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European Commission - Speech [Check Against Delivery] Keynote speech by Commissioner Várhelyi at the high-level conference “Medical Devices: Innovation and Patient Safety” Brussels, 16 March 2026 Ladies and gentlemen, Welcome to this high-level conference on medical devices: innovation and patient safety. You are a diverse audience: regulators, clinicians, patients, manufacturers, notified bodies and researchers. Thi...
European Commission - Speech [Check Against Delivery] Keynote speech by Commissioner Várhelyi at the high-level conference “Medical Devices: Innovation and Patient Safety” Brussels, 16 March 2026 Ladies and gentlemen, Welcome to this high-level conference on medical devices: innovation and patient safety. You are a diverse audience: regulators, clinicians, patients, manufacturers, notified bodies and researchers. This diversity of expertise and your perspectives on the medical device sector matter. This sector matters to our healthcare systems. It matters to our economies. And above all, it matters to our patients and their close ones. The medical device sector can – and should – take pride in being one of the most diverse and innovative industries in Europe. It thrives in the Union's medical device market, which ranks as the second largest in the world. In 2024, this sector had an estimated value of 170 billion euro. It employs over nine-hundred-thousand people in more than thirty-eight thousand medtech companies across the EU. And 90% of them are small and medium-sized companies. From pacemakers and joint implants to AI-driven diagnostic tools and advanced blood tests – medical devices are key to the future of healthcare. Thanks to innovative diagnostics, genomic tests, digital monitoring tools and connected devices, treatments can be tailored to exactly what a patient needs. We can detect diseases earlier. And we can choose treatments more precisely. It's what innovation is all about – making a real difference in people's lives. Europe has long been a global leader in this sector. And we want to keep it that way. We want Europe to remain a place where innovation thrives — without ever compromising on patient safety. The current Regulations on medical devices were adopted in 2017 with the intention of making devices safer. So they raised the bar for clinical evidence, they improved traceability of products and made surveillance more stringent. That time there was a political need to respond to serious incidents that overshadowed the regulatory framework. Led by the intention to restore trust in our system, the co-legislators adopted strict legislation that, as we see it, also missed the right balance. Seven years after the entry into force, we must also face reality: the implementation has revealed structural challenges, which could not be overcome by the several postponements that was made in the previous years. Medtech Sector is facing high administrative burden, and absorbing hundreds of thousands of euros for repetitive procedures that do not add to patient safety. And they are suffering if not already about closing business. In addition, some rules have not been interpreted consistently by the notified bodies, who also lack regulatory capacities. As a consequence, innovation is not supported enough, since new ideas face great risks of ending up in the valley of death of our regulatory labyrinth or find market elsewhere. All this has led to issues around the availability of devices, undermining patient care, and ultimately, patient safety. Because unavailability of devices and missed opportunities of making them more efficient is ultimately a problem of patient safety. I have listened carefully to the concerns that many of you raised about these new rules. From industry and healthcare professionals, from patients and their families, and from colleagues in the European Parliament and Council. You told me that many of the rules are very complex, and that we needed to revise them – quickly. We heard your calls. Our evaluation based on public consultations, call for evidence and countless of exchanges clearly showed we needed to revise and simplify the medical device regulations to make them more fit-for- purpose. During my hearing at the European Parliament, I committed to delivering measures that would provide relief to the sector. And we did. In parallel, we adopted a number of measures to support the sector in the short-term. We establish fixed timeframes for conformity assessments carried out by notified bodies. This will make the certification process more uniform and predictable. We also expanded the list of well-established devices, which have been in use for decades and do not need clinical evidence and complicated certification schemes to remain on the market. We expect these measures to be adopted already this month. Looking towards the longer-term, we also proposed to simplify the Medical Device and In Vitro Diagnostic Regulations. We want to make it easier for companies to bring devices to the market, while maintaining the highest standards of patient safety. Simplification means smarter regulation. It means focusing resources where the risks are greatest. It means getting rid of duplication and inefficiency. And it means creating a system that is robust, predictable and sustainable. We need everyone who is part of the system to play their part. For the medical device sector, that means continuing to innovate and manufacture in Europe. For notified bodies, it means upholding your role in protecting public health. For public authorities, it means strengthening your cooperation and helping the system run smoothly. For healthcare professionals, it means continuing to take care of patients. For researchers, it means looking at how you can best contribute to innovation. Ultimately, the expectations we've set for ourselves are high. Patients in Europe should have timely access to safe, effective, state-of-the-art medical devices. Healthcare professionals should have the devices they need and be able to trust that they offer the best quality of care for their patients. Companies should be able to trust in a regulatory environment in Europe that is predictable, proportionate and globally competitive. For example, Innovation will receive an unprecedented support, by a series of measures: breakthrough technologies will receive preferential treatment, sandboxes at national and at EU level will enable fit for the purpose market entry procedures AI rules will be fully incorporated in the medical devices legislation. Companies don't need to re-certify their devices every five years; reporting will be more in line with the real-patient safety needs; clinical studies will not be needed for devices that are in use for decades without any problems; Investors should see Europe as an attractive place to develop and scale up health technologies. These goals are part of a broader strategic vision for Europe, as outlined by the President of the Commission. This is Europe's choice. A choice to lead in innovation. A choice to build strategic resilience in critical sectors. A choice to support our SMEs while upholding high standards. In health, we have a strong plan to make this happen. We have revised our pharmaceutical legislation to reward innovation, help address unmet medical needs and improve access to medicines across EU countries. The Biotech Act will support cutting-edge biotechnology, help companies scale up, and reduce barriers for entrepreneurs in strategic sectors. For instance, products combining medical devices and pharmaceuticals will undergo a single clinical trial process. With the EU Safe Hearts Plan, we are stepping up prevention, early detection and integrated care for cardiovascular diseases – and unleashing the potential of new technologies to help us without waiting for the MDR reform to be adopted. Ladies and gentlemen, The medical devices sector is a strategic asset for Europe and a cornerstone of our health system. This is why so many of you urgently asked us for this revision, and we have delivered. I am confident that the European Parliament will make good progress. As for the Council, I am counting on governments to recognise the challenges and give clear political guidance to their technical experts to make quick progress, including on adopting the short-term measures. Ultimately, it is national healthcare services that are already facing the consequences of unavailability of medical devices. We developed our proposal based on the extensive input we received from all of you, and many others. We used years of experience in implementing the regulations. We've made a lot of progress since I took office last year. Now it is your turn. Take part today and share your views – on the work that has been done and on the work that's still to come. So that we build rules that are more proportionate and effective, firmly based on patient safety. Together, we can deliver for European patients. Thank you. SPEECH/26/619
Speech Brief