As reported by, MedTech Europe, along with 34 national associations, has sent an open letter to the European Commissioner for Health, Stella Kyriakides, urging for a comprehensive structural reform in the European regulatory framework for medical technologies. This call for reform specifically focuses on the In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR), which have not fully achieved their intended objectives despite more than six years of implementation.
The medtech industry is represented by these 35 organizations across all EU Member States and Switzerland. They emphasize the importance of having an adequate regulatory system in place to ensure that medical technologies can reach patients and healthcare systems across Europe in a timely manner. However, they argue that there are structural problems within the current regulations that cannot be resolved simply through implementation. These problems make the regulations unpredictable, complex, and lacking agile avenues for innovation.
While acknowledging the efforts made by the European Commission and the Medical Devices Coordination Group (MDCG) to address near-term implementation challenges, MedTech Europe believes that achieving the goals of IVDR and MDR will require comprehensive changes in efficiency, innovation, and governance while maintaining high standards of patient safety.
MedTech Europe puts forward three key requests in their open letter:
1. An efficient CE marking system: The organization advocates for a more efficient and resource-efficient CE marking system that improves predictability, reduces administrative burden, and adapts to external changes. This would streamline the process of bringing medical technologies to market.
2. Innovation support: MedTech Europe calls for the inclusion of an innovation principle within the regulatory framework. This principle would facilitate rapid connections between the latest medical technologies and patients by establishing specific evaluation pathways and promoting early dialogues with developers.
3. A responsible governance structure: The establishment of a single dedicated structure is proposed to oversee and manage the regulatory system effectively. This structure would be responsible for appointing and supervising Notified Bodies and would have the authority to make system-level decisions.
Truly, MedTech Europe is urging the European Commission to address these issues in relevant health policy debates and collaborate with all medical technology stakeholders to develop lasting solutions. By reforming the regulatory framework for medical technologies, it is hoped that Europe can foster innovation, improve efficiency, and ensure patient safety in the healthcare sector.
To read the full open letter from MedTech Europe to Commissioner Kyriakides, click (here)(https://www.medtecheurope.org/wp-content/uploads/2023/09/medtech-europe_open-letter-to-commissioner-kyriakides.pdf).