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

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

Getting checked

Posted on 07.09.2023

The value of timely interventions in emergency care: IVDs laying the groundwork for urgent care success

As we have learned over the last few years, we cannot postpone reforms to our public health systems if we want to combat and prepare for future pandemics. As someone who has worked in the in-vitro diagnostic (IVD) industry for more than 25 years, I believe in the importance of setting high-quality standards for IVD […]

By Daniel White Vice President Europe, Cepheid

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

Business

Posted on 22.03.2023

Can IVD market sustain stellar growth?

Europe’s in vitro diagnostics (IVD) market has expanded sharply since 2020, with demand for SARS-CoV-2 tests driving double-digit growth for the past two years. In 2020, total revenues for the IVD sector rose by 29.1%That striking growth rate was eclipsed by 2021’s unprecedented growth of 43.7%.

By Teodora Angelova Senior Manager Market Data

Digital

Posted on 17.11.2022

Artificial Intelligence pushing the frontiers of healthcare

Working for a company that is at the frontline of digital innovation in medical technologies, I believe that with continued advances in artificial intelligence (AI)-enabled medical devices, the possibility for improving patient lives can reach an entirely new level. AI in healthcare has the potential to solve pressing challenges for European healthcare systems. However, there […]

By Chantal Vets Senior Legal Director, Medtronic