July 8th, 2025.
The European medical technology sector is at a turning point. Recent discussions among leading stakeholders, including MedTech Europe, AESGP, COCIR, EAAR, EUROM, and FIDE, highlight a strong consensus: the current governance structure for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) is fragmented, inefficient, and in need of urgent reform to maintain Europe’s competitiveness and ensure timely patient access.
Why is governance reform needed?
Eight years after the implementation of the MDR and IVDR, structural weaknesses have become evident:
- Multiple layers without clear accountability. The current system involves the European Commission, Medical Devices Coordination Group (MDCG), national Competent Authorities, Notified Bodies, Expert Panels, and other actors with overlapping or unclear responsibilities.
- Inefficiencies and delays. Fragmented decision-making has resulted in high costs, delayed market access, and regulatory unpredictability.
- Missed opportunities for global competitiveness. Without a centralised leadership, Europe risks losing its attractiveness as an innovation hub for medical technologies.
Industry proposals for a centralised governance structure
The joint industry paper calls for a new central governance structure with clear accountability and a patient-centric mission to:
✅ Ensure timely availability of safe and performing medical devices and IVDs
✅ Improve efficiency, transparency, and predictability in regulatory processes
✅ Foster innovation and strengthen Europe’s global competitiveness
Key recommendations include:
- Centralising critical tasks under a single empowered authority with a clear mandate, mission, and vision for Europe’s medical technology sector.
- Maintaining the decentralised Notified Body system but improving its oversight, efficiency, and harmonisation through the new central body.
- Creating dedicated pathways for EU-wide derogations, innovation support, and orphan device approvals.
- Ensuring consistent stakeholder involvement, including SMEs, patients, healthcare professionals, and industry representatives in governance decisions.
- Promoting international alignment and coherence with other EU legislation to avoid contradictory requirements and streamline global market access.
Insights from recent high-level meetings
As summarised by Ludger Möller (EAAR Chair), recent governance discussions emphasised:
- Costs are important, but must be approached carefully. Direct comparisons with pharmaceutical governance structures are limited due to structural differences.
- Centralised scrutiny tasks could make the system self-financing. For example, shifting Notified Body oversight to a central EU structure could free up national resources.
- The EU Authorized Representative (EAR) role may evolve. Article 51 MDR implies involvement in classification disputes; future governance structures should clarify and potentially strengthen the EU REP’s role.
Next steps
The European Commission’s Targeted Evaluation of the MDR/IVDR is underway. Industry stakeholders advocate for swift implementation of governance reforms to address:
- Current inefficiencies and high costs
- Slow availability of medical technologies for patients
- Declining competitiveness of Europe’s medtech sector
Our perspective
As an EU Authorized Representative and regulatory consultancy, we fully support initiatives that improve regulatory efficiency, predictability, and innovation support. We will continue to monitor these developments and represent our clients’ interests in shaping a governance system that is fit for the future.
Contact us
For tailored guidance on how upcoming governance reforms may impact your medical device business strategy in the EU, UK, and Switzerland, contact our team.
Future Governance of EU Medical Technologies – What Manufacturers Should Know
Q&A Explainer
Q: What is the "Future Governance of Medical Technologies" discussion paper?
A: It’s a joint discussion paper released in March 2025 by major European medical technology industry associations, including MedTech Europe, the European Association of Authorised Representatives (EAAR), AESGP, COCIR, EUROM, and FIDE[1]. The paper advocates for reform of the EU’s medical device regulatory framework to address current challenges in the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), and to enhance the governance of medical technologies[2].
Q: Why are industry groups calling for regulatory reform now?
A: It’s been about eight years since the EU adopted the new MDR and IVDR, and significant structural challenges have emerged in that time[3]. The current decentralized system lacks a central authority to ensure timely access to devices, resolve inefficiencies, and consistently promote European standards worldwide[4]. This has led to concerns about delays in getting medical innovations to patients and uneven implementation of rules across EU member states. Industry stakeholders feel that without reform, the goals of the new regulations – patient safety and innovation – could be compromised.
Q: What solutions or changes does the paper propose?
