504 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

Ethics

Posted on 07.01.2025

Third-party litigation in Europe: could it fuel a US-style class action culture?

The new EU Product Liability Directive could open the door to a surge in class actions. To protect consumers, we need to curtain abuses while ensuring that individuals have access to appropriate compensation. If you were hoping for a quiet start-of-year period, I am the bearer of bad news – at least for those of […]

By Pablo Rojas Abad Senior Legal Counsel, MedTech Europe

Posted on 21.11.2024

Why now is the time to talk about procurement in the medical technology sector

With the EU set to review public procurement rules, healthcare stakeholders should highlight the role of Value-based Procurement in driving sustainability and innovation A quiet revolution has been taking place in how hospitals and health systems purchase the products and services they need to run vital services. By working together to prioritise value, stakeholders can […]

By Hans Bax Senior Adviser Value & Innovation-based Access

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

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

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