61 results
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 […]
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 […]
Posted on 14.03.2024
Building resilient healthcare systems in Europe
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 […]
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 […]
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 […]
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 27.07.2021
This is no time to further unsettle EU medtech legislation
Policymakers spent years on agreeing on one of the most modern medtech rules in the world – this should not be undermined by revisions to horizontal legislation. As Brussels powers down for a short summer lull, I find myself in a reflective mode. The pandemic has transformed our lives – suffice to say that we […]
Posted on 26.05.2021
MDR enters into full application and challenges remain
After 4 years of transition period followed by a pandemic year, we reached the date of application of the medical device regulation 2017/745 on May 26, 2021. A lot of uncertainty is still associated with this date and key stakeholders are still questioning the readiness of the system. Twenty notified bodies out of fifty applicants […]