In March 2025, the leading European medical technology industry, represented by MedTech Europe, AESGP, COCIR, EEAR, EUROM, and FIDE, issued a joint discussion paper advocating for a reform of the European regulatory system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs). This paper highlights the need for a more efficient, transparent, predictable, and patient safety governance framework to ensure timely access to safe and innovative medical technologies across Europe.

Identified Challenges in the Current System

The existing governance structure is implemented by a number of different actors with overlapping or unclear roles and responsibilities, which leads to inefficiencies and delays in the CE marking process. This complexity hampers the smooth functioning of the regulatory system, hindering the timely availability of safe and effective new and existing devices for patients and healthcare systems, and undermining the competitiveness of the European medical technology sector. A notable concern is the absence of a centralized authority with clear accountability to oversee and streamline regulatory processes.

Proposed Centralized Governance Structure

The discussion paper proposes the establishment of a centralized governance entity endowed with specific roles and responsibilities to enhance the regulatory framework’s efficiency and effectiveness.

• Accountability and Empowerment: Defining clear accountability within the governance structure to uphold the integrity and effectiveness of the regulatory system.
• International Alignment and Coherence within EU Legislation: Promoting alignment with international standards and coherence within EU legislation to streamline regulatory requirements.
• Notified Body System Oversight & Harmonization: Centralizing the oversight of Notified Bodies to ensure consistent and harmonized practices across Europe.
• Appeal Possibility & Resolution of Disputes: Establishing clear appeal processes and mechanisms for resolving disputes efficiently.
• Dedicated Pathways: Developing specialized pathways for innovative products, orphan devices, and addressing unmet medical needs to facilitate timely market access.
• Guidance Development & Harmonized Application: Creating and implementing harmonized guidelines to ensure uniform application of regulations.
• Stakeholder Engagement: Facilitating active engagement with stakeholders, including patients, healthcare professionals, and industry representatives, to incorporate diverse perspectives.
• Innovation Capacity and Competitiveness of the Medical Technologies Sector: Implementing strategies to promote innovation within the medical technology sector and enhance Europe’s global competitiveness.

Next Steps and Stakeholder Engagement

The paper emphasizes the importance of establishing guiding principles for this centralized structure before conducting a detailed impact assessment to define its optimal setup and functioning. This approach aims to facilitate constructive exchanges among all stakeholders involved, ensuring that the reformed governance system effectively addresses current challenges and meets the evolving needs of patients and healthcare systems.

This collaborative effort reflects a significant move towards enhancing the regulatory landscape for medical technologies in Europe, aiming to balance patient safety with the timely availability of innovative medical solutions.