76 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

Ethics

Posted on 07.11.2024

Beyond the checkbox: My views on compliance

By embedding compliance at the core of decision-making, medtech and life science companies will be ready to rise to future challenges When we think about the key trends shaping the healthcare sector, it quickly becomes clear that ethics and compliance have a central role to play in the future of our industry. Consider the risks […]

By Samih Al Mawass Abbott, Divisional Vice President, Abbott Vascular for Europe, Middle East and Africa

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

Getting checked Global

Posted on 13.06.2023

AMR pandemic: rising to the challenge with medical technologies

Antimicrobial resistance (AMR) is now on the political agenda like never before. The WHO has called AMR a ‘silent pandemic’. The issue has been discussed by the G7 and it is among the priorities highlighted in the mission letter sent by European Commission President Ursula von der Leyen to the Commissioner responsible for health, Stella […]

By Miriam D’Ambrosio Senior Manager Communications, MedTech Europe

Digital

Posted on 02.12.2022

Innovating with health data: a story from the inside out

There is no arguing that digital transformation has helped revolutionise many industries, including healthcare. In my role as a data scientist, I have seen our field’s solutions and strategies change as technology advanced and patients’ expectations evolved. Now that I work as a data and Artificial Intelligence (AI) partnerships lead, I strive for a multi-disciplinary […]

By Ymke de Jong Data Science Professional, Philips

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

shutterstock_1126283543
Global

Posted on 22.11.2021

AMR action plans – what are we missing?

The recent pandemic has bluntly exposed some of the gaps in our healthcare systems across Europe and one thing stuck with me the most: we were not prepared. In many ways, we can think of this as a test run of how the world responds to large-scale healthcare crises. There are more complex threats ahead, […]

By Johanna Engelage Team Leader of Marketing Urinalysis at Sysmex Europe GmbH