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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 […]

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 […]

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 […]

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 […]

The MedTech Europe Manifesto: A four-point plan for how the EU can do more for our wellbeing ‒ patients must be centre to building a healthy future Across Europe, campaigning is underway ahead of June’s European Parliament elections. This marks the beginning of a new chapter in the cycle of EU decision-making and offers us […]

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 […]

Every year during Breast Cancer Awareness Month, Breast Reconstruction Awareness Day aims to educate, engage, and empower women who have been diagnosed with breast cancer to know their breast reconstruction options, and to be confident in having an informed discussion with their care team about what’s best for them. While breast reconstruction may not be […]

After a few calmer summer weeks, the legislative work on the European Health Data Space (EHDS) is back to running at full steam towards adopting new policy with the potential to reshape the landscape for medtech innovation. The proposed secondary use policies outlined by EHDS will allow medtech companies to accelerate the development of artificial […]

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 […]