76 results

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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, […]