Six leading European industry organisations, including MedTech Europe, EFPIA, and EIT Health, have jointly published a vision paper on the future governance of medical technologies in the EU. The central theme of the document is the need to improve patient access to innovative solutions while maintaining safety and sustainable healthcare financing.

Six major EU healthcare organisations call for improved coordination in the regulation and reimbursement of medical technologies. Their joint vision includes a unified HTA system, stronger digital infrastructure, and patient-centred policy development. The paper also supports broader use of EHDS for decision-making. It contributes to shaping future health policy across the EU.

Key systemic challenges

The paper identifies several structural issues affecting the current EU environment for medical technologies:

  • lack of alignment between MDR/IVDR and national reimbursement pathways,
  • fragmented approaches to Health Technology Assessment (HTA),
  • limited availability and interoperability of clinical data across Member States.

These challenges are seen as obstacles to the efficient adoption of innovation in healthcare systems across Europe.

The value of EHDS and digital health data

The authors emphasise the strategic importance of the European Health Data Space (EHDS) as an enabler of better clinical decision-making and more effective reimbursement evaluations. They call for investments in interoperable infrastructures and the secure exchange of patient data within and between Member States.

MedTech industry recommendations

The paper outlines concrete proposals, including:

  • the development of a unified EU HTA system with structured patient involvement,
  • support for public-private partnerships to foster innovation,
  • streamlined regulatory pathways for low-risk devices,
  • full digitalisation of registration and reimbursement procedures.

Political significance

Although the paper is non-binding, it serves as a key contribution from the industry to the EU policy dialogue. It aims to shape upcoming decisions on the implementation of EHDS and broader reforms in the governance of health technologies—particularly in light of Europe’s digital transition.

Joint discussion paper on future governance of medical technologies in Europe