In representing the medical technology industry across the European Union Member States and Switzerland, 35 organizations stress the vital importance of a regulatory system that is tailored to the needs of the industry. This system should ensure that medical technologies can efficiently reach patients and healthcare systems throughout Europe without unnecessary delays.
MedTech Europe points out that despite more than six years of implementation, the intended goals of the medical technology regulations IVDR and MDR have not been fully realized. These regulations suffer from inherent structural issues that cannot be easily resolved through implementation alone. As a result, they are characterized by unpredictability, complexity, and a lack of flexible pathways for innovation.
The organization acknowledges the efforts made by the European Commission and the Medical Device Coordination Group (MDCG) in addressing short-term implementation challenges. However, achieving the full objectives of IVDR and MDR will necessitate comprehensive changes in the areas of efficiency, innovation, and governance. All of this must be accomplished while upholding the highest standards of patient safety.
MedTech Europe is advocating for the following:
1. Efficient CE Marking System: The organization proposes a more streamlined and resource-efficient CE marking system. This system should enhance predictability, reduce administrative burdens, and adapt effectively to external changes.
2. Support for Innovation: They recommend the inclusion of an innovation principle that expeditiously connects the latest medical technologies with European patients and healthcare systems. This should be facilitated through dedicated assessment pathways and early dialogues with developers.
3. Accountable Governance Structure: MedTech Europe calls for the establishment of a single, dedicated structure responsible for overseeing and managing the regulatory system. This includes designating and overseeing Notified Bodies, which should have the authority to make decisions at the system level.
MedTech Europe is urging the European Commission to prioritize these issues in relevant health policy discussions and collaborate with all stakeholders in the medical technology sector to collectively devise long-lasting solutions.
