Calls for structural reform of Europe’s medical technology regulatory frameworks

Together with 34 national associations, MedTech Europe has sent an open letter to Commissioner for Health, Stella Kyriakides, regarding the need for comprehensive structural reform in the European regulatory framework for medical technologies (IVDR and MDR).

Representing the medical technology industry across all EU Member States and Switzerland, the 35 organisations emphasise the importance of a fit-for-purpose regulatory system which ensures that medical technologies can reach patients and healthcare systems across Europe in a timely manner.

Despite more than six years of implementation, the medical technology regulations IVDR and MDR have not fully achieved their intended objectives. There are structural issues in the regulations which cannot be solved simply through their implementation, and which make them unpredictable, complex, and lacking in agile pathways for innovation.

MedTechEurope says it and the letter’s signatories acknowledge the considerable work which has been done by the European Commission and Medical Device Coordination Group (MDCG) to address the short-term implementation challenges. But reaching the objectives of the IVDR and MDR in full will require comprehensive change across the areas of efficiency, innovation, and governance – all while maintaining the highest standards of patient safety.

The letter calls for:

  • An efficient CE marking system: A more efficient and resource-effective CE marking system that improves predictability, reduces administrative burden, and adapts to external changes.
  • Support for innovation: The inclusion of an innovation principle that swiftly connects the latest medical technologies to European patients and health systems through dedicated assessment pathways and early dialogues with developers.
  • An accountable governance structure: The establishment of a single, dedicated structure to oversee and manage the regulatory system, including the designation and oversight of Notified Bodies, with the authority to make system-level decisions.

The letter asks the European Commission to elevate these pressing issues in relevant health policy debates and work with all medical technology stakeholders to jointly craft lasting solutions.

The letter concludes: “Only together can we deliver on the original goals of the IVDR and MDR to develop an effective and fit-for-purpose regulatory system for the benefit of European patients, health systems and society.”

Click here to read the full letter.


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