This collaborative discussion paper builds upon MedTech Europe’s 2023 position paper and presents a unified perspective from the European medical technology industry, represented by MedTech Europe, AESGP, COCIR, EEAR, EUROM, and FIDE. It advocates for a reform in the governance of the European regulatory system for medical technologies.
The document underscores the need to establish fundamental guiding principles for a patient-focused, streamlined governance framework tailored specifically to medical technologies. This structure aims to safeguard the availability of safe and effective devices for patients, healthcare professionals, and health systems. The paper identifies key areas where roles and responsibilities must be centralized and restructured to achieve this objective:
- Oversight and harmonization of Notified Bodies
- Dedicated regulatory pathways for innovation, orphan devices, and unmet medical needs
- Alignment with international and EU legislative frameworks
- Mechanisms for dispute resolution and appeal
- Development and consistent application of guidance
- Enhanced stakeholder engagement
- Support for innovation and competitiveness
- Clear accountability structures
With these core principles established, a comprehensive impact assessment can then be conducted to determine the most effective setup and operation of the proposed governance model.
This discussion paper serves as a foundation for dialogue and collaboration among all stakeholders.
The full report can be accessed using the following link
