325 results

Regulation

Posted on 10.01.2025

MDR/IVDR Article 10a – A new bureaucratic challenge for manufacturers you may have missed

The latest update to the medical device regulations aims to protect patients from supply interruptions, but this may eventually result in more red tape for companies.  Medical technology companies take their responsibilities to patients and health systems very seriously. Their daily focus is to deliver devices and solutions that are safe and performing, so that […]

By Frank Matzek Vice President Regulatory & Governmental Affairs, BIOTRONIK

Digital Ethics

Posted on 18.11.2024

Can Europe unlock the power of data while protecting privacy?

Key points Health data can drive better outcomes and support patient safety Total anonymisation would make secondary use of device or research data impossible MedTech Europe has developed a framework that balances data protection with data-driven opportunities to help perform the analysis of re-identification risks We live in an increasingly data-driven world. Innovative medical technology […]

By Renate van Kempen Data Anonymization Expert and Data Scientist

Research & Innovation

Posted on 12.10.2024

From burden to breakthrough: Orthopaedic innovations for osteoarthritis care

On World Arthritis Day, we are reminded of over 40 million people in Europe, who live with osteoarthritis (OA), a condition affecting 15% of the global population over the age of 30. In France, for example, it is the second-leading reason for medical consultations, after cardiovascular conditions. As life expectancy increases, the burden of osteoarthritis […]

By Andrew Dalton EMEA Vice President, Johnson & Johnson MedTech, Orthopaedics

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

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 22.01.2024

Artificial Intelligence in Healthcare: Effective Regulation Can Boost Use of Explainable Innovation in Healthcare

In 2023, the impact of Artificial Intelligence (AI), including Machine Learning, on our lives became evident. Now is the right time to guide use of this pure technology with a legal and ethical framework. We need to apply fair use of AI rules so that explainable AI-based technologies can also be used in clinical care […]

By Corinne Dive-Reclus Global Head of Digital Diagnostics, Roche

Digital

Posted on 25.10.2023

Decisions driven by health data: why access is the key to unlocking patient empowerment.

You only have to look at the popularity of wearable fitness-driven devices to know that there is an increasing appetite for one’s own data. Watches or rings that go beyond step count and measure heart rate variability, track sleep, monitor blood oxygen levels and so much more, have become a desirable accessory for the masses. […]

By Gozde Briggs Programme Manager, European Patients'​ Forum

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