In preparation to the next 2024-29 EU political cycle, MedTech Europe has published its manifesto detailing possible actionable policies based on the achievements of the closing mandate. According to the industrial association of the medtech industry, health systems must become more patient-centric, digitally advanced, resilient and sustainable. Medical technologies may support this transformation, provided they reach patients and healthcare systems. As for patient-centric healthcare, key challenges should be tackled by making the current CE marking system for medical technologies more efficient and predictable. Harmonised applications are deemed useful to make Europe more attractive for investments and R&D.
A true single market for digital health and health data, aligning EU countries in their approach for the identification, authentication, security and interoperability of digital medical technologies, would also be needed to support the European leadership in developing the best environment for AI-enabled medical technologies. Resilience of healthcare systems would require improved crisis preparedness and response through well-coordinated mechanisms for joint procurement of medical countermeasures, together with a regulatory framework able to embrace the full potential of real-world evidence. Sustainability of healthcare systems should be based on a future legislation consistent with sector-specific regulatory requirements.