Europe takes great pride in its robust social security systems and the fundamental principles of equitable healthcare access. Data indicates however that significant efforts are still required to ensure that all patients across the continent enjoy top-tier quality care and unfettered access to medical services and technologies.
Medical technologies empower early diagnoses, timely interventions, and remarkable outcomes. Medical technologies mend, revive, and improve body functions, while telemedicine and connected devices bring patient monitoring to new frontiers. Innovations speed up recovery, safeguard well-being, and equip healthcare workers with vital insights for optimal decisions and fewer complications. By relieving strain on healthcare systems, fostering social and economic vitality, averting complications, and advancing efficiency through cutting-edge data and machine learning, medical technologies are high-tech, high-value game-changers in healthcare. Diagnostic technologies also act as a first line of defence against disease outbreaks and help support their management.
Because of its innovation power, and its positive impact on patients, healthcare professionals, and health systems, the medical technology sector has developed into a key industry with an important economic and societal impact in Europe.
"Europeans like to solve problems. This is why the power of innovation in Europe is so strong and Europe’s medtech sector is so important, not only for Europe but for the rest of the world.”
Rob ten Hoedt, Chairman of the Board of MedTech Europe
European leadership for the benefit of patients
Europe’s 34,000 medical technology companies invest heavily in improving existing and innovating breakthrough technologies for the benefit of patients. These companies, 95% of which are SMEs, drive economic growth, provide employment in Europe, and boost EU exports. In doing so, the sector adheres to strict regulatory standards that ensure safe devices which live up to their performance claims. Patient health and well-being in mind, no other region in the world sets such high standards to guarantee that medical technologies are safe for patients and healthcare professionals to use.
Despite Europe’s fundamental strengths in health and medical solutions, there are growing indications that new and existing products will struggle to reach European patients and health systems in a timely manner: 17% of today’s in vitro diagnostics are expected to be discontinued in Europe, particularly among SMEs and approximately 50% of medical device manufacturers are deprioritising the EU market (or will do so) as the geography of choice for first regulatory clearance of their new devices.
MedTech Europe, the leading European medical technology trade association, believes that there are persistent, system-level issues within the European regulations for medical technologies which lead to unpredictability and delays, dampen innovation, and undermine confidence in the long-term viability of the regulatory framework.
To remain a global leader in medical technologies, the EU must deliver a more patient-centred and innovation-friendly regulatory framework that addresses the system-level challenges of today while preparing for the opportunities of tomorrow.
Getting through the maze
Beyond the medical technology industry’s sector-specific developments, fundamental changes have been brought about in the last decade by the mega trends of digitalisation and sustainability. Such trends contribute to a revolution in the way innovation in medical technologies is happening, driving the need for a more forward-looking regulatory mentality to allow innovation to thrive.
Legislative activity of the EU in this area has been, rightly, immense – and much more needs to be done to ensure that all the rules-in-development which will impact medical technologies will actually work together to deliver products to patients. The EU’s Digital Strategy, driving regulation on artificial intelligence, cybersecurity, and data, including the European Health Data Space and the European Green Deal will legislate tectonic changes, including in the area of product design, are coming with a substantial set of new or updated requirements for medical technologies.
Against this background, substantial legislations are also being revised, such as the ones on Product Liability and Corporate Sustainability Due Diligence. It is paramount to include principles that ensure patients across the EU can benefit from a high level of protection and businesses are provided with legal certainty.
These new rules will significantly impact the way and speed in which technologies can be brought to market and accessed by those who need them. Getting medical technology innovations to European patients and healthcare systems in fact can often feel like navigating a complex and ever-shifting maze.
“On paper, the EU is a Single Market, but the rules for accessing that market are still not truly harmonised and coherent with each other as we need them to be.”
Oliver Bisazza CEO MedTech Europe
As a result, whether for R&D investment, clinical research, manufacturing or new product launches, Europe slowly losing ground to other geographies on innovation, because the maze seems to be getting harder to navigate. The EU thus has a big task ahead to further its efforts towards driving harmonisation and creating an environment of legal certainty for businesses.
The slowly approaching end of the EU legislative cycle is a unique opportunity to reflect on what has been achieved and what is still to be done. It is not a time to rush to the finish line but to stay level-headed and look for effective solutions to ensure medical technologies reach patients on time. We need to solve existing challenges in a comprehensive, sustainable manner, setting the tone for a future environment that will allow patients to continue benefiting from first-line, quality medical technologies and more equitable access to healthcare, and health systems to build the long-term resilience they need. The medical technology industry in Europe stands ready to contribute and collaborate to make this a reality.
In partnership with
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This article was produced in partnership with Medtech Europe. MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health.