Challenges for the European Medtech Industry: Interviews with Industry Experts

Abstract

This chapter brings together interviews with key stakeholders in the European MedTech sector. Over the past decade, the European MedTech industry has undergone a significant transformation driven by regulatory, technological, and societal changes. The introduction of the MDR and IVDR marked a turning point, increasing safety standards but also imposing heavy bureaucratic burdens, particularly on SMEs. This has impacted innovation, led to product withdrawals, and reduced Europe's competitiveness. At the same time, the sector has embraced digitalization and AI, offering new patient care models and pushing for sustainability through circular economy practices and greener production. The COVID-19 pandemic accelerated these trends and highlighted the strategic importance of the industry. However, trust remains a core challenge, with calls for transparent ethics, innovation aligned with patient needs, and more efficient regulation. Despite regulatory setbacks, Europe remains strong in early-stage R&D, driven by a robust research ecosystem, strong SME presence, and focus on universal healthcare. The future competitiveness of the sector will depend on regulatory reforms, sustainability leadership, and strategic innovation frameworks.

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