, MedTech Europe

Ethics

Posted on 28.06.2024

MedTech Europe Code: Trust is a priceless asset in healthcare

With new global challenges on the horizon, compliance with the MedTech Europe Code is an investment in the future  If my years as a legal and compliance professional in Europe’s medical technology sector have taught me anything, it is the value of trust. It is vital that healthcare professionals and patients trust us to produce […]

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

Value

Posted on 14.03.2024

Building resilient healthcare systems in Europe

MedTech Europe Manifesto: The EU has a key role in preparing for future challenges, from AMR and climate to global trade distortions and supply chain disruption  European health systems have faced severe stress tests in recent years, revealing some of the strengths and weaknesses of our services and institutions. Learning from this experience will be […]

By Oliver Bisazza Chief Executive Officer, MedTech Europe

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 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