A: The paper proposes establishing a single, centralized governing authority for medical technologies that is patient-centric and properly empowered[5]. Under this new structure, key regulatory functions would be centralized and strengthened – for example, stricter and more harmonized oversight of Notified Bodies, special approval pathways for innovative or rare (“orphan”) devices, a clear appeals process for disputed decisions, and more consistent EU-wide guidance interpretation[6]. In short, the industry is asking for a more coordinated approach to make the system more efficient, transparent, and supportive of innovation while maintaining high safety standards.
Q: How would a centralized EU medical technology authority benefit manufacturers and patients?
A centralized authority could significantly enhance consistency and efficiency in regulatory processes. For manufacturers, this means clearer rules and expectations across all EU countries, reducing duplication and uncertainty when bringing a product to market. For patients and healthcare providers, it promises faster access to safe new technologies, as regulators can respond more quickly and uniformly to innovations. Overall, the goal is to maintain rigorous safety oversight while removing unnecessary obstacles, creating a system that protects patients and encourages medical device innovation and competitiveness in Europe.
Q: Would this reform change the role of Notified Bodies?
A: Notified Bodies would still play a crucial role in assessing and certifying devices, but their oversight and coordination would be strengthened[7]. The paper suggests improving the Notified Body system to make it more efficient, cost-effective, and predictable for manufacturers[8]. In practice, this could mean stronger EU-level supervision of how Notified Bodies operate, more uniform standards for their performance, and better resource allocation – ensuring that device approvals are consistent in quality and timelines, regardless of which Notified Body is used.
Q: What impact could these changes have on innovation in the medtech sector?
A: The proposed reforms are designed to foster innovation by eliminating unnecessary barriers and delays in the approval process. If regulatory pathways become more streamlined and supportive, medical device companies – including startups with novel technologies – could bring innovations to market faster. Industry leaders believe that a robust yet flexible governance system will support the availability of safe, cutting-edge devices and keep Europe competitive. In short, a better governance structure should help innovative treatments reach patients sooner without compromising safety or quality.
Q: What happens next – will these ideas become law?
A: For now, the joint paper is a proposal meant to spark discussion among regulators, industry, and other stakeholders. It lays out guiding principles and suggests that a detailed impact assessment be conducted to determine the best way to establish a central governance structure. Any actual legal changes would require action by EU authorities, such as the European Commission and Member States, which will take time and consensus. Manufacturers should closely monitor these discussions and continue to comply with the existing MDR/IVDR requirements. Engaging with industry associations or participating in public consultations can also help companies articulate their needs as the regulatory framework evolves.
Q: How can QNET support manufacturers during these regulatory changes?
A: QNET is actively monitoring these developments and advising clients on the potential implications for their businesses. As an experienced EU Authorized Representative and regulatory consulting firm, QNET assists medical device manufacturers in staying compliant with current regulations and preparing for future changes. We provide guidance through every step of the CE marking and regulatory process, acting as a trusted partner so manufacturers can focus on innovation. In the face of regulatory shifts, QNET’s role is to ensure that our clients adapt smoothly and maintain access to the European market, thereby reinforcing our commitment to supporting clients through regulatory change.
LinkedIn News Post
Industry Call for Stronger MedTech Regulation in Europe: A coalition of leading medical technology industry groups has issued a joint paper urging reform of the EU’s device regulations. Co-authored by associations including MedTech Europe and EAAR, the paper advocates for a single, patient-centric European authority to oversee medical device governance[9]. The goal is to ensure timely access to safe devices while fostering innovation and competitiveness in the sector.
For manufacturers, this initiative could mean a more streamlined and predictable compliance process in the future. The proposal highlights needs such as improved coordination and oversight of Notified Bodies, dedicated pathways for breakthrough or orphan devices, an EU-wide appeals mechanism for regulatory decisions, and clearer, harmonized guidance across all member states. These changes aim to reduce inefficiencies and help innovative medical technologies reach patients faster.
QNET welcomes this industry-led call for better governance. As an EU Authorized Representative and regulatory affairs partner, we support clients through regulatory change by guiding them in compliance and helping navigate updates to requirements. We will continue to closely follow these developments ensuring that our clients are prepared for the future of medical device regulation in Europe.
#MedTech #MedicalDevices #Regulation #Innovation