Calls for Overhaul of CE Marking Process in Europe
The European medical technology industry has proposed a wide-ranging reform of the regulatory system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) in Europe. Key stakeholders, including MedTech Europe, AESGP, COCIR, EAAR, EUROM, and FIDE, have jointly published a discussion paper outlining a vision for a more efficient, patient-centered governance structure.
Identified Challenges in the Current System
The discussion paper highlights significant shortcomings in the existing multilayered CE marking process, which medical devices must undergo to be marketed in Europe. According to industry leaders, inefficiencies in the system are creating delays in the availability of medical devices to patients and healthcare systems, while also harming the competitiveness of the European MedTech sector. These delays have sparked concern over their impact on patient outcomes and the ability of healthcare systems to adopt innovative technologies swiftly.
Proposed Centralized Governance Structure
The reform proposal emphasizes the need to centralize key components of the regulatory system. The proposed governance structure aims to streamline processes and establish clearly defined roles and responsibilities across stakeholders. Proponents believe centralization would improve efficiency, reduce administrative complexity, and enhance the system’s overall effectiveness.
The document underscores the importance of starting with foundational steps, such as:
- Establishing Guiding Principles for the reformed governance model.
- Defining Roles and Responsibilities for each stakeholder involved in the process.
- Determining the Level of Empowerment for centralized entities.
Only after these foundational elements are established will a detailed impact assessment be carried out to optimize the structure’s functioning.
Focus on Device Availability and Competitiveness
The central goals of the proposed reform include ensuring faster availability of devices to patients, improving patient outcomes, and promoting competitiveness in the healthcare technology industry. By addressing the challenges of the current system, stakeholders aim to create a regulatory environment that fosters innovation and reduces barriers for the industry.
Engaging Stakeholders in the Process
This joint discussion paper is intended as a catalyst for debate and collaboration among healthcare professionals, MedTech innovators, regulatory bodies, and other key stakeholders. Industry leaders are encouraging active participation in discussions to ensure a regulatory framework that balances efficiency, innovation, and patient safety.
What’s Next?
The publication of this paper represents the first step in what is likely to be an ongoing dialogue about the future of medical device regulation in Europe. MedTech Europe and its partners aim to facilitate exchanges with all relevant stakeholders to refine and implement the proposed centralization efforts.
For healthcare professionals, innovators, and regulators, this could mark the beginning of an important transformation aimed at delivering better healthcare outcomes and strengthening Europe’s role as a leader in medical technology innovation.
Book a demo of V-Apps.cloud
V-Apps.Cloud offers a reliable and complete platform to help companies meet security and compliance standards with ease.
Transform your work with advanced tools and personalized support.
Book a demo today and discover the benefits of our innovative solutions